ISO 9001:2000 (& 2008) - Interpretations 101

Marc

Hunkered Down for the Duration
Staff member
Admin
#1
So far, my experiences haven't been this drastic. But, food for thought. If You have gone through registration, what did you experience?

***************************
Newsgroups: misc.industry.quality
Subject: Re: ISO 9000 is an unnecessary business expense
Date: Tue, 27 Nov 2001 01:28:39 GMT
Organization: RoadRunner - TampaBay

"mnprinsloo" wrote in message
news:[email protected]
> I'm 2 days away from my 6th certification audit as mng.rep of a company.
> First time ISO9001:2000.
> The old standard had a lot of requirements that I would never even have
> worried about. There were elements in the 1994 standard that I would not
> handle in any other way than window dressing, they were required by the
> standard but totally unaplicable to certain industries/companies.
> But now whe have the 2000 standard. This standard illustrates the
processes
> and minor processes with in a company and exactly how everything else fits
> in with it. At last a system where you can apply the "Say what you do and
do
> what you say" principle.

I've put in a number of :2000 systems and been audited to it already about four or five times, in different industries. One big problem arises, which no doubt will be the topic of much discussion for the next five years (when they re-write it again.)

Registrar interpretation of ISO 9K2K is miserable. Of three registration companies, and about seven auditors, none had an interpretation in line with the others. Simply put, most of these companies are not up to the job of training their people properly in 9K2K, and the client is the one who suffers.

Real life case examples from a variety of registrars within the past six months:

1.) Auditor cites minor nonconformance because an updated Quality Manual "still had too much 1994 language in it." Was it lacking 2000 language? "No, I just don't think having 1994 language in a 2000 system is appropriate."

2.) When asked why a preassessment audit completely failed to cover a software team, despite requests that it do so, the auditor says, "Well, the new standard doesn't really apply to software."

3.) Auditor cites minor nonconformances to a Quality Manual which abandoned a numbering scheme that followed EITHER standard, saying "I didn't have enough time to find how you addressed the shall clauses. If I had more time, I might have found major nonconformances."

4.) Auditor opens the registration opening meeting with the comment "I've read your documentation, and you fail to meet the intent of the 2000 standard." Company president almost has a heart attack. "Where are the nonconformances?" we ask. "Oh, there aren't any, you just don't meet the intent. Your system is still based on MIL 45208, and the new standard is based on MIL-Q-9858." [NOTE: Despite this weirdness, we passed the audit.]

5.) Auditor cites nonconformance to Training, saying "Your ISO Management Rep must, at a minimum, attend the 5-Day RAB Lead Assessor Course." when challenged, he mutters something about "the new standard requires it." [NOTE: The RAB would freak if they heard a registrar demanding people go to their classes or face nonconformances. Collusion lawsuit anyone?]

And, the topper:

6.) VP of a major registration company --- and one of the members of TC 176! --- issues directive threatening MAJOR nonconformance to all clients whose ISO Management Reps are not involved in "budgeting and planning" of their companies. VP cites "ISO 9000:2000", the normative reference, in an arcane tranlation of the meaning of "management." I'm still waiting to meet a QA Manager that has any real leverage in budgeting their own department, never mind the entire company.

In summary, the term "the new standard" has become a means for bad registration auditors to blame their poor interpretations on ISO. The problem now is that the ISO 9001:2000 standard's language is so murky, it becomes hard for grievance committees --- and the accreditation body itself --- to countermand bad interpretations. Companies are left holding invalid nonconformances in the process, and ISO 9000's credibility erodes further.

***************************

If you've gone through a registration audit, tell us your experience.

Theres also some 'food for thought' at: Are Flow Charts REQUIRED by ISO 9001 and Corrective Action vs. Preventive (Predictive) Action (CAPA)
 
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gpainter

Quite Involved in Discussions
#2
This is the info I like to see, it helps those who are in the transformation process. Same as the old standard, a lot of the problem is interpretation and the training/professionalism of the 3rd party auditor or lack of. In my opinion the judgement as to wether a QMS is effective can be based on (few) customer complaints and effective corrective action. :D
 

E Wall

Just Me!
Super Moderator
#3
Get checklist from YOUR registrar!

This is exactly why, when anyone asks for the checklist file I have, I always state that their registrar may have a different interpretation and they should petition for a checklist copy from them in order to prepare properly.
 
A

Aaron Lupo

#4
Re: ISO 9001:2000 - Interpretations 101

I would be curious to know who the 3 Registrars were, you may be right about the training or lack of training. The Registrar we use when I ask questions about 9K2K I am told, oh we have not yet been trained on 9K2K (I say under my breath what the hell is your company waiting for)! I am fortunate enought to have had training on the new standard and even before it was released I was actively pursuing the changes.

1.) Auditor gave a N/C for verbage that was used in the Quality Manual, now thats a joke! I know supplier replaced subcontractor and orginization replaced supplier etc... but there is no requirement that states you have to use the terms the way they are used in the Standard, I would have told the auditor show me the requirement if they were unable to I would not have signed the N/C that was written.

3.) Auditor gave a N/C for the numbering scheme that was used, and said he may have found majors but he didn't have enough time..... Is the Lead Auditor not supposed to review the QM before he arrives at the audit, seems to me as if this auditor did not do thier job and was covering their own butt. Once again i would have asked to have been shown the requirement that a certian numbering scheme be used, if unable to show me I would not have signed the N/C.

5.) Auditor gives N/C stating that the Mgmt Rep. at a minimum must attend a 5 day Lead Auditor Course. Wow where the hell is that coming from I don't even see anyplace in 9K2K where you could make the jump, that one makes me just scratch my head!

Lastly I would agree with the statement Mr. YYYYYYYYYY made about bad auditors. That is why it is very important for you to talk to the auditors before you choose a Registrar. If they are unable to answer your questions I would look elsewhere.
 
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Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Re: Get checklist from YOUR registrar!

Originally posted by E Wall
This is exactly why, when anyone asks for the checklist file I have, I always state that their registrar may have a different interpretation and they should petition for a checklist copy from them in order to prepare properly.
Definitely. :thedeal:
 
C
#6
I have said it before on this forum, however I have not posted as of late.

There should be NO "interpretation" of the standard. That is why it is called a "STANDARD"!!!!

Any time there is a non-conformance, the auditor/registrar should be able to show you the EXACT reference in the standard that clearly indicates that you have not met the criteria set forth. Othewise, it is NOT a finding.

There is only one reason they get away with this total lack of consistency. Because WE let them! I have questioned registrars several times and you know what? I have ALWAYS prevailed. Not because I am smarter than the registrar, or know more about my processes, or am better versed in the standard. But because I prepare for my audits by going through the standard, section by section and ask myself this question..Where is the OBJECTIVE EVIDENCE that this is being done. If I show documentation and evidence of meeting each section of the standard and they insist on having a finding because of their interpretation, I will offer them one last peice of documentation....the visitors log so they can sign out and go home. I will find another registrar, they are a dime a dozen and in these lean economic times, I am sure I can find one that can audit OBJECTIVELY and without the interpretation.

I have had legitimate non-conformances that needed to be addressed also and in those cases I have taken the lumps and corrected the system.

Anyone who puts up with a registrar "interpreting" the standard deserves every non-conformance that they get. Auditors working for a registrar are not there to give you their point of view, in spite of what they say. They are there to find OBJECTIVE EVIDENCE that you do, or do not meet each section of the standard. Allowing the standard to continue to be "interpreted" gives ISO 9000 a complete lack of credibility.

We, as a collective, are allowing this to happen and for the sake of our profession, we should stop.

Regards,

Carl-
 
A

Aaron Lupo

#7
Originally posted by Carl


They are there to find OBJECTIVE EVIDENCE that you do, or do not meet each section of the standard.

Carl-
Carl not just objective evidence to the Standard(s), but also to your company procedures too.
 
U

Unregistered

#8
ISO GUY,

And just exactly where does it say that my company procedures must be followed (other than those outlined in 4.2 )?

Carl-
 
A

Aaron Lupo

#9
Correct me if I am wrong Carl, if you were not following your internal procedures and you received a N/C you would not accept it?

If that is the case then why bother having procedures at all, just let everyone do it however they want to do it!

Look at Section 4.9.
 
C
#10
ISO GUY,

You are correct. If I received a N/C concerning a procedure not identified in the ISO 9001:2000 standard while being audited to that standard I would not accept it (with the possible exception of a safety concern)

You are incorrect in citing 4.9

ISO 9001:2000 does not have a section 4.9

I disagree with your comment: "If that is the case then why bother having procedures at all, just let everyone do it however they want to do it! "

You must have those procedures outlined per the standard and adhere to them.

Carl
 
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