SBS - The best value in QMS software

Changes in AS9100 Revision C - The scope of AS9100 has been broadened

Elsmar Forum Sponsor
A

AndyJP - 2012

#12
Re: What will change in AS9100 Rev.C?

Hi
Speaking as a contractor who does some defence work that is not aerospace biased the use of aerospace standards will not work. I ahve in the past few years worked for two major UK based defence fims on both marine and land weapon systems and both have wanted automotive practices to be introduced. I am now contracting to a large aerospace firm and again they want automotive practices as the teh aerospace ones just do not cut it for the desiging in of quality to the product or supply base. Or have I missed something.

As for ISO is 1985 - allways though the USA was slow on the uptake;) :notme: as teh standard it came from was BS 5750 which surfaced is 1979 and before that AQAP standards...

Not wanting to tar all US suppliers with the same brush the worst ones on many of these projects have been US ISO9000 / AS9100 suppliers
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#13
Re: What will change in AS9100 Rev.C?

Hi
Speaking as a contractor who does some defence work that is not aerospace biased the use of aerospace standards will not work. I ahve in the past few years worked for two major UK based defence fims on both marine and land weapon systems and both have wanted automotive practices to be introduced. I am now contracting to a large aerospace firm and again they want automotive practices as the teh aerospace ones just do not cut it for the desiging in of quality to the product or supply base. Or have I missed something.
You might have missed a spell checker:tg: ...And I am not referring to defence vs. defense. There are some automotive tools such as APQP that Aerospace organizations could implement and benefit from, but in this side of the Atlantic, I don't see Defense contractors implementing automotive standards. The Aerospace OEMs are starting to develop standards defining how processes (e.g. New Product Introduction) are supposed to be conducted (a scary thought!:mg: ). For more information on this, browse this presentation.
 
A

AndyJP - 2012

#14
Re: What will change in AS9100 Rev.C?

My spiel chucker was on strike yesterday.

Now that is very interesting about the NPI and a push towards process capability. I have spent the past two months sorting out our requirements for the supply chain and now the APQP issues for our internal processes.

I will admit I have cheated a bit and based in on Ford's systems as I know that one to work most of the time.

The supply base one has been accepted.

I was very interested to see that both Boeing and Airbus are pushing for these as they are both major customers of my client and we just put a bid / tender document in that has the supply chain issues in it.

If you would like to see where we are so far I am willing to send you a copy but untill it is all done and dusted I'll not be putting it out there in the cove for all to see yet.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#17
Re: What will change in AS9100 Rev.C?

The attached presentation (from the last IAQG meeting in Orlando, FL) gives a pretty good indication of some of the changes to the 9100 document, as well a significant revamping of the 9101 checklist to allow for a true process based approach. Further, it indicates that 9100 Rev. C will be ready for publication around November 2008. Finally, it gives some information about additional initiatives and enhancements to the ICOP process, in response to rumblings concerning the integrity of a percentage of 9100 certificates out there.
 

Attachments

Sidney Vianna

Post Responsibly
Staff member
Admin
#19
There we go...

Got a copy of the Coordination Draft of AS9100 Rev.C, dated November 8th, 2007. Still digesting the changes. But one thing that caught my attention are the anticipated adders additional requirements for "risk management". Section 7.1.2 of AS9100 draft states

7.1.2 Risk Management
The organization shall establish a process for managing risk to the achievement of customer requirements. As a minimum the process shall provide for the
a) assignment of responsibilities for risk management,
b) definition of the criteria for risk acceptance,
c) identification, assessment and communication of risks throughout product realization,
d) identification, implementation and management of actions to mitigate risks that are above the defined acceptance criteria, and
e) acceptance of risks remaining after implementation of mitigating actions.​
What concerns me is how this is going to be flown down and explained to hundreds of small machine shops currently certified and a few hundred more going for certification. Explaining risk exposure, risk acceptance, risk avoidance, risk mitigation, etc... to unsophisticated users will be a monumental task or we might end up with another wave of meaningless "managing risk" procedures...but guaranteed to pass an audit....Don't get me wrong, managing risk is critical. As long as you are in business, you will have risks to be managed. But not all business owners understand the concept. The word risk appears 16 times in this draft of 9100 Rev.C. Interesting, indeed.
 
Thread starter Similar threads Forum Replies Date
T AS9100 Maintain Approval When Business Ownership Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
R Verification of Process Changes (AS9100 clause 7.5.1.2) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Changes Assessment as per AS9100 Clause 7.5.1.2 Control of Production Process Changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
howste AS9100 comparison with draft changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
S Need solution to AS9100 signature requirements on the plans, and/or changes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
P Interim Order Authorization Changes Canada Medical Device Regulations 0
R Changes vs CMO - How can we simplify this process? Supplier Quality Assurance and other Supplier Issues 3
Ed Panek What are the limits on manufacturing changes and substantial changes? EU Medical Device Regulations 6
F Hospital Rebrand & Name changes Document Control Systems, Procedures, Forms and Templates 4
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
Aymaneh ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
E ASTM F2118 - Fatigue testing of bone cement - Changes between the 2003 and the 2014? Other Medical Device Related Standards 1
qualprod Documented actions and changes in the QMS by COVID 19 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B ASTM E18-2020 - Rockwell testing standard changes? General Measurement Device and Calibration Topics 2
D Recent changes to ISO 14971 - SOP required for managing standard revisions ISO 13485:2016 - Medical Device Quality Management Systems 1
I Dating controlled documents after changes - Revision History Document Control Systems, Procedures, Forms and Templates 13
F Medical Devices - Hong Kong - Post approval changes regulation (China's MOH) Other Medical Device Regulations World-Wide 3
F Medical Devices-South Africa _Post approval changes and Software Other Medical Device Regulations World-Wide 0
K Changes in process dispersion, and location hypotheses tests Using Minitab Software 3
NDesouza When Customers Make Changes to Orders Contract Review Process 24
S Managing specification changes on standard parts purchased through trading companies Document Control Systems, Procedures, Forms and Templates 2
I MSA requirement for 5 Micrometers + CP changes need customer approval? IATF 16949 - Automotive Quality Systems Standard 2
A ISO13485:2016 name and ownership changes questions ISO 13485:2016 - Medical Device Quality Management Systems 3
R What are the changes in 5th Edition of FMEA manual? FMEA and Control Plans 6
S Examples of software changes that required a 510k US Food and Drug Administration (FDA) 2
D 510K and Changes to Verification and Validation US Food and Drug Administration (FDA) 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
M What are the changes in supervising according to ISO17025? ISO 17025 related Discussions 7
U Changes to Internal Processes and Risk Evaluation - Mitigations Risk Management Principles and Generic Guidelines 10
M Informational New Zealand – Changes to Medical Device Adverse Event Reporting process Medical Device and FDA Regulations and Standards News 0
R Rationale for changes to ISO Standards Other Medical Device Related Standards 4
M Informational TGA Consultation: Proposed changes to medical device essential principles for safety and performance Medical Device and FDA Regulations and Standards News 0
A Changes to an already certified product (IIb, MDR) EU Medical Device Regulations 1
I Tracking Protoype Changes; 8D or simple document revision? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C What if the foreign manufacturer of a medical device changes the Authorized Representative in Saudi Arabia? Other Medical Device Regulations World-Wide 0
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
J Ethicon suture box design changes - 2019 Other Medical Device Regulations World-Wide 2
E Changes to medical device submitted through a variation? EU Medical Device Regulations 1
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
S ISO9001:2015 6.3 - Planning of Changes - OFI from auditor ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
M Medical Device News TGA Consultation: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia Medical Device and FDA Regulations and Standards News 0
F Device Standards - Managing Changes to existing standards that apply to our devices Other Medical Device Related Standards 1
S Ballooned Drawings and Engineering Changes Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
supadrai Changes to QMS - Contract Term ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 9001:2015 6.2 - Planning Changes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Significant Organizational Changes - Documented Responsibilities Document Control Systems, Procedures, Forms and Templates 4
M Medical Device News Health Canada - Proposed Changes - List of Recognized Standards for Medical Devices Canada Medical Device Regulations 3
Marc 9 September 2018 - Upcoming User Group Changes Forum News and General Information 1

Similar threads

Top Bottom