Transcript
Quality Management System
ISO 9001:2008 Awareness Program
2
What is Quality ?
“ THE TOTALITY OF FEATURES AND CHARACTERISTICS OF A PRODUCT OR SERVICE THAT BEAR UPON
ITS ABILITY TO SATISFY STATED OR IMPLIED NEEDS “
Fitness for use Conformance to requirements Accuracy Perfection Zero Defect Adequacy Cost Effectiveness
What is System ?
A group of interacting, interrelated, or interdependent elements forming a complex whole
Set of detailed methods ,procedures and routines established or formulated to carry out a specific activity , perform a duty , or solve a problem
What is QMS ?
Quality Management System
A System of coordinated activities which is meant to “direct” and “control” an organization with regard to quality.
What is ISO ?
International Organization for Standardization
Founded in 1946 in Geneva , Switzerland
ISO is a non-governmental organization that forms a bridge between the public
and private sectors.
"ISO", derived from the Greek. ISO, meaning "equal". Whatever the country,
whatever the language, the short form of the organization's name is always ISO.
"ISO", is a system audit not for product audit
ISO is composed of more than 90 members countries
World's largest developer and publisher of International Standards.
ISO 9000
OHSAS18001
ISO14001
SA8000
QS90
ISO 9000 STANDARDS
ISO 9001:2008 - Quality Management Systems Requirements
ISO 9000:2000 - Quality Management Systems fundamentals and vocabulary
ISO 9004:2000 - Quality Management System guidelines for performance improvements
ISO 19011:2000- Guide for Auditing Management System
ISO 9001: 2008
ISO 9000 series evolution: 1987- initial publishing 1994- first revision 2000- Second revision 2008- Current edition
Based on eight
quality
management
principles
Based on eight
quality
management
principles
LeadershipLeadership
Process
approachProcess
approach
Involvement
of peopleInvolvement
of people
System
approach to
Management
System
approach to
ManagementContinual
improvementContinual
improvement
Factual
approach to
decision
making
Factual
approach to
decision
making
Mutual
beneficial
supplier
relationship
Mutual
beneficial
supplier
relationship
Customer
focusCustomer
focus
Principles of Standards
Customer Focus
DETERMINE CUSTOMER NEEDS & EXPECTATIONS
DETERMINE CUSTOMER NEEDS & EXPECTATIONS
REQUIREMENTSREQUIREMENTS
CUSTOMER SATISFACTIONCUSTOMER SATISFACTIONPrinciple 1
Organizations
Depends on
Customers .
Leadership
Principle 2
Leaders must set the direction of the organization
Leaders must create and maintain internal environment that encourages people to achieve the organization’s objectives
Involvement of People
Principle 3
Must help people to develop and use their abilities
Must encourage the involvement of people at all level
Process Approach
Principle 4
Activities+
Resources
Input Output
A desired result is more efficiently achieved when resources and activities are managed as a process
A desired result is more efficiently achieved when resources and activities are managed as a process
Control
Process A
Process B Process D
InputOutputControl
Process C
Processes – understand interaction
Process
Any activity that takes “inputs” and converts them to “outputs”
Process Approach
The systematic identification and management of these activities and the interaction between activities.
Example - Purchasing Process
Performance Measurements
• Delivery status – On-time, On spec, etc
• Supplier evaluation
Performance Measurements
• Delivery status – On-time, On spec, etc
• Supplier evaluation
Outputs• Receipt of
Material on right condition
• Right Quality Right Quantity
• Right Time
Outputs• Receipt of
Material on right condition
• Right Quality Right Quantity
• Right Time
Purchasing Procedure
Purchasing Procedure
Interactions to• Storage• Inspection and
Testing• Manufacturing• Finance
Interactions to• Storage• Inspection and
Testing• Manufacturing• Finance
Inputs• Demand for
material • Item specs
and Date• Supplier
source• Suppliers
capability to meet our requirements
Inputs• Demand for
material • Item specs
and Date• Supplier
source• Suppliers
capability to meet our requirements
System Approach to Management
Principle 5
Identifying , understanding and managing a system of interrelated process for a given objective improves the organization effectiveness and efficiency
Deming’s wheel
(P.D.C.A.)
Deming’s wheel
(P.D.C.A.)
ISO9000
PLAN DO
ACT CHECK ContinualImprovement
Customer Focus
Continual improvement of the organization's overall performance should be a permanent objective of the organization.
Continual Improvement
Principle 6
The “Plan-Do-Check-Act” Cycle(Deming’s Cycle)
Factual Approach to decision making
Principle 7
Effective decisions are based on the analysis of data and information
Mutual beneficial supplier relationships
Principle 8
An organization and its suppliers are interdependent, and a mutually beneficial relationship enhances the ability of both to create value
Continual improvement of theQuality Management System
CU
STO
MER
S
ManagementResponsibility
Measurement,Analysis andImprovement
ResourceManagement
Product /Service
Realization
InputData
ProductService
OutputData
Req
uire
men
ts
Satis
factio
n
CU
STO
MER
S
ISO 9001:2008 Requirements
The Structure
0 Introduction1 Scope2 Normative reference3 Terms and definitions4 Quality management system requirements5 Management responsibility6 Resource management7 Product realization8 Measurement, analysis and improvement
System Requirements / Structure of the Standard
Provision of resources(6.1)
Human resources(6.2)
Infrastructures(6.3)
Work environment(6.4)
6 Resource Management
General requirements (4.1)
Documentation Requirements(4.2)
Management Commitment(5.1)
Customer focus (5.2)
Quality policy(5.3)
Planning(5.4)
Responsibility, authority & communication(5.5)
Management Reviews (5.6)
5 Management Responsibility
8 Measurement Analysis & improvement
4 Quality Management System
7 Product Realization
General (8.1)
Monitoring & measurement(8.2)
Control of NCP(8.3)
Analysis of data(8.4)
Improvements(8.5)
Planning(7.1)
Customer related processes(7.2)
Design & development(7.3)
Purchasing(7.4)
Production & service provision(7.5)
Control of monitoring & measuring devices(7.6)
4.0 Quality Management System
4.1 General requirements
Establish , document , implement and maintain a QMS and continually improve its effectiveness in accordance with the standard
4.0 Quality Management System
4.1 General Requirements
Determine the processes necessary for QMS
Determine the sequence and interaction of processes
Determine criteria & methods to ensure effective operation & control of the processes
Ensure availability of resources and information needed to support the operation & monitoring of the processes
Measure , monitor and analyze processes
Implement action necessary to achieve planned results & continual improvement
4.2 Documentation Requirements
• Extent • Size and type of
organization• Complexity and
interaction of processes• Competence of
personnel
• Note3 (Documentation may be in any type of media)
• To Include• Documented procedures
required by standard• Documents required by
organization to ensure effective operation and control process
• Note 1 (Where the term “documented procedure” appears)
4.0 Quality Management System
General
• 4.2.2 Quality Manual– The organization shall establish a Quality Manual that
include:• Scope of QMS• Documented procedures or reference to them• Description of interaction between the process of QMS
4.2 Documentation Requirements
4.0 Quality Management System
4.2 Documentation Requirements
4.0 Quality Management System
4.2.3 Control of Documents
Documented procedures to: Approve documents prior to issue Review , update as necessary and re-approve documents To identify the changes and the current revision status of documents To ensure documents remain legible , readily identifiable Ensure relevant versions of applicable documents are available at
points of use Ensure that the documents of external origin are identified and
distribution controlled Obsolete documents are prevented from unintended use and
identified if kept for any reason
Documents required by the quality management system shall be controlled
4.2 Documentation Requirements
4.0 Quality Management System
4.2.4 Control of Records Records must be established and maintained Records must be legible , readily identifiable and retrievable Documented procedure for control of identification , storage ,
retrieval ,retention time and disposition of quality records
• 5.1 Management Commitment
• 5.2 Customer Focus
• 5.3 Quality policy
• 5.4 Planning– 5.4.1Quality
objectives– 5.4.2 Quality
Planning
• 5.5 Responsibility, authority and communication
– 5.5.1 Responsibility & authority
– 5.5.2 Management representative
– 5.5.3 Internal communication
• 5.6 Management Review– 5.6.1 General– 5.6.2 Review input– 5.6.3 Review output
5.0 Management Responsibility
5.1 Management Commitment
• Provide evidence of commitment to the development and improvement of QMS by:
– Communicating the importance of meeting customer and legal/regulatory requirements.
– Establishing quality policy and objectives.– Management Reviews– Provision of resources.
5.0 Management Responsibility
5.2 Customer Focus
• Top Management shall ensure that customer needs & expectations are determined, converted into requirements & fulfilled with the aim of achieving customer satisfaction
5.0 Management Responsibility
5.3 Quality Policy• Appropriate to the purpose of
organization.• Commitment to meeting
requirements and continual improvements
• Frame work for establishing and reviewing quality objectives
• Communicated and understood at appropriate levels
• Is reviewed for continuing suitability
5.0 Management Responsibility
• Establish quality objectives at relevant functions and levels
• Objectives must be measurable and consistent with the quality policy including the commitment to continual improvement
• Include those needed to meet requirements for product
5.4 Planning5.4.1 Quality Objectives (Cont)
5.0 Management Responsibility
5.4 Planning5.4.1 Quality Objectives (Cont)
Quality Objectives should be:• Set• Measurable• Achievable• Realistic• Timed
5.0 Management Responsibility
5.4.2 Quality Management System Planning
• Identify and plan processes needed to achieve quality objectives• Plan the development of QMS• Plan the implementation of
QMS• Plan the improvement of QMS
5.0 Management Responsibility
5.5 Responsibility, Authority and Communication
5.5.1 Responsibility and authority
Functions and their interaction, responsibilities and authorities shall be defined and communicated to facilitate effective quality management
5.0 Management Responsibility
5.5.2 Management Representative
• Member of the management who has responsibility and authority for – ensuring that processes of the QMS are established
and maintained– Reporting on performance of QMS including needs for
improvement– Promoting awareness of customer needs and
requirements• Note: Responsibilities may include liaison with
external parties in relation to QMS
5.0 Management Responsibility
5.5.3 Internal Communication
• Ensure communication between various levels and functions regarding the processes of the QMS and their effectiveness
5.0 Management Responsibility
5.6 Management Review5.6.1 General
• Review of QMS by top management at planned interval to;– ensure QMS suitability,
adequacy and effectiveness– Evaluate the need for
changes to QMS including policy and objectives
Records from Management Reviews shall be maintained (see 4.2.4).
5.0 Management Responsibility
5.6.2 Review Input
• Review performance and improvement opportunities related to:– Audit results– Customer feedback– Process performance and product conformance– Status of preventive and corrective actions– Follow up actions from earlier reviews– Change that could affect the QMS– Recommendations for improvement
5.0 Management Responsibility
5.6.3 Review Output
• Output to include actions related to – improvement of the effectiveness QMS and its
processes– improvement of product related to customer
requirements– resource needs
5.0 Management Responsibility
• 6.1 Provision of resources• 6.2 Human resources
– 6.2.1 General– 6.2.2 Competence, awareness and training
• 6.3 Infrastructure• 6.4 Work environment
6.0 Resource Management
6.1 Provision of Resources
• The organization shall determine and determine the resources needed for :– implement and maintain the QMS and
continually improve its effectiveness.– Enhance customer satisfaction by
meeting customer requirements.
6.0 Resource Management
6.2 Human Resources6.2.1 General
• Those who have responsibilities defined in the QMS must be competent on the basis of appropriate education, training, skills and experience
6.0 Resource Management
6.2.2 Competency, Awareness and Training
• Identify competency needs• Provide required training• Evaluate the effectiveness of
training provided• Ensure staff is aware of
relevance and importance of their activities and contribution to achieving quality objectives
• Maintain appropriate records of education, training, qualification and experience
6.0 Resource Management
6.3 Infrastructure
• Identify, provide and maintain the infrastructure needed to achieve product conformity
• This shall include :– Workspace & associated utilities– Equipment, hardware and software– Supporting services (transport or
communication)
6.0 Resource Management
6.4 Work Environment
• The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
6.0 Resource Management
• 7.1 Planning of product realization• 7.2 Customer related processes• 7.3 Design & development• 7.4 Purchasing• 7.5 Production & service operation• 7.6 Control of measuring & monitoring devices
7.0 Product Realization
7 Product Realization
7.1 Planning of Product Realization
• Sequence of process to achieve product• Consistent with QMS and documented to suit
method of operations• Quality objectives and requirements for the
product• The need for processes, documentation, resources
and facilities specific to the product• Verification and validation activities and
acceptance criteria• Records
7.0 Product Realization
7.2 Customer Related Processes
7.2.1 Determination of requirements related to the product
7.2.2 Review of product requirements7.2.3 Customer communication
7.0 Product Realization
7.2.1 Determination of requirements related to the product
• Product requirements specified by the customer including requirements for delivery and post-delivery activities
• Requirements not specified but necessary for intended or specified use
• Obligations related to product, including regulatory and legal requirements
• any additional requirements determined by the organization
7.0 Product Realization
7.2.2 Review of requirements related to the product
• Review identified requirements and ensure before commitment to supply product that;– Product requirements are defined– For verbal orders requirements are confirmed– Difference between tender and contract are
resolved– Organization has ability to meet the
requirements
– Records of the results arising from the review shall be recorded.
7.0 Product Realization
7.2.3 Customer Communication
• Identify and implement arrangements for communication with customers relating to:– product information– inquiry, contract or order handling, including
amendments– Customer feedback including complaints
7.0 Product Realization
7.3 Design & Development
• 7.3.1 Design & development planning• 7.3.2 Design & development inputs• 7.3.3 Design & development outputs• 7.3.4 Design & development review• 7.3.5 Design & development verification• 7.3.6 Design & development validation• 7.3.7 Control of design and development
changes
7.0 Product Realization
7.4 Purchasing
• 7.4.1 Purchasing process
• 7.4.2 Purchasing information
• 7.4.3 Verification of purchased product
7.0 Product Realization
7.4.1 Purchasing Process
• Purchased product meets requirements• Type & extend of control depends on effect
purchased product may have on realization processes and their output
• Selects suppliers based on their ability to supply conforming product
• Define criteria for selection and periodic evaluation and re-evaluation of suppliers
• Results of evaluation and follow up actions must be recorded
7.4.2 Purchasing Information
• Purchasing information shall describe the product to be purchased, including where appropriate:
– Requirements for approval of product,procedures, processes and equipment.
– Requirements for qualification of personnel.
– Quality management system requirements.
7.4.3 Verification of Purchased
Product• Identify and implement activities needed
to verify purchased product• Where organization or its customer
purpose verification at supplier premises, organization must specify in purchasing information:– verification arrangements– method of product release.
7.5 Production & Service Provision
• 7.5.1Control of production and service provision
• 7.5.2Validation of processes for production and service
provision• 7.5.3 Identification and traceability• 7.5.4Customer Property• 7.5.5Preservation of Product
7.5.1 Control of production and service provision
Control production & services operations through:
• Availability of information specifying product characteristics
• Work instructions available where necessary
• Use and maintenance of suitable equipment
• Availability & use measuring and monitoring devices
• Implementation of monitoring activities
• Implementation of defined processes for release, delivery and post delivery activities
7.5.2 Validation of Processes
Validation arrangements must be defined and must include as applicable– qualification of the process– qualification of equipment and
personnel– use of defined methodologies &
procedure– requirements for record– re-valuation
7.5.3 Identification & Traceability
• Where appropriate identify product through all stages of operations
• Identify status with respect to measurement & monitoring requirements
• Where traceability is required control & record unique identification of product
I can not remember
7.5.4 Customer Property
• Care for customer’s property being under organization’s control or being used by organization
• Identification, verification, protection & maintenance of customer property provided for use or incorporation
• Any customer property that is lost, damaged or found un- suitable must be recorded & reported to customer
• Customer Property - tangible / intangible
7.5.5 Preservation of Product
• Preserve conformity of product during internal processing and final delivery to intended destination
• Include identification, handling, packaging, storage and protection
• This applies to constituent parts of product
7.6 Control of monitoring & measuring devices
• Calibrate & adjust measuring and monitoring devices at specified intervals as prior to use
• Traceability to international or national standards. Where no such standard exist record the basis
• Safeguard MMD from adjustments invalidating calibration
• Protect MMD from damage or deterioration during handling, maintenance or storage
• Record results of calibration• Assess validity of previous results when
devices found to be out of calibration
8 Measurement, Analysis and Improvement
• 8.1 General• 8.2 Monitoring &
Measurement– 8.2.1 Customer
satisfaction
– 8.2.2 Internal audit– 8.2.3 Monitoring and
measurement of
processes– 8.2.4 Monitoring and
measurement of
product
• 8.3 Control of non-conforming
product• 8.4 Analysis of data• 8.5 Improvement
– 8.5.1 Continual
improvement– 8.5.2 Corrective action– 8.5.3 Preventive action
8.1 General
• Define, plan & implement measurement and monitoring activities needed to assure conformance and achieve improvement
• This include determination of the need and use of applicable methodologies and statistical techniques
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
• Organization shall monitor information on customer satisfaction and /or dis-satisfaction
• The methodologies for obtaining and utilizing such information must be determined
8.2.2 Internal Audit
• Conduct periodic internal audit to determine if QMS:– Conforms to the requirements of the
standard– Has been effectively implemented &
maintained • Plan the audit program
considering:– Status and importance of the activity– results of previous audits
• Define audit scope, frequency and methodologies performed by personnel not performing audited work
• The documented procedure must cover:– Responsibilities &
authorities for conducting audits
– Ensuring independence– Recording results and
reporting to management– Timely corrective actions– Follow up to verify & report
implementation of verification results
8.2.2 Internal Audit
8.2.3 Measurement and Monitoring of
Processes
• Apply suitable methods for measurement and monitoring of those realization processes necessary to meet customer’s requirements.
• Measure & monitor product characteristics to verify conformance at appropriate stages of realization processes
• Evidence of conformity with the acceptance criteria must be documented, records must indicate the authority responsible for release of product
• Release or delivery must not proceed until all the specified activities have been completed unless otherwise approved by the customer
8.2.3 Measurement and Monitoring of
Product
VERIFIED 19/5/01 PASSED
HOLD
8.3 Control of Non conforming Product
• Documented procedures for control of non conforming product to prevent unintended use or delivery
• Non conforming product shall be corrected
• Re-verify after correction
• If non-conformance detected after delivery take appropriate action
• It is often required that the proposed rectification be reported for concession to the customer, the end user, regulatory or other body
8.4 Analysis of Data
• Collect & analyze data, determine suitability and effectiveness of QMS and to identify improvements that can be made
• Data from measurement & monitoring & other related sources
• Analyze data provide info on:– Customer satisfaction and/or
dissatisfaction– Conformance to customer requirement– Process, product characteristics and their
trends– Suppliers
8.5 Improvement8.5.1 Continual improvement
• Planning for Continual Improvement• The organization must plan and manage
processes necessary for continual improvement of the QMS
• Facilitate continual improvement using:– quality policy– objectives– audit results– analysis of data– corrective actions– preventive actions
• Management Review
8.5.2 Corrective Action
• Organization must take corrective action to eliminate the causes of non-conformance to prevent recurrence
• Action appropriate to the impact of problem
• Documented procedures shall define requirements for:– identifying non conformities– determine the causes– evaluating the need for corrective action– determine corrective action needed and
implemented– Recording results of action
• Organization must identify preventive action to eliminate the causes of potential non conformances to prevent occurrences
• Actions appropriate to the impact of potential problem
• Documented procedures must define the requirements for– Identification of potential non-
conformances and their causes– Determining and ensuring
implementation of preventive action needed
– Recording results of action taken
8.5.3 Preventive Action
Situation Warranting Corrective Action
• Identification of major non-conformance.• Large number of minor non-conformities.• The reoccurrence of a problem with a process or
activity.• Non-conformities observed during audits.• Customer Complaints.
• Non-conforming deliveries from vendors.
Stages of Corrective & Preventive Action
• REPORTING • INVESTIGATION • ACTION• FOLLOWUP• CLOSING
EXPECTED BENEFITS
Transparency in working at all level Data availability : Hidden Factors are
openCreates AccountabilityPlanning & scheduling improved Rework & Rejection are known and
being controlled Customer feedback through regular
surveys Employees Participation enhanced Continuos Improvements Program
launchedMarket Reputation
Thank You !
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