ISO 9001:2000 (& 2008) - Interpretations 101

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Aaron Lupo

My fault I assumed you were talking about 9000:94. If it is 9K2K. I wonder how others on this forum feel. Maybe it is me that is off my rocker, but if I had a procedure in place that we were not following, I would expect to receive a N/C.

Look ar 4.2.1 d for 9K2K.

Please dont take this the wrong way, but I wonder about you sometimes Carl. Do you come in here to stir things up or do you really believe the things you say. The only reason I say this is that you are not registered, what exactly do you do for a living?


:bonk:
 
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JodiB

Well Carl, it does say that you have to control your processes.
Are you saying that you can "control" without procedures that are followed? If the procedures aren't followed, you aren't demonstrating control. Nor are you meeting internal requirements. And isn't a failure to meet requirements a nonconformance? And doesn't the standard require that nonconformances are addressed?

Looks to me like I could find any number of ways that ISO says you have to follow your procedures.;)
 
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Carl-

Folks,

All I am saying is that an ISO audit concerns your QMS system as outlined by the standard. If I received a N/C for something concerning my QMS, I would obviously have no alternative but to take the N/C and correct it. As well I should.

As ISO GUY states, look at 4.2.1 "the Quality Management System documentation shall include....." If it is a procedure that lies outside those outlined, NO I would not accept an N/C!!! That does not mean I would not fix it, or that I am in the right for not following my own procedures, but where does it end? If an ISO auditor is present when our controller performs a function that is questionable in reference to GAP, do they write an N/C? How about ordering lunch for a business meeting from an unapproved source? This may seem ridiculous, but that is why we have the standard.

Lucinda, Give me a section number of the standard that states I must follow ANY procedure which lies outside my QMS.

If I have evidence of a functioning non-conformance system, I meet the standard for that reference. There is not one company out there that is running PERFECTLY so a single, or even several instances of procedures outside the QMS not being followed should not bring an N/C. As long as there is evidence that you have a Non-conformance system in place for your QMS and have evidence that you are continually improving it, you are meeting the requirements.

To answer the other question:
I am an ASQ CQM, I have been in Quality for over 12 years, Have been the Management Representative for 4 Companies that were successful on the first attempt, and consulted for two other successful first attempts. I received my lead assessor cert. in 1994 and have performed approximately 75 Internal Audits and 30 Vendor or "second party" audits since.

I obviously know I am going to take heat with some responses because there are many registrars and and consultants who feel threatened or uneasy. That does not make them right.

It is my beleif that the standard is being treated as a subjective document open to interpretation and it should not be.

No offense here ISO GUY, I tend to only respond to those posts I feel strongly about. If I am out of line, let me know.

Regards

Carl-
 

E Wall

Just Me!
Trusted Information Resource
Back to basics

I think we should all keep in mind that (for the y2k version) we're expected to identify the companies Goals, Objectives, and Measureables (G/O/M)...and these are the basis of your entire Business Managment System!

It is up to you to define what Processes are used, what the Goals, Objectives, and Measureables are for each of these processes to support the previously identified Company G/O/M. As well as determining what your procedure (documented or not) will be to implent and meet your criteria.

Back to Carl's question "And just exactly where does it say that my company procedures must be followed (other than those outlined in 4.2 )?" - Your companies Quality Manual addresses the Requirements of the Standard by describing what is to be followed. If you chose to have a documented procedure (beyond what the standard requires) then you are expected to have outlined responsibilites.

The issue regarding interpretations if very basic as well. We can all read what the standard requires, we can implement (and show evidence) to meet the criteria - TO OUR INTERPRETATION. The problems arise when an auditor doesn't agree that you have provided sutible/sufficient evidence to show you are efffectively meeting the requirement. Which any good MR (corp or plant level), QA Manager or ISO Coordinator will be prepared to discuss in detail. After discussion - you either convince them your right, accept a finding if you haven't, or challenge a finding through the dispute process in place with your registar.

By the way....good points Lucinda! And welcome to the Cove
:bigwave:
 
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Carl

E Wall,

Sorry, I have to disagree

You state: "I think we should all keep in mind that (for the y2k version) we're expected to identify the companies Goals, Objectives, and Measureables" and "If you chose to have a documented procedure (beyond what the standard requires) then you are expected to have outlined responsibilites."

Those "expectations are in reference to the QMS and I really don't care what is "expected" Just show me where it says "I shall".


Carl-
 
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Aaron Lupo

Carl, would I be safe in saying that is how you interpret the standard?
 

E Wall

Just Me!
Trusted Information Resource
OMG - More Semantics?????????

Just for you Carl - expected/shall/required....substitute what ever term you actually use!

I also generally respect the right of anyone to have a different opinion than my own, However...in this case, it isn't opinion...so I will rebutt the comment:

Have you read the 2000 standard version? :confused:

4.1 The organization SHALL establish, document, implement and maintain a QMS and .....
The organization SHALL:
a) Identify the processes needed for the QMS *AND* their application throughout the organization.
:eek:

I'm not going to retype the standard here...why not open a copy and re-read the entire 4.1 section? Then move on through 4.2...and the rest of the standard. Which all, by the way Lucinda referred to whith her comments.

As for G/O/M....4.2.1 a) requires (with a shall) documented statements of both a quality policy and quality objectives...as well as c) documented procedures required by the standard AND d) documents needed by the organization to ensure the effective planning, operantion and control of its processes. Not to mention countless process/measurement/records/data analysis etc... interactions mentioned throughout the standard.

I'm sure there are a number of simple similar references that I could have used, but need to get back to my own duties here at work.

Best Regards, Eileen :frust:

PS: If I am wayyyyy off the mark here - please accept my apology and clarify the comment.
 
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Carl

1. ISO GUY, I don't need to "interpret" the standard. It is pretty clear. I prefer to remain Objective rather than subjective, perhaps that is why I have a record of success.

2. E Wall, yes I have read the Standard. The term "shall" is used throughout the 9K2K standard. "expect" is not. There is good reason for not interchanging them.

3. I also respect your opinion, but...."in god we trust, all others bring evidence"

4. E wall is correct. If a process is part of the QMS, you have to document, follow, improve and show evidence. Outside the QMS you can operate however you like.

Now, I have to get back to work on an "objective" audit.

Regards,

Carl-
 
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JodiB

Wow

Ok, look, interpretations are essentially (and please let's not have to interpret what I mean by essentially) definitions. And it is important, particularly with an international standard, to use language that is easily translatable. But even within the same room, there will be a different interpretation of what a word means. Even Webster's will give you more than one meaning or use of a word and that doesn't take into account all the regional or colloquial (sp?) meanings of a word.

This is why ISO9000 exists, and why it not only provides a definition of numerous terms that may be misconstrued, but also provides a methodology in the development of the words used. And this is also why it is prudent to include definitions of terms used in the company procedures that are written. So that everyone is using the same language.

Carl, a standard is just words. Words backed by intentions. ..Words that are not ALL defined because they appear to be common. And the way that they are used is supposed to provide a reasonable person with the intented meaning. That is where interpretation comes into play. :) We can't get away from interpretation, whether it is the interpretation of the writers of ISO9k2k (shall we consult with them on every instance?), or whether it is the interpretation that a user puts into action. Somebody somewhere decides what the standard says. If you want to kick it back to the committee, then which member's interpretation do you use? Or do you assume that all the members agreed on every single point?

There are guidance documents precisely to provide the committee's further interpretations. Interpretations. Now, these are interpretations you can wave under an auditor's nose. Other than that, it is your interpretation against the auditors. (How many times can I get "interpretation" into this paragraph?:frust:

Carl, your additional point about having procedures outside of your QMS is somewhat puzzling, although I guess what you are referring to are some employee policies or accounting type procedures. And if I had an NCR written because some employee was given more vacation than a procedure indicated he should receive, or something to that effect, then yes, I would scream too.:))
 
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Carl

OK, I'm the outsider here, but...

You can dice it up with all the rhetoric you want. The fact remains, any time you enter a situation where opinions, subjectivity, interpretation...call it whatever you want, are thrown into the mix, you lose control. The more objectivity, the more control, the more subjectivity the less control. It doesn't matter if it is a court of law, an ISO audit or haggling over the price of a Pizza, the less defined, the less control you have over the system. Is there always going to be SOME "Interpretation"? Of course. But we certainly should not condone it! we should try to minimize it.

How much subjectivity would you allow if you WERE being falsely accused of a serious crime?
How much subjectivity is acceptable? Obviously not much to me, I consider it pretty serious, not as serious as being falsely accused of a Felony or something, but a lot of effort, time and money being spent should indicate the importance.

So there you have it. However much subjectivity exists, we (AND the RAB and Registrars) should be trying to improve it. (unless Registrars are exempt from continuous improvement)

Thanks to all for your point of view.

Carl
 
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