The upcoming changes to ISO 9001 & ISO 9004: The upcoming changes to ISO 9001 & ISO 9004 An update Sidney Vianna 17 August 2007


About the presenter and DNV: About the presenter and DNV DNV is one of the leading Certification Bodies in the World, as well as the USA. DNV certifies over 60,000 organizations around the World, to a multitude of Management System Standards. Sidney Vianna is the Director of Aviation, Space & Defense certification services for DNV, in the USA. He represents DNV in the Registration Management Committee of the Americas Aerospace Quality Group. He has been involved with ISO 9001 audits since 1989 and was one of the first IRCA certified Lead Auditors in the USA. He manages 23 DNV lead assessors in the West Coast of the US and Canada.


Current ISO 9000 Family: Current ISO 9000 Family


The ISO 9001 Revision process: The ISO 9001 Revision process Under the auspices of the Technical Committee TC 176, the ISO 9000 “family of documents” is continually reviewed and revised. First Edition – 1987 Second Edition – 1994 Third Edition – 2000 Standards are revised because they must be kept up to date with the user’s expectations. Quality Management is a dynamic process and evolves over time. Thus, the Standards should follow suit. For the upcoming revision <AMENDMENT> of ISO 9001, a design specification was balloted, back in 2005. By design, the 4th Edition of ISO 9001 is supposed to include only MINOR clarifications to the existing document. No significant changes are proposed nor expected.


Design Specification for an amendment of ISO 9001: Design Specification for an amendment of ISO 9001 2. Purpose and scope of the amendment process 2.1 Purpose The purpose of the amendment is to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004. 2.2 Scope The amended standard shall remain generic and be applicable to all sizes and types of organization operating in any sector. The changes shall be restricted so that the impact of the amendment on the users is limited, and also that changes will only be introduced where there are clear benefits to users The ISO 9001:2000 support package should be used to assist the writers in identifying issues for clarification. Drafts of the amended standard shall be subjected to verification against the design specification, and to validation by users.


Design Specification for an amendment of ISO 9001: Design Specification for an amendment of ISO 9001 4. Compatibility There are two main areas where compatibility issues shall be addressed: 4.1 ISO 14001 In the case of a Management System Standard, “compatibility” shall mean that common elements of the standards can be implemented by organizations in a shared manner, in whole or in part, without unnecessary duplication or the imposition of conflicting requirements. “Compatibility” shall not mean that the text of the common elements of the standards needs to be identical, although it should be whenever this is possible in practice. 4.2 Sector specific and other standards A number of other management system standards are based on ISO 9001:2000 and have used its structure and text. The writers of the amendment need to be aware of the impact of changes on the compatibility of other management system standards to ISO 9001.


Design Specification for an amendment of ISO 9001: Design Specification for an amendment of ISO 9001 9. Guidance on drafting the standard is free from cultural bias. the standard is written in a clear style that avoids the excessive use of quality terms and jargon, and can be understood by all interested parties, not just quality specialists. the standard is written to be unambiguous, to give a common understanding that prevents multiple interpretations. sentences are kept short, to reduce excessive wordiness without becoming ambiguous the effect of any proposed change on the other requirements of ISO 9001:2000 is considered before it is implemented. requirements are written in such a manner as to enable them to be audited the standard can be translated into other languages.


Decision matrix: Decision matrix


Proposed changes: Proposed changes 0.1 – Introduction


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Proposed changes: Proposed changes


Next steps: Next steps Before being released, October 31, 2008, we expect to see 2 more stages of the document: DIS and FDIS IAF has not decided yet on transition timeframe for organizations certified to the 3rd Edition of ISO 9001. If document is maintained as is, no reason for additional time during the “transition audit” is expected. So, don’t worry. Be happy!


Impact on other standards : Impact on other standards AS9100/9110/9120 – Major changes expected TS-16949 – No changes expected TL-9000 – Unclear at this time ISO 14001 – TC 176 and TC 207 working even closer, but against some rumors, no integrated Q&E ISO Standard in in the works. OHSAS 18001 revised and released in July 2007; closer to ISO 14001:2004


ISO 9004:2009: ISO 9004:2009 Management for sustainability – a quality management approach It will not contain the text of ISO 9001 any longer. Purpose of ISO 9004:2009 is to assist organizations who are users of ISO 9001 obtain sustained benefit from the implementation of a more broad-based and in-depth quality management system. It reminds organizations that are critical stakeholders, other than customers, that are also critical for the success of any enterprise.


Multiple stakeholders perspective: Social Financial Environment Share Holders Customers Employees Business Partners Local Communities Government NGOs Consumers Multiple stakeholders perspective


Promote self assessment: Promote self assessment


Documents were free: Documents were free


Questions?: Questions?


For further contact: For further contact For further enquiries, please email me sidney.vianna@dnv.com