The document provides an overview of ISO 9001 and its evolution over time. It summarizes the key requirements of ISO 9001:2008, including developing, documenting, implementing and maintaining a quality management system. It outlines requirements for management responsibility, resource management, product realization, measurement and customer satisfaction.

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

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 ISO 9002 & ISO 9003 (1987 and 1994) incorporated in ISO 9001:2000 and withdrawn

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

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

10. 1 Scope (1.1 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

11. 1.2 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

12. 2 Normative reference ISO 9000 : 2005, Quality management systems - Fundamentals and vocabulary.

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

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

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

16. 4.1 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

17. 4.2 Documentation requirements 4.2.1 General QMS documentation: Quality policy, objectives Quality manual Documented procedures and records Documents, including records determined by the organisation

18. 4.2.1 General Documented procedure means that it must be established, 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

19. 4.2.2 Quality manual Quality manual must include as minimum: The scope of QMS including details of, and justification for, any exclusions Documented procedures or reference thereto Description of the interaction between the processes of the QMS

20. 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 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

21. 4.2.4 Control of records Records to provide evidence are controlled Documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention and disposition of quality records. Records must be legible, readily identifiable and retrievable.

22. 5 Management responsibility 5.1 Management commitment 5.2 Customer focus 5.3 Quality policy 5.4 Planning 5.4.1 Quality objectives 5.4.2 QMS 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

23. 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

24. 5.2 Customer focus Determine customer requirements Meet requirements Customer satisfaction

25. 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

26. 5.4.1 Quality objectives Establish quality objectives Measurable & consistent with the quality policy Include those needed to meet requirements for product

27. 5.4.2 Quality management system planning Planning of the QMS is carried out in order to meet requirements given in 4.1, as well as the quality objectives Maintain the integrity of the QMS integrity when changes are planned and implemented

28. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority define and communicate responsibilities and authorities

29. 5.5.2 Management Representative Member of the organization’s management Ensures that processes needed for the QMS are established, implemented and maintained Reports on performance of QMS including needs for improvement Promotes awareness of customer requirements

30. 5.5.3 Internal communication Communication processes are established Communication takes place regarding the effectiveness of QMS

31. 5.6 Management Review 5.6.1 General Review of the QMS by top management at planned intervals to: ensure QMS suitability, adequacy & effectiveness assess opportunities for improvement evaluate the need for changes to QMS including policy & objectives Records maintained.

32. 5.6.2 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 Management Review

33. 5.6.3 Review output improved effectiveness of the QMS improvement of product resource needs Management Review

34. 6 Resource Management 6.1 Provision of resources 6.2 Human resources 6.2.1 General 6.2.2 Competence, training and awareness 6.3 Infrastructure 6.4 Work environment

35. 6.1 Provision of resources Determine & provide the resources needed to: implement, maintain the QMS and continually improve its effectiveness enhance customer satisfaction

36. 6.2 Human Resources 6.2.1 General Personnel performing work affecting conformity to product requirements must be competent on the basis of : appropriate education training skills experience.

37. 6.2.2 Competence, 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, skills and experience

38. 6.3 Infrastructure Determine, provide & maintain the infrastructure needed to achieve product conformity. Infrastructure includes, as applicable: buildings, workspace equipment supporting services

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

40. 7 Product realization 7.1 Planning of product realization 7.2 Customer related processes 7.3 Design & development 7.4 Purchasing 7.5 Production & service provision 7.6 Control of measuring & monitoring equipment

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

42. 7.2 Customer related processes 7.2.1 Determination of requirements related to product 7.2.2 Review of requirements related to product 7.2.3 Customer communication

43. 7.2.1 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, any additional requirements

44. 7.2.2 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, 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.

45. 7.2.3 Customer communication Effective arrangements for communication with customers relating to : product information enquiry, contract & order handling including amendments customer feedback including complaints

46. 7.3 Design & development (not applicable in L&M) 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 & development changes

47. 7.3.1 Design & development (D&D) planning Plan & control D&D of the product. Planning to include: D&D stages required review, verification and validation activities responsibilities & authorities for D&D Interfaces between groups must be managed Planning to be updated as the D&D progresses

48. 7.3.2 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, unambiguous and not in conflict with each other

49. 7.3.3 Design & development outputs D&D output in a form suitable for verification D&D output must meet the input requirements provide information for purchasing, production and service provision contain or reference acceptance criteria define characteristics essential for proper & safe use Approve output prior to release

50. 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

51. 7.3.5 Design & development verification Verify D&D to ensure that output meets the input requirements Record the results of verification and necessary actions

52. 7.3.6 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

53. 7.3.7 Control of design and development changes Design & development changes must be identified and records maintained Changes must be reviewed, verified and validated as appropriate and approved before implementation Record results of review of changes and any necessary actions

54. 7.4 Purchasing 7.4.1 Purchasing process 7.4.2 Purchasing information 7.4.3 Verification of purchased product

55. 7.4.1 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, evaluation and re-evaluation of suppliers Results of evaluation and any necessary actions must be recorded

56. 7.4.2 Purchasing information Purchasing information must include where appropriate: requirements for approval of product, 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

57. 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

58. 7.5 Production and service provision 7.5.1 Control of production and service provision 7.5.2 Validation of processes for production and service provision 7.5.3 Identification & traceability 7.5.4 Customer property 7.5.5 Preservation of product

59. 7.5.1 Control of production and service provision Plan and carry out production & service provision under controlled conditions. Controlled conditions include as applicable: a) availability of information describing product characteristics b) availability of work instructions, 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

60. 7.5.2 Validation of processes Validate processes where outcome is not verified and as a consequence, 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

61. 7.5.3 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

62. 7.5.4 Customer property Care for customer’s property while it is under organisation’s control or being used by organisation Identification, verification, protection & safeguarding customer property provided for use or incorporation Any customer property that is lost, damaged or found unsuitable must recorded & reported to customer Customer property includes intellectual property & personal data

63. 7.5.5 Preservation of product Preserve the product during internal processing and final delivery to intended destination Include identification, handling, packaging, storage and protection This applies to constituent parts of a product

64. 7.6 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

65. 7.6 Control of monitoring & measuring equipment 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 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

66. 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 & measurement of processes 8.2.4 Monitoring & measurement of product 8.3 Control of nonconforming product 8.4 Analysis of data 8.5 Improvement 8.5.1 Continual improvement 8.5.2 Corrective action 8.5.3 Preventive action

67. 8.1 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

68. 8.2.1 Customer satisfaction Organisation shall monitor information related to customer perception as to whether the organisation has met customer requirements. The methods for obtaining and using this information must be determined

69. 8.2.2 Internal audit Conduct internal audits at planned intervals to determine if : QMS conforms to the planned arrangements, 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, scope, frequency & methodologies

70. 8.2.2 Internal audit Select auditors to ensure objectivity and impartiality. Auditor must not audit own work. 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

71. 8.2.3 Monitoring and measurement of processes Apply suitable methods for monitoring and, where applicable, 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

72. 8.2.4 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. 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, unless otherwise approved by a relevant authority, and where applicable by the customer

73. 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 re-verified to demonstrate conformity

74. 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

75. 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

76. 8.5 Improvement 8.5.1 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

77. 8.5.2 Corrective action Take actions to eliminate the causes of nonconformities to prevent recurrence. 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

78. 8.5.3 Preventive action Determine action to eliminate the causes of potential nonconformances to prevent occurrence. 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