Iso 9000 standards

Key requirements of ISO 9001:2000 standards

Key requirements of ISO 9001:2000

The requirements of the standard are specified in following clauses of the standard:

4. Quality Management System

5. Management responsibility

6. Resource management

7. Product realization

8. Measurement, analysis and improvement

Key requirements of the standard are shown in subsequent slides.

Clause 4 : General requirements

The organization shall establish, document, implement, maintain and continually improve the effectiveness of a QMS.

To implement the quality management system, the organization shall:

a) Identify the processes needed for the QMS;b) determine the sequence and interaction of these processes;c) Implement actions necessary to achieve planned results and continual improvement.

Ensure control over outsourced processes

Clause 4 requirements (Contd….)

Documentation requirements


Documentation requirements

QMS documentation must include:

a) documented quality policy & objectivesb) Quality Manualc) documented procedures required in this standard d) documents required by the organization to ensure the effective planning, operation and control of its processese) quality records


Quality Manual

The quality manual must include:

- Scope of QMS, with justification for any exclusions- Documented procedures, or reference to them- Description of interaction between the QMS processes


Control of Documents and Records

• Documents required by the quality management system shall be controlled for ensuring availability of authentic and updated documents for all concerned.

• Records shall be established and maintained to provide evidence of conformity to requirements and effective operation of Quality Management System.

Clause 5 : Management Responsibility

Top management shall ensure that customer requirements are determined and fulfilled with the aim of enhancing customer satisfaction.

Clause 5 : Management Responsibility Requirements

Customer Focus


Top management shall ensure that the quality policy:

a) is appropriate to the purpose of the organization;b) includes a commitment to meeting requirements and to continually improve effectivenessc) provides a framework for establishing and reviewing quality objectives;d) is communicated and understood within the organizatione) is reviewed for continuing suitability.

Quality policy

Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1a) are established at relevant functions and levels within the organization..

The quality objectives shall be measurable and consistent with the quality policy.


Quality objectives


Top management shall ensure that:

a. Planning of the QMS is carried out in order to meet

requirements of 4.1. As well as the quality objectives

b. The integrity of the QMS is maintained when changes

to the QMS are planned and implemented

Quality management system planning


Top management shall appoint a member of the management who, irrespective of other responsibilities, shall have responsibility and authority that includes:

Ensuring the promotion of awareness of customer requirements throughout the organization.

Management representative


Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS.

Internal communication

Internal Communications

Since most planning activities are carried by multifunctional teams, effective internal communication should be established by documenting decisions taken during meetings and responsibilities assigned.

Systems should be established in various departments so that information of activities of QMS is passed on to persons concerned. Proper distribution of procedures and instructions is an important means of internal communication


Internal Communications

Employees should be encouraged to give feedback about effectiveness of QMS and corrective action and problems if any.

One way to improve internal communication is to designate a QMS nodal officer in each department who could receive feedback and pass on to appropriate authority and Management Representative for necessary action.


Inputs to management review shall include current performance and improvement opportunities related to the following:

a) results of audits;b) customer feedback;c) 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 QMSg) recommendations for improvement


Management review input

The outputs from the management review shall include any decisions and actions related to:

a) Improvement of the effectiveness of the QMS and its processes;b) Improvement of product related to customer requirements;c) Resource needs.


Management review output

Clause 6 : Resource Management Requirements

The organization shall:

a) determine the necessary competence for personnel performing work affecting product quality;b) provide training or take other actions to satisfy these needs;c) evaluate the effectiveness of 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.

Clause 6 : Resource Management Requirements

Competence, awareness and training

The organization shall determine, provide and maintain the infrastructure needed to achieve the conformity to product requirements. Includes:

a) buildings, workspace and associated facilities;b) process equipment (hardware and software);c) supporting services (transport, communication)


Infrastructure

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.


Work Environment

Clause 7 : Product Realization Requirements

Planning of product realization

In planning product realization, the organization shall determine the following, as appropriate:

a) quality objectives and requirements for the productb) Need to establish processes, documents and provide resources specific to the productc) Required verification, validation, monitoring, inspection and test activities specific to the product and criteria for product acceptanced)Records needed

Clause 7 : Product Realization

Requirements

Determination of requirements related to product shall include:

a) Requirements specified by the customer, including the requirements for delivery and post-delivery activities;b) Requirements not stated by the customer but necessary for specified or intended use, where known;c) Statutory and regulatory requirements related to productd) Any additional requirements determined by the organization


Customer-related processes

Where customer provides no documented statement of requirement, requirements shall be confirmed before acceptance.

Note: In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.


Review of requirements related to product

Customer organization shall 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


Customer communication

Customer Communications

ISO 9001: 1994 specifies communication only for contract review. The new standard with its focus on customer satisfaction goes much further. It requires that communication channel be established with the customer for general enquiries and for providing information about products, contract, order program and customer feedback/complaints.

Marketing, Sales and customer service departments should be given clear responsibility for providing requisite information concerning their field of activity.

Customer contact groups such as telephone operators and reception should be informed of the responsibilities so that customers are directed to the right person. Customers may also be informed about departments handling different aspects.

Customer Communications

There is no significant change in other requirements of product realization processes which were earlier given in clause .of ISO 9001:1994.


Other Requirements of Production Realization

Clause

Clause 8 : Measurement, Analysis and

Improvement Requirements

General Requirements

The organization shall plan and implement the monitoring, measurement, analysis and improvement processes needed.

This shall include the determination of applicable methods, including statistical techniques, and the extent of their use.

Clause 8 : Measurement, Analysis and Improvement Requirements


Monitoring and measurement

• Customer satisfaction:

The organization shall monitor information relating to customer perception as to whether the organization has fulfilled customer requirements. The methods for obtaining and using this information shall be determined.

• Internal audit:

The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

The management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected non-conformities and their causes.Follow up actions shall include the verification of the actions taken, and the reporting of verification results.


Monitoring and measurement


Analysis of data

The organization shall determine, collect and analyze appropriate data to determine the suitability and effectiveness of the quality management system and to evaluate where continual improvement of effectiveness of the QMS can be made.

The organization shall analyze this data to provide information on:

a) customer satisfaction;b) conformance to product requirements;c) characteristics and trends of processes and products

including opportunities for preventive actiond) suppliers

The organization 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.


Continual improvement

Section 5

Documentation

It is information and its supporting medium.

Examples: Specification, drawing, procedure and records

The medium of document could be papers, magnetic, electronic,optical disc, photograph or a sample.

(ISO 9000:2000, 3.7.2)

Documentation

What is a document ?

Need for Documentation

In managing an organization, documentation is used:

• As a tool for information transmission and communication

• Evidence of conformity that what is planned has been done.

• Preservation of knowledge of the organization such as design data, studies conducted and documented experience.

Documentation Objectives of the New Standards

Two of the major objectives in the revision of ISO 9000 series of standards were:

• To identify simplified standards that will be equally applicable to different types of organizations including small scale industries.

• For the amount and detail of documentation required to be more relevant to the desired results of organization’s activities.

Extent of Documentation

ISO 9000:2000 has significantly reduced the documentation requirements and is much less prescriptive than the 1994 version of the standard. It allows an organization more flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS.

It is stressed that ISO 9001 requires a “Documented quality management system”, and not a “system of documents”.

Documentation Requirements

ISO 9001:2000 clause 4.2.1 states that the quality management system documentation shall include:

• Documented statements of a quality policy and quality objectives;

• a quality manual

• documented procedures required by this International Standard

• documents needed by the organization to ensure the effective planning, operation and control of its processes, and

• records required by this International Standard.

Flexibility in Documentation

The new standard is less prescriptive than 1994 version and allows flexibility to the organization in developing QMS documentation which may differ from one organization to other due to:

• Size of the organization and type of its activities

• Complexity of processes and their interactions, and

• Training and competence of personnel

Existing Documentation in the Organization

Most organizations in the organized sector would already be having considerable documentation for successful management of their business. This documentation may include:

• Company rules & procedures

• departmental and operating manuals

• Product specifications / product drawings

• Process plans/instructions

• Production schedules

• Approved supplier lists

• Test and inspection plans, etc.

Adoption of Existing Documents in QMS Documentation

There is a need to analyze existing documentation for their usefulness in effective control over important processes for assuring customer satisfaction. It has also to be verified whether these documents are being followed. If so, these documents must be given unique identity and brought under document control for integration into QMS documentation

Determination of Need for New Documents

• In addition to adaptation of existing documents for implementation of quality management system, the organization may need certain additional documents to comply with ISO 9001:2000.

• The type of documents and records which may possibly be required by the companies in the organized sector is given in the succeeding slides.

• List of clause-wise documents and records is suggestive in nature. The management decision to have these documents will depend on the complexity of the processes and the training/competence of staff.

ISO 9001:2000 Clause 4

Documents

• Quality manual

• Flow chart of major processes and their interaction

• Document control procedure

• Record control procedure.

• Description of out sourced services and their control procedure.

Records

• Document updating records

• Disposal of quality records


Documents

• Quality objectives at organizational and functional level.

• Organization structure and responsibilities of management representative and key functionaries whose job affects product quality.

• Description of internal communication channel. ( This could be specified in quality manual. Also see slide 96,97 & 98 )

• Procedure for management review Records

• Evidence of quality planning

• Record of management review


Documents

• Specific requirement of qualification and competence of personnel

• Procedure for identifying training needs and yearly training plan

• List of special facilities or work environments affecting quality

• Procedure for maintenance of buildings equipment and facilities

Record

• Record of training and experience of personnel

• Maintenance record


Documents

• Quality plan or other documents showing how quality is planned in products/projects

• Method of capturing customer requirements

• Review of orders or contracts to assess capability to meet customer’s requirements

• Specifications for company’s products

• Procedure for design and development

• Specifications for purchased materials

ISO 9001:2000 Clause 7 (contd….)

• Procedure for selection and approval of suppliers

• Procedure for review of suppliers performance

• Procedure for verification of purchased products and dealing with non conforming supplies.

• Procedures or work instruction for critical processes.

• Procedure for assessing process capability and approval of processes.

• Qualification of operators and processes where quality cannot be verified after work is finished.

• Procedure for maintenance of critical equipment.

• Procedure for identification and traceability of materials (where required).


• Inspection and testing plans/instructions.

• Procedure for showing inspection/test status of materials/equipment.

• Procedure for calibration measuring devices.

• Procedure for handling customer property.

• Procedure for preservation, packaging and storage of product.


Records

• Contract review of major contracts

• Design review record

• Results of design verification/validation

• Inspection results of purchased materials.

• Record of qualification of operators and processes where output cannot be assessed for non conformity.

• Inspection and testing records

• Record of rework and rejection

• Calibration record of measuring devices.

• Record of damaged or lost customer property (where applicable).

Formulation of Quality Policy

Quality policy is the first step in the development of quality management system

• The quality policy emanates from the vision and mission of the organization. It should describe what quality means to your business and customers.

• Quality policy should reflect top management’s commitment to quality.

• To make the policy meaningful it must include overall quality goals for your business.

• Quality policy must be brief for ease of understanding by employees.

• Quality Policy is normally included in quality management manual.

Quality Manual

Quality manual is the basic document which describes the QMS

• ISO 9001 standard does not prescribe any specific format or a model for the quality manual. It could either be structured in the order of process flow in the organization or according to the applicable elements of the standard. In case of process flow model it may be useful to provide cross reference with the standard clauses for ease of internal and external audit.

• Quality manual should contain an overview of the different processes of organization and how various requirements of the standard are met.

Quality Manual (contd….)

Quality manual is high level document as such it contains very little detail of the processes. However, it provides reference to departmental manuals and other documents which give further information of processes.

As quality manual can also be used as promotional material, it should not contain anything that is confidential.

Contents of Quality Manual

Quality manual should normally include the following though not necessarily in the same order:

• Brief background of the company

• Scope of the QMS with justification for exclusions if any.

• Quality policy

• QMS documentation containing list of documents such as departmental manuals, procedures and other documents required to operate QMS.

• Quality records and their control

• Organizational structure

Contents of Quality Manual (contd….)

• Quality related responsibilities of main functionaries including management representative.

• Document control

• Management commitment for QMS

• Method of internal communication

• Human resource management

• Infrastructure and work environment

• Production or service planning

• Product development (where applicable)

• Purchase control

• Control of production and/or service

Contents of Quality Manual (contd….)

• Identification and traceability

• Preservation of product

• Care of customer property

• Measurement of products and processes

• Control of non conforming products

• Corrective and preventive action

• Monitoring and measurement of customer satisfaction

• Internal audit of QMS

• Continual improvement