AS9100:2016 Update and Review
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AS9100:2016 Update and Review
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AS9100:2016 Update and Review
- 1. AS9100:2016 Update and Review Welcome and Thanks for Attending Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 1
- 2. Agenda • Introduction • Importance of AS • Changes to 2009 version • Implementation • Transition • Questions • Thank you Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 2
- 3. Cavendish Scott, Inc. • ISO Consulting Training, and Internal Auditing Since 1985 – ISO 9001, AS9100, ISO 13485, ISO 14001, ISO 17025, ISO 27001 • Guarantee Success (audits and consulting) • Registered Lead Auditors • Thousands of successful consulting registrations • Thousands of trained ISO auditors • Experience with most industries including manufacturing and service industries • Colin Gray • colin@cavendishscott.com • www.cavendishscott.com 3Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com
- 4. Importance of AS • Mandated by the industry • Assures at least a consistent terminology and understanding of key processes/controls • Assures a systemic approach to management and process control to ensure consistently effective products and services the customer can rely on • World-wide Copyright © 2015 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 4
- 5. Changes Annex SL • Annex SL • Purpose and Strategic Direction • Context, Issues, Interested Parties • Risks • Opportunities • Leadership Expectations • Knowledge • Change Management Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 5
- 6. Changes AS (ISO) 4 4.1 Context New 4.2 Interested Parties New 6 6.1 Risk and Opportunities New 7.1.2 People New 7.1.6 Knowledge New 8.5.5 Post Delivery Activities New 8.5.6 Change of processes New 4.3 Scope Changed 4.4 The QMS Changed Changed Changed 5 5.1.1 Leadership Changed Changed Changed 5.1.2 Customer Focus Changed 6.2 Objectives Changed 6.3 Planning of changes Changed 7 7.1.1 Resources - General Changed 7.4 Communication Changed 8 8.1 Operations Planning Changed 8.4 Externaly provided processes Changed 10.2 Nonconformity and Corrective Action Changed 7.3 Awareness Minor 7.5 Documented Information Minor 8.2 Customer Reqs Minor 8.3 Design Minor 8.5.1 Control of processes Minor 8.6 Release of proudct Minor 8.7 Control of NC outputs Minor 9 9.1.1 Perfomance Evaluation - General Minor 9.1.3 Analysis Minor 10 10.1 General Minor 10.3 Continual Improvement Minor Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 6
- 7. Implementation • Existing AS – New structure and terminology – A lot of similar processes established for 2009 – New processes for Annex SL • Purpose, Strategy, Context, Interested Parties – Process Approach – Strong Leadership Involvement – Risk… • New to AS – Not lightly – Process approach from the start – Deliberate, defined management and success Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 7
- 8. Transition • April 2016 • Transition of existing certificates no later than Sept 2018 • 2 years 5 months • November 2016 • 1 year 10 months • Don’t bank on anything in the last 3-4 months – 1 year 6 months • Allow upward of 6 months to complete Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 8
- 9. Questions Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 9
- 10. Cavendish Scott • 30 years with ISO/AS • Guarantee Successful Certification • Practical business focused approach • Provision of Expert AS 9100 internal auditing • Gap Analysis and Training Copyright © 2016 Cavendish Scott, Inc. All Rights Reserved. www.CavendishScott.com 10
Notes de l'éditeur
- Cavendish Scott has been working with AS and similar management system standards for 30+ years. We have never had a failure and always generate a prqactical, b usiness focused solution. We have always adopted a process approach.
- AS is incredibly important to the industry (areospaqce, defense, etc.) these industries require high precision, solid reliability, consistent, reliable and effective suppliers. As provides a model, which when applied well provides those characteristics in a meaningful manner. AS should support the supplier deliver everything the customer needs. Customers are so much in needs of these features they “mandate” that suppliers adopt the standard. There aqre always exceptions and variations but those that seriously supply the industry have adopted it and do it well. AS is not some minor local requirement it is in agreement with Asia, Europe and the Americas – the majority of the industry.
- AS is based on ISO 9001 and ISO 9001 changed in September of 2015. AS has not yet changed and is still in a format agreed and published in 2009 – based on the 2008 version of ISO 9001. However, they have committed to changing the standard (series of standards – AS9100, AS9110 and AS9120) to align it with the new 20`5 version of ISO 9001. In practice many of the same enhancements that were specified for the 2009 version will be re-specified appropriately for the 2016 version of AS. The standard will come – has come, from a number of sources. The first is the introduction of Annex SL which significantly changed ISO 9001. The goal was an imposition by ISO that all management system standards should follow is similar format and terminology. It didn’t make sense if you were doing ISO 9001 and ISO 14001 that you would treat records control differently or that the definition for corrective action was subtly different. The solution was to define the structure and wording for all management system standards and limit the ability of developers (e.g. of ISO 9001) to change it. Annex SL changed the structure and numbering, terminology and language and introduced some brand new requirements – new processes, and changed some existing ones (some quite substantially). The new stuff is the most significant and introduces significant processes to define and develop strategic and business oriented controls (context), a broader adopt of risk including a risk process and a commitment to promote risk based thinking and a stronger commitment for leadership to be involved and accountable. These changes are implemented in ISO 9001 and are thus adopted by AS. AS could change some aspect of them…but they haven’t. The approach is to add more prescription or additional requirements. The question remains – what changes did AS make to the new version of ISO 9001. it would appear that there are no significant changes over and above what they added to the 2008 version of ISO 9001. So the content that was sitting on top of ISO 9001:2008 has been taken, made to fit with the new structure and content and applied to the 2015 version of ISO 9001. Yes some wording differences but nothing that those who are already AS certified need to be scared of. Scared on 9001 yes but what AS is doing – it does not appear to be so. The final point here relates to implementation the standard was due to be published April 2016 but due to a failed vote it is delayed. Anything can happen!
- Here is a more detailed list of the changes that occurred to ISO 9001 and thus are also changes with AS9100
- If you are already AS certified you need to consider that your documentation must be process based. If its numbered or even just built around the standard then you need to restructure it. You could at least hide it by grouping and dropping the numbering. In practice it means combining some documents and generating some new process based documentation. The new processes introduced with ISO including context, risk and leadership also need to be addressed. And while we are on the topic, it is essential that management recognize that their involvement is mandatory (involvement in success rather than their ISO/AS system as such) and that the expectation is that they will talk to the system rather than the management rep, they will be audited and they will be required to demonstrate some specific characteristics including accountability. In some respect if an organization is new to AS it gets to start afresh. A process based system, management involvement from the beginning and addressing all processes in the standard. Done well it will provide a formality and discipline that adds value. But it should not be taken on lightly. These markets are good, generally strong and pay well. But they are competitive and AS is a serious standard that doesnt allow much benefit of the doubt.
- The plan was to publish in April 2016. it didn’t happen. Reportedly a failed vote caused more review and a setback to the vote. Currently the plan is expected for November of 2016. The original plan was to insist that all currently certified AS organizations transition to the new standard in September 2018 to align with the withdrawal of ISO 9001:2008. That would leave 6 months less time to complete the transition than for ISO 9001 organizations. Rumor has it that that is the same plan. Now the standard is delayed to the end of the year it will mean a very shortened transition period. Further complicating the issue is that in 2009 AS published formal auditor training and changes to the certification process around it. There is an expectation that they will mandate new training and possibly other controls and there is no word yet and to the truth and any progress.. Perhaps they will delay the transition deadline. It is worth staying very close to this.
- If you have questions you can always contact us. We are always happy to get involved in questions and discussions about the standard. Contact us on info@cavendishscott.com