CONTENTS Abstract Acknowledgement CHAPTER 1: AN INTRODUCTION TO ISO.......................3 1.1 WHAT IS ISO?......................................3 1.2 THE NEED FOR STANDARDS...............................3 1.3 THE ISO BRAND......................................5 CHAPTER 2: QUALITY MANAGEMENT SYSTEM....................7 2.1 INTRODUCTION........................................7 2.1.1General.........................................7 2.1.2 Process approach...............................7 2.2 REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM.............10 2.2.1 Scope.........................................10 2.2.2Normative Reference............................11 2.2.3 Terms and definitions.........................11 2.2.4General Requirements...........................11 2.2.5 Documentation requirements....................11 2.2.6Management responsibility......................14 2.2.7Planning.......................................15 2.2.8Responsibility, authority and communication....15 2.2.9 Management review.............................16 2.2.10 Resource Management..........................17 2.2.11 Product realisation..........................18 2.2.12 Measurement, analysis and improvement........24 2.3 IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM............28 2.3.1 Purchase the Standard.........................28 2.3.2 Review support literature and software........28 2.3.3 Assemble a team and agree your strategy.......28 2.3.4 Consider Training.............................28 2.3.5Review Consultancy Options.....................28 2.3.6Choose a registrar.............................28 2.3.7 Develop a Quality manual......................29 2.3.8 Develop support documentation.................29 2.3.9 Implement your Quality Management System......29 2.3.10 Consider a pre-assessment....................29 2.3.11 Gain registration............................29 2.3.12 Continual assessment.........................29 CHAPTER 3: JEHAN GREENWALLS ..................30 1
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CONTENTS
Abstract
Acknowledgement
CHAPTER 1: AN INTRODUCTION TO ISO....................................................3
1.1 WHAT IS ISO?.....................................................................................31.2 THE NEED FOR STANDARDS..................................................................31.3 THE ISO BRAND..................................................................................5
CHAPTER 2: QUALITY MANAGEMENT SYSTEM........................................7
2.1 INTRODUCTION.....................................................................................72.1.1General.............................................................................................72.1.2 Process approach............................................................................7
2.2 REQUIREMENTS OF A QUALITY MANAGEMENT SYSTEM.........................102.2.1 Scope.............................................................................................102.2.2Normative Reference......................................................................112.2.3 Terms and definitions.....................................................................112.2.4General Requirements....................................................................112.2.5 Documentation requirements.........................................................112.2.6Management responsibility..............................................................142.2.7Planning..........................................................................................152.2.8Responsibility, authority and communication..................................152.2.9 Management review.......................................................................162.2.10 Resource Management................................................................172.2.11 Product realisation........................................................................182.2.12 Measurement, analysis and improvement....................................24
2.3 IMPLEMENTATION OF A QUALITY MANAGEMENT SYSTEM..........................282.3.1 Purchase the Standard...................................................................282.3.2 Review support literature and software..........................................282.3.3 Assemble a team and agree your strategy.....................................282.3.4 Consider Training...........................................................................282.3.5Review Consultancy Options..........................................................282.3.6Choose a registrar...........................................................................282.3.7 Develop a Quality manual..............................................................292.3.8 Develop support documentation.....................................................292.3.9 Implement your Quality Management System................................292.3.10 Consider a pre-assessment.........................................................292.3.11 Gain registration...........................................................................292.3.12 Continual assessment..................................................................29
CHAPTER 3: JEHAN GREENWALLS .......................................30
3.1 INTRODUCTION...................................................................................303.2 JEHAN GREEN WALLS QUALITY MANUAL................................................31
Company Profile .....................................................................................31Quality policy ..........................................................................................33Quality objectives :..................................................................................34Scope (Clause number: 1)......................................................................35Normative reference (Clause number: 2)................................................35
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Terms and definitions (Clause number: 3).............................................36Quality management system (Clause number: 4)...................................38Management responsibility (Clause number: 5)......................................41Resource management (Clause number: 6)...........................................45Product realization (Clause number: 7)...................................................46Measurement, analysis and improvement(Clause number: 8)................51
3.3 PROCEDURES.........................................................................................553.3.1 Document and Record control........................................................563.3.2 Control of Records.........................................................................603.3.3 Management Review Meeting........................................................613.3.4 Internal audit...................................................................................623.3.5 Corrective and Preventive Action...................................................653.3.6 Non conformity Procedure..............................................................673.3.7 Customer complaint.......................................................................703.3.8 Contract Review.............................................................................713.3.9 Purchase........................................................................................713.3.10 Equipment Maintenance...............................................................723.3.11 Training........................................................................................733.3.12 Communication............................................................................74
3.4 FORMS...................................................................................................773.4.1 Internal Audit Plan..........................................................................783.4.2Internal Audit Schedule...................................................................793.4.3 Non conformity Report...................................................................803.4.4 Non Conformity Report Register....................................................813.4.5 Internal Audit Checklist...................................................................823.4.6 Internal Audit Summary Report......................................................873.4.7 Corrective Action Request..............................................................883.4.8 Customer Complaint Report...........................................................893.4.9 Customer Complaint Register........................................................903.4.10 Customer Satisfaction Survey......................................................913.4.11 Supplier Pre-Qualification.............................................................923.4.12 Supplier Evaluation......................................................................933.4.13 Approved Supplier List.................................................................943.4.14 Training Need Analysis................................................................953.4.15 Training Plan................................................................................963.4.16 Training Attendance Sheet...........................................................973.4.17 Training Feedback........................................................................983.4.18 Employée Training Record...........................................................993.4.19 Training Evaluation.....................................................................1003.4.20 Equipments Calibration..............................................................1013.4.21 Equipments Preventive Maintenance.........................................1023.4.22 Maintenance Breakdown............................................................1033.4.23 Documents & Distribution Control..............................................1043.4.24 Amendment Form.......................................................................1053.4.25 Amendment Register..................................................................1063.4.26 Quality Objectives......................................................................1073.4.27 Non Conformity Report (Purchase)............................................1083.4.28 Joining & Induction.....................................................................1093.4.29 Interview Assessment................................................................1103.4.30 Management Review Meeting....................................................111
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CHAPTER 4: CONCLUSIONS....................................................................113
4.1 CONCLUSIONS.................................................................................113
References...................................................................................................114
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Chapter 1: An Introduction to ISO
1.1 What is ISO?
ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards.
ISO is a network of the national standards institutes of 162 countries, one member per country, with a Central Secretariat in Geneva, Switzerland, that coordinates the system.
ISO is a non-governmental organization that forms a bridge between the public and private sectors. On the one hand, many of its member institutes are part of the governmental structure of their countries, or are mandated by their government. On the other hand, other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations.
Therefore, ISO enables a consensus to be reached on solutions that meet both the requirements of business and the broader needs of society.
1.2 The need for standards
Standards make an enormous and positive contribution to most aspects of our lives.
Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability - and at an economical cost.
When products and services meet our expectations, we tend to take this for granted and be unaware of the role of standards. However, when standards are absent, we soon notice. We soon care when products turn out to be of poor quality, do not fit, are incompatible with equipment that we already have, are unreliable or dangerous.
When products, systems, machinery and devices work well and safely, it is often because they meet standards. And the organization responsible for many thousands of the standards which benefit the world is ISO.
ISO standards:
Make the development, manufacturing and supply of products and services more efficient, safer and cleaner
Facilitate trade between countries and make it fairer
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Provide governments with a technical base for health, safety and environmental legislation, and conformity assessment
Share technological advances and good management practice Disseminate innovation Safeguard consumers, and users in general, of products and services Make life simpler by providing solutions to common problems
ISO standards provide technological, economic and societal benefits:
For businesses, the widespread adoption of International Standards means that suppliers can develop and offer products and services meeting specifications that have wide international acceptance in their sectors. Therefore, businesses using International Standards can compete on many more markets around the world.
For innovators of new technologies, International Standards on aspects like terminology, compatibility and safety speed up the dissemination of innovations and their development into manufacturable and marketable products.
For customers, the worldwide compatibility of technology which is achieved when products and services are based on International Standards gives them a broad choice of offers. They also benefit from the effects of competition among suppliers.
For governments, International Standards provide the technological and scientific bases underpinning health, safety and environmental legislation.
For trade officials, International Standards create "a level playing field" for all competitors on those markets. The existence of divergent national or regional standards can create technical barriers to trade. International Standards are the technical means by which political trade agreements can be put into practice.
For developing countries, International Standards that represent an international consensus on the state of the art are an important source of technological know-how. By defining the characteristics that products and services will be expected to meet on export markets, International Standards give developing countries a basis for making the right decisions when investing their scarce resources and thus avoid squandering them.
For consumers, conformity of products and services to International Standards provides assurance about their quality, safety and reliability.
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For everyone, International Standards contribute to the quality of life in general by ensuring that the transport, machinery and tools we use are safe.
For the planet we inhabit, International Standards on air, water and soil quality, on emissions of gases and radiation and environmental aspects of products can contribute to efforts to preserve the environment
1.3 The ISO Brand
Democratic
Every full member of ISO has the right to take part in the development of any standard which it judges to be important to its country's economy. No matter what the size or strength of that economy, each participating member in ISO has one vote. Each country is on an equal footing to influence the direction of ISO's work at the strategic level, as well as the technical content of its individual standards.
Voluntary
ISO standards are voluntary. As a non-governmental organization, ISO has no legal authority to enforce the implementation of its standards. ISO does not regulate or legislate. However, countries may decide to adopt ISO standards - mainly those concerned with health, safety or the environment - as regulations or refer to them in legislation, for which they provide the technical basis. In addition, although ISO standards are voluntary, they may become a market requirement, as has happened in the case of ISO 9001 quality management systems, or of dimensions of freight containers and bank cards.ISO itself does not regulate or legislate.
Market-driven
ISO only develops standards for which there is a market requirement. The work is mainly carried out by experts from the industrial, technical and business sectors which have asked for the standards, and which subsequently put them to use.
Consensus
ISO standards are based on international consensus among the experts in the field. Consensus, like technology, evolves and ISO takes account both of evolving technology and of evolving interests by requiring a periodic review of its standards at least every five years to decide whether they should be maintained, updated or withdrawn. In this way, ISO standards retain their position as the state of the art.
Globally relevant
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ISO standards are technical agreements which provide the framework for compatible technology worldwide. They are designed to be globally relevant - useful everywhere in the world.ISO standards are useful everywhere in the world.
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Chapter 2: Quality Management System
2.1 Introduction
2.1.1 General
The adoption of a quality management system should be a strategic decision of an organization. The design and implementation of an organization‘s quality management system is influenced by: its business environment, changes in that environment, or risks associated with that environment; its varying needs; its particular objectives; the products
it provides; the processes it employs; its size and organizational structure.
It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.
The quality management system requirements specified in this report are complementary to requirements for products.
2.1.2 Process approach
This International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.
For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process.
Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach“.
An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
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When used within a quality management system, such an approach emphasizes the importance of:
a) Understanding and meeting requirements,b) The need to consider processes in terms of added value,c) Obtaining results of process performance and effectiveness, andd)Continual improvement of processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in clauses 4 to 8. This illustration shows that customers play a significant role in defining requirements as inputs. Monitoring of customer satisfaction requires the evaluation of information relating to customer perception as to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of this International Standard, but does not show processes at a detailed level.
In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows.
Plan: Establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization‘s policies.
Do: Implement the processes.
Check: Monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
Act: Take actions to continually improve process performance.
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Figure 2.1 Model of a process based quality Management System
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2.2 Requirements of a quality management system
2.2.1 Scope
General
This International Standard specifies requirements for a quality management system where an organization:
a) Needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, andb) Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
In this International Standard, the term "product" only applies to:
a) Product intended for or required by a customerb) Any intended output resulting from the product realization processes
Statutory and regulatory requirements may be expressed as legal requirements.
Application
All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.
Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.
Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.
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2.2.2 Normative Reference
A record of referenced documents that is indispensable for the application of the Quality Management system. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
2.2.3 Terms and definitions
For the purposes of this International Standard, the terms and definitions given in ISO 9000 apply.
2.2.4 General Requirements
The organization should establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard.
The organization should
a) Determine the processes needed for the quality management system and their application throughout the organization. b) Determine the sequence and interaction of these processes.c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective.d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes.e) Monitor, measure (where applicable), and analyse these processes.f) Implement actions necessary to achieve planned results and continual improvement of these processes.
These processes should be managed by the organization in accordance with the requirements of this International Standard.
Where an organization chooses to outsource any process that affects product conformity to requirements, the organization should ensure control over such processes. The type and extent of control to be applied to these outsourced processes should be defined within the quality management system.
2.2.5 Documentation requirements
General
The quality management system documentation should include
a) Documented statements of a quality policy and quality objectives.b) A quality manual.
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c) Documented procedures and records required by this International Standard. d) Documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes.
Where the term “documented procedure” appears within the International Standard, this means that the procedure is established, documented, implemented and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
The extent of the quality management system documentation can differ from one organization to another due to
a) The size of organization and type of activitiesb) The complexity of processes and their interactionsc) The competence of personnel.
The documentation can be in any form or type of medium.
Quality Manual
The organization should establish and maintain a quality manual that includes:
a) The scope of the quality management system, including details of and justification for any exclusion. b)The documented procedures established for the quality management system, or reference to them.c) A description of the interaction between the processes of the quality management system.
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Control of Documents
Documents required by the quality management system should be controlled. Records are a special type of document and should be controlled according to the requirements of the QMS
A documented procedure should be established to define the controls needed
a) To approve documents for adequacy prior to issue.b) To review and update as necessary and re-approve documents.c) To ensure that changes and the current revision status of documents are identified.d) To ensure that relevant versions of applicable documents are available at points of use.e) To ensure that documents remain legible and readily identifiable.f) To ensure that the documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled.g) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
Control of records
Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system should be controlled.
The organization should establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of records.
Records should remain legible, readily identifiable and retrievable
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2.2.6 Management responsibility
Management commitment
Top management should provide evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by:
a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements.b) Establishing the quality policy.c) Ensuring that quality objectives are established.d) Conducting management reviewse) Ensuring the availability of resources.
Customer Focus
Top management should ensure that customer requirements are determined and are met with the aim of enhancing customer satisfaction.
Quality Policy
Top management should ensure that the quality policy:
a) Is appropriate to the purpose of the organization.b) Includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system.c) Provides a framework for establishing and reviewing quality objectives.d) Is communicated and understood within the organizatione) Is reviewed for continuing suitability.
2.2.7 Planning
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Quality Objectives
Top management should ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the organization. The quality objectives should be measurable and consistent with the quality policy
Quality management system planning
Top management should ensure that:
a) The planning of the quality management system is carried out in order to meet the requirements given in as well as the quality objectives.b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
2.2.8 Responsibility, authority and communication
Responsibility and authority
Top management should ensure that responsibilities and authorities are defined and communicated within the organization.
Management Representative
Top management should appoint a member of the organization’s management who, irrespective of other responsibilities, should have responsibility and authority that includes.
a) Ensuring that processes needed for the quality management system are established, implemented and maintained.b) Reporting to top management on the performance of the quality management system and any need for improvement.c) Ensuring the promotion of awareness of customer requirements throughout the organization.
The responsibility of a management representative can include liaison with external parties on matters relating to the quality management system.
Internal communication
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Top management should ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.
2.2.9 Management review
General
Top management should review the organization‘s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review should include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.
Records from management reviews should be maintained
Review input
The input to management review should include information on:
a) Results of auditsb) Customer feedbackc) Process performance and product conformity.d) Status of preventive and corrective actions.e) Follow-up actions from previous management reviews.f) Changes that could affect the quality management system.g) Recommendations for improvement.
Review output
The output from the management review should include any decisions and actions related to:
a) Improvement of the effectiveness of the quality management system and its processes.b) Improvement of product related to customer requirementsc) Resource needs.
2.2.10 Resource Management
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Provision of Resources
The organization should determine and provide the resources needed
a) To implement and maintain the quality management system and continually improve its effectiveness.b) To enhance customer satisfaction by meeting customer requirements.
Human Resources
General
Personnel performing work affecting conformity to product requirements should be competent on the basis of appropriate education, training, skills and experience.
Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the quality management system.
Competence, training and awareness
The organization should:
a) Determine the necessary competence for personnel performing work affecting conformity to product requirements.b) Where applicable, provide training or take other actions to achieve the necessary competence.c) Evaluate the effectiveness of the actions taken.d) Ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.e) Maintain appropriate records of education, training, skills and experience.
Infrastructure
The organization should determine, provide and maintain the infrastructure needed to achieve conformity to product requirements.
Infrastructure includes, as applicable
a) Buildings, workspace and associated utilities.b) Process equipment (both hardware and software).c)Supporting services (such as transport, communication or information systems).
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Work Environment
The organization should determine and manage the work environment needed to achieve conformity to product requirements.
The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
2.2.11 Product realisation
Planning of product realisation
The organization should plan and develop the processes needed for product realization. Planning of product realization should be consistent with the requirements of the other processes of the quality management system
In planning product realization, the organization should determine the following, as appropriate:
a) Quality objectives and requirements for the product.b) The need to establish processes and documents, and to provide resources specific to the product.c) Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance.d) Records needed to provide evidence that the realization processes and resulting product meet requirements.
The output of this planning should be in a form suitable for the organization‘s method of operations.
A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan.
Customer related processes
Determination of requirements related to the product
The organization should determine:
a) Requirements specified by the customer, including the requirements for delivery and post-delivery activitiesb) Requirements not stated by the customer but necessary for specified or intended use, where known.c) Statutory and regulatory requirements applicable to the product.
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d) Any additional requirements considered necessary by the organization.
Review of requirements related to the product
The organization should review the requirements related to the product. This review should be conducted prior to the organization‘s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and should ensure that:
a) Product requirements are defined.b) Contract or order requirements differing from those previously expressed are resolved.c) The organization has the ability to meet the defined requirements.Records of the results of the review and actions arising from the review should be maintained
Where the customer provides no documented statement of requirement, the customer requirements should be confirmed by the organization before acceptance.
Where product requirements are changed, the organization should ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Customer communication
The organization should determine and implement effective arrangements for communicating with customers in relation to
a) Product information.b) Enquiries, contracts or order handling, including amendments.c) Customer feedback, including customer complaints.
Design and development
Design and development planning
The organization should plan and control the design and development of product.
During the design and development planning, the organization should determine:
a) The design and development stages.b) The review, verification and validation that is appropriate to each design and development stage.c) The responsibilities and authorities for design and development.
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The organization should manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.
Design and development inputs
Inputs relating to product requirements should be determined and records maintained.
These inputs should include:
a) Functional and performance requirements.b) Applicable statutory and regulatory requirementsc) Where applicable, information derived from previous similar designs.d) Other requirements essential for design and development.
The inputs should be reviewed for adequacy. Requirements should be complete, unambiguous and not in conflict with each other.
Design and development outputs
The outputs of design and development should be in a form suitable for verification against the design and development input and should be approved prior to release.
Design and development outputs should:
a) Meet the input requirements for design and development.b) Provide appropriate information for purchasing, production and for service provision.c) Contain or reference product acceptance criteriad) Specify the characteristics of the product that are essential for its safe and proper use.
Design and development review
At suitable stages, systematic reviews of design and development should be performed in accordance with planned arrangements:
a) To evaluate the ability of the results of design and development to meet requirements.b) To identify any problems and propose necessary actions.
Participants in such reviews should include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions should be maintained.
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Design and development verification
Verification should be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions should be maintained.
Design and development validation
Design and development validation should be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, where known. Wherever practicable, validation should be completed prior to the delivery or implementation of the product.
Records of the results of validation and any necessary actions should be maintained.
Control of design and development changes
Design and development changes should be identified and records maintained. The changes should be reviewed, verified and validated, as appropriate, and approved before implementation. The review of design and development changes should include evaluation of the effect of the changes on constituent parts and product already delivered.
Records of the results of the review of changes and any necessary actions should be maintained
Purchasing
Purchasing process
The organization should ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product should be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization should evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation should be established.
Records of the results of evaluations and any necessary actions arising from the evaluation should be maintained.
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Purchasing information
Purchasing information should describe the product to be purchased, including where appropriate
a) Requirements for approval of product, procedures, processes and equipment.b) Requirements for qualification of personnel.c) Quality management system requirements.
The organization should ensure the adequacy of specified purchase requirements prior to their communication to the supplier.
Verification of purchased product
The organization should establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.
Where the organization or its customer intends to perform verification at the supplier‘s premises, the organization should state the intended verification arrangements and method of product release in the purchasing information.
Production and service provision
Control of production and service provision
The organization should plan and carry out production and service provision under controlled conditions.
Controlled conditions should include, as applicable:
a) The availability of information that describes the characteristics of the product.b) The availability of work instructions, as necessary.c) The use of suitable equipment.d) The availability and use of monitoring and measuring equipment,e) The implementation of monitoring and measurement, andf) The implementation of product release, delivery and post-delivery activities.
Validation of processes for production and service provision
The organization should validate any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered.
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Validation should demonstrate the ability of these processes to achieve planned results.The organization should establish arrangements for these processes including, as applicable:
a) Defined criteria for review and approval of the processes.b) Approval of equipment and qualification of personnel.c) Use of specific methods and procedures.d) Requirements for records.e) Revalidation.
Identification and traceability
Where appropriate, the organization should identify the product by suitable means throughout product realization.
The organization should identify the product status with respect to monitoring and measurement requirements throughout product realization.
Where traceability is a requirement, the organization should control the unique identification of the product and maintain records
Customer property
The organization should exercise care with customer property while it is under the organization‘s control or being used by the organization. The organization should identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, the organization should report this to the customer and maintain records.
Preservation of product
The organization should preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements.As applicable, preservation should include identification, handling, packaging, storage and protection. Preservation should also apply to the constituent parts of a product
Control of monitoring and measuring equipment
The organization should determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements.
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The organization should establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
Where necessary to ensure valid results, measuring equipment should:
a) Be calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification should be recorded b) Be adjusted or re-adjusted as necessary.c) Have identification in order to determine its calibration status;d) Be safeguarded from adjustments that would invalidate the measurement result.e) Be protected from damage and deterioration during handling, maintenance and storage.
In addition, the organization should assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization should take appropriate action on the equipment and any product affected.
Records of the results of calibration and verification should be maintained.
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application should be confirmed. This should be undertaken prior to initial use and reconfirmed as necessary.
2.2.12 Measurement, analysis and improvement
General
The organization should plan and implement the monitoring, measurement, analysis and improvement processes needed
a) To demonstrate conformity to product requirements,b) To ensure conformity of the quality management system, andc) To continually improve the effectiveness of the quality management system.
This should include determination of applicable methods, including statistical techniques, and the extent of their use.
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Monitoring and measurement
Customer satisfaction
As one of the measurements of the performance of the quality management system, the organization should monitor information relating to customer perception as to whether the organisation has met customer requirements. The methods for obtaining and using this information should be determined.
Internal audit
The organization should conduct internal audits at planned intervals to determine whether the quality management system
a) Conforms to the planned arrangements, to the requirements of this International Standard and to the quality management system requirements established by the organizationb) Is effectively implemented and maintained.
A documented procedure should be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results.
An audit programme should be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods should be defined. Selection of auditors and conduct of audits should ensure objectivity and impartiality of the audit process. Auditors should not audit their own work.
Records of the audits and their results should be maintained.The management responsible for the area being audited should ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.
Follow-up activities should include the verification of the actions taken and the reporting of verification results
Monitoring and measurement of processes
The organization should apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods should demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action should be taken, as appropriate.
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Monitoring and measurement of product
The organization should monitor and measure the characteristics of the product to verify that product requirements have been met. This should be carried out at appropriate stages of the product realization process in accordance with the planned arrangements Evidence of conformity with the acceptance criteria should be maintained.
Control of nonconforming product
The organization should ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure should be established to define the controls and related responsibilities and authorities for dealing with nonconforming product.
Where applicable, the organization should deal with nonconforming product by one or more of the following ways:
a) By taking action to eliminate the detected nonconformity;b) By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;c) By taking action to preclude its original intended use or application.d) By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.
When nonconforming product is corrected it should be subject to re-verification to demonstrate conformity to the requirements.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, should be maintained
Analysis of data
The organization should determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and to evaluate where continual improvement of the effectiveness of the quality management system can be made. This should include data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data should provide information relating toa) Customer satisfaction,b) Conformity to product requirements c) Characteristics and trends of processes and products including opportunities for preventive action d) Suppliers
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Improvement
Continual improvement
The organization should continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.
Corrective action
The organization should take action to eliminate the causes of nonconformities in order to prevent recurrence. Corrective actions should be appropriate to the effects of the nonconformities encountered.
A documented procedure should be established to define requirements for:a) Reviewing nonconformities (including customer complaints),b) Determining the causes of nonconformities,c) Evaluating the need for action to ensure that nonconformities do not recur,d) Determining and implementing action needed,e) Records of the results of action takenf) Reviewing the effectiveness of the corrective action taken.
Preventive action
The organization should determine action to eliminate the causes of potential nonconformities in order to prevent their occurrence. Preventive actions should be appropriate to the effects of the potential problems.A documented procedure should be established to define requirements for:a) Determining potential nonconformities and their causes,b) Evaluating the need for action to prevent occurrence of nonconformities,c) Determining and implementing action needed,d) Records of results of action takene) Reviewing the effectiveness of the preventive action taken.
In any organization where a quality management system has been implemented, it is important for everyone amongst the staff to be aware of the quality policy and objectives The above clauses also include function specific policies. Instead of teaching employees the clauses, companies usually have general ISO training which cover the minimum requirements for the organization. They also provide specific training to each department.
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2.3 Implementation of a Quality Management System
There are key steps that every company implementing a QMS will need to consider
2.3.1 Purchase the StandardBefore you can begin preparing for your application, you will require a copy of the standard. You should read this and make yourself familiar with it.
2.3.2 Review support literature and softwareThere are a wide range of quality publications and software tools designed to help you understand, implement and become registered to a quality management system.
2.3.3 Assemble a team and agree your strategyYou should begin the entire implementation process by preparing your organizational strategy with top management. Responsibility for a QMS lies with Senior Management; therefore it is vital that Senior Management is involved from the beginning of the process.
2.3.4 Consider TrainingWhether you are the Quality Manager seeking to implement a quality management system or a Senior Manager who would like to increase your general awareness of ISO 9001:2000, there are a range of workshops, seminars and training courses available.
2.3.5 Review Consultancy OptionsYou can receive advice from independent consultants on how best to implement your quality management system. They will have the experience in implementing a QMS and can ensure you avoid costly mistakes.
2.3.6 Choose a registrarThe registrar is the 3rd party, like CIUK, who come and assesses the effectiveness of the quality management system, and issue a certificate if it meets the requirements of the standard. Choosing a registrar can be a complex issue as there are so many operating in the market. Factors to consider include industry experience, geographic coverage, price and service level offered. The key is to find the registrar who can best meet your requirements.
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2.3.7 Develop a Quality manualA Quality manual is a high level document that outlines your intention to operate in a quality manner. It outlines why you are in business, what your intentions are, how you are applying the standard and how your business operates.
2.3.8 Develop support documentationThis is typically a procedures manual that supports the Quality manual. Quite simply, it outlines what you do to complete a task. It describes who does what, in what order and to what standard.
2.3.9 Implement your Quality Management SystemThe key to implementation is communication and training. During the implementation phase everyone operates to the procedures and collects records that demonstrate you are doing what you say you are doing.
2.3.10 Consider a pre-assessmentA pre-assessment by your registrar normally takes place about 6 weeks into the implementation of the quality system. The purpose of the pre-assessment is to identify areas where you may not be operating to the standard. This allows you to correct any areas of concern you may have before the initial assessment.
2.3.11 Gain registrationYou should arrange your initial assessment with your registrar. At this point the registrar will review your QMS and determine whether you should be recommended for registration.
2.3.12 Continual assessmentOnce you have received registration and been awarded your certificate, you can begin to advertise your success and promote your business. To maintain your registration, all you need to do is continue to use your quality system. This will be periodically checked by your registrar to ensure that your Quality System continues to meet the requirements of the standard.
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Chapter 3: Jehan Greenwalls, an example of a Quality Management system
3.1 Introduction
The following sections give an example of the quality management system implemented in Jehan Greenwalls. I have worked on the documentation of this company and have conducted the pre-certification audits.
The clause numbers are been indicated in brackets as per the ISO certification requirement
This section also includes the procedures and forms required for ISO 9001:2008 certification
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3.2 Jehan Green Walls Quality Manual
COMPANY PROFILE:
Jehan Green Walls FZE has been operating since November 2008 in UAE. The office will be established in Hamriyah Free Zone in the same proposed plot for manufacturing unit in Hamriyah Free Zone-Phase II, Sharjah to Manufacture Pre-Cast Panels. The advantage of setting up the facility provides fast and easy erection, insect resistant, water absorption, impact resistant, biologically inert good thermal & sound insulation, structurally stable and exceptional level of finish considering the cost-conscious building systems.
Jehan has leased a land (Plot # 4C-02 to 4C-08) at the Hamriyah Free Zone-Phase II in Sharjah, UAE. Jehan Green Walls is setting up a manufacturing facility in the leased land. The total project area is 35,000 m2 out of which 9000 m2 will be the built up area during Phase 1 and remaining area will be as open land and will be developed based on the market potential and requirement.
The panels consist of welded wire frame integrated with a polystyrene insulation core. The panel consists of an EPS core with a thickness ranging from 50 to 150 mm sandwiched between two plane parallel welded wire mesh sheets and inclined diagonal wires in between that go through the EPS core and are electrically welded to the cover mesh’s line Manufacturing of Pre Cast Panels Jehan Green Walls FZE wires. Then the panel placed in a position to convert into pre-cast panes by applying either of concrete or glass reinforced gypsum plaster mix on both sides. Laboratories and the administrative office will be set inside the facility.
The main features of the machineries/equipment used for different process is as follows:
1. Polystyrene (EPS) processing plant
Steam boiler Water treatment plant Pre-expander Raw material silo Raw Material conveyor Fluidized bed dryer Silo plant Blockmould Filing silo Roller Conveyor Hot wire cutting plant Recycling plant / Grinder with pre-breaker Mixing and metering plant
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Steam accumulator2. Welding plant
Automatic welding plant Swivelling crane Wire mesh welder Automatic coiler Butt welding machine
3. Handling Equipment
Wire spooling machine 3D panel cutter Wire mesh flattening and shearing device Compressed air station Cooling water station
4. Casting unit
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QUALITY POLICY
We, Jehan Green Walls FZE take pride and honor in declaring the company’s commitment to satisfy our customers by providing high quality products and services.
Jehan Green Walls FZE will maintain and continually improve quality of its products and services to our customers.
The management will provide necessary resources and training for our employees to enable and implement the company’s objectives.
In order to achieve and maintain this, Jehan Green Walls FZE Jehan Green Walls FZE commits to
Continually improve of our QMS through systematic identification of the root causes behind the non-conformities and subsequent elimination of the same
Strive to provide timely delivery of our products to satisfy our customers
Establish, implement and continually measure the achievement of our quality objectives
Communicate this policy to all our employees, customers, suppliers.
QUALITY OBJECTIVES:
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The objective of JEHAN is:
To clearly define the procedures and responsibilities of a total quality assurance program with the ultimate goal being to provide our valued customers with a precision part or product that will meet or exceed their individual specifications or requirements.
Provide detailed procedures required to accomplish uniform quality assurance for this company’s parts or products.
Furnish general-purpose information useful in the administration of quality assurance activities.
Any product supplied by JEHAN, under a contract shall be manufactured under appropriate institutes’ and societies’ specifications or their supplemental specifications and shall be subject to the quality control standards outlined therein.
A copy of this manual will be issued to all department managers, sales representatives and operation for JEHAN, as a required reference. A copy of the JEHAN, Quality Manual is available to qualified personnel upon request. Revisions to our policy will be issued when deemed necessary and shall be recorded and authorized on the revision notice page of this manual. Revisions shall be numbered, dated and indicated sections and paragraphs revised
Ref. : FRM-JEHAN-26
SCOPE (Clause number: 1)
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General (Clause number: 1.1)
Jehan Green Walls FZE has developed and implemented a Quality Management System to consistently satisfy the needs of its customers and improve the quality management of the company. The quality management system complies with the international standard ISO 9001:2008. It covers quality-related activities of the concerned departments of the company.
It also aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable regulatory requirements.
The scope of the company for the QMS is
Production of finest Precast insulated walls to support environment-friendly construction.
Application (Clause number: 1.2)
Quality management system is relevant to the nature of its organization and services, and to customer and regulatory requirements. Requirements of the ISO 9001:2008 standard that do not apply are excluded from the scope of this quality system.
Exclusions:ISO 9001:2008 Exclusion Table:
Clause/ Sub clause No.
Exclusion Justification
7.3 Design & Development
JEHAN do not carry out any design and development activities
NORMATIVE REFERENCE (Clause number: 2)
References in this manual are as per ISO 9000:2005, Quality management systems – Fundamentals and
vocabulary
ISO 9001:2008, Quality management systems – Requirements
TERMS AND DEFINITIONS (Clause number: 3)
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Terms Definitions
Supplier A organization or person that provides a product.Product can be physical as well as service
Organization An organization is a group of people intentionally organized to accomplish an overall, common goal or set of goals
Customer
Company
One that buys goods or services
Jehan Green Walls FZE
Conformity Fulfillment of specified requirements
Contract Review Systematic activities carried out by the supplier before signing the contract to ensure that requirements for quality are adequately defined, free from ambiguity, documented and can be realized by the supplier.
Defect Non-fulfillment of an intended usage requirement or reasonable expectation, including one concerned with safety.
Inspection Activity such as measuring, examining, testing or gauging one or more characteristics of an entity and comparing the results with specified requirements in order to establish whether conformity is achieved for each characteristic.
Management Review Formal evaluation by top management of the status and adequacy of the quality system in relation to the quality policy and objectives.
Objective Evidence Information, which can be proved true, based on facts obtained through observation, measurement, test or other means.
Procedure Specified way to perform an activity
Process Set of inter-related resources and activities which transform inputs into outputs (resources may include personnel, finance, JEHANilities, equipment, techniques and methods)
Qualification Process Process of demonstrating whether an entity is capable of fulfilling specified requirements
Quality Assurance All the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfil requirement for quality
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AuditSystematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
Quality Control Operational techniques and activities that are used to fulfil requirements for quality
Quality Management All activities of the overall management function that determine the quality policy, objectives and responsibilities, and implement them by means such as quality planning, quality assurance, quality control and quality improvement within the quality system.
Quality Manual Document stating the quality policy and describing the quality system of an organization
Quality Plan Document setting out the specific quality practices, resources and sequences of activities relevant to a particular product, project or contract
Quality Planning Activities that establish the objectives and requirements for quality and for the application of the quality system elements
Quality Policy Overall intentions and direction of an organization with regard to quality, as formally expressed by the top management
Quality System Organizational structure, procedures, processes and resources needed to implement quality management
Quality Degree to which a set of inherent characteristic meets requirements.
Record Document which furnishes objective evidence of activities performed or results achieved
Specification Document stating requirements
Traceability Ability to trace the history, application and location of an entity (a product, process or an activity) by means of recorded identification
Verification Confirmation by examination and provision of objective evidence that specifies requirements have been fulfilled
QUALITY MANAGEMENT SYSTEM (Clause number: 4)
General Requirements (Clause number: 4.1)
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Jehan Green Walls FZE has established, documented, implemented and maintains a quality management system and continually improves its effectiveness in accordance with the requirements of ISO 9001:2008 Standard.
Jehan Green Walls FZE identifies the processes needed for the quality management system and their application throughout the company (ie., management activities, provision of resources, product realization and measurement), determines the sequence and interaction of these processes, determines criteria and methods needed to ensure that both the operation and control of these processes are effective, ensures the availability of resources and information necessary to support the operation and monitoring of these processes, monitors, measures and analyzes these processes, and implements actions necessary to achieve planned results and continual improvement of these processes
These processes are properly managed by the company in accordance with the requirements of ISO 9001:2008 Standard.
Where the company chooses to outsource any process that affects product conformity with requirements (like some maintnance works), it ensures control over such processes. Control of such outsourced processes are identified within the quality management system (if any).
Quality Manual (QM) is a reflection of the Quality Management System, which is strictly adhered in “Jehan Green Walls FZE.” and is in accordance with the applicable clauses of ISO 9001: 2008 Quality Management System. It is a controlled document with a specified distribution list. Uncontrolled copies, although, may be provided at the discretion of General Manager.
The purposes of this manual are to: Define the scope of the quality management system Give details of and justification for any exclusions, Describe the interactions between the processes of the quality
management system, Define the authorities and responsibilities of the top management
personnel, Provide general procedures (or reference to them) for all activities
comprising the quality management system, Present our quality management system to our customer(s) or other
interested parties in order to inform them what specific controls are in place and implemented for effective quality assurance.
This manual describes the quality management system as adopted by the company and applies to all activities, which contribute to the quality of products provided by the company.
Management Representative (MR) is responsible for updating, maintaining, and distributing the respective documents. No alterations can be done in this manual without prior approval from GM.
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Documentation Requirements (Clause number: 4.2)
General (Clause number: 4.2.1)The quality management system documentation includes:
Quality policy and quality objectives, Quality manual (the same document), Procedures, Technical documents needed by the company to ensure the effective
planning, operation and control of its processes (for example, work instructions), and
Records.
Quality Manual (Clause number: 4.2.2)
Jehan Green Walls FZE has established a comprehensive quality manual to provide information on its quality management system. Briefly, it addresses the requirements of ISO 9001:2008 standard along with:
Information on the documented procedures and
--
Quality ManualQuality Manual
ProceduresProcedures
Works InstructionWorks Instruction
Records/ FormsRecords/ Forms
Quality Policy
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Intertpies of the various processes with regard to their respective inputs and outputs.
The contents of the quality manual apply specifically to Jehan Green Walls Processes and covers all elements of ISO 9001: 2008. All mandatory procedures have been established and referred throughout the manual
Control of Documents (Clause number: 4.2.3)
Documents required by Jehan Green Walls FZE are controlled. Records are a special type of document. Management Representative has overall responsibility for ensuring that all QMS documents, including forms used to create quality records are controlled as per procedures.
A documented procedure (Ref. QP/JEHAN/01) is established to define the controls needed:
To approve documents for adequacy prior to issue. To review and update as necessary and re-approve documents. To ensure that changes and the current revision status of documents
are identified. To ensure that relevant versions of applicable documents are available
at points of use. To ensure that documents remain legible and readily identifiable. To ensure that documents of external origin are identified and their
distribution controlled. To prevent the unintended use of obsolete documents, and to apply
suitable identification to them if they are retained for any purpose.
Quality system documents such as Quality Manual, documented procedures, Operational procedures and work-instructions are controlled by the Management Representative (MR) of the company. Records register, index sheet of forms (used by the process owners) and reference documents are controlled in a similar manner as mentioned above.
Upon receipt of the document change request from the Process Owners, MR reviews the required amendments and incorporates them into the appropriate document(s). All quality system documents are periodically reviewed for their effectiveness against the set objectives and continuous improvement. Amendments, obsolete and master copies are maintained by the Management representative.
Uncontrolled documents are issued by the respective Process Owners and/or his designates whenever demanded contractually. However, respective POs’ will issue these documents after obtaining the permission from the General Manager.
Control of Records (Clause number: 4.2.4)
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A documented procedure is established for the control of records under procedure (Ref: QP/JEHAN/02).
The procedure briefly covers:
Identification and legibility of records Responsible staff Place of record Accessibility Protection and retrieval Review mechanism Retention and disposal criteria.
All process owners and MR have together developed and designed appropriate process forms for their respective processes and are controlled. These forms when filled become the evidence of the conformity to the requirements and effective use of the quality management system
MANAGEMENT RESPONSIBILITY (Clause number: 5)
Management Commitment (Clause number: 5.1)
The management ensures that the objectives formulated are consistent with the overall policies of the company. A strategic framework is established for the operational management to produce the quality objectives. The objectives set are continuously monitored and reviewed in the management meetings. Minutes of such meetings are kept by MR. The Top management of Jehan Green Walls FZE is committed to provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by:
Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements: Customers needs are identified and complaints are resolved to achieve customer satisfaction and statutory and regulatory requirement.(Ref. FRM/JEHAN/08, FRM/JEHAN/09, FRM/JEHAN/10)
Establishing the Quality Policy: Quality Policy is prepared and communicated within the organization, so that the organization achieves continual improvement and customer satisfaction. (Ref. Quality Policy)
Ensuring that Quality Objectives are established: Quality Objectives are developed and communicated within the organization, so that the organization achieves continual improvement and customer satisfaction. (Ref. Quality Objectives File, FRM/JEHAN/26)
Conducting management reviews: MRM is conducted in planned intervals, so that the QMS system is in place and effective, targeting continual improvement in all facility. (Ref. FRM/JEHAN/ 30)
Ensuring the availability of resources: The Top management ensures that the resources needed to be implemented in QMS are determined
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and provided. This includes provision of human resources, infrastructure, work environment and other facilities needed to maintain and continually improve the QMS. (Ref. QP/JEHAN/11)
Customer Focus (Clause number: 5.2)
The top management of Jehan Green Walls FZE ensures that customer requirements are determined and met with the aim of enhancing customer satisfaction. (Ref. FRM/JEHAN/10)We continually look for other ways to interact directly with individual customers to ensure proper focus to their unique needs/expectations. (e.g. customer feedback, customer visits etc.) These customer focused communications and interactions ultimately yield clear, explicit customer requirements and expectations in the form of a contractual agreement or customer order. The procedure for marketing contract review is prepared which clearly details the correspondence with the customer. (Ref QP/JEHAN/12. QP/JEHAN/08)
In order to enhance the ability to satisfy customers, the management ensures that it is aware of its marketplace(s) in which it operates. The management is able to determine the current, new and potential customer requirements. This is achieved through various activities carried out by the Sales section who are the process owners. Briefly, these activities are selected from the following options:
Annual market surveys Test marketing Evaluating competitor’s product Information obtained from communication with individual customers Feedback from sales and marketing staff
The management decides where, how and when to use its resources to ensure that it obtains information related to customer requirements and works towards satisfying its customers by meeting these requirements.
Quality Policy (Clause number: 5.3)
The General Manager has formulated the quality policy of Jehan Green Walls FZE in consultation with the management team, which includes process owners and MR. The quality policy is consistent with local legislation and appropriate to the company’s operations. It includes the structure and review of the set objectives. The policy ensures that the objectives are reviewed periodically for its continuing suitability.
The quality policy and objectives are communicated to all the employees by suitably displaying the frames at strategic locations, circulars, formal and informal training sessions and meetings with staff.
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General Manager and Top management is fully committed to the continual improvement of the company operations in its entire field of application. Formal management reviews exercise the control mechanism in evaluating the effectiveness of the QMS against its objectives and policy.
Planning (Clause number: 5.4)
Quality Objectives (Clause number: 5.4.1)
Jehan Green Walls FZE overall quality goal is to achieve our quality policy, and maintain the integrity of policy and continually improve a QMS compliant with ISO 9001:2008.Jehan Green Walls FZE top management shall ensure that quality objectives, including those needed to meet requirements for service are established at relevant functions and different processes levels within the organization. The quality objectives shall be measurable and consistent with the Quality Policy. (Ref. Quality Objectives File, FRM/JEHAN/26)
QMS Planning (Clause number: 5.4.2)
Top management ensures that the planning of the quality management system is carried out in order to meet the requirements mentioned in 4.1, as well as the quality objectives, and the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.Jehan Green Walls FZE, top management ensures that:
The planning of the QMS is carried out in order to meet the organizational and customer requirements as given in sub clause 4.1 of this manual. The quality objectives are planned at the start of every year. (Ref. FRM/JEHAN/26)
The integrity of the QMS is maintained when changes to the QMS are planned and implemented by conducting audits and MRM.
Responsibility,Authority and Communication (Clause number: 5.5)
Responsibilty and Authority (Clause number: 5.5.1)
Jehan Green Walls FZE , top management is ensuring that responsibilities and authorities are defined and communicated within the organization.Responsibility and Authority of each Person is maintained with HOD of respective Department.
Management Representative (Clause number: 5.5.2)
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Jehan Green Walls FZE, top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes:
Ensuring that processes needed for the QMS are established implemented and maintained.
Reporting to top management on the performance of the QMS and any need for improvement.
Ensuring the promotion of awareness of customer requirements throughout the organization.
Internal Communication (Clause number: 5.5.3)
Management personnel ensures that appropriate communication processes are established within the company and that communication takes place regarding the effectiveness of the quality management system(Ref QP/JEHAN/12)
Management Review (Clause number: 5.6)
General (Clause number: 5.6.1)
Regular Management Review meetings are being carried out in order to ensure the quality system continuing suitability and effectiveness in satisfying the requirements of the standard and in meeting the client’s requirements. The General Manager may call unscheduled Management Review meeting at any time. The Management Review meeting will be called and chaired by the General Manager. The management review is carried out as per the procedure for management review (Ref: - Management Review Procedure - QP/JEHAN/03)
Review Input (Clause number: 5.6.2)
Inputs to management review shall include information on: Results of audits Customer feedback Process performance and service conformity Status of preventive and corrective actions Follow up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement
Review Output (Clause number: 5.6.3)
The output from management review shall include any decisions and actions related to:
Improvement of the effectiveness of the QMS and its processes Improvement of service related to customer requirements Resource needs
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RESOURCE MANAGEMENT (Clause number: 6)
Provision of Resources (Clause number: 6.1)
Jehan Green Walls FZE determines and provides the resources needed to implement and maintain the quality management system and continually improves its effectiveness, and enhances customer satisfaction by meeting customer requirements. Based on the marketing forecasts, feedback from customers, statutory and government requirements and management review, management decides the financial budget. The budget strategy is formulated considering business expansion/ diversification and/or provision of new services.
Human Resources (Clause number: 6.2)
General (Clause number: 6.2.1)
The company believes in its human resource as the most important resource. Emphasize is given to the staff being competent and skilled in their area of work. Appropriate schedule is prepared and the necessary training is imparted and then evaluated for its effectiveness. Requirements for human resource are discussed in the review meetings and appropriate actions is taken and followed up.
Competency Training, and Awareness (Clause number: 6.2.2)
The Company ensures that all personnel performing activities influencing quality have adequate qualifications. The company ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, This is achieved by recruitment of suitably qualified personnel and provision of adequate training. Appropriate records for personnel qualification and training are maintained. The trainings are carried out as per the procedure for admin ( Ref :- QP/JEHAN/11)
Infrastructure (Clause number: 6.3)The basic infrastructural facilities like appropriate location, work area, necessary hardware and software, building floor space ,necessary utilities, communication facilities both external and internal that are required for effective customer communication are identified, provided and maintained to suit the growing and potential needs to achieve the conformity to the requirements.The availability of the necessary requisites and supporting facilities like communication are reviewed by MR and top management during the management review meeting for the capability to meet to the requirements of the customers and interested parties. Contingency plan like back up (automatic/periodic) is taken to protect the computerized data from damage. The top management ensures the availability of appropriate infrastructure to support the company’s growth plans, Quality objectives, and conformity to market requirements and expectations and performance of the Quality
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system. The infrastructure requirements shall be reviewed in the management review and identified resources are provided.
Work Environment (Clause number: 6.4)
The company ensures that the work environment is conductive to meeting customer and regulatory body requirements. All the suggestions are accepted for overcoming the shortcomings of the system and improvement of the implemented QMS. Proper ventilation and illumination is available in all departments. The work environment requirements are assessed even on the sites and suitable requirements identified are communicated to the client or supplied by the JEHAN.
PRODUCT REALIZATION (Clause number: 7)
Planning of Product Realization (Clause number: 7.1)
JEHAN, shall plan and develop the processes needed for service realization. Planning of service realization shall be consistent with the requirements of the other processes of the QMS. In planning service realization, JEHAN, shall determine the following, as appropriate:
Quality objectives and requirements for the service The need to establish processes, documents, and provide resources
specific to the service. Required verification, validation, monitoring, inspection and test
activities specific to the service and the criteria for service acceptance. Records needed to provide evidence that the realization processes and
resulting service meet requirements.The output of this planning shall be in a form suitable to the organization’s method of operations.
Customer related processes (Clause number: 7.2)
To achieve quality policy , JEHAN is determine, understand, and consistently meet or exceed customers’ requirements and expectations, and for that, we establish effective communication systems with our customers with regards to service information, inquiries, contract or order handling and related changes, and customer satisfaction survey, including complaints. These efforts are described below.
Determination of requirements related to the product (Clause number: 7.2.1)
The requirements of the customer related to the product or service is determined according to the procedure for contract review. The present and future needs of the customer are assesses during the order reception and
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proposal preparation, which has to be mutually agreed with the customer. The statutory and regulatory requirements are also determined during this phase. (Ref: - Procedure for Contract Review QP/JEHAN/08)
Review of the Requirements related to the Product (Clause number: 7.2.2)
The company reviews the requirements related to the service i.e. After preparing the proposal, it is reviewed and approved by the management. This review is conducted prior to the organization’s commitment to deliver a service to the customer in the presence of General Manager. (e.g. submission of tenders, acceptance of contracts or work orders, acceptance of changes to contracts or orders) and shall ensure that:This review ensures that:
Product requirements are defined Contract or order requirement differing from those previously
expressed are resolved The company has the ability to meet the defined requirements
Records of the results of the review and actions arising from the review are maintained.Where the customer provides no documented statement of requirement, the customer requirements are confirmed in the proposal before acceptance.Where product or service requirements are changed, the company ensures that relevant documents are amended and that relevant personnel are made aware of the changed requirements.
Customer Communication (Clause number: 7.2.2)
The company determines and implements effective arrangements for communicating with customers in relation to: (Ref: Customer Satisfaction Survey form FRM/JEHAN/10, Customer Complaint Register FRM/JEHAN/09.)
The product enquiry information is accepted through sales manager or any members of the sales team. Such enquiries are recorded in the project enquiry register.
Enquiries, contracts or order handling, including amendments is handled and communicated as per the procedure for service
Customer feedback, including customer complaints are handled according to the procedure for marketing Customer Focus (Ref: Procedure for Customer Complaint QP/JEHAN/07)
For the effective implementation to meet the requirements of our customer’s appropriate channels of communication are established in relation to the product information, enquiries and feedback including complaintsVarious interfaces with the customers are defined in relevant procedures for solicitation of feedback on service standards. It begins from sales inquiry, order handling, contract review, and delivery to customers. Communication with the customer can be in the form of emails, letters, fax, verbal or other methods. Complaints received from the customers are reported through customer complaints register. Customer satisfaction survey is conducted at
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periodic intervals to get the feedback of the services offered to access opportunities for companywide improvements.
Design and Development – Excluded (Clause number: 7.3)
Design and Development Planning - Excluded
Design and Development Inputs - Excluded
Design and Development Outputs - Excluded
Design and Development Review - Excluded
Design and Development Verification - Excluded
Design and Development Validation - Excluded
Design and Development Changes - (Excluded)
Purchasing (Clause number: 7.4)
Purchasing Process (Clause number: 7.4.1)
The company has developed, documented and implemented a purchase procedure to ensure that the raw materials purchased from suppliers conform to specified requirements.The company selects and evaluates their suppliers based on their ability to supply product in accordance with its requirements. Criteria for selection, evaluation and revaluation have been established.( Ref FRM/JEHAN/11, FRM/JEHAN/12 & FRM/JEHAN/13)
Purchasing Information (Clause number: 7.4.2)
Purchasing information describes the product to be purchased, including (where appropriate) requirements for approval of product, procedures, processes and equipment, requirements for qualification of personnel, and quality management system requirements. The company ensures the adequacy of specified purchase requirements prior to their communication to the Supplier.
Verification of purchased product (Clause number: 7.4.3)
The company ensures that the purchased products meet specified purchase requirements in accordance with quality requirements. The verification of purchased materials and services including customer-supplied material is the responsibility of procurement coordinator. Material specification is maintained by the procurement officer and shall be verified by the quality control department as per the procedure procurement.
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Production and Service Provision (Clause number: 7.5)
Control of production and service provision (Clause number: 7.5.1)
The company has established and maintains service provision procedure under controlled conditions, which includes the following:JEHAN, utilize a process-focused approach to plan and control operations and support services related to service provision. Our initial focus is to assure the quality of process inputs - that is, employees, facilities and equipment, and methods. JEHAN, shall plan and carry out service provision under controlled conditions. Controlled conditions shall include, as applicable:
The availability of information that describes the characteristics of the services
The availability of SOP/work instructions as necessary. The implementation of monitoring and measurement..
Validation of Processes for Production and Service Provision (Clause number: 7.5.2)
JEHAN shall validate any processes for service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where deficiencies become apparent only after the service is in use or the service has been delivered.
Validation shall demonstrate the ability of these processes to achieve planned results.
The organization shall establish arrangements for these processes, including, as applicable:
Defined criteria for review and approval of the processes Approval qualification of personnel Use of specific methods and procedures Requirements for records Revalidation
Identification and Traceability (Clause number: 7.5.3)
Where appropriate, JEHAN shall identify the product by suitable means throughout product realization. The organization shall identify the product status with respect to monitoring and measurement requirements, where traceability is a requirement; the organization shall control and record the unique identification of the products
Customer property (Clause number: 7.5.4)
JEHAN exercises care with documents or any other property provided by the customer for provision of services
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Such customers are properly identified, verified, protected and safeguarded while in JEHAN custody. Any customer property which is lost, damaged or otherwise found unsuitable for use is reported to the customer.
Preservation of material (Clause number: 7.5.5)
Necessary arrangements, handling, proper storage and safety precautions are practiced in order to preserve the materials in specified area. The procedure for stores specifies the methods to be implemented by stores department for identification, handling, storage and protection.
Control of monitoring and measuring equipments(Clause number: 7.6)
The company has determined the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of services to determine requirements.The company has established processes to ensure that monitoring and measurement can be carried out in a manner that is consistent with the monitoring and measurement requirements.To ensure valid results, measuring equipment;
Are verified at specified intervals, or prior to use against measurement standards be adjusted or re- adjusted as necessary.
are identified with identification number to enable the maintenance status to be determined.
Are safeguarded from adjustments that would invalidate the measurement result.
Are protected from damage and deterioration during handling maintenance.
In addition, the organization does assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization then takes appropriate action on the equipment affected.
MEASUREMENTS, ANALYSIS AND IMPROVEMENT (Clause number: 8)
General (Clause number: 8.1)
The company has established the overall combination of monitoring and measurement of all its key processes, product characteristics, customer perceptions and quality system operations to be undertaken in order to demonstrate conformity of both product and the quality management system. The processes and support needed to find, on a continual basis, opportunities for improving the effectiveness of the quality management system have been
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established. Adequate data analysis is carried out to detect process trends, customer perceptions etc. The top management is committed to provide adequate resources necessary to perform the monitoring, measurement and improvement processes. Statistical Analysis is carried out for Customer satisfaction, sales index, Quality Index, Wastage during production, electricity /water consumption, timely project completion and Man day’s consumption.
Monitoring and Measurement (Clause number: 8.2)
Customer satisfaction (Clause number: 8.2.1)
Customer satisfaction is the main element in the QMS of the company. As one of the measurements of the performance of the quality management system, the company monitors information relating to customer perception as to whether the company has fulfilled customer requirements. The methods for obtaining and using this information are determined as per the procedure for Marketing Customer Focus.
(Ref: QP/JEHAN/08, FRM/JEHAN/09, FRM/JEHAN/10)
Internal Audit (Clause number: 8.2.2)
The company, shall conduct internal quality audits at planned intervals to determine whether the QMS
Conforms to the planned arrangements, to the requirements of ISO 9001:2008 and to the QMS requirements established by the organization
Is effectively implemented and maintainedThe company conducts internal audits at planned intervals to determine whether the quality management system conforms to the requirements of ISO 9001:2008 Standard and to the quality management system requirements established by the company, and is effectively implemented and maintained.An audit program is planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors do not audit their own work.The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in a documented procedure.The management responsible for the area being audited ensures that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities include the verification of the actions taken and the reporting of verification results. The internal audits are carried out as per the Procedure for Internal Audit QP/JEHAN/04.
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Monitoring and Measurement of Processes (Clause number: 8.2.3)
The company applies suitable methods for monitoring and, where applicable, measurement of the quality management system processes. Measurable Quality Objectives are set for processes which are monitored at predetermined intervals. These methods demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action are taken, as appropriate, to ensure conformity of the product. Appropriate process measurements and targets are defined during the management review meetings. The data is reviewed against the planned results and is presented to the top management using statistical tools. These reports are reviewed in the following management review meeting to initiate suitable corrective actions like resetting of targets, inclusion of new process measures or any other appropriate action.
Monitoring and measurement of product (Clause number: 8.2.4)
The company monitors and measures the characteristics of the product to verify that product requirements are fulfilled. This is carried out at appropriate stages of the product realization process in accordance with the planned arrangements. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person(s) authorizing release of product.Product release and delivery are not preceded until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer
Control of Non-conforming product (Clause number: 8.3)
The company ensures that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product are defined in a documented procedure. (Ref. Procedure QP/JEHAN/06).
The company deals with nonconforming product by one or more of the following ways:By taking action to eliminate the detected nonconformity;
By authorizing its use, release or acceptance under concession by a relevant authority and, where applicable, by the customer;
By taking action to preclude, its original intended use or application.
Records of the nature of nonconformities and any subsequent actions taken, including concessions obtained are maintained. When nonconforming product is corrected, it is subject to re-verification to demonstrate conformity to the requirements. When nonconforming product is detected after delivery or use
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has started, the company takes action appropriate to the effects, or potential effects, of the nonconformity.
Analysis of data (Clause number: 8.4)
The company determines, collects and analyzes appropriate data to demonstrate the suitability and effectiveness of the quality management system and evaluates where continual improvement of the quality management system can be made. This includes data generated as a result of monitoring and measurement and from other relevant sources.
The analysis of data provides information relating to Customer satisfaction, Sales, Quality index, Wastage during production, electricity /water consumption, timely project completion and Man days consumption, trends of non conformances, internal audit NC’s, Quality Objectives (Ref FRM/JEHAN/26)
Improvement (Clause number: 8.5)
Continual Improvement (Clause number: 8.5.1) The company shall continually improve the effectiveness of the QMS through
the use of the quality policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and management review.
Corrective Action (Clause number: 8.5.2)
The company takes action to eliminate the cause of non-conformities in order to prevent recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.
A documented procedure (Ref. Procedure QP/JEHAN/05) is established to define requirements for
Reviewing nonconformities (including customer complaints) Determining the causes of nonconformities Evaluating the need for action to ensure that nonconformities do not
recur Determining and implementing action needed Records of the results of action taken Reviewing corrective action taken
Preventive Action (Clause number: 8.5.3)
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The company has determined action to eliminate the cause of potential non-conformities in order to prevent their occurrence. Preventive actions taken are appropriate to the effects of the potential problems.A documented procedure (Ref. Procedure QP/JEHAN/05) is established to define requirements for
Determining potential nonconformities and their causes Evaluating the need for action to prevent occurrence of
nonconformities Determining and implementing action needed Records of the results of action taken Reviewing preventive action taken
3.3 Procedures
SR. NO.
TITLE PROCEDURE NO.
1. DOCUMENT & DATA CONTROL QP-JEHAN-01
2. CONTROL OF RECORD QP-JEHAN-02
3. MANAGEMENT REVIEW QP-JEHAN-03
4. INTERNAL QUALITY AUDIT QP-JEHAN-04
5. CORRECTIVE & PREVENTIVE ACTION QP-JEHAN-05
6. CONTROL OF NON CONFORMITY QP-JEHAN-06
7. CUSTOMER COMPLAINTS QP-JEHAN-07
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8. CONTRACT REVIEW QP-JEHAN-08
9. PURCHASE CONTROL QP-JEHAN-09
10. EQUIPEMENT MAINTENANCE QP-JEHAN-10
11. TRAINING QP-JEHAN-11
12. COMMUNICATION QP-JEHAN-12
3.3.1 Document and Record control
PurposeThe purpose of this procedure is to CONTROL all Quality related documents, Quality manual, procedures manual, , Forms, etc., are controlled Documents . Scope This procedure covers all copies of the quality system and related documents
ResponsibilityThe Management Representative is responsible to prepare and implement this procedure and it is issued & approved by MD DefinitionsDOCUMENTATION - A set of Instructions, Procedures, Work instructions or Standard Operating procedures which describe how to perform an activity. CONTROLLED COPY: A copy of documents the originator has the responsibility to keep updated as and when required.
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UNCONTROLLED COPY: A copy of a document which is not subject to revision control.
OBSOLETE COPY: These are outdated copies of documents which are not used in quality management system of Jehan Green Walls.
CHANGE REQUEST FORM: A Form describing proposed changes to control documents
Procedure:
Sr. No
ActivityResponsible/Authorized
Record/ References
5.0 GENERAL:5.1 "Controlled" documents shall be those,
which are monitored for version. JEHAN maintains a hard & soft copy based QMS.
5.2 The Quality Manual shall be prepared & reviewed by MR approved & issued by the MD.All mandatory procedures shall be prepared, reviewed, approved and issued by MR.
MRMD
Master File: QMS
5.3 The Quality Processes & related all the system documents shall be prepared and reviewed by the MR and approved & issued by MD
MR
5.4 The quality policy, objectives, organization chart, responsibilities - authorities and desired – current competencies are approved by the MD.
MDMaster File: QMS
5.6 All QMS master copies, which shall be used for making additional controlled copies is signed in original by MR and marked with ‘MASTER COPY’ Stamp on backside of each page.
MR -
5.7 The master hard & soft copies shall remain with the MR. The soft copies shall be backed up as a part of regular backup process by MR.All QMS soft documents shall be available as in ‘Read-Only’ format for relevant process owners/as concerned as authorized by MR
MR -
5.8 The controlled copies are stamped with ‘CONTROL COPY’ stamp on front side of each page are distributed to relevant process owners.
MR -
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Sr. No
ActivityResponsible/Authorized
Record/ References
5.9 All stamps related to QMS are kept in the custody of MR.
MR -
5.10
Obsolete documents shall be removed from points of issue and use. Master hard copies shall be clearly marked ‘obsolete COPY’ (Red in Color) and retained in the obsolete file maintained by the MR.
MRObsolete documents file
5.11
Master Lists shall identify the current issue status of controlled documents and would also serve to preclude the use of obsolete documents.
MRMaster List File
6.0 AMENDMENTS:6.1 Amendments to controlled documents
shall be made by the same position/function, who reviewed and approved the original document.
MRAmendment Register
6.2 Approval of amendments is done by the MR in consultation with the concerned process owner after which the Amendment Register updated by the MR. The amended document is reviewed by the concerned process owner and then approved by the MR
MRAmendment Register
6.3 The changes are communicated to concerned holders by appropriate means, and the upgraded documents are made available.
6.4 Those seeking amendments to documents shall provide pertinent background information for review by the position/function with the authority to approve changes.
6.5 The amended document is allocated a new version as mentioned subsequently in this procedure.
MRMaster List File6.6 The master list of documents is updated
to reflect the latest versions by the MR.
7.0 DATA:7.1 Data includes -
Approved Vendor List. Master Lists
MR -
8.0 DOCUMENT IDENTIFICATION: The QMS has been given a unique identification with version & date, as follows:
58
Sr. No
ActivityResponsible/Authorized
Record/ References
8.1 For Manuals: QM Q identifies the Quality M identifies the Manual
The version and date shall be clearly indicated in the left side of footer of the manuals.
MRMaster List File
8.2 For Procedures: QP/JEHAN/ XX QP identifies a Procedure JEHAN identifies Organization
Name XX is the procedure number
The version and date shall be clearly indicated in the left side of footer of the procedures.
MRMaster List File
8.3 For Forms: FRM/JEHAN/YY FRM identifies a Form JEHAN identifies
Organization Name YY is the form number
The version and date shall be clearly indicated in the left side of footer of the forms.
MRMaster List File
8.4 All document’s version shall be controlled by date of issue and & version number. They shall be versioned as 1.00 when the documents are created. The version control procedure is as follows: In case of minor changes (e.g. small
amendment in single document) the second part 00 is updated to 01
In case major updates (e.g. when all quality system documents undergo change together) the first part of the version number is updated to 2.00
MR Master List
9.0 FORMS
59
Sr. No
ActivityResponsible/Authorized
Record/ References
9.1 Each form shall be identified. The master hard copies of forms are maintained with the MR. Control is by comparison with these master copies and/or by version / number. It shall be the responsibility of the users to obtain the latest copy of the desired form from the MR .
MRMaster List File
10.0
STANDARDS/EXTERNALLY GENERATED DOCUMENTS
10.1
Details of Externally Generated Documents shall be entered onto the Master List.
MR
Master List File
10.2
Details of externally generated documents / Standards (Name, Publication and distribution details) are mentioned in the List of External Documents maintained with the MR.
MR.
10.3
The reissued / amended standards / externally generated documents shall be kept with the MR .
10.4
The MR contact the applicable sources to check validity of externally controlled documents.
10.5
The MR ensures that process owner obtain a hard copy / photocopy of the Standards / Externally Generated Documents and amendments.
3.3.2 Control of Records
PurposeThis document details the Procedure to be followed by JEHAN for the Control of all the records viz Quality Records which are maintained to demonstrate the achievement of the required Quality and the effective operation of the Quality System Scope This Procedure applies to all the records generated by JEHAN.
ResponsibilityThe Management Representative is responsible to prepare and implement this procedure and it is issued & approved by MD
Definitions:Quality Record
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A document which furnishes objective evidence of the activities performed or results achieved. Customer Complaints records, Approved Suppliers List , Client P.O & Invoices. Administrative recordsAll the records related to administrative activities, which includes Training records, Personal records, Minutes of the Meetings, budget, etc.
Technical records:
JEHAN Quality System RecordsEach staff member of JEHAN is responsible for ensuring that Quality, Admin &Technical Records (Customer Complaints records, Client P.O., Approved Suppliers List, Training & Personal Records, generated within their work area are identified in accordance with this Procedure.
All Records are generated electronically and where appropriate will be Filed, Stored (on soft copies and or hard copy) and maintained in a good and safe way so that they are readily retrievable and loss or deterioration is minimized.
It is the responsibility of the person generating a document to ensure that they are legible, accurate, complete and identifiable, and that they are stored and maintained.
No unauthorized personnel are allowed access to Quality, Admin & Technical Records. Internal and External Auditors shall be given full access to review these Records. The request for such access shall be approved by the Management Representative of JEHAN
External Customers will not have any accesses to these records unless and otherwise authorized by the JEHAN
On detecting the mistakes/, they are crossed out not erased, made illegible or deleted & the correct value is entered. All such changes to records is signed by MR.
In case of records stored electronically care is taken to avoid loss or change of original data. For all electronic records, back up is taken on monthly basis.Electronic data stored in CD on monthly basis with unique identification system
Storage of FilesAll Quality Records (Customer Complaints records, Approved Suppliers List, Client P.O, Invoices, Training & Personal Records are stored in a clean / tidy area for the retention period of 5 years. After 5 yrs records shall be destroyed (Back up is taken electronically & stored).
3.3.3 Management Review Meeting
Purpose
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This document details the procedure to be followed by JEHAN management in their review of the Quality Management System to ensure its continued suitability and effectiveness.
ScopeThis procedure applies to all Management Review activities carried out by JEHAN.
ResponsibilitiesThe Management Representative is responsible to prepare and implement this procedure and it is issued & approved by MD
DefinitionsManagement Review - The periodic review of the Quality Management System to ensure its continued suitability and effectiveness.
MR - Management Representative.
ProcedureThe Management Review Meeting shall be conducted every year, normally in the end of the year.
All such meetings shall be fully recorded in the Minutes of Meeting.
The meeting shall be attended by all senior staff members and all attendees will sign the Minutes of Meeting.
The meeting will be held to discuss as a minimum the following :-- Review of the minutes of the last meeting.- Review of suitability & effectiveness of the Quality Management
System - Review of trends in non-conformances, corrective & preventive actions.- Customer complaints.- Review of internal and external auditing.- Training.- Supplier’s evaluation. - Recommendation for Improvement- Any other business / Date of next meeting.
Minutes of meeting will be kept as a record of Management Review
RecordsThe following record will be kept while implementing this procedure: -Minutes of the Management Review Meeting - FRM-JEHAN-30
3.3.4 Internal audit
PurposeThis document details the Procedure to be followed by JEHAN for Internal Quality Audit. The purpose of this Procedure is to ensure that a system for
62
evaluating the effectiveness, suitability and the degree of implementation of JEHAN Quality System is initiated and maintained.
Scope and ResponsibilitiesThis procedure applies to all Internal Quality Audits performed at JEHANThe Management Representative is responsible to prepare and implement this procedure and it is issued & approved by MD.DefinitionsAudit - A systematic and independent examination to determine whether Quality activities and their related results comply with the requirements of the Quality System.Internal Audit - An Audit carried out internally by JEHAN personnel to evaluate performance.Non-Conformance - A Quality System failure where an element of Quality Management System has not been followed in line with the requirements of the International Standard.Observation - Where the Auditor brings attention to a minor system failure that does not warrant being classed as a non-conformance.
Procedure
Sr. No.
Activity Records /References
Responsibility / Authority
4.0 AUDIT PLANNING 4.1 An internal quality audit to verify
compliance of the QMS shall be undertaken at least twice in a year.
Audit Plan MR
4.2 Based upon an evaluation of each element of the system, the more important activities shall be audited more frequently.
MR
4.3 An Audit Schedule shall be maintained, which lays out the planned IQA dates for 12 months.
Audit Plan MR
5.0 SCHEDULING AND PREPARATION OF AUDITS
5.1 Auditors shall not audit their own work. Audit Schedule
MR
5.2 The Management Representative shall be responsible for scheduling, preparing, performing, reporting the audit. The Audit Plan states the planned activities for each audit.
Audit Plan MR
5.3 The Management Representative shall arrange to be assisted by others who are suitably trained.
Audit Schedule
MR
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Sr. No.
Activity Records /References
Responsibility / Authority
5.4 During the scheduling and preparation for an audit, the Management Representative and other auditors who are part of the audit team may prepare Audit Check List(s), or alternatives, based on the audit scope and the system elements to be audited and including reference to previous audit reports and findings.
--- MR/Auditors
6.0 PERFORMANCE OF THE AUDIT6.1 The audit shall be carried out by the
auditor asking a series of questions to the auditee and examining the objective evidence made available, in line with previously developed checklists or alternatives.
--- Auditor
6.2 Objective evidence is often in written form.
--- Auditee
6.3 The mechanism of auditing is to "sample" the Quality System by examining examples of outcomes and comparing these with documented requirements, so that the auditor is able to form a balanced opinion as to whether the Quality System complies with the requirements of the Standard, and the organization’s own documentation (e.g.: If maintaining a certain record is a stated requirement, is this record available?).
-- --
6.4 The Auditors shall record instances of compliance or non-conformances and any comments alternatively on the:Audit Check List(s)Their own notes
Audit Check List(s) / Auditors’ notes
Auditors
6.5 Any non-conformance finding resulting from an audit shall be documented by the auditor by initiating a Corrective Action Request
NCR Auditor
6.6 At the conclusion of the audit, the Management Representative may discuss non-conformance findings to ensure that they are understood by the auditee, and get an acknowledgment and signature on each Corrective Action Request.
NCR Auditor/MR
64
Sr. No.
Activity Records /References
Responsibility / Authority
6.7 NCR forms and Audit Check List / notes are maintained in the IQA file.
IQA file MR
7.0 AUDIT REVIEW AND FILING7.1 Outcomes of internal quality audits
shall be an agenda item for Management Reviews.
--- MR
7.2 Audit related documents (Audit Schedule, Opening meeting conduction, Audit Check List / notes, NCR form etc.) shall be retained as records.
IQA file MR
3.3.5 Corrective and Preventive Action
PurposeThis document details the Procedure to be followed by JEHAN to have control of Corrective and Preventive Action. The purpose of this procedure is to establish a controlled method to determine the causes of any deficiencies in the Quality System, its implementation and to consider the actions needed to remedy such deficiencies
Scope & responsibilityThis procedure covers all quality related problems identified during Process, Internal Audit & Customer Complaint. The Management Representative is responsible to prepare and implement this procedure and it is issue & approved by MD
DefinitionsNon-Conformance - The non-compliance to specified requirements.Customer Complaint - Negative or unfavorable comments from a Customer.NC / CA - Non Conformance / Corrective Action CAR/NCR: Corrective Action Request Report or Non Conformance ReportProcedure
65
Sr. No
ActivityResponsibility / Authority
Records / References
4. General
4.1
Corrective actions and Preventive action may be taken on: Customer Complaints
Respective Process Owners/MR
Customer Complaint Form
(Significant / Recurring) Non Conformances from Customer Complaint
MRM Record
IQA/TPA Findings
Various other non-conformances as identified via day to day operations.
NC Register
Corrective actions identified during MRM
MRM Record
5. Corrective Action
5.1
Based on the nature of the non conformances, corrective actions are planned and implemented.
Process Owners
NC, CAR form/NC Register
5.2
The steps involved in taking corrective action are: Reviewing non-conformances and
identifying their cause. Evaluating the need for action in
order to ensure that the same non-conformance does not recur.
Deciding the action to be taken, assigning responsibility for taking actions, and target dates, and implementing the action.
Reviewing of action taken and its effectiveness (this may be done in subsequent IQAs).
Process Owners
NC,CAR Form/ NC Register/ MRM Record
5.3
Records of Corrective Action are maintained in MR NC Registers, CAR Forms, or various process records.
Process Owners
5.4
On dealing with Corrective Action, due attention is given to: Accurate description of the non-
conformance Corrective Action to be fixed. Long term corrective action to
prevent recurrence
Process Owners
NC Register/ CAR FormsMRM Record
66
Sr. No
ActivityResponsibility / Authority
Records / References
Verification that corrective action undertaken has been effective from MRM Input.
Corrective Action may involve, for example: Changes in documented processes /
procedures to reflect the corrective action and
Up gradation of competence to ensure changed documented processes / procedures are implemented in practice.
6. Customer Complaints
6.1
Customer Complaints are addressed as mentioned in the Management Process and all operations process.
MRCustomer Complaint form
7.Preventive Actions
7.1
Documents which record instances of unsatisfactory performance are reviewed and analysed by process owners / MR on a regular basis to detect potential non-conformances.
Process Owners / MR
--
7.2Process owners may suggest preventive actions to the MR at any time.
Process Owners
-
7.3
The MR is responsible for analysing proposed preventive actions. The proposed preventive action is accepted / rejected based on: The nature of the potential non
conformance and its cause The probability of occurrence / the
potential severity of impact / potential benefits
The evaluation of the need for taking action to prevent the occurrence of this non conformance
If accepted, actions are determined and implemented, and the preventive actions taken are reviewed.
MR
NC RegisterMRM Report
7.4The preventive actions identified and actions taken are reviewed and summarized by process owners.
Process Owners / MR
MRM Report
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7.5
Preventive actions may includes following aspects: Revising
documentation/formats/guidelines Up-gradation of the processes/
specifications. Planning competence up gradation etc.
3.3.6 Non conformity Procedure
PurposeThe purpose of this document is to establish system for identification, documentation, evaluation segregation and disposition from non-conforming services.This document sets out the procedure that company uses to ensure that above requirements are met. Scope and Responsibility:This procedure is applicable to deviations and deficiencies identified during company’s Day to day operations and Quality System.The Management representative is responsible to prepare and implement this procedure and it is issued & approved by MD
DefinitionsNon Conformity - Non-fulfillment of specified requirement Verification : Conformation by examination and provision of objective evidence that specified requirements have been fulfilled
Specified Requirement: Documented instructions, procedures, specifications or guidelines.
Corrective Action: Action taken to eliminate the cause of an existing non-conformity, defect, or other undesirable situation.
Preventive Action: Action taken to eliminate the cause of potential non-conformity, defect or undesirable situation in order to prevent it’s reoccurrence.
Sr. No.
ActivityResponsibility/Authorized
Record/ References
1.0 General - -
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Sr. No.
ActivityResponsibility/Authorized
Record/ References
1.1
Non Conformances may be of the following three types:
System Non Conformances - Non conformances in the design & documentation of the QMS. For example: Non full filment of a ISO 9001 requirement in the Quality Manual, i.e., the QMS scope is not mentioned in the manual.
Process Non Conformances - Non conformances arising out of the execution of any of the processes identified as a part of JEHAN. For example, the process profile of Admin process says that training shall be imparted to new employee but in reality it doesn't do so and not maintaining records is the process non conformance.
- -
2.0 System Non Conformances
2.1System non conformances may occur in the MR process.
2.2
These are recorded in the MR process' NC Register, together with identified causes and corrections / corrective actions / preventive actions.The responsibility for analysis of the NC and the decision on the disposition actions rests with the MR.
MRNC Register
2.3
Some of the non-conformances arising during IQA may also be treated as system non-conformances and are addressed as described in the Procedure for Internal Quality Audits.
MR
Refer Procedure for Internal Quality Audits
3.0 Process Non Conformances - -
3.1Process non-conformances may occur in any of the processes forming a part JEHAN,
- -
3.2
These are recorded in the MR- NC Register, together with identified causes and corrections / corrective actions / preventive actions.The responsibility for analysis of the NC and the decision on the disposition
Process OwnerNC Register
69
Sr. No.
ActivityResponsibility/Authorized
Record/ References
actions rests with the concerned Process Owner in coordination with the MR, depending on the nature of the NC.
3.3
Some of the non-conformances arising during IQA may also treated as Process non conformances and are addressed as described in the Procedure for Internal Quality Audits.
MR
Refer Procedure for Internal Quality Audits
4.0 Service Non Conformances
4.1Services non conformances may occur while rendering services to customers.
- -
4.2
These are recorded in various process related records, or onto the MR- NC register, together with identified causes and corrections / corrective actions / preventive actions as appropriate. Some examples are:
The responsibility for analysis of the NC rests with the process owner of the stage at which the NC was raised, in coordination with process owners of all preceding stages, as applicable. The decision on the disposition actions rests with the Process Owner of the stage at which the NC was raised, in consultation with the MR
Respective Process Owners
NC register
6.0 Review of Non Conformances
6.1 NC registers and other records identifying non conformances
Process Owners / MR
NC Registers
6.2
Significant / recurring non-conformances may also be reviewed in the Management Review Meeting, and corrections / corrective actions / preventive actions identified.
MRMRM Report
3.3.7 Customer complaint
Purpose
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To ensure that the organizations main focus is on its customers/clients to provide best service that meets their requirement.
Scope This procedure will be applicable to all customer complaints and feedback and revieW of all complaints and feedback received from the customers.
ResponsibilityThe Sales Manager is responsible to prepare and implement this procedure and it is issued & approved by MD
ProcedureThe current and future needs of the customers is Identified by SALES MANAGER and recorded for the review.
All the customer feedback /complaints recorded and evaluated by the SALES MANAGER and discuss during the review meetings.
For each customer complaint –
Records of complaints include the following information: Details of the complaint Root cause analysis Selection & implementation of corrective action Monitoring of Corrective action Follow up verification Audit
Where specified in the contract the customer or his representative shall be allowed to inspect the product at JEHAN premises.
3.3.8 Contract Review
Purpose This document details the procedure to be followed by JEHAN Management in the Enquiry and order reviewing prior to acceptance as well as execution and follow up of the orders.
ScopeThis procedure will be applicable to all orders and review of all orders received from the customers prior to acceptance.
ResponsibilitiesThe Sales Manager is responsible to prepare and implement this procedure and it is issued & approved by MD
Definitions
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Contract Review -The review of the documents and confirmed orders such as General terms and technical conditions, specifications etc, to identify the stated and implied needs of the client.
ProcedureAll the orders received from the clients whether it’s a verbal telephonic or email shall be registered on the electronic data by the JEHAN and job no/ reference no given to all such orders. All the orders/ contract shall be reviewed by Sales Manager & MD for verifying the capability of the JEHAN whether they shall meet the requirements of customer.
3.3.9 Purchase
PurposeTo ensure that purchased services and purchased items meets the requirement and received in agreed time.
Scope This procedure covers the requirements, systems and controls for the systems and services at company premises..
ResponsibilityThe Purchase Manager is responsible to prepare and implement this procedure and it is issued & approved by MD
Definitions L.P.O. - Local Purchase order or Local Purchase Contract Contract: An agreement between JEHAN representative and customer
ProcedureThe Purchase Manager will maintain a Schedule of Key Suppliers who will be the first point of contact in tendering for supply of items. The presence of a supplier on the list does not imply that he is pre-approved to supply anything in his line of business. To assist in purchasing, Supplier Performance Schedule will be maintained giving the date, supplier, P/O number, what provided, Purchase Manager, and a grade (A = excellent, B = good, C = Satisfied, D = unacceptable) for delivery (time), quality and price, which will be graded by the Purchase Manager
Supplied goods or services shall be procured only from the approved supplier.
Based on past experience ability to meet the requirement, evaluation of suppliers shall be done and vendor rating will be given and list of approved suppliers shall be generated. The Purchase Manager shall approve the list.
The inclusion of the new suppliers / vendor list must be authorized by the Purchase Manager & MDOther new suppliers shall be required to reply the questionnaire/ supplier’s Qualification statement established by the company and submit the pre
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qualification file containing name of the company, experience, previous references, applied quality system, qualification and experience personnel.The Purchase Manager will evaluate the new suppliers pre qualification file and will decide the subcontractor can be approved on the basis of information provided or if require the audit at suppliers premises carried out.
The performance of the approved suppliers shall be monitored by the Purchase Manager. All remarks, comments or complaints must be recorded. The records shall be reviewed at least once in a year. Communication shall be established with the vendors. Warnings about performance below the mark, corrective actions measures taken and if the performance of the vendor is not up to the mark such vendors shall be deleted from the list.
3.3.10 Equipment Maintenance
PurposeTo ensure that the all the equipments used in JEHAN is suitable for their intended use.
ResponsibilityThe Production Manager is responsible to prepare and implement this procedure and it is issued & approved by MD DefinitionsCorrective maintenance: Immediate action (breakdown maintenance)Preventive maintenance: Proactive action
ProcedureJEHAN shall give more importance to equipment maintenance. Corrective maintenance / breakdown maintenance registered maintained by the JEHAN in case of any break down in the equipment.Preventive maintenance of JEHAN equipment is done by means of yearly calibration and where ever possible service contract maintain with the equipment supplier/ manufacturer.All the records of verification maintained in the file
3.3.11 Training
PurposeTo ensure that the training needs of the staff members of JEHAN whose work affects quality, are identified and that the training is provided accordingly.
Scope and ResponsibilityThis procedure specifies the training needs, ways of achieving the required level of training.Responsibility – Administrative AssistantAdministrative Assistant is responsible to prepare and implement this procedure and it is issued & approved by MD
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DefinitionsInduction training: Introductory training provided to each new employee on appointment.
In process training: To improve the performance, accommodate new techniques and processes etc., training provided to company’s employees.Procedure:
1. Induction training:
New staff upon joining JEHAN will be given induction training within their particular department. Steps as follows;
introduction to company’s Quality Policy, the Quality System and employee’s own responsibility for Quality,
instruction on safety, health and environmental requirements,
Internal rules of JEHAN.
Introduction to job requirements.
In case of staff who are required to perform specific assigned tasks and special processes, adequate specialized training shall be provided by senior employees or external resources as appropriate.
2. In process training.
The Administrative Assistant/MD shall review performance of all their staff in order to assess the training needs in JEHAN. Such review will be carried out annually.
Administrative Assistant / MD will review the TRAINING NEEDS and decide on approval of training.
Based on approved reports Administrative Assistant/MD shall in consultation with MR compile training plan for the following year and submit to the MD for approval.
The MD reviews the plan, discusses it if necessary with the Administrative Assistant and approves it.
Administrative Assistant accordingly, will arrange training courses according to the approved plan. For each participating employee the record of attendance will be established.
Post training performance of employees will be monitored and necessary actions to be taken if necessary.Training Record of employees is established as appropriate to monitor the status of training in the company.
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3.3.12 Communication
Purpose:
To identify the types of communication carried out by JEHAN staff in all its business activities
To identify, establish and control the different methods of communication both within and outside units involving JEHAN & its business related activities
Scope: The scope of this document covers:
Internal Communications between the various levels and functions of JEHAN
Receiving, Documenting and responding to relevant communications from External Interested Parties like customers, suppliers, consultants etc.,
The scope of this document extends to all Process Owners and its subordinates in terms of the Inter-relationships of personnel and the communications necessary to facilitate effective Quality Management System
Responsibility:The Process Owner & MR are responsible to prepare and implement this procedure and it is issued & approved by MD
PROCEDURE:Internal Communication
The information related to the Company Policy towards Quality, are communicated through Inter-office memos, Notice Board Displays, training sessions, pamphlets , posters and other such means. Verbal means are also used by Process Owners and coordinators in communicating the intention of the same across all the levels of organization. This shall be monitored through periodic Internal Audits, Performance appraisals, on the job training and review by Process Owners
In case of a new employee, Admin Assistant shall ensure that the personnel is given initial introduction to other staff members, the company facilities, the do’s and don’ts.
Other means of general inter departmental communications are in the form of e-mail, letters, reports and meetings and group discussions. The details of such meeting or discussions are recorded through appropriate means and communicated to the concerned across the organization. The records of the same are maintained with the concerned department.
Communication mainly intended towards employee awareness and implementation of Quality, and its impacts are carried out in the form of SOP, Process Flow Charts, Reference to International and Local standards, Legal and Statutory requirements, assembly points in case
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of emergency, on the job training, periodic review reports etc., The records of the same are maintained at respective departments.
Training is considered as one of the effective means of communicating the company stand towards achieving JEHAN objectives and the same shall be identified, reviewed, conducted and evaluated by respective Process Owners as and when necessary and it monitored by the Administrative Assistant as per the laid down company policy and procedures. Records of such trainings are maintained at identified places and are used for continual enhancement of employee involvement in the business growth
The performance and compliance of the organization in line with the requirements of Quality Management System policy and procedures and other business targets are reviewed once in every 6 months and the details of discussions held, action planned are minutes on the “Minutes of JEHAN Management Review Meeting)” and the same is communicated to the concerned Process Owners, top management through hard or soft copies.
In case of key personnel going on planned long leave, the same shall be communicated to the immediate supervisors and transfer of their responsibilities shall be done as per company policy and procedure. If found necessary both verbal and written communication is used during responsibility transfer.
External Communication
External communication is carried out with customers, suppliers, contractors, local authorities, international customers & consultants through E-mail, fax, telephonic conversations, letters, and complimentary gifts are considered as the prime means of communication.
In case of customers communication is made possible through feedbacks, technical help, operational guidelines and complaints.
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3.4 FormsThe following are the sample formats of forms which are mandatory to maintain as per the ISO 9001:2008 requirements
SR.NO. TITLE FORM NO.
1. Internal Audit Plan FRM-JEHAN-012. Internal Audit Schedule FRM-JEHAN-023. Non Conformity Report – Internal Audit FRM-JEHAN-094. Non Conformity Report Register FRM-JEHAN-045. Internal Audit Checklist FRM-JEHAN-056. Internal Audit Summary Report FRM-JEHAN-067. Corrective Action Request FRM-JEHAN-078. Customer Complaint Report FRM-JEHAN-089. Customer Complaint Register FRM-JEHAN-0910. Customer Satisfaction Survey FRM-JEHAN-1011. Supplier Pre-Qualification FRM-JEHAN-1112. Supplier Evaluation FRM-JEHAN-1213. Approved Supplier List FRM-JEHAN-1314. Training Need Analysis FRM-JEHAN-1415. Training Plan FRM-JEHAN-15
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16. Training Attendance Sheet FRM-JEHAN-1617. Training Feedback FRM-JEHAN-1718. Employée Training Record FRM-JEHAN-1819. Training Evaluation FRM-JEHAN-1920. Equipments Calibration FRM-JEHAN-2021. Equipments Preventive Maintenance FRM-JEHAN-2122. Maintenance Breakdown FRM-JEHAN-2223. Documents & Distribution Control FRM-JEHAN-2324. Amendment Form FRM-JEHAN-2425. Amendment Register FRM-JEHAN-2526. Quality Objectives FRM-JEHAN-2627. Non Conformity Report (Purchase) FRM-JEHAN-2728. Joining & Induction FRM-JEHAN-2829. Interview Assessment FRM-JEHAN-2930. Management Review Meeting FRM-JEHAN-30
3.4.1 Internal Audit Plan
Procedure
Jan
Feb
Mar
Apr
May
June
July
Aug
Sep
Oct
Nov
Dec
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Prepared By Authorized by
Management Representative MD
3.4.2 Internal Audit Schedule
IA No:
Date:
DateTime
Procedure / Function to be audited
Auditee(s)
Auditor(s)From
To
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Prepared By Authorized by
Management Representative MD
3.4.3 Non conformity Report
Procedure/Area Name: IA No & Date:Auditor Name: Auditee Name: NCR No: Details of Non Conformity ISO 9001 Clause No:
Auditee Sign: Date :
Root Cause Analysis:
Auditee Sign: Date :
Corrective Action:
Propose implementation Date –Auditee Sign: Date :
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Preventive Action
Auditee Sign: Date :
Verification/Follow Up Audit Details:
Auditee Sign: Auditor Sign: Date: Date :
3.4.4 Non Conformity Report Register
AUDIT NO.
NCRNO
NCR ISSUED TO:
AUDIT DATE
ACTION COMPLETION DATE
PROPOSED FOLLOW UP DATE
DATE NCR CLOSED
MR SIGN
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3.4.5 Internal Audit Checklist
4. Quality Management System Observation4.1 General RequirementsIs the Quality Management System established, documented, implemented, maintained and continually improved in line with this standard?Does the organization manage these processes in line with this standard?4.2 Documentation requirements4.2.1 GeneralDoes the Quality Management System documentation include:a) Documented statements of a quality policy and quality
objectives?b) a quality manual?c) Documented procedures required in this standard?d) Documents required by the organization to ensure effective
operation and control of its processes?4.2.2 Quality ManualIs a Quality Manual established and maintained that includes:a) The scope of the Quality Management System (including
details and justification for any exclusions)?b) documented procedures, or reference to them?c) a description of the interaction between the processes
included in the Quality Management System?4.2.3 Control of DocumentsAre documents for the Quality Management System controlled?
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Are documents defined as records controlled?4.2.4 Control of Quality RecordsAre Quality records established and maintained to provide evidence of conformity to requirements and effective operation of the Quality Management System?Are Quality records legible, readily identifiable and retrievable?Is a procedure established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of quality records?5. Management Responsibility5.1 Management commitmenta) Is there evidence to demonstrate top management
commitment to the development and improvement of the Quality Management
5.2 Customer FocusHas top management ensured that customer requirements are determined, and fulfilled – with the aim of enhancing Customer Satisfaction?5.3 Quality PolicyHas top management ensured that the Quality Policy:Is the Quality Policy controlled?5.4 Planning5.4.1 Quality objectivesAre Quality objectives established at all relevant functions and levels within the organization?Are the Quality objectives:a) measurable?b) consistent with the Quality Policy?5.4.2 Quality PlanningDoes top management ensure that:a) the planning of the Quality Management System is carried
out in order to meet the requirements of 4.1, as well as the quality objectives?
b) the integrity of the Quality Management System is maintained when changes to the Quality Management System are planned and implemented?
5.5 Responsibility, authority and communication5.5.1 Responsibility and AuthorityAre functions and interrelations within the organization, including responsibilities etc, defined and communicated?5.5.2 Management RepresentativeAre appointed member(s) of management responsible for:a) ensuring that Quality Management System processes are
established, implemented and maintained?b) reporting to top management on the performance of the
Quality Management System, including needs for improvement?
c) ensuring the promotion of customer requirements throughout the organization?
5.5.3 Internal CommunicationAre there communication processes established within the organization? Does communication take place in respect of the effectiveness of the Quality Management System?5.6 Management Review
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5.6.1 GeneralIs the Quality Management System reviewed by top management, at planned intervals, to ensure ongoing suitability and effectiveness?Does the Management Review include assessing opportunities for improvement and the need for changes to the Quality Management System – including quality policy and objectives?Are records of management reviews maintained?6. Resource Management6.1 Provision of ResourcesDoes the organization determine, and provide the resources needed to:a) implement and continually improve the Quality Management
System processes?b) to enhance customer satisfaction by meeting customer
requirements?6.2 Human Resources6.2.1 GeneralAre personnel who are assigned responsibilities in the Quality Management System competent on the basis of education, training, skills and experience?6.2.2 Training, Awareness and Competency6.3 InfrastructureDoes the organization determine, provide and maintain the facilities it needs to achieve conformity of product and/or service, including:a) buildings, workspace and associated utilitiesb) process equipment, both hardware and software, andc) supporting services such as transport, communications, etc.6.4 Work EnvironmentDoes the organization determine and manage the work environment needed to achieve conformity to product requirements?7. Product Realization7.1 Planning of Product RealizationHas the organization planned and implemented the process needed for product realization? 7.2 Customer-related processes7.2.1 Determination of requirements related to the product7.2.2 Review of requirements related to productAre product-related requirements reviewed prior to commitment to supply of a product to a customer?Are review results and follow-up actions recorded?7.2.3 Customer CommunicationAre effective arrangements determined and implemented for communication with customers in relation to:a) product informationb) enquiries, contracts or order handling (including changes)?c) customer feedback, including complaints?7.3 Design and Development - Excluded Excluded
7.4 Purchasing7.4.1 Purchasing Process
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Does the organization ensure that purchased product conforms to specified purchase requirement?Is the type and extent of control applied to supplier / purchased product dependent on the effect of the purchased product on subsequent product realization?Are suppliers evaluated and selected on the basis of their ability to supply product in line with requirements?Are criteria for selection and evaluation established?Are records of evaluations / follow-up actions maintained?7.4.2 Purchasing InformationDoes purchasing information describe the product to be purchased, including, where appropriate:Are steps taken to ensure the adequacy of specified purchase requirements prior to communication to supplier?7.4.3 Verification of purchased productAre inspection or other activities necessary for ensuring product meets specified purchase requirements established and implemented?7.5 Production and service provision7.5.1 Control of production and service provisionAre production and service provision carried out under controlled conditions? – including, as applicable:7.5.2 Validation of processesAre production and service processes validated where the resulting output cannot be verified by subsequent measurement and/or monitoring?7.5.3 Identification and traceabilityIs the product/service identified by suitable means throughout product realization?7.5.4 Customer propertyIs care exercised with customer property ?Is such property, provided for use or incorporation into the product, identified, verified, protected and safeguarded?Are details of such property recorded and reported to the customer if lost, damaged or otherwise found unsuitable?7.6 Control of monitoring and measuring devicesDoes the organization determine the monitoring & measurement to be undertaken, and the monitoring & measuring devices needed, to provide evidence of conformity to determined requirements?8. Measurement, analysis and improvement8.1 GeneralDoes the organization plan and implement the monitoring, measurement, analysis and improvement activities needed to:a) demonstrate conformity of product?b) ensure conformity of the Quality Management System?c) to continually improve the effectiveness of the Quality
Management System?Do these include the determination of the need for applicable methods, including statistical techniques?8.2 Measurement and monitoring8.2.1 Customer Satisfaction
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Is information on customer satisfaction / dissatisfaction monitored as a measure of performance of the Quality Management System?Are methodologies for obtaining and using this defined?8.2.2 Internal AuditAre internal audits conducted at planned intervals to confirm that:a) the Quality Management System conforms to planned
arrangements, the requirements of ISO9001 and the organization’s own requirements?
b) it has been effectively implemented and maintained?Is the audit programme planned taking into consideration:a) status and importance of processes and areas to be
audited?b) results of previous audits?Is audit criteria, scope, frequency and methods defined?Is there a documented procedure for planning and conducting audits, and reporting / maintaining recordsDo management take timely action on audit findings?Do follow-up actions include verification of actions and reporting of verification results?8.2.3 Measurement and monitoring of processesAre suitable methods applied for measurement and monitoring of the QMS processes?8.3 Control of non-conforming productIs product which does not conform, identified and controlled to prevent unintended use/delivery?Are these controls and related responsibilities / authorities defined in a documented procedure?8.4 Analysis of data Is appropriate data collected and analyzed to demonstrate the suitability and effectiveness of the Quality Management System and to identify improvements that can be made?Is this data analyzed to provide information on:a) customer satisfaction?b) conformance to product requirements?c) characteristics and trends of processes and products,
including opportunities for preventive action?d) suppliers?8.5 Improvement8.5.1 Planning for continual improvementIs the effectiveness of the Quality Management System continually improved through the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive action, and management review?8.5.2 Corrective actionIs corrective action taken to eliminate the cause of non-conformities, in order to prevent recurrence?Is corrective action taken appropriate to the impact of the problems encountered?Is preventive action taken to eliminate the cause of potential non-conformities, in order to prevent occurrence?Is preventive action taken appropriate to the effects of the potential problems?
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3.4.6 Internal Audit Summary Report
TYPE OFAUDIT DATE OF AUDIT : AUDIT REPORT NO.
AUDIT TEAM: AUDIT STANDARD:: AUDIT LOCATION:
OPENING MEETING:
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FOLLOW-UP AUDIT RQUIRED : DATE OF FOLLOW UP AUDIT –
3.4.7 Corrective Action Request
CAR NO. AUDIT NO. AUDIT DATE:
SECTION/UNIT AUDITED
AUDITEE/GIVEN TO AUDITOR/GIVEN BY
PROCEDURE/SYSTEM AUDITED/REFERRED
AGAINST DOC.REF. CLAUSE REF.:
Details of Observation:
Signature: Signature: ______________________ (Auditor/Raised by) (Auditee/concerned person)
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PART B REMEDIAL / PREVENTIVE ACTION (To be filled by Auditee)
1. Summary of Root Cause:
2. Immediate Action Plan:
3. Long Term Action Plan:
Signature: ___________ Date: _______________
Agreed Date For Implementation: ___________
PART C FOLLOW-UP AND CLOSE OUT (To be filled by Auditor)
Propose Follow-Up Date: ____________ Close Out Date: ____________ Signature: ____________
Follow-Up Notes and Details (Indicate how corrective action was implemented. Attach wherever possible, an evidence and/or audit trails by giving appropriate references and documents verified).
_______ ________________ _________________________AUDITOR DATE MR
3.4.8 Customer Complaint Report
Customer: Complaint No:
Verbal Written
Description of complaint:
Sales Manager Date:
Root Cause Analysis :
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Process Owner
Immediate Corrective Action ;
Proposed Completion Date :
Process Owner : Date :
Proposed Preventive Action:
Process Owner Date :
Corrective & Preventive Action Review By Management Representative
MR Sign: Date :
GM Approval/ Comments:
MD Sign Date:
3.4.9 Customer Complaint Register
CCR
NO.
DATE RECD
.
CLIENT DATE FORWARDE
D TO GM
DATE FORWARDE
D TO MR
DATE CORRECTIV
E ACTION RECD.
DATE REPLIE
D TO CLIENT
REMARKS/
STATUS OF CCR CLOSED
Y / N
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3.4.10 Customer Satisfaction Survey
Dear Customer,
Our company following International Quality Management System ISO 9001: 2008 and in this concern we are in a process to measure Customer Satisfaction level, and give more quality service.Therefore, we are expecting answer of following question. Please fill in the blanks and oblige.
GM Sr.Nos
.Question Excellen
t5
Good4
Satisfied3
Acceptable2
Dissatisfied1
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1 Service as per schedule time
2 Handling of complaints on time
3 Response of inquiry service
4 Quality of Product
5 Competitiveness of pricing
Questionnaire is based on rating system5 = Excellent, 4 = Good, 3 = Satisfied, 2 = Acceptable, 1 = Dissatisfied
Customer/ Company Name
Name of the Person
Designation
Signature
Date
3.4.11 Supplier Pre-Qualification
92
3.4.12 Supplier Evaluation
93
The supplier should be appraised for each element listed below by placing A, B, C, and D in the relevant column. The new grading should be based on the average of the four appraised elements
SUPPLIERS
NAME
COMPLAINTS
0=A, 1=B, 2=C, more than 2=D,
NON CONFORMIT
Y
DELIVERY TIME
PRODUCT/
SERVICE QUALITY
PREVIOUS
GRADING
NEW GRADIN
G
A= Excellent, B = Good, C = Satisfied, D = Black List
3.4.13 Approved Supplier List
94
Sr. No.
Name of the
Product /
Service
Name and Address of
the Organization
Name of the
Contact Person
Phone Numbers
/ Fax Numbers / E-Mail
Date of Additio
n
Re-Evaluatio
n Frequenc
y
Re-Evaluation
Responsibility
3.4.14 Training Need Analysis
95
Personal Details
Name
Designation
Department
Job Competency Assessment (Knowledge or Skills Maintained or Developed)
Skills / Knowledge Requirements
Outstanding
Good
Average
With Shortcoming
s
Poor-Less than
Acceptable
Sign (Department Head )
Date
Training Needs
Areas to Be Trained Approved (Y / N)
Status
Sign (Management
Representative)
Date
3.4.15 Training Plan
TRAINING PLAN FOR ……………YEAR
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Training
Jan Feb
Mar
Apr
May
Jun Jul Aug
Sep
Oct
Nov
Dec
3.4.16 Training Attendance Sheet
Course Title
97
Date
Trainer
S.N.
Name Designation Signature
3.4.17 Training Feedback
98
Date: Name:
Training Undergone
Provided By
Trainer
Trainee’s Comments
Please Tick
Poor Fair Good V. Good Excellent
1 Course Contents
2 Course Delivery
3 Course Materials
4 Trainer
5 Overall
Trainee Date
3.4.18 Employée Training Record
PART 1
99
NameDesignationDate of Joining
EducationYear Degree Institute
Work ExperienceYear Position Company
PART 2
Training DetailsDate of
TrainingTraining Name Trainer
3.4.19 Training Evaluation
Training Subject/Topics: Date:
100
Department: Name of Trainee:
1) Objectives of the training:
2) How were the objectives related to JEHAN’s Quality Objectives?
3) What new concepts/ideas did you learn in the session?
4) How do you propose to implement these ideas at our end?
5) What personal changes would you make in yourself to demonstrate the effect of the learning?
6) How the training would help yourself and the company?
To be filled in by Admin and the M. R. :
1. Results achieved:
Sign : MR
3.4.20 Equipments Calibration
Sr.Nos.
Equipment Name
Model
Calibration Type
Internal /
Calibration Done
Date
Next Calibratio
n Due
Calibration Responsibilit
y
101
External Date
3.4.21 Equipments Preventive Maintenance
ITEM OR EQUIPMENTJAN
FEB
MAR
APR
MAY
JUN
JUL
AUG
SEP
OCT
NOV
DEC
102
3.4.22 Maintenance Breakdown
103
Sr. Nos
.
Date Equipments
Time of Completio
n of Repair
Down
Time
Reason for Breakdown
3.4.23 Documents & Distribution Control
104
Sr.No.
Document Name
Document Number
Document Version &
Date
Name of Process Owner
Sign. of PO
3.4.24 Amendment Form
105
Document Affected :
New/ Change Required:
Signed (Process Owner)
Date:
Approved YES NO
Comment:
Signed (Management Representative)
Date:
Change Completed and Document status:
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3.4.25 Amendment Register
Sr. No.
Date
Name of Procedur
e
Procedure
Doc./Form No.
Page
No.
What Chang
e made?
Earlier Versio
n
New Versio
n
Change Authorize
d by
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3.4.26 Quality Objectives
Department
Objectives
Target
Parameter
Data Sour
ce
Responsibility
Monitoring
Frequency
Actual
Result
Remark
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3.4.27 Non Conformity Report (Purchase)
Supplier Name:
P.O Nos.:
Date:
Item :
Details of Non Conformity
Process Owner Date :
Root Cause Analysis:
Process Owner : Date :
Corrective Action:
Propose implementation Date –
Process Owner: Date :
Preventive Action
Process Owner Date :
General Manager Approval/ Comments:
General Manager Date:
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3.4.28 Joining & Induction
Name of Employee :..................................................................
Birth Date :
Joining Date :
Address :
(Signature of Employee)
Word of welcome. Explain over all departmental organization and its relationship to other
activities. Explain employee individual contribution to the objectivities of
department. Discuss job content with the employee. Explain working condition, such as hours of works, safety habits. Requirements for continuance of employment such as performance of
duties, attendance and punctuality, handling confidential information, general appearance.
Introduce new staff member to manager (s) and other staff. Release employee to immediate supervisor who will:
a) Introduce new staff member to fellow Employee.b) Familiarize the employee with work place.
(For Office Use Only)
Position & Department: Grade:
Employee Code:
Reporting To:
Signature Admin Assistant………
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3.4.29 Interview Assessment
Interview for the position of
Date & Time
Name of Candidate Qualification Phone No.Date of Birth Email I.D.Interviewer 1 Interviewer 2
Weightage0-Not Acceptable, 1-Below Avg., 2- Average., 3-Good, 4-Outstanding
0 1 2 3 4
Appearance and Attitude:(Courtesy, appropriate dress, growing, manners)Personality: (Poise, Bearing, rapport, Total Impact, Attire)Communication: (Ability to adequately express himself, Spoken & Written)Relevant Technical CompetenceG. K. & AwarenessPotential: (Ability & motivation to grow or advance)Long term commitment: (See continuity with last employer also)
Score
Nos. of years of relevant experienceReason for changing jobSalary DrawnSalary ExpectedLead time to join
Other Comments (if any)
Recommendations
Offer Hold Reject
111
3.4.30 Management Review Meeting
Date Meeting No: Meeting Attended ……
Subjects discussed & actions taken:
No.
Subject
1 Review of minutes of the last meeting
2 Results of Internal & External Audits
3 Non Conformity reports & Corrective action
.
4 Customer feedback / Complaint analysis
5 Status of Corrective & preventive action
6 Review of process performances
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7 Adequacy of Existing resources
8 Training Requirements
9 Quality Policy & Objectives :
10 Supplier performance, Effectiveness of communication, Service Delivery monitoring other topics including work environment and housekeeping
11 Recommendations for improvement
Signature
Management Representative
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Chapter 4: Conclusions
4.1 Conclusions
I have understood that through the implementation of a Quality Management System staff can be motivated since their key roles and responsibilities are defined. Cost savings can be made through improved efficiency and productivity, as product or service deficiencies will be highlighted.From this, improvements can be developed, resulting in less waste, inappropriate or rejected work and fewer complaints. Customers will notice that orders are met consistently, on time and to the correct specification. This can open up the market place to increased opportunities
At Sanbook Quality consultancy I have been exposed to the process of certification for various standards such as Quality, Environment (ISO 14001:2004), Occupational health and safety (OHSAS 18001) and lab accreditations (ISO 17025).
The exposure to various types of organization which seek certification has thought me a lot about the market and industry and at the same time helped me develop my personality as a professional.
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References
1. Quality Management Systems: A Practical Guide by Howard.S.Gitlow 2. Quality Management Demystified by Sid Kemp3. Quality Management essentials by David Hoyle4. Total Quality Management: Strategies and Techniques Proven at
Today's Most Successful Companies by Stephen George and Arnold Weirmerskirch
5. International standard for ISO 9001:2008 6. www.iso.org
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