After a year of delays and several extra drafts, AS9100:2016 Rev D was published this week. This revised version of the Aerospace Quality Management System encompasses ISO 9001:2015 and adds the QMS requirements for aerospace and defense industries (approx. 105 additional requirements).
Below we have listed some of the major changes in the revision (not an exhaustive list but just the major points)
- AS9100:2016 will be based on the ISO 9001:2015 standard, therefore follows the Annex SL high level structure
- New clauses taken from ISO 9001 – context of the organisation, interested parties, risk based thinking, top management involvement
- Annexes from ISO 9001:2015 remain, but AS9100 have added notes to help clarify them
- ISO 9001:2015 doesn’t say that we had to have a quality manual, but AS9100:2016 suggests that a manual may be the way forward
- Several new clauses added or enhanced including
- Product safety
- Prevention of counterfeit parts
- Human factors
- Configuration management
- Management representative requirement (yes they have added it back in)
- The number of “shalls” is expected to increase from 53 to 66
When comparing AS9100 Rev C and AS9100 Rev D, the changes in the additional aerospace requirements are not that significant, the biggest change is in the base ISO 9001:2015 standard.
For most organisations, the elephant in the room is that the new revision of AS9100 should have been released shortly after ISO 9001:2015, but has been delayed by a year. But the same 3 year transition period has been given to both ISO 9001 and AS9100 (September 2018), meaning that you will only have 2 years to transition your AS9100 system and not 3!
Interestingly, if you have both ISO 9001 and AS9100 certification, if you move your ISO 9001 system over to the 2015 revision you may run the risk of not fulfilling the requirements of AS9100 Rev C.
Revised versions of AS9110 – Requirements for Maintenance Organizations and AS9120 – Requirements for Stockist Distributors are also due to be published at the end of 2016 (possibly November).
Now that the standard has been published, the transition process can begin and plans can be drawn up. If you are thinking of an early transition, be aware that the revised version of AS9101 Quality Systems Assessments is not due to be published until late 2016, therefore certification audits may not happen until early 2017.
Below is a brief overview of the changes to the new AS9100:2016 standard.
|Clause||High level changes|
|Clause 1 – Scope||Added Risk Based Thinking (RBT)
Added a PDCA model (Plan Do Check Act)
|Clause 2 – Normative References||No normative references|
|Clause 3 – Terms and Definitions||Terms for ISO 9001:2015 are defined in ISO 9000:2015
AS9100 specific terms added (e.g. counterfeit product, product safety)
|Clause 4 – Context of the Organization||Acceptable exclusions not limited to operations and realization processes
Quality manual not technically required but maintained documentation required
QMS processes have performance indicators
|Clause 5 – Leadership||QMS requirements integrated into business processes
Processes deliver their intended outputs
|Clause 6 – Planning||Determine actions needed to address risks and opportunities
Enhanced requirements for planning changes
|Clause 7 – Support||Must determine organizational knowledge requirements|
|Clause 8 – Operation||Planning for product obsolescence
Planned activities needed to ensure product safety
Prevention of counterfeit parts
Process to validate test reports for raw materials used in critical items
|Clause 9 – Performance Evaluation||Assess performance of QMS processes
Added Note to evaluate performance indicators on internal auditors
|Clause 10 – Improvement||Evaluate the need for action based on human factors|
How can Batalas help your transition to the revised standard?
Now that the standard has been published we are busy developing resources and events to support you through the changes. This support will include:
AS9100:2016 transition training – classroom training at public venues or in-house at your offices
AS9100:2016 transition webinars – live online event hosted by our expert trainers
AS9100:2016 top management overview – we come to you and explain the high level changes to your top management team