AS9100:2016 D - Intent of 8.4.3 (K) - Implement QMS

#1
Good Afternoon,
I am on a quest to find supporting information with regard to 8.4.3(k) intent and I am having difficulty. I then thought of this wonderfully smart and sharing group of people. Here goes...

When the standard states "implement a QMS", does this imply a compliant QMS (to ISO?) or would anything labeled as a QMS suffice?

Context - We have a supplier that has a quality manual that states its compliant to ISO 9001: 2008. There is debate as to whether or not this is adequate. additionally, we have an internal requirement that states "The supplier is required to have a Quality Management System compliant to the ISO standard". Because it doesn't say "current" people are suggesting 2008 is acceptable. When I asked if ISO 9001:1994 would also be acceptable, no one responded.

So I am looking for guidance on 2 fronts, per ISO and how our internal requirement is written. Any help is appreciated (24 years experience in 13485, 1 year in AS9100)
 
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John Predmore

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#2
I didn’t find the answer in section 8.4.3 but I may have found it in section 5.1. The section on Leadership and Commitment says top management will take accountability for the effectiveness of the QMS, communicate the importance of an effective QMS and conforming to requirements, and support other management roles to demonstrate their leadership in their areas of responsibility. Section 5.2.1.d requires commitment to continual improvement of the QMS. It is questionable to claim commitment, leadership and continual improvement using an outdated playbook.

If I had a supplier using Windows 95 and Excel 1997, I would challenge them to upgrade to the latest versions because they cannot be fully effective using outdated methods and thinking. There is a risk to my company if my supplier uses obsolete software, and there is a risk when they are not in alignment with internationally accepted standards and best practices.
 

Cari Spears

Super Moderator
Staff member
Super Moderator
#3
Section 5 is about your own organization.

Section 8.4.3 says you have to communicate your requirements for the need for your suppliers to implement a quality management system. It means you get to decide. We don't have a requirement for all of our suppliers to implement a QMS; the only ones we do have some requirements for is if our customer requires Nadcap or ISO17025 - then we have to ensure we only use suppliers with those accreditations. We don't care if they're ISO or AS.

So if your organization's requirement gives room for various interpretations, then clarify it. Or get rid of it if it isn't adding value.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
There is no organization in the aero supply chain that does not have a quality management system. The question is how formalized, structured and mature the system may be.

Also remember one thing: ISO 9001:1994, ISO 9001:2008, AS9100C, etc. are NOT quality systems; they are STANDARDS.
 
#5
Good Afternoon,
I am on a quest to find supporting information with regard to 8.4.3(k) intent and I am having difficulty. I then thought of this wonderfully smart and sharing group of people. Here goes...

When the standard states "implement a QMS", does this imply a compliant QMS (to ISO?) or would anything labeled as a QMS suffice?

Context - We have a supplier that has a quality manual that states its compliant to ISO 9001: 2008. There is debate as to whether or not this is adequate. additionally, we have an internal requirement that states "The supplier is required to have a Quality Management System compliant to the ISO standard". Because it doesn't say "current" people are suggesting 2008 is acceptable. When I asked if ISO 9001:1994 would also be acceptable, no one responded.

So I am looking for guidance on 2 fronts, per ISO and how our internal requirement is written. Any help is appreciated (24 years experience in 13485, 1 year in AS9100)
It would depend on the organization. If compliance to the 1994 standard is OK then why not. However your customer may have a different opinion. Many times this flow down requirement is something your customer has included in their T&Cs. AS9100 8.4.3k only states that the organization shall flow down "its" requirements for the need to implement a Quality Management system. It does not specify to what standard. It is up to the organization what is acceptable.
 

Kronos147

Trusted Information Resource
#6
If your organization transitioned from ISO 9001:2008 to ISO 9001:2015 (AS9100 D), then you may know the important additions you would like for your supplier to address. Like Counterfeit 8.4.1.4 stuff. Add that stuff to your T's & C's, flow down the new rev with a cover letter, and call it a day.
 
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