Transitioning to ISO 9001:2008. Profession Development for ASQ Chapter 309 Tanzco Management Consulting, LLC

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Janice Rodgers
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1 Transitioning to ISO 9001:2008 Profession Development for ASQ Chapter 309 Tanzco Management Consulting, LLC

2 ISO 9001 ISO 9001 is the most widely used standard for quality management systems in the world Over 1,000,000 companies are certified in 170 countries World-wide, certifications continue to grow at about 15% year Standards are reviewed and revised periodically because the must keep up to date with stakeholders expectations. Quality management is a dynamic process and evolves over time The ISO 9000 family of documents are continually reviewed and revised through the Technical Committee TC 176 First Edition 1987 Second Edition 1994 Third Edition 2000 Fourth Edition 2008 (November 15)

3 ISO 9001:2008 in Brief ISO 9001:2008 clarifies legal requirements Outsourcing Competence design and development Internal audit Monitoring and measurement Control of non-conforming product The goal of this version is to improve your organizations QMS and improve profitability It includes a 24 month implementation plan

5 ISO 9001:2008

6 Compatibility with ISO 14001:2004

7 ISO & IAF ISO and the International Accreditation Forum have jointly issued the following rules for the transition: Twenty four months after publication of ISO 9001:2008 any existing certifications issued to ISO 9001:2000 shall not be valid One year after publication of ISO 9001:2008 all accredited certifications issued shall be to ISO 9001:2008 Certification of conformity of ISO 9001:2008 and /or national equivalents shall only be issued after official publication and after routine surveillance of recertification audit against ISO 9001:2008 Transition can be done during any scheduled recertification or periodical audit in the 24 month period

8 Transition Process

9 Implementation Process

10 Decision Tree for Certificate START HERE All 2000 certificates end within 24 months after ISO 9001: ISO 9001:2000 or 9001: Certificate issued at Stage 2 or Recertif n Audit Y The certificate s end date is 3 years from its effective date N Certificate is issued using end date of previous certificate

11 Management Systems

12 Management Systems should be performance-based

13 Why Notes?

14 Main Changes Introduced

15 Main Changes

16 Consequence

18 Main Changes

19 Main Changes

20 Implication

21 Main Changes

22 Implication

23 Main Changes Clause 0.3 (Relationship with ISO 9004) Revised to emphasize continual improvement and to remove references to applicable statutory and regulatory requirements. Specifies that ISO 9004 can be used to go beyond the requirements of ISO 9001 No longer the consistent pair

24 Main Changes

25 Main Changes

26 Main Changes

27 OUTSOURCING the type and extent of the control to be applied to these outsourced processes shall be defined with the QMS When an organization outsources training, they may write specific details in the Outsourcing Process, such as: the trainer must have attended a train-thetrainer course. The organization then requires feedback from the Master Trainer to evaluate the competency of the trainer

28 Implications

29 Main Changes

30 Main Changes

31 Main Changes

32 Main Changes

33 Main Changes

34 Implications

35 Main Changes

36 Personnel Included

37 Main Changes - Clarified satisfy these needs

38 Explanation

39 Implication

40 Example: Main Changes

41 Main Changes

42 Explanation

43 Implication

44 Main Changes The New Note: is almost identical to the current note in ISO/TS 16949:2000

45 Main Changes process

46 Main Changes

47 Main Changes

48 Example

49 Main Changes

50 Main Changes

51 Main Changes A change of terms: Changed and/or to or in sub-clause a), so it now reads be calibrated or verified, or both To have identification in order to determine its calibration status

52 Explanation

53 Main Changes

54 Implication The note regarding computers would mean that an auditor should typically check that the program can perform its intended purpose

55 Main Changes

56 Main Change

57 Main Changes

58 Example

59 Main Changes

60 Implications How far am I required to go? As far as necessary to establish, maintain, improve, and demonstrate that your processes operate under controlled conditions to achieve output requirements.

61 Main Changes

62 Implications

63 Examples A package is misdirected during shipment and arrives late. The company decides to refund all or part of the shipping charges. This is not a correction but a recovery action.

64 Main Changes

65 Example

66 Main Changes

67 Implications

68 Additional Resources

69 To Obtain ISO 9001:2008 You can purchase a print or an electronic copy at ASQ Standards Central at The updated introduction and support package for ISO 9001 is available online for free download at or

70 THANK YOU! Feel free to contact me at any time with your questions: (914) or at Auditors must take a transition course that meets all of the requirements of the IRCA and RABQSA. to maintain certification. Copies of ISO 9001:2008 are available from ASQ at Questions?

Implementation Guidance for ISO 9001:2008

Document: ISO/TC 176/SC 2/N 836 Our ref Secretariat of ISO/TC 176/SC 2 Date: 15 October 2008 Implementation Guidance for ISO 9001:2008 CONTENTS 1.0 INTRODUCTION 2.0 BACKGROUND ON ISO 9001:2008 REVISION