SBS - The best value in QMS software

Lessons Learned so far from my current ISO9001 adventure

Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#12
There should never be a requirement for an interpretation document for the standard in an industry.
Well...why do we have industry specific standards, such as ISO/TS 16949, AS9100, ISO 13485, TL-9000? Simply because these Industry Sectors believed that ISO 9001 (the all encompassing, universal QMS standard) did not address their specific needs.
The company's documented system is their interpretation of how the requirements of ISO 9001 are met in their market sector.
That is the theory. In practice we do know that, for many organizations, their Quality Manual is simply a regurgitation of the standard, and the rest of the command media is a disconnected patchwork of documents; one could say that the organization did a lousy job of "interpreting" the standard.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#13
Well...why do we have industry specific standards, such as ISO/TS 16949, AS9100, ISO 13485, TL-9000? Simply because these Industry Sectors believed that ISO 9001 (the all encompassing, universal QMS standard) did not address their specific needs. That is the theory. In practice we do know that, for many organizations, their Quality Manual is simply a regurgitation of the standard, and the rest of the command media is a disconnected patchwork of documents; one could say that the organization did a lousy job of "interpreting" the standard.
you read my previous post about the QM so if you opened the attachment you probably saw exactly what you say about a lot of QMs. I did that on purpose because I felt I was better off focusing on training and functional procedures than trying to make the QM a work of art. It ain't but it meets the minimum requirements.
I feel that my registrar still wants the QM to be more than it needs to be but he did convince me to make it more "my own" than a regurgitation of the standard.
Our processes are good and are fairly well conncected but there are some missing links that a really good process diagram in the manual would probably have helped diagnose.
So consider that lesson 6

PLUS - integrating the CE marking directive we follow into the ISO system makes it another ball game - this is why an "interpretation" from our registrar would have helped a lot.
 
Last edited:

Paul Simpson

Trusted Information Resource
#14
Well...why do we have industry specific standards, such as ISO/TS 16949, AS9100, ISO 13485, TL-9000? Simply because these Industry Sectors believed that ISO 9001 (the all encompassing, universal QMS standard) did not address their specific needs.
Ahh, Sidney, don't get me started. This is one of my hobby horses. :D

There is no need for TS, TL, AS etc., etc. if:
  • All auditors operating in an industry sectors are competent
  • CBs can be trusted to ensure competent auditors are assigned to their customers
  • Industry requirements are clearly specified and understood
Going back to the good / bad old days I was auditing suppliers to the automotive OEMs long before QS came out and assessing to see they understood SPC / FMEA etc., etc. and were using it properly.

Unfortunately not all my colleagues / competitors were doing so!

That is the theory. In practice we do know that, for many organizations, their Quality Manual is simply a regurgitation of the standard, and the rest of the command media is a disconnected patchwork of documents; one could say that the organization did a lousy job of "interpreting" the standard.
Not sure what "command media" are Sidney but the problem is organizations are chasing what the certification body are after, not developing systems that suit their needs (and sector requirements).
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#15
There is no need for TS, TL, AS etc., etc. if:
From a very recent article published in the IRCA INform magazine:

Joe Bransky, General Motors representative to the IATF, believes that while the ISO 9001 provides an excellent, ‘foundation standard’, some fields require greater specificity. He says: ‘Industries like the automotive, aerospace and telecommunications sectors are typically global and may involve extensive supply chain resources. They involve greater complexity based on the materials, components, interactions, final product and volume. I know of a number of other industry sectors also considering a sector specific approach.’
The problem is not the ISO 9001 standard itself, rather it involves certification credibility. As Bransky points out: ‘The legitimacy of the certificate is the real issue. I see this problem manifesting itself in a number of ways, for example: organizations going through the motions of certification; auditors not auditing but selling and marketing to clients; lack of due diligence on the part of the auditor or certification bodies in the audit or in making the certification decision; lack of accountability of certification bodies to accreditation bodies; and lack of accountability of accreditation bodies to anyone.’
Bransky continues: ‘Ultimately, there are two key components of an effective sector standard. First, the sector standard needs to be robust with the requirements appropriately tailored to meet the industry needs. This requires a collaborative and consensus approach among the industry or sector members. Second, and equally importantly, there needs to be a credible certification scheme that includes meaningful oversight of the recognized certification bodies that is satisfactory to the industry or sector’*.
*emphasis added by me.
 
#16
It's more than a little ironic that in many ways it's Mr. Bransky's employer demanding 'ISO Certification' from it's suppliers which drives the 'say what you do, do what you say' mentality which is a large part of the problem. He's critical of third party audit bodies, but, of course, doesn't mention the suppliers' behaviours driven by deadline compliance demands.......:frust:
 

Paul Simpson

Trusted Information Resource
#17
From a very recent article published in the IRCA INform magazine:
Can't say I disagree fundamentally with anything in the article except the conclusion that you need to have a sector specific standard to address the issues. The section by Mr Bransky (and especially the bits you emphasized in your post, Sidney) just confirms my bulleted list. If you can't trust the CBs to run the show properly you manage them (instead of leaving it to the ABs).

I covered some of the points in a letter in response to Paul Hardiman's article on TS in the CQI's Quality World magazine back in 2005. Here.

Taking just one area.

ISO 9001 requires organizations to implement Quality Planning (Clause 5.4). If the automotive industry standard or customer requirements call up (for example) APQP and / or the APQP manual then auditors should understand APQP and it should be part of the assessment.

I had an introduction to a similar article published in the same issue of InForm here. My point is that if an auditor understands what is in front of them then they can assess whether a standard (that they also understand) is effectively implemented. I have to disassociate myself from everything other then the first four paragraphs, though, as they aren't my thoughts and I don't agree with them! :notme:

I know this is all shutting the stable door after the automotive / aerospace / pharmaceuticals / telecoms / food industry horses have all bolted but, as I said earlier, it is a hobby horse of mine. :frust:
 
Last edited:

ScottK

Not out of the crisis
Staff member
Super Moderator
#18
Another lesson learned - the $US and Euro exchange rate would have made it cheaper for us to go with a US based registrar.
 
Thread starter Similar threads Forum Replies Date
B Lessons Learned Implementing ISO 50001 (Chemical Engineering Progress) Other ISO and International Standards and European Regulations 0
tnorton Lessons learned from implementing Customer Complaints Customer Complaints 1
R IATF 16949 Clause 6.1.2.1 - Lessons Learned and Risk Analysis IATF 16949 - Automotive Quality Systems Standard 6
M What do the terms "Lessons Learned" and "Best Practices" mean ? Preventive Action and Continuous Improvement 2
M Linking Risk Management with Lessons Learned ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
D Lessons Learned - from ANAB 2013/06/06 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
J Three Best Practices and Lessons Learned in APQP APQP and PPAP 1
P Implementing a Lessons Learned Program Benchmarking 2
P Lessons Learned Identification - Potential Preventive Action Responsibilities Preventive Action and Continuous Improvement 4
L Lessons Learned from our recent ISO/TS 16949:2009 Surveillance Audit IATF 16949 - Automotive Quality Systems Standard 2
Sidney Vianna Lessons learned from the AS9100 Rev. C Transition Process AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
T Lessons Learned - Document Control? Document Control Systems, Procedures, Forms and Templates 6
T Lessons Learned in a Product Development Project Quality Tools, Improvement and Analysis 2
H Capturing temporary actions in PFMEA in terms of manpower, lessons learned FMEA and Control Plans 9
M "Lessons Learned System" - Evidence for Audit IATF 16949 - Automotive Quality Systems Standard 10
D Lessons Learned Reporting/Utilizing Quality Manager and Management Related Issues 1
S Lessons learned? Asked by my boss to compile a list of lessons learned Preventive Action and Continuous Improvement 33
G What to present for 'Lessons Learned" from audits to Sony Ericsson - Supplier to SE Misc. Quality Assurance and Business Systems Related Topics 2
A Manufacturing Lessons Learned - New product from Design into Manufacturing Design and Development of Products and Processes 4
F Capturing Lessons Learned from a CAPA - One Point Lessons Nonconformance and Corrective Action 6
B Example of Lessons Learned Plan Misc. Quality Assurance and Business Systems Related Topics 4
U Applying Lessons Learned to other products Misc. Quality Assurance and Business Systems Related Topics 2
PatMaz Help creating a Lessons Learned Database Document Control Systems, Procedures, Forms and Templates 3
J Implementing a Pull System in a manufacturing line? Lessons Learned? Manufacturing and Related Processes 8
G Gage R&R derivation with respect to ndc - Lessons Learned Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C MSA on CMM Hard Learned Lessons - Look Before you Leap Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 13
J Database Lessons Learned - Real issue with the quality of the data being entered Philosophy, Gurus, Innovation and Evolution 0
D 4.1.1 Lessons Learned - Use of Design Data - How to Implement Design and Development of Products and Processes 5
B Lessons Learnt template - Information Security Management System Experiences Document Control Systems, Procedures, Forms and Templates 1
S How to Capture and Share Project Lessons and Improvement Ideas? Lean in Manufacturing and Service Industries 6
RoxaneB Life's Lessons Amidst the Blooms Imported Legacy Blogs 2
P Kaizen your life with the Ten Lessons for Good Health World News 15
S Single Point Lessons Used in Production - Seeking Examples Lean in Manufacturing and Service Industries 21
S Training technical operators on production floor - E.g. Single Point Lessons Training - Internal, External, Online and Distance Learning 5
T Corporate Lessons Coffee Break and Water Cooler Discussions 2
C Quality Lessons from the Field - The need to understand your true costs The Reading Room 18
A Corporate lessons Funny Stuff - Jokes and Humour 7
C Shakespeare's Lessons in Leadership: Macbeth The Reading Room 30
C Shakespeare's Lessons in Leadership: Hamlet Registered Visitor Articles Archive 64
C 6 Business Lessons From Martha Stewart Coffee Break and Water Cooler Discussions 4
M Is a Lesson not Learned if there is no Corrective Action? Misc. Quality Assurance and Business Systems Related Topics 3
L Lesson Learned Database for Audits Internal Auditing 4
Sidney Vianna Mutually Beneficial Supplier Relationships in the real world - GM learned a lesson? Quality Manager and Management Related Issues 1
Q Lesson Learned or OFI (Opportunities for Improvements)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Lesson Learned Cards for Problem Solving and Prevention after 8D Problem Solving, Root Cause Fault and Failure Analysis 1
K Time Management - Lesson Learned , Decades Ago Misc. Quality Assurance and Business Systems Related Topics 0
Chennaiite What is meant by 'Lesson Learned' in the context of Problem Solving Quality Tools, Improvement and Analysis 6
T What have you learned today...? Imported Legacy Blogs 1
B Lesson Learned Funny Stuff - Jokes and Humour 6
Q All I Need to Know About Manufacturing I Learned in Joe's Garage Book, Video, Blog and Web Site Reviews and Recommendations 0

Similar threads

Top Bottom