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9001 2008 details
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9001 2008 details

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  • 1. Introduction to ISO 9001:2008
  • 2. Evolution of quality standards ISO 9001 2008 ISO 9001 1987 ISO 9001 1994 ISO 9001 2000
  • 3. Quality System Standard <ul><li>generic (ISO 9000) </li></ul><ul><li>industry related (AS 9000, TL 9000) </li></ul>
  • 4. ISO 9002 and 9003 <ul><li>Prior to ISO 9001:2000, there were ISO 9002 and ISO 9003 too. These were subsets of ISO 9001 with certain exclusions. </li></ul><ul><li>ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn </li></ul>
  • 5. Process approach <ul><li>Process approach to quality management encouraged </li></ul><ul><li>An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. </li></ul>
  • 6. Processes: Activities or set of activities Input Output Controls Resources
  • 7. Processes - understand interactions Process A Process D Process B Process C Input Output Controls Resources
  • 8. Customer satisfaction C U S T O M E R S C U S T O M E R S Management responsibility Resource management Measurement, Analysis and improvement Product Product realisation Continual Improvement of the Quality Management System R e q u i r e m e n t s S a t i s f a c t i o n Input Output
  • 9. Relationship with ISO 9001 and ISO 9004 <ul><li>Designed to complement each other </li></ul><ul><li>Can be used independently </li></ul><ul><li>Different scope - similar structure </li></ul><ul><li>ISO 9001 can apply for certification or contractual purposes and focuses on effectiveness </li></ul><ul><li>ISO 9004 provides wider focus on quality management </li></ul>
  • 10. 1 Scope (1.1 General) <ul><li>Standard specifies QMS requirements for use to: </li></ul><ul><li>demonstrate organisation’s ability to consistently provide product meeting customer & applicable statutory & regulatory (legal) requirements </li></ul><ul><li>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 </li></ul>
  • 11. 1.2 Application <ul><li>Requirements are generic </li></ul><ul><li>Requirement may be excluded if cannot be applied due to the nature of organisation and its product </li></ul><ul><li>Exclusions must: </li></ul><ul><ul><li>Not affect ability or responsibility to provide conforming product </li></ul></ul><ul><ul><li>Be limited to Clause 7 </li></ul></ul>
  • 12. 2 Normative reference <ul><li>ISO 9000 : 2005, Quality management systems - Fundamentals and vocabulary. </li></ul>
  • 13. 3 Terms and definitions <ul><li>The term “product” also means “service” </li></ul>
  • 14. 4.1 General requirements <ul><li>Establish, document, implement and maintain a QMS and continually improve its effectiveness in accordance with the standard </li></ul>
  • 15. 4.1 General Requirements <ul><li>Determine the processes necessary for QMS </li></ul><ul><li>Determine the sequence and interaction of processes </li></ul><ul><li>Determine criteria & methods to ensure effective operation & control of the processes </li></ul><ul><li>Ensure availability of resources and information needed to support the operation & monitoring of the processes </li></ul><ul><li>Monitor, measure where applicable and analyse processes </li></ul><ul><li>Implement actions necessary to achieve planned results & continual improvement </li></ul>
  • 16. 4.1 General Requirements <ul><li>Manage the processes in accordance with the standard </li></ul><ul><li>Ensure control of outsourced processes affecting product conformity </li></ul><ul><li>Define control of outsourced processes within the QMS </li></ul><ul><li>Control over outsourced processes does not absolve the organization of its responsibilities </li></ul>
  • 17. 4.2 Documentation requirements <ul><li>4.2.1 General </li></ul><ul><li>QMS documentation: </li></ul><ul><ul><li>Quality policy, objectives </li></ul></ul><ul><ul><li>Quality manual </li></ul></ul><ul><ul><li>Documented procedures and records </li></ul></ul><ul><ul><li>Documents, including records determined by the organisation </li></ul></ul>
  • 18. 4.2.1 General <ul><li>Documented procedure means that it must be established, documented, implemented and maintained </li></ul><ul><li>Extend of documentation may differ due to </li></ul><ul><ul><li>Size & type of organisation </li></ul></ul><ul><ul><li>Complexity & interaction of processes </li></ul></ul><ul><ul><li>Competence of personnel </li></ul></ul><ul><li>Documentation may be in any type of media </li></ul>
  • 19. 4.2.2 Quality manual <ul><li>Quality manual must include as minimum: </li></ul><ul><ul><li>The scope of QMS including details of, and justification for, any exclusions </li></ul></ul><ul><ul><li>Documented procedures or reference thereto </li></ul></ul><ul><ul><li>Description of the interaction between the processes of the QMS </li></ul></ul>
  • 20. 4.2.3 Control of documents <ul><li>Documented procedures to: </li></ul><ul><ul><li>approve documents prior to issue </li></ul></ul><ul><ul><li>review, update as necessary and re-approve documents </li></ul></ul><ul><ul><li>to identify the changes and the current revision status of documents </li></ul></ul><ul><ul><li>to ensure documents remain legible, readily identifiable </li></ul></ul><ul><ul><li>ensure relevant versions of applicable documents are available at points of use </li></ul></ul><ul><ul><li>ensure that documents of external origin necessary for planning and operation of QMS are identified and distribution controlled </li></ul></ul><ul><ul><li>obsolete documents are prevented from unintended use and identified if kept for any reason </li></ul></ul>
  • 21. 4.2.4 Control of records <ul><li>Records to provide evidence are controlled </li></ul><ul><li>Documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of quality records. </li></ul><ul><li>Records must be legible, readily identifiable and retrievable. </li></ul>
  • 22. 5 Management responsibility <ul><li>5.1 Management commitment </li></ul><ul><li>5.2 Customer focus </li></ul><ul><li>5.3 Quality policy </li></ul><ul><li>5.4 Planning </li></ul><ul><ul><li>5.4.1 Quality objectives </li></ul></ul><ul><ul><li>5.4.2 QMS planning </li></ul></ul><ul><li>5.5 Responsibility, authority and communication </li></ul><ul><ul><li>5.5.1 Responsibility & authority </li></ul></ul><ul><ul><li>5.5.2 Management representative </li></ul></ul><ul><ul><li>5.5.3 Internal communication </li></ul></ul><ul><li>5.6 Management review </li></ul><ul><ul><li>5.6.1 General </li></ul></ul><ul><ul><li>5.6.2 Review input </li></ul></ul><ul><ul><li>5.6.3 Review output </li></ul></ul>
  • 23. 5.1 Management commitment <ul><li>Provide evidence of commitment to the development implementation and continual improvement of QMS by: </li></ul><ul><ul><li>communicating the importance of meeting customer and statutory and regulatory requirements </li></ul></ul><ul><ul><li>establishing quality policy & objectives </li></ul></ul><ul><ul><li>management reviews </li></ul></ul><ul><ul><li>provision of resources </li></ul></ul>
  • 24. 5.2 Customer focus Determine customer requirements Meet requirements Customer satisfaction
  • 25. 5.3 Quality policy <ul><li>appropriate to the purpose of the organisation </li></ul><ul><li>commitment to comply with requirements </li></ul><ul><li>continually improve the effectiveness of the QMS </li></ul><ul><li>framework for establishing & reviewing quality objectives </li></ul><ul><li>communicated and understood </li></ul><ul><li>reviewed for continuing suitability </li></ul>
  • 26. 5.4.1 Quality objectives <ul><li>Establish quality objectives </li></ul><ul><li>Measurable & consistent with the quality policy </li></ul><ul><li>Include those needed to meet requirements for product </li></ul>
  • 27. 5.4.2 Quality management system planning <ul><li>Planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives </li></ul><ul><li>Maintain the integrity of the QMS integrity when changes are planned and implemented </li></ul>
  • 28. 5.5 Responsibility, authority and communication <ul><li>5.5.1 Responsibility and authority </li></ul><ul><li>define and communicate responsibilities and authorities </li></ul>
  • 29. 5.5.2 Management Representative <ul><li>Member of the organization’s management </li></ul><ul><li>Ensures that processes needed for the QMS are established, implemented and maintained </li></ul><ul><li>Reports on performance of QMS including needs for improvement </li></ul><ul><li>Promotes awareness of customer requirements </li></ul>
  • 30. 5.5.3 Internal communication <ul><li>Communication processes are established </li></ul><ul><li>Communication takes place regarding the effectiveness of QMS </li></ul>
  • 31. 5.6 Management Review <ul><li>5.6.1 General </li></ul><ul><li>Review of the QMS by top management at planned intervals to: </li></ul><ul><ul><li>ensure QMS suitability, adequacy & effectiveness </li></ul></ul><ul><ul><li>assess opportunities for improvement </li></ul></ul><ul><ul><li>evaluate the need for changes to QMS including policy & objectives </li></ul></ul><ul><li>Records maintained. </li></ul>
  • 32. 5.6.2 Review input <ul><ul><li>audit results </li></ul></ul><ul><ul><li>customer feedback </li></ul></ul><ul><ul><li>process performance </li></ul></ul><ul><ul><li>product conformity </li></ul></ul><ul><ul><li>status of PAs and CAs </li></ul></ul><ul><ul><li>follow up actions from earlier reviews </li></ul></ul><ul><ul><li>changes that could affect the QMS </li></ul></ul><ul><ul><li>recommendations for improvement </li></ul></ul>Management Review
  • 33. 5.6.3 Review output <ul><li>improved effectiveness of the QMS </li></ul><ul><li>improvement of product </li></ul><ul><li>resource needs </li></ul>Management Review
  • 34. 6 Resource Management <ul><li>6.1 Provision of resources </li></ul><ul><li>6.2 Human resources </li></ul><ul><ul><li>6.2.1 General </li></ul></ul><ul><ul><li>6.2.2 Competence, training and awareness </li></ul></ul><ul><li>6.3 Infrastructure </li></ul><ul><li>6.4 Work environment </li></ul>
  • 35. 6.1 Provision of resources <ul><li>Determine & provide the resources needed to: </li></ul><ul><ul><li>implement, maintain the QMS and continually improve its effectiveness </li></ul></ul><ul><ul><li>enhance customer satisfaction </li></ul></ul>
  • 36. 6.2 Human Resources <ul><li>6.2.1 General </li></ul><ul><li>Personnel performing work affecting conformity to product requirements must be competent on the basis of : </li></ul><ul><ul><ul><li>appropriate education </li></ul></ul></ul><ul><ul><ul><li>training </li></ul></ul></ul><ul><ul><ul><li>skills </li></ul></ul></ul><ul><ul><ul><li>experience. </li></ul></ul></ul>
  • 37. 6.2.2 Competence, training and awareness <ul><li>Determine the necessary competence </li></ul><ul><li>Provide training or take other action to satisfy those needs </li></ul><ul><li>Evaluate the effectiveness of actions taken </li></ul><ul><li>Ensure staff aware of relevance and importance of their activities and contribution to achieving objectives </li></ul><ul><li>Maintain appropriate records of education, training, skills and experience </li></ul>
  • 38. 6.3 Infrastructure <ul><li>Determine, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable: </li></ul><ul><ul><li>buildings, workspace </li></ul></ul><ul><ul><li>equipment </li></ul></ul><ul><ul><li>supporting services </li></ul></ul>
  • 39. 6.4 Work environment <ul><li>Determine and manage the work environment needed to achieve product conformity. </li></ul>
  • 40. 7 Product realization <ul><li>7.1 Planning of product realization </li></ul><ul><li>7.2 Customer related processes </li></ul><ul><li>7.3 Design & development </li></ul><ul><li>7.4 Purchasing </li></ul><ul><li>7.5 Production & service provision </li></ul><ul><li>7.6 Control of measuring & monitoring equipment </li></ul>
  • 41. 7.1 Planning of product realization <ul><li>Planning must determine as appropriate: </li></ul><ul><ul><li>quality objectives and requirements for the product </li></ul></ul><ul><ul><li>the need for processes, documentation, resources specific to the product </li></ul></ul><ul><ul><li>verification and validation activities & acceptance criteria </li></ul></ul><ul><ul><li>Records to provide evidence </li></ul></ul>
  • 42. 7.2 Customer related processes <ul><li>7.2.1 Determination of requirements related to product </li></ul><ul><li>7.2.2 Review of requirements related to product </li></ul><ul><li>7.2.3 Customer communication </li></ul>
  • 43. 7.2.1 Determination of requirements related to product <ul><li>Organisation must determine: </li></ul><ul><ul><li>requirements specified by the customer </li></ul></ul><ul><ul><li>requirements not specified but necessary </li></ul></ul><ul><ul><li>statutory and regulatory requirements applicable to product, </li></ul></ul><ul><ul><li>any additional requirements </li></ul></ul>
  • 44. 7.2.2 Review requirements related to the product <ul><li>Review requirements before commitment to supply product & ensure that: </li></ul><ul><ul><li>product requirements are defined </li></ul></ul><ul><ul><li>difference between contract requirements from those previously expressed resolved </li></ul></ul><ul><ul><li>organisation has ability to meet the requirements </li></ul></ul><ul><li>Record the results of review and actions </li></ul><ul><li>Confirm requirements, when customer does not provide documented requirements </li></ul><ul><li>When requirements are changed ensure that documents are amended and relevant persons are made aware of the changes. </li></ul>
  • 45. 7.2.3 Customer communication <ul><li>Effective arrangements for communication with customers relating to : </li></ul><ul><ul><li>product information </li></ul></ul><ul><ul><li>enquiry, contract & order handling including amendments </li></ul></ul><ul><ul><li>customer feedback including complaints </li></ul></ul>
  • 46. 7.3 Design & development (not applicable in L&M) <ul><li>7.3.1 Design & development planning </li></ul><ul><li>7.3.2 Design & development inputs </li></ul><ul><li>7.3.3 Design & development outputs </li></ul><ul><li>7.3.4 Design & development review </li></ul><ul><li>7.3.5 Design & development verification </li></ul><ul><li>7.3.6 Design & development validation </li></ul><ul><li>7.3.7 Control of design & development changes </li></ul>
  • 47. 7.3.1 Design & development (D&D) planning <ul><li>Plan & control D&D of the product. </li></ul><ul><li>Planning to include: </li></ul><ul><ul><li>D&D stages </li></ul></ul><ul><ul><li>required review, verification and validation activities </li></ul></ul><ul><ul><li>responsibilities & authorities for D&D </li></ul></ul><ul><li>Interfaces between groups must be managed </li></ul><ul><li>Planning to be updated as the D&D progresses </li></ul>
  • 48. 7.3.2 Design & development inputs <ul><li>Determine & record product requirements including: </li></ul><ul><ul><li>functional & performance requirements </li></ul></ul><ul><ul><li>applicable statutory and regulatory requirements </li></ul></ul><ul><ul><li>information from previous similar designs </li></ul></ul><ul><ul><li>any other essential requirements </li></ul></ul><ul><li>Review input for adequacy </li></ul><ul><li>Requirements must be complete, unambiguous and not in conflict with each other </li></ul>
  • 49. 7.3.3 Design & development outputs <ul><li>D&D output in a form suitable for verification </li></ul><ul><li>D&D output must </li></ul><ul><ul><li>meet the input requirements </li></ul></ul><ul><ul><li>provide information for purchasing, production and service provision </li></ul></ul><ul><ul><li>contain or reference acceptance criteria </li></ul></ul><ul><ul><li>define characteristics essential for proper & safe use </li></ul></ul><ul><li>Approve output prior to release </li></ul>
  • 50. 7.3.4 Design & development review <ul><li>At suitable stages systematic reviews of D&D to: </li></ul><ul><ul><li>evaluate the ability to meet requirements </li></ul></ul><ul><ul><li>identify problems and propose follow up </li></ul></ul><ul><li>Involve all functions concerned </li></ul><ul><li>Record the results and any necessary actions </li></ul>
  • 51. 7.3.5 Design & development verification <ul><li>Verify D&D to ensure that output meets the input requirements </li></ul><ul><li>Record the results of verification and necessary actions </li></ul>
  • 52. 7.3.6 Design & development validation <ul><li>Perform D&D validation to confirm that product is capable of meeting the requirements for the specified or intended use </li></ul><ul><li>Whenever applicable to be completed prior to delivery </li></ul><ul><li>Results of validation and necessary actions must be recorded </li></ul>
  • 53. 7.3.7 Control of design and development changes <ul><li>Design & development changes must be identified and records maintained </li></ul><ul><li>Changes must be reviewed, verified and validated as appropriate and approved before implementation </li></ul><ul><li>Record results of review of changes and any necessary actions </li></ul>
  • 54. 7.4 Purchasing <ul><li>7.4.1 Purchasing process </li></ul><ul><li>7.4.2 Purchasing information </li></ul><ul><li>7.4.3 Verification of purchased product </li></ul>
  • 55. 7.4.1 Purchasing process <ul><li>Ensure that purchased product meets requirements </li></ul><ul><li>Type & extend of control depends on effect purchased product may have on the final product </li></ul><ul><li>Evaluate and selects suppliers based on their ability to supply conforming product </li></ul><ul><li>Establish criteria for selection, evaluation and re-evaluation of suppliers </li></ul><ul><li>Results of evaluation and any necessary actions must be recorded </li></ul>
  • 56. 7.4.2 Purchasing information <ul><li>Purchasing information must include where appropriate: </li></ul><ul><ul><li>requirements for approval of product, procedures, processes and equipment </li></ul></ul><ul><ul><li>requirements for qualification of personnel </li></ul></ul><ul><ul><li>quality management system requirements </li></ul></ul><ul><li>Ensure adequacy of specified purchase requirements prior to their communication to supplier </li></ul>
  • 57. 7.4.3 Verification of purchased product <ul><li>Establish & implement inspection or other activities needed to ensure purchased product conformity </li></ul><ul><li>Where organisation or its customer propose verification at supplier’s premises, organisation must specify in purchasing information: </li></ul><ul><ul><li>verification arrangements </li></ul></ul><ul><ul><li>method of product release </li></ul></ul>
  • 58. 7.5 Production and service provision <ul><li>7.5.1 Control of production and service provision </li></ul><ul><li>7.5.2 Validation of processes for production and service provision </li></ul><ul><li>7.5.3 Identification & traceability </li></ul><ul><li>7.5.4 Customer property </li></ul><ul><li>7.5.5 Preservation of product </li></ul>
  • 59. 7.5.1 Control of production and service provision <ul><li>Plan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable: </li></ul><ul><ul><li>a) availability of information describing product characteristics </li></ul></ul><ul><ul><li>b) availability of work instructions, as necessary </li></ul></ul><ul><ul><li>c) the use of suitable equipment </li></ul></ul><ul><ul><li>d) availability & use of monitoring and measuring equipment </li></ul></ul><ul><ul><li>e) implementation of monitoring and measurement </li></ul></ul><ul><ul><li>f) the implementation of product release, delivery and post delivery activities </li></ul></ul>
  • 60. 7.5.2 Validation of processes <ul><li>Validate processes where outcome is not verified and as a consequence, deficiencies may become apparent after delivery </li></ul><ul><li>Validation shall demonstrate the ability of processes to achieve results </li></ul><ul><li>For these processes establish: </li></ul><ul><ul><li>criteria for review and approval of the process </li></ul></ul><ul><ul><li>approval of equipment and qualification of personnel </li></ul></ul><ul><ul><li>use of defined methods & procedures </li></ul></ul><ul><ul><li>requirements for records </li></ul></ul><ul><ul><li>revalidation </li></ul></ul>
  • 61. 7.5.3 Identification and traceability <ul><li>Where appropriate identify product by suitable means throughout product realization </li></ul><ul><li>Identify status with respect to measurement & monitoring requirements throughout product realization </li></ul><ul><li>Where traceability is required control the unique identification of product </li></ul><ul><li>Maintain records </li></ul>
  • 62. 7.5.4 Customer property <ul><li>Care for customer’s property while it is under organisation’s control or being used by organisation </li></ul><ul><li>Identification, verification, protection & safeguarding customer property provided for use or incorporation </li></ul><ul><li>Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer </li></ul><ul><ul><li>Customer property includes intellectual property & personal data </li></ul></ul>
  • 63. 7.5.5 Preservation of product <ul><li>Preserve the product during internal processing and final delivery to intended destination </li></ul><ul><li>Include identification, handling, packaging, storage and protection </li></ul><ul><li>This applies to constituent parts of a product </li></ul>
  • 64. 7.6 Control of monitoring & measuring equipment <ul><li>Determine monitoring and measurements to be made & measurement & monitoring equipment needed to provide evidence of conformity of product </li></ul><ul><li>Ensure measuring and monitoring is carried out consistently with monitoring and measurement requirements </li></ul><ul><li>Suitability of measuring/monitoring software must be confirmed prior to use and re-confirm as necessary </li></ul>
  • 65. 7.6 Control of monitoring & measuring equipment <ul><li>Calibrate or verify or both at specified intervals or prior to use against international or national standards. Where no such standard exist record the basis </li></ul><ul><li>Adjust or re-adjust as necessary </li></ul><ul><li>Have identification to determine calibration status </li></ul><ul><li>Safeguard from adjustments invalidating calibration </li></ul><ul><li>Protect from damage or deterioration during handling, maintenance& storage </li></ul><ul><li>record results of calibration </li></ul><ul><li>assess and record validity of previous results when device found to be out of calibration </li></ul>
  • 66. 8 Measurement, analysis and improvement <ul><li>8.1 General </li></ul><ul><li>8.2 Monitoring/measurement </li></ul><ul><ul><li>8.2.1 Customer satisfaction </li></ul></ul><ul><ul><li>8.2.2 Internal Audit </li></ul></ul><ul><ul><li>8.2.3 Monitoring & measurement of processes </li></ul></ul><ul><ul><li>8.2.4 Monitoring & measurement of product </li></ul></ul><ul><li>8.3 Control of nonconforming product </li></ul><ul><li>8.4 Analysis of data </li></ul><ul><li>8.5 Improvement </li></ul><ul><ul><li>8.5.1 Continual improvement </li></ul></ul><ul><ul><li>8.5.2 Corrective action </li></ul></ul><ul><ul><li>8.5.3 Preventive action </li></ul></ul>
  • 67. 8.1 General <ul><li>Plan & implement measurement, monitoring analysis and improvement processes needed to: </li></ul><ul><ul><li>demonstrate conformity to product requirements </li></ul></ul><ul><ul><li>ensure conformity of the QMS </li></ul></ul><ul><ul><li>continually improve the effectiveness of the QMS </li></ul></ul>
  • 68. 8.2.1 Customer satisfaction <ul><li>Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements. </li></ul><ul><li>The methods for obtaining and using this information must be determined </li></ul>
  • 69. 8.2.2 Internal audit <ul><li>Conduct internal audits at planned intervals to determine if : </li></ul><ul><ul><li>QMS conforms to the planned arrangements, requirements of the standard and organisation’s requirements </li></ul></ul><ul><ul><li>QMS is effectively implemented & maintained </li></ul></ul><ul><li>Plan the audit programme considering: </li></ul><ul><ul><li>status and importance of the processes and the areas </li></ul></ul><ul><ul><li>results of previous audits </li></ul></ul><ul><li>Define audit criteria, scope, frequency & methodologies </li></ul>
  • 70. 8.2.2 Internal audit <ul><li>Select auditors to ensure objectivity and impartiality. </li></ul><ul><li>Auditor must not audit own work. </li></ul><ul><li>The documented procedure must cover: </li></ul><ul><ul><li>responsibilities & requirements for planning and conducting audits </li></ul></ul><ul><ul><li>reporting results and maintaining records </li></ul></ul><ul><li>Corrective actions without undue delay </li></ul><ul><li>Follow up to verify actions taken & report verification results </li></ul>
  • 71. 8.2.3 Monitoring and measurement of processes <ul><li>Apply suitable methods for monitoring and, where applicable, measurement of QMS processes </li></ul><ul><ul><li>These methods shall demonstrate the ability of the processes to achieve planned results </li></ul></ul><ul><ul><li>Where planned results are not achieved corrections and corrective actions must be taken </li></ul></ul>
  • 72. 8.2.4 Monitoring and measurement of product <ul><li>Monitor & measure product characteristics to verify conformity at appropriate stages </li></ul><ul><li>Evidence of conformity with the acceptance criteria must be maintained. </li></ul><ul><li>Records must indicate the person(s) authorising release of the product for delivery to the customer </li></ul><ul><li>Release or delivery must not proceed until all the planned arrangements have been satisfactorily completed, unless otherwise approved by a relevant authority, and where applicable by the customer </li></ul>
  • 73. 8.3 Control of nonconforming product <ul><li>Nonconforming product must be identified and controlled to prevent unintended use or delivery </li></ul><ul><li>Documented procedure to define controls, responsibility and authority </li></ul><ul><li>When the nonconforming product is corrected it must be re-verified to demonstrate conformity </li></ul>
  • 74. 8.3 Control of nonconforming product <ul><li>Organisation must deal with nonconforming product by one or more of the following ways: </li></ul><ul><ul><li>action to eliminate detected nonconformity </li></ul></ul><ul><ul><li>concession </li></ul></ul><ul><ul><li>preclude original intended use or application </li></ul></ul><ul><ul><li>Taking actions appropriate to the effects, when nonconformity is detected after delivery </li></ul></ul><ul><li>Records of the nature of nonconformity and any subsequent action including concessions must be maintained </li></ul>
  • 75. 8.4 Analysis of data <ul><li>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 </li></ul><ul><li>Data from measurement & monitoring & other relevant sources </li></ul><ul><li>Analyze data to provide information on: </li></ul><ul><ul><li>customer satisfaction </li></ul></ul><ul><ul><li>conformity to product requirements </li></ul></ul><ul><ul><li>process, product characteristics and their trends including opportunities for preventive action </li></ul></ul><ul><ul><li>suppliers </li></ul></ul>
  • 76. 8.5 Improvement <ul><li>8.5.1 Continual improvement </li></ul><ul><li>Organisation shall continually improve the effectiveness of the QMS through use of: </li></ul><ul><ul><li>quality policy </li></ul></ul><ul><ul><li>quality objectives </li></ul></ul><ul><ul><li>audit results </li></ul></ul><ul><ul><li>analysis of data </li></ul></ul><ul><ul><li>corrective actions </li></ul></ul><ul><ul><li>preventive actions </li></ul></ul><ul><ul><li>management review </li></ul></ul>
  • 77. 8.5.2 Corrective action <ul><li>Take actions to eliminate the causes of nonconformities to prevent recurrence. </li></ul><ul><li>Corrective actions appropriate to the impact of the problem </li></ul><ul><li>Documented procedure shall define requirements for: </li></ul><ul><ul><li>reviewing nonconformities (including customer complaints) </li></ul></ul><ul><ul><li>determining the causes of nonconformities </li></ul></ul><ul><ul><li>Evaluating the need for corrective action </li></ul></ul><ul><ul><li>determining & implementing action needed </li></ul></ul><ul><ul><li>recording results of action taken </li></ul></ul><ul><ul><li>reviewing the effectiveness of the corrective action taken </li></ul></ul>
  • 78. 8.5.3 Preventive action <ul><li>Determine action to eliminate the causes of potential nonconformances to prevent occurrence. </li></ul><ul><li>Actions appropriate to the impact of the potential problem </li></ul><ul><li>Documented procedure must define the requirements for </li></ul><ul><ul><li>determining potential nonconformances & their causes </li></ul></ul><ul><ul><li>evaluating the need for preventive action </li></ul></ul><ul><ul><li>determining and implementing action needed </li></ul></ul><ul><ul><li>recording the results of action taken </li></ul></ul><ul><ul><li>reviewing the effectiveness of the preventive action taken </li></ul></ul>

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