Concerned over the fact that third-party certification's added value is being questioned more and more, added to the apparent lack of understanding by 3rd-party auditors about the process approach and how to effectively audit organizations using the ISO 9001:2000 model, the "ISO Community" is establishing an ISO 9001 ADVISORY GROUP (IAG) to develop a best practice guidance document on how to audit ISO 9001:2000 QMS systems.

See attached

Must admit that it does seem wrong that such a group is required - is it an indication that the writers of ISO9000:2000 have failed ?

Jim, I hope it does not come as a surprise to you, but I share most of your concerns.

Since 1994 (maybe Marc remembers), I have been voicing my concern (in other forums) over the fact that too much emphasis has been placed in the certification aspect of the "ISO 9000 movement".

There are a lot of problems associated with all facets of this subject:
- implementation,
- consulting,
- auditing,
- certification,
- accreditation, etc . . .

Unfortunately, I believe that 3rd-party auditing aspect, being one of the most visible parts, gets more scrutiny than others, thus the guidance document being developed.

One thing I wished would get changed in this whole process are the qualifications necessary for one to attain lead auditor status. I wish that lead auditors would be required to truly demonstrate their understanding of the BIG Q, and much less emphasis on their knowledge of tools associated with qc techniques. People that have worked for 30+ years in qc misperceiving quality as the result of inspection and test, brainwashed to the archaic approach to quality still make a good percentage of the "ISO 9000" - involved people, in the capacities of implementators, consultants and auditors. Obviously, some have been able to "see the light" and effectively make the transition from q to Q.

What you're talking about Sid is what I express in all of the accredited and other courses I teach.

I tell my students that in order to be successful in the ISO field as an individual, thus maximizing the potential for success of the systems they are invloved with, is to break down the artificial barrier I call Tunopia (tunnel vision / myopia) that ensnares people. Doing this goes beyond the "Big Q" as you put it and "Environmental Compliance". What is required is an overall unsderstanding of functional realtionships and how they are related/interact within systems/processes.

Functional professionals have a history of and continue to look upon organizational processes thru a "soda straw". and that "soda straw" being their own function/department.

Sometimes I think the best thing to do would be to pull the chain and flush everything in order to get a fresh start.

Well, the ad-hoc group mentioned in the starting post of this thread has released some documents and they are all available at

http://isotc176sc2.elysium-ltd.net/APG_index.html

The Guidance Documents are NOT endorsed by ISO/TC 176, so be aware. Nevertheless, these documents are aimed at enhancing the effectiveness of auditing to ISO 9001:2000.

There is one powerpoint file endorsing the Sydney (not to be confused with Sidney) model ;)

Happy New Year

Well, the ad-hoc group mentioned in the starting post of this thread has released some documents and they are all available at

http://isotc176sc2.elysium-ltd.net/APG_index.html

The Guidance Documents are NOT endorsed by ISO/TC 176, so be aware. Nevertheless, these documents are aimed at enhancing the effectiveness of auditing to ISO 9001:2000.

There is one powerpoint file endorsing the Sydney (not to be confused with Sidney) model ;)

Happy New Year

Thanks for the information, now I have some reading to do.

Doug

Well I went through the PowerPoint presentation of the Sydney Model and presume they are trying to present an ISO 9000 Model for Excellence. I do not see that it is much different than a typical Quality Operating System where you are monitoring your key performance measures and taking appropriate actions to ensure that you meet your business objectives - much like Ford's QOS (a presentation attached).

Doug

The auditor should seek to determine if the auditee has attempted to set objectives that establish the correlation between the 3 factors of: corporate objectives, customer needs, and market expectations. Thereafter, it is up to the organization to balance the need for improving internal efficiency and the need to progress with external performance (although the two are very often closely related). No one in isolation can ever be considered as being “enough” or “not enough”.

Glad this is only a guidance document, for our Top Management is not wanting to go the route of incorporating a Business Plan into the Quality Management System. They do not want outside or inside Quality Auditors meddling in their business affairs.

Doug

Glad this is only a guidance document, for our Top Management is not wanting to go the route of incorporating a Business Plan into the Quality Management System. They do not want outside or inside Quality Auditors meddling in their business affairs.

Doug

Doug,

Am I wrong, or isn't the real intent of ISO 9001 to provide a template for business management? It appears to me that your Top Management doesn't get the fact that this is NOT a "Quality Department" initiative/requirement, but is supposed to be a "business" initiative. Your organization can (and maybe) certified to the Standard, but from your statement I would have to assume that the "quality" system is in place just for that purpose, and NOT for business improvement.

Please understand that this is not aimed at you personally, and is not meant as an personal attack, my aim is towards your Top Management and their apparent lack of understanding as to the purpose of the Standard (which sadly is NOT unusual).

· Determination of the “where appropriate” processes
· Auditing the “where appropriate” requirements

I got out a different colored marker to highlight where this phrase was used and found it only in two requirements (7.4.2 & 7.5.3) just before a listing of items. I found "as appropriate" four times (7.1, 7.3.1, 7.3.7, 8.2.3). I found "as applicable" three times (6.3, 7.5.1, 7.5.2), and "where applicable" four times(7.3.2, 8.2.3, 8.2.4, & 8.3). There is one "as necessary" in 7.5.1 b, one "where necessary" in 7.6, and a "wherever practicable" in 7.3.6. All of these requirements indicate a condition where the auditor has to evaluate the auditee's "ability to satisfy its customers' requirements."

The two guidance documents primarily focused on the auditor's "sector knowledge, competence and auditing skills" in determining the Scope of the Quality Management System and their ability "to demonstrate knowledge of a process that is being examined and to be able to apply their skill in evaluating whether the ‘where appropriate’ requirements are appropriate or not."

I guess the only point I am trying to make is that just determining the Scope of the QMS can not be the sole criteria for evaluating the requirements listed above.

Doug

Doug,

Am I wrong, or isn't the real intent of ISO 9001 to provide a template for business management? It appears to me that your Top Management doesn't get the fact that this is NOT a "Quality Department" initiative/requirement, but is supposed to be a "business" initiative. Your organization can (and maybe) certified to the Standard, but from your statement I would have to assume that the "quality" system is in place just for that purpose, and NOT for business improvement.

Please understand that this is not aimed at you personally, and is not meant as an personal attack, my aim is towards your Top Management and their apparent lack of understanding as to the purpose of the Standard (which sadly is NOT unusual).

David,

Maybe, but the title still indicates Quality Management System and this company was traumatized during its attempt to register to the previous ISO-9001:1994 Standard. Their registration audit was performed along with RAB oversight auditors and they ended up with a good number of non-conformances, so many that they decided not to continue that certification effort. Top Management has read a number of horror stories and they are not completely sold on how this new Process-Based Approach is going to make them a better company. To a great extent their primary motivation is marketing competitiveness. My perception is that if they wanted to get into a business management approach they would have chosen a MBQA project where the Business Plan is a stated element of the system (like QS was).

Since the Business Plan is not a stated element in the ISO 9001:2000 Standard, then how or why are these guidance documents focusing on this aspect without calling it out as a Business Plan?

Yes, I have my work cut out for me and I wish that there was a sure fire way to make this transformation in management - but I got to satisfy my customers!

Thanks,
Doug

Glad this is only a guidance document, for our Top Management is not wanting to go the route of incorporating a Business Plan into the Quality Management System. They do not want outside or inside Quality Auditors meddling in their business affairs.

Doug

Douglas,

our auditor/registrar has always been keenly interested in what we do for business plans/planning and always makes it part of the audit to sit with the President and go over the business and talk about what we do as far as planning. That has been true with 1994 and 2000 standard. They've always stressed the part about ISO being looked at as business practices, not just another, unimportant department in the company called Quality.

That being said, any business plans and related materials are not necessarily a part of the QMS, nor do we want them to be. Reference to this part of it comes through in our Management Review, but there's no 3 or 5 year plan sitting in our QMS.

Joe