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)
 
Elsmar Forum Sponsor

John Predmore

Quite Involved in Discussions
#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 It is questionable to claim commitment, leadership and continual improvement using an outdated playbook.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and Excel 1997, I would challenge them to upgrade to the latest versions because they cannot be fully effective using outdated methods and thinking.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.
 
Thread starter Similar threads Forum Replies Date
M Looking for Cross reference of AS9100:2016 to ISO13485 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
K AS9100:2016 (Rev. D) Required Procedures AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 19
W Is ISO9001:2015 required for AS9100:2016 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A ISO9001:2015 comparison with AS9100:2016 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Sidney Vianna First AS9100:2016 certificate issued, March 2017 - Status of Transition Sept. 2018 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 117
R AS9100:2016 Rev. D - Status and Information - May 2014 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
hockeyhead Existing process never included in AS9100 scope of certification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
W Major NCRs within AS9100 - What is the most frequent reason for Major NCRs? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
was named killer AS9100 Supplier Approval Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
R AS9100 - 8.4.2 - Receiving Inspection Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
B AS9100 8.4.1 Supplier Selection/Evaluation criteria and reevaluations AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
S Effective nonconforming process for AS9100 8.7 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
O Adding ISO 13485 to an AS9100 QMS ISO 13485:2016 - Medical Device Quality Management Systems 10
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
NDesouza AS9100 - D Capacity Planning Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
D ISO 9001 & AS9100 Certificate issued by a consultant for a Distributor Registrars and Notified Bodies 11
B FAR/Prime Contractor Flow-down Tool - AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
K AS9100 - 7.3 - Are these black and white questions with specific correct answers AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
M When is FAI required? AS9100 8.5.1.3 and 8.4.3 requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 9
M Ethics and Legality AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 25
classical_quality AS9100 Surveillance Audit - advice on drafting strong responses AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
L AS9100 - Infrastructure or Product? Inflight internet connectivity network AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 1
C AS9100 Rev D 8.1.1 & APQP - Operational risk management process AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
T AS9100 - Changing PEARs target AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 41
R AS9100 DELTA FAI - Sub-supplier for plating changed AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
G AS9100-8.1.2 Configuration Management AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
R AS9100 REV D gap analysis matrix AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
Sidney Vianna Informational New IAQG Document - AS9100 Clarifications of Intent AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
E Recommendations for CBs south of England AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
E AS9100 installtion procedure AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 0
Q Connecting AS9100 D Clause 4.2 to 9.3.2 b - Interested parties and relevant issues AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 24
D AS9100 Inspection records - Is there a requirement to have gauge ID and calibration status AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
O Identifying KPI for AS9100 8.1.4 - Prevention of Counterfeit Parts - PCB assembly contract manufacturer AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 16
L AS9100 and Agile development processes AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 8
I Is this a Major AS9100 QMS change - Quality Concerns AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
C E signatures on Engineering Change Notes AS9100 / AS9116 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
T QMS Training for my organization - IATF16949 and also AS9100 or 9145 Manufacturing and Related Processes 2
W Tying the need for Demand Planning to a section of AS9100/9110 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
bryan willemot Documenting past problem history for fasteners for AS9100 Rev D AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
was named killer AS9100 FAIR - True Position hole out by .0011" on 50 parts AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
APHX02 Thread Roll Process Verification w/in AS9100 (i.e. BSP-F-69/AS8879) Manufacturing and Related Processes 2
I AS9100 8.4.2 Type and Extent of Control - External provider test reports Manufacturing and Related Processes 24
F AS9100 D - Verification of purchased product - Sheet metal and aluminum extrusion stock AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
A A Question about Continual improvement process in AS9100 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
Prashant G AS9100 Requirement - Verification of characteristics results with drawing requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 13
Similar threads


















































Top Bottom