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Introduction to ISO 9001:2008



Evolution of quality standards

ISO 9001 1987

ISO 9001 1994

ISO 9001 2000

ISO 9001 2008



Quality System Standard

• •

generic (ISO 9000) industry related (AS 9000, TL 9000)



ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn QualityGurus.ISO 9002 and 9003 • • Prior to ISO 9001:2000.com 4 . there were ISO 9002 and ISO 9003 too. These were subsets of ISO 9001 with certain exclusions.

Process approach • • Process approach to quality management encouraged An activity using resources. can be considered as a process. QualityGurus.com 5 . and managed in order to enable the transformation of inputs into outputs.

Processes: Resources Input Controls Output Activities or set of activities QualityGurus.com 6 .

understand interactions Resources Input Process A Process B Controls Process C Output Process D QualityGurus.Processes .com 7 .

Customer satisfaction C U S T O M E R S Continual Improvement of the Quality Management System R e q u i r e m e n t s Management responsibility Resource management Input Product realisation Measurement. Analysis and improvement Output Product C U S T O M E R S S a t i s f a c t i o n QualityGurus.com 8 .

com .similar structure ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness ISO 9004 provides wider focus on quality management 9 QualityGurus.Relationship with ISO 9001 and ISO 9004 • • • • • Designed to complement each other Can be used independently Different scope .

1 General) Standard specifies QMS requirements for use to: • demonstrate organisation’s ability to consistently provide product meeting customer & applicable statutory & regulatory (legal) requirements • enhance customer’s satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable statutory & regulatory requirements 10 QualityGurus.1 Scope (1.com .

com .2 Application • • • Requirements are generic Requirement may be excluded if cannot be applied due to the nature of organisation and its product Exclusions must: – Not affect ability or responsibility to provide conforming product – Be limited to Clause 7 11 QualityGurus.1.

Quality management systems Fundamentals and vocabulary.2 Normative reference • ISO 9000 : 2005.com 12 . QualityGurus.

3 Terms and definitions • The term “product” also means “service” QualityGurus.com 13 .

implement and maintain a QMS and continually improve its effectiveness in accordance with the standard QualityGurus. document.com 14 .4.1 General requirements • Establish.

measure where applicable and analyse processes Implement actions necessary to achieve planned results & continual improvement 15 QualityGurus.com .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 Monitor.

4.com .1 General Requirements • • • • Manage the processes in accordance with the standard Ensure control of outsourced processes affecting product conformity Define control of outsourced processes within the QMS Control over outsourced processes does not absolve the organization of its responsibilities 16 QualityGurus.

2 Documentation requirements • 4. objectives Quality manual Documented procedures and records Documents.2.4. including records determined by the organisation QualityGurus.com 17 .1 General QMS documentation: – – – – Quality policy.

2. documented. implemented and maintained Extend of documentation may differ due to – Size & type of organisation – Complexity & interaction of processes – Competence of personnel • Documentation may be in any type of media 18 QualityGurus.4.1 General • • Documented procedure means that it must be established.com .

4. and justification for.2 Quality manual • Quality manual must include as minimum: – The scope of QMS including details of.com 19 . any exclusions – Documented procedures or reference thereto – Description of the interaction between the processes of the QMS QualityGurus.2.

4. readily identifiable ensure relevant versions of applicable documents are available at points of use ensure that documents of external origin necessary for planning and operation of QMS are identified and distribution controlled obsolete documents are prevented from unintended use and identified if kept for any reason QualityGurus.2.com 20 . update as necessary and re-approve documents to identify the changes and the current revision status of documents to ensure documents remain legible.3 Control of documents • Documented procedures to: – – – – – – – approve documents prior to issue review.

2. protection. storage. retrieval. QualityGurus. retention and disposition of quality records.com 21 .4 Control of records • • • Records to provide evidence are controlled Documented procedure to define the controls needed for the identification.4. Records must be legible. readily identifiable and retrievable.

5.3 Quality policy 5.4 Planning – – 5.6. authority and communication – – – Customer focus 5.1 Responsibility & authority 5.6.3 Internal communication 5.5 Responsibility.6 Management review – – – QualityGurus.1 General 5.4.1 Quality objectives 5.2 Review input 5.3 Review output • 5.6.2 Management representative 5.2 QMS planning • 5.5 Management responsibility • • • • 5.4.com 22 .1 Management commitment 5.

com .5.1 Management commitment • Provide evidence of commitment to the development implementation and continual improvement of QMS by: – communicating the importance of meeting customer and statutory and regulatory requirements – establishing quality policy & objectives – management reviews – provision of resources 23 QualityGurus.

2 Customer focus Determine customer requirements Meet requirements Customer satisfaction 24 QualityGurus.5.com .

5.3 Quality policy • • • • • • appropriate to the purpose of the organisation commitment to comply with requirements continually improve the effectiveness of the QMS framework for establishing & reviewing quality objectives communicated and understood reviewed for continuing suitability 25 QualityGurus.com .

com 26 .4.5.1 Quality objectives • • • establish quality objectives measurable & consistent with the quality policy include those needed to meet requirements for product QualityGurus.

as well as the quality objectives Maintain the integrity of the QMS integrity when changes are planned and implemented QualityGurus.com 27 .1.5.2 Quality management system planning • • planning of the QMS is carried out in order to meet requirements given in 4.4.

1 Responsibility and authority • define and communicate responsibilities and authorities QualityGurus.5. authority and communication 5.5 Responsibility.com 28 .5.

5.5.com 29 . implemented and maintained reports on performance of QMS including needs for improvement promotes awareness of customer requirements QualityGurus.2 Management Representative • • • • Member of the organization’s management ensures that processes needed for the QMS are established.

3 Internal communication • • Communication processes are established Communication takes place regarding the effectiveness of QMS QualityGurus.5.com 30 .5.

1 General Review of the QMS by top management at planned intervals to: – ensure QMS suitability. QualityGurus.6.com 31 .6 Management Review • 5.5. adequacy & effectiveness – assess opportunities for improvement – evaluate the need for changes to QMS including policy & objectives • Records maintained.

6.2 Review input audit results customer feedback process performance product conformity status of PAs and CAs follow up actions from earlier reviews changes that could affect the QMS recommendations for improvement 32 Management Review QualityGurus.com .5.

3 Review output Management Review improved effectiveness of the QMS improvement of product resource needs QualityGurus.5.6.com 33 .

1 Provision of resources 6.2.2 Competence. training and awareness • • 6.3 Infrastructure 6.6 Resource Management • • 6.4 Work environment 34 QualityGurus.com .2.2 Human resources – 6.1 General – 6.

6.com 35 . maintain the QMS and continually improve its effectiveness – enhance customer satisfaction QualityGurus.1 Provision of resources • Determine & provide the resources needed to: – implement.

com 36 .6.2. QualityGurus.1 General Personnel performing work affecting conformity to product requirements must be competent on the basis of : • • • • appropriate education training skills experience.2 Human Resources • 6.

com . skills and experience 37 QualityGurus. training and awareness • • • • • Determine the necessary competence Provide training or take other action to satisfy those needs Evaluate the effectiveness of actions taken Ensure staff aware of relevance and importance of their activities and contribution to achieving objectives Maintain appropriate records of education. training.2.2 Competence.6.

Infrastructure includes. as applicable: – buildings.3 Infrastructure • Determine. provide & maintain the infrastructure needed to achieve product conformity.6.com . workspace – equipment – supporting services 38 QualityGurus.

6.4 Work environment • Determine and manage the work environment needed to achieve product conformity.com 39 . QualityGurus.

com .6 Planning of product realization Customer related processes Design & development Purchasing Production & service provision Control of measuring & monitoring equipment 40 QualityGurus.4 7.2 7.3 7.5 7.7 Product realization 7.1 7.

com . documentation. resources specific to the product – verification and validation activities & acceptance criteria – Records to provide evidence 41 QualityGurus.7.1 Planning of product realization • Planning must determine as appropriate: – quality objectives and requirements for the product – the need for processes.

1 Determination of requirements related to product Customer related processes 7.3 Customer communication QualityGurus.2.2 Review of requirements related to product 7.2.com 42 .

any additional requirements QualityGurus.2.7.com 43 .1 Determination of requirements related to product • Organisation must determine: – – – – requirements specified by the customer requirements not specified but necessary statutory and regulatory requirements applicable to product.

7.com . when customer does not provide documented requirements When requirements are changed ensure that documents are amended and relevant persons are made aware of the changes. 44 QualityGurus.2.2 Review requirements related to the product • Review requirements before commitment to supply product & ensure that: – – – product requirements are defined difference between contract requirements from those previously expressed resolved organisation has ability to meet the requirements • • • Record the results of review and actions Confirm requirements.

7. contract & order handling including amendments – customer feedback including complaints QualityGurus.2.3 Customer communication • Effective arrangements for communication with customers relating to : – product information – enquiry.com 45 .

4 7.3 7.3.3.com .6 7.5 Design & development planning Design & development inputs Design & development outputs Design & development review Design & development verification Design & development validation Control of design & development changes 46 QualityGurus.3.1 7.3 Design & development 7.3.2 7.7.3.

verification and validation activities – responsibilities & authorities for D&D • • Interfaces between groups must be managed Planning to be updated as the D&D progresses 47 QualityGurus.1 Design & development (D&D) planning • • Plan & control D&D of the product.com .7.3. Planning to include: – D&D stages – required review.

2 Design & development inputs • Determine & record product requirements including: – – – – functional & performance requirements applicable statutory and regulatory requirements information from previous similar designs any other essential requirements • • Review input for adequacy Requirements must be complete.3.com . unambiguous and not in conflict with each other 48 QualityGurus.7.

3. production and service provision contain or reference acceptance criteria define characteristics essential for proper & safe use • Approve output prior to release 49 QualityGurus.3 Design & development outputs • • D&D output in a form suitable for verification D&D output must – – – – meet the input requirements provide information for purchasing.7.com .

7.3.4 Design & development review • At suitable stages systematic reviews of D&D to: – evaluate the ability to meet requirements – identify problems and propose follow up • • Involve all functions concerned Record the results and any necessary actions QualityGurus.com 50 .

5 Design & development verification • • Verify D&D to ensure that output meets the input requirements Record the results of verification and necessary actions QualityGurus.com 51 .3.7.

6 Design & development validation • • • Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use Whenever applicable to be completed prior to delivery Results of validation and necessary actions must be recorded 52 QualityGurus.7.3.com .

7 Control of design and development changes • • • Design & development changes must be identified and records maintained Changes must be reviewed.com .7. verified and validated as appropriate and approved before implementation Record results of review of changes and any necessary actions 53 QualityGurus.3.

4 Purchasing 7.2 7.4.com 54 .3 Purchasing process Purchasing information Verification of purchased product QualityGurus.4.

4.7.1 Purchasing process • • • • • Ensure that purchased product meets requirements Type & extend of control depends on effect purchased product may have on the final product Evaluate and selects suppliers based on their ability to supply conforming product Establish criteria for selection.com . evaluation and re-evaluation of suppliers Results of evaluation and any necessary actions must be recorded 55 QualityGurus.

com 56 • . procedures. processes and equipment – requirements for qualification of personnel – quality management system requirements Ensure adequacy of specified purchase requirements prior to their communication to supplier QualityGurus.2 Purchasing information • Purchasing information must include where appropriate: – requirements for approval of product.4.7.

7.4.3 Verification of purchased product • • Establish & implement inspection or other activities needed to ensure purchased product conformity Where organisation or its customer propose verification at supplier’s premises. organisation must specify in purchasing information: – verification arrangements – method of product release 57 QualityGurus.com .

3 Production and service provision 7.5 Control of production and service provision Validation of processes for production and service provision Identification & traceability Customer property Preservation of product 58 QualityGurus.4 7.com .7.5.1 7.2 7.5.5.

as necessary c) the use of suitable equipment d) availability & use of monitoring and measuring equipment e) implementation of monitoring and measurement f) the implementation of product release. delivery and post delivery activities 59 QualityGurus.com . Controlled conditions include as applicable: a) availability of information describing product characteristics b) availability of work instructions.5.7.1 Control of production and service provision • Plan and carry out production & service provision under controlled conditions.

deficiencies may become apparent after delivery Validation shall demonstrate the ability of processes to achieve results For these processes establish: – criteria for review and approval of the process – approval of equipment and qualification of personnel – use of defined methods & procedures – requirements for records – revalidation 60 QualityGurus.com .2 Validation of processes • • • Validate processes where outcome is not verified and as a consequence.7.5.

com .7.3 Identification and traceability • • • • Where appropriate identify product by suitable means throughout product realization Identify status with respect to measurement & monitoring requirements throughout product realization Where traceability is required control the unique identification of product Maintain records 61 QualityGurus.5.

protection & safeguarding customer property provided for use or incorporation Any customer property that is lost.4 Customer property • • • Care for customer’s property while it is under organisation’s control or being used by organisation Identification.7.5. verification. damaged or found unsuitable must recorded & reported to customer Customer property includes intellectual property & personal data 62 QualityGurus.com .

5.com 63 . storage and protection This applies to constituent parts of a product QualityGurus.7. packaging. handling.5 Preservation of product • • • Preserve the product during internal processing and final delivery to intended destination Include identification.

6 Control of monitoring & measuring equipment • Determine monitoring and measurements to be made & measurement & monitoring equipment needed to provide evidence of conformity of product Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements Suitability of measuring/monitoring software must be confirmed prior to use and re-confirm as necessary 64 • • QualityGurus.7.com .

6 Control of monitoring & measuring equipment • • • • • • • Calibrate or verify or both at specified intervals or prior to use against international or national standards.7. Where no such standard exist record the basis Adjust or re-adjust as necessary Have identification to determine calibration status Safeguard from adjustments invalidating calibration Protect from damage or deterioration during handling. maintenance& storage record results of calibration assess and record validity of previous results when device found to be out of calibration QualityGurus.com 65 .

1 General 8.8 Measurement.2.5.3 Control of nonconforming product 8.3 Monitoring & measurement of processes 8.2.2 Internal Audit 8.com 66 .1 Continual improvement 8.2 Monitoring/measurement – – – – 8.2. analysis and improvement • • Customer satisfaction 8.4 Analysis of data 8.2.5 Improvement – – – 8.2 Corrective action 8.4 Monitoring & measurement of product • • • 8.3 Preventive action QualityGurus.

1 General • Plan & implement measurement. monitoring analysis and improvement processes needed to: – demonstrate conformity to product requirements – ensure conformity of the QMS – continually improve the effectiveness of the QMS QualityGurus.8.com 67 .

8. The methods for obtaining and using this information must be determined QualityGurus.1 Customer satisfaction • • Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements.2.com 68 .

requirements of the standard and organisation’s requirements – QMS is effectively implemented & maintained • Plan the audit programme considering: – status and importance of the processes and the areas – results of previous audits • Define audit criteria. frequency & methodologies 69 QualityGurus. scope.2.com .8.2 Internal audit • Conduct internal audits at planned intervals to determine if : – QMS conforms to the planned arrangements.

2 Internal audit • • • Select auditors to ensure objectivity and impartiality.8.com . The documented procedure must cover: – responsibilities & requirements for planning and conducting audits – reporting results and maintaining records • • Corrective actions without undue delay Follow up to verify actions taken & report verification results 70 QualityGurus.2. Auditor must not audit own work.

8.com 71 . where applicable.3 Monitoring and measurement of processes • Apply suitable methods for monitoring and.2. measurement of QMS processes – These methods shall demonstrate the ability of the processes to achieve planned results – Where planned results are not achieved corrections and corrective actions must be taken QualityGurus.

unless otherwise approved by a relevant authority. Records must indicate the person(s) authorising release of the product for delivery to the customer Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed.8.4 Monitoring and measurement of product • • • • Monitor & measure product characteristics to verify conformity at appropriate stages Evidence of conformity with the acceptance criteria must be maintained. and where applicable by the customer QualityGurus.com 72 .2.

8.3 Control of nonconforming product

• • •

Nonconforming product must be identified and controlled to prevent unintended use or delivery Documented procedure to define controls, responsibility and authority When the nonconforming product is corrected it must be reverified to demonstrate conformity


8.3 Control of nonconforming product • Organisation must deal with nonconforming product by one or more of the following ways: – action to eliminate detected nonconformity – concession – preclude original intended use or application – Taking actions appropriate to the effects, when nonconformity is detected after delivery Records of the nature of nonconformity and any subsequent action including concessions must be maintained


8.4 Analysis of data
• • • Determine, collect & analyse appropriate data to demonstrate the suitability and effectiveness of QMS and to evaluate where continual improvement of the QMS can be made Data from measurement & monitoring & other relevant sources Analyze data to provide information on:
– – – – customer satisfaction conformity to product requirements process, product characteristics and their trends including opportunities for preventive action suppliers 75


1 Continual improvement Organisation shall continually improve the effectiveness of the QMS through use of: – – – – – – – quality policy quality objectives audit results analysis of data corrective actions preventive actions management review 76 QualityGurus.8.5.com .5 Improvement • 8.

com .2 Corrective action • • • Take actions to eliminate the causes of nonconformities to prevent recurrence.5.8. Corrective actions appropriate to the impact of the problem Documented procedure shall define requirements for: – – – – – – reviewing nonconformities (including customer complaints) determining the causes of nonconformities Evaluating the need for corrective action determining & implementing action needed recording results of action taken reviewing the effectiveness of the corrective action taken 77 QualityGurus.

com .3 Preventive action • • • Determine action to eliminate the causes of potential nonconformances to prevent occurrence.8. Actions appropriate to the impact of the potential problem Documented procedure must define the requirements for – – – – – determining potential nonconformances & their causes evaluating the need for preventive action determining and implementing action needed recording the results of action taken reviewing the effectiveness of the preventive action taken 78 QualityGurus.5.

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