SBS - The Best Value in QMS software

Standards Committee Talk


Hunkered Down for the Duration with a Mask on...
Staff member
Subject: Re: Product and Process Audits /../Arter
Date: Mon, 21 Jun 1999 11:47:57 -0600
From: ISO Standards Discussion <[email protected]>

From: Dennis Arter <[email protected]>
Subject:RE: Product and Process Audits /../Arter

Heather El-Homsi wrote:
>I would be very interested in participating in the endeavor you
>mentioned -USA standards for management audits & product/process
>How can list members link into this effort?

Within the USA, quality management standards are developed by one of two committees: The Z1 committee and the ASQ Standards committee. Both are accredited by the American National Standards Institute (ANSI). To become accredited, both must develop and implement processes to achieve "consensus" in the standards writing process. At all stages in that development process, we put the proposals out for formal voting and comments.

Consensus does not give one person veto power over the work of the entire committee. It requires that everyone's vote be received and addressed. If the person is not pleased with the resolution, they have rights of appeal. This is one of the reasons why standards take so much time to get published.

Members of this list (and others) may participate up front in the writing efforts. At no charge. But they must contribute to remain on the writing committees. Or they can participate at the back end, when potential standards are circulated to the public for comment.

Since I don't even know if I have the backing of a "critical mass" of auditing experts yet, I don't know how this is going to shake out. I agreed to work with Charlie Robinson (former chair of the ASQ Quality Audit Division) to develop a position paper and present it to the Division members for reaction. I hope to have that done by August. Then we shall see.

If this project moves forward, one of the first steps would be to gather "experts" together for a writing group. Through the power of the internet, I feel we should not have difficulty letting folks know if and when the project has started. Stay tuned...

>Also, if needed (and I get their okay), I can think of a couple of
>companies that seem to have good processes in place for different
>types of audits that we might be able to pull in as references as

If you have contacts with *proven* ways of performing process audits (remember, the term hasn't even been defined yet!), I would be pleased to consider them as possible paper presenters for the 9th annual quality audit conference next March in Reno. But I need the 1/2 page abstract by the end of June - latest! The call for papers is posted on

* * * * * * *

Also, Danielle Kenyon wrote:

>Dennis Arter wrote about proposed new USA standards for auditing
>product/process and management. I wonder if this wouldn't be a
>logical next initiative for ISO TC176 (I think it's 176???)

Nope. IMHO, the international crowd is too focused on third party registration. Perhaps this is where they should be spending their energy. There are absolutely huge forces around this planet to bring sense to the current practice of issuing certificates of conformance to ISO 9001 or 9002. Throw in environmental management system registrations to the ISO 14000 series and you have big bucks and lots of activity. We have two major ISO technical committees involved: TC 176 (quality) and TC 207 (environment) There are other ISO technical committees, dealing with aerospace and medical devices and software, involved. The current efforts to revise the ISO 10011 and 14010 auditing standards are struggling with big issues world-wide. Most of that energy now is focusing on third-party applications of compliance auditing. Let's support those efforts.

But let's also see if we can develop something here in the USA to address the other five forms of the audit.

Dennis R. Arter, "The Audit Guy"
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Sidney Vianna AAQSC - Americas Aerospace Quality Standards Committee of the SAE Aerospace Council AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
S MDR GSPR Standards EU Medical Device Regulations 0
S Class 1 and 2 changes in CM standards (aerospace industry) Federal Aviation Administration (FAA) Standards and Requirements 0
S 316 Stainless Steel Standards Other Medical Device Related Standards 0
U Is there any website out there that summarizes all relevant standards? Medical Device and FDA Regulations and Standards News 1
M Packaging standards - ASTM vs ISTA Other Medical Device Related Standards 1
M Label Making & Printing Standards ISO / ASTM ISO 13485:2016 - Medical Device Quality Management Systems 5
M Why are EU harmonized particular standards so old & out-of-date? IEC 60601 - Medical Electrical Equipment Safety Standards Series 11
R Weld Penetration Standards and Requirements Manufacturing and Related Processes 2
S Any ISO standards around Artificial Intelligence and Machine Learning? Medical Information Technology, Medical Software and Health Informatics 4
M ERP / QMS related software standards for Validation IEC 62304 - Medical Device Software Life Cycle Processes 6
M MDR harmonized standards EU Medical Device Regulations 3
S Where do l get calibration standards to run a calibration lab? Other ISO and International Standards and European Regulations 2
C Appendix Z in Harmonised Standards? EU Medical Device Regulations 13
Ajit Basrur Corporate management standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
R Applicable ISO standards - packaging and others Medical Device and FDA Regulations and Standards News 4
Q Standards for Shipping by Sea US Food and Drug Administration (FDA) 2
N Database that lists labs accredited to ASTM / ANSI standards Various Other Specifications, Standards, and related Requirements 6
S API Spec.Q1 Standards Version in Purchasing Information Oil and Gas Industry Standards and Regulations 1
B Exclusions or justification for non-applicability of IEC standards Reliability Analysis - Predictions, Testing and Standards 1
P Citing EN standards Other Medical Device Related Standards 6
Ed Panek Compliance with Standards? When a standard is updated/revised CE Marking (Conformité Européene) / CB Scheme 3
N Harmonized Standards for MDR Certification EU Medical Device Regulations 7
A Some questions about voluntary consensus standards in traditional 510(k) submission US Food and Drug Administration (FDA) 6
D Imaging/Image Quality Standards Other Medical Device Related Standards 1
R ECG Risk Analysis Standards ISO 14971 - Medical Device Risk Management 2
I Management review in conformity assessment standards - Certification Bodies Management Review Meetings and related Processes 6
Govind Informational ISO COVID-19 response: freely available ISO standards Other ISO and International Standards and European Regulations 1
C Does a CE mark infer meeting all applicable standards? CE Marking (Conformité Européene) / CB Scheme 4
T Assessing Hazard-Related Use Scenarios where control measures exist through standards IEC 62366 - Medical Device Usability Engineering 32
Richard Regalado Informational ISO makes available relevant BCMS standards free for online access Business Continuity & Resiliency Planning (BCRP) 6
A Technical File - Updating Applied Standards EU Medical Device Regulations 4
A NB (Notified Body) Audit of Standards ISO 13485:2016 - Medical Device Quality Management Systems 3
R Applicability of new non-harmonized standards (MDD/MDR) EU Medical Device Regulations 14
dgrainger Informational EU published new Harmonised Standards List for the Directives (25/3/2020) Medical Device and FDA Regulations and Standards News 0
P Static Electricity/Pacemaker - Standards for static electricity generation CE Marking (Conformité Européene) / CB Scheme 3
M Referencing Harmonised Standards in Declarations of Conformity EU Medical Device Regulations 4
Pmarszal External Standards and Regulations Management Process Document Control Systems, Procedures, Forms and Templates 10
S IVF medical devices standards and test methods Medical Device and FDA Regulations and Standards News 4
M What are the standards for malls management? ISO 14001:2015 Specific Discussions 1
A Complaint alert levels - Industry standards pertaining to alert levels for complaints Customer Complaints 5
R MDR standards - which standards to comply with ? EU Medical Device Regulations 3
D Why does Official Journal list superseded standards? EU Medical Device Regulations 6
M MDR "Common Specifications" (CS) - If not standards, then what? EU Medical Device Regulations 5
L In house calibration - Our CMM's are outside certified can I use them to certify our standards General Measurement Device and Calibration Topics 4
F AS9100D, raw material standards are a requirement for manufacturing? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
S Industry Labelling Standards - non medical Manufacturing and Related Processes 0
J Medical device related standards or regulations - Disposed records log ISO 13485:2016 - Medical Device Quality Management Systems 2
S How many mandays required for the below mentioned standards IEC 27001 - Information Security Management Systems (ISMS) 3

Similar threads

Top Bottom