Auditor kept saying 9004:2000 is the "interpretation" of 9001:2000

[Caster]

*sigh*

....
ISO 9004 is unknown by the vast majority of organizations certified to ISO 9001. .

OK, now that is about the saddest thing I have heard lately. I bought all the ISO numbered docs I could find, and read them all to take any ideas I liked. Sad to be in the minority.

9004 helped me over the "gee I wish I had an example" hurdle of 9001.....

Possibly this could be a single "acid test" question of seriousness....any company who has not looked at 9004 is just after "the plaque on the wall"?

 

[Helmut Jilling]

Our auditor is fond of saying "have you looked to see what 9004 has to say about clause X?" - which I like, a guiding hand without telling me. I can't imagine anyone ever trying to audit you to 9004 or trying to say that it is the only way of doing things. If it were that then why don't we all have certificates that say we comply with ISO 9004?

Of all these posts, this one has the best comment from an auditor, IMO. This auditor sounds wise. The original auditor is clearly incorrect.

I also mention ISO 9004 to my clients. I encourage them to read it to help understand the ISO program, get good ideas for implementing things that make sense. We auditors cannot advise clients, so it's a great place to show how something COULD be done. But, never, under any circumstances can we write an nc because a client did not add some of the extra text to their system. It is optional, explanatory, gives good ideas, but is over and above.

PS: If you haven't read ISO 9004, please get a copy pronto. It is the best thing ISO has published. Almost all of my clients use 9004 after they have read it, because it is such a powerful tool. However, I never audit them to the extra stuff. I audit them to the requirements of 9001, because 9004 is not certifiable.

PPS: A lot of the TS requirements derive from some of the additional material in 9004. It is a good read.

 

[Helmut Jilling]

We just went through a pre-assessment for ISO 9001:2000 and the auditor kept saying that 9004:2000 is the "interpretation" of 9K2K...

Is this what registrars are going to start doing?

Not that I mind. It's like an essay question in school...add more "fluff" and you may get a better grade...

Anyway, we bought the 9004:2000 Standard and I'm revising the current procedures up to the new language.

Please don't add fluff that you don't believe in. That is not how to win an audit certificate, nor a way to get your people to develop any respect for it. Your system should define what you have determined are the best practices for your processes, and how you will meet the ISO requirements.

I think 9004 is great, and it is good you bought it. If you find some things you like in 9004, or Lean, or Baldridge, Deming, Juran, etc., and YOU think it would be good to add it, cool. Go ahead.

But to tailor a system to the whims of your auditor is a no win game. It has to make sense to you. (PS, I am an auditor and often carry 9004. But I'll never hold people to what is discussed in it. It is a good reference only.)

 

[Jeff Frost]

As Dr. Wayne Dwyer is found of saying “go to the source” and in this case that would be Clause 1 “Scope” of ISO 9004. The very last line of this document it clearly states “This International Standard (ISO 9004:2000 added for clarity) consists of guidance and recommendation and is not intended for certification, regulatory or contractual use, nor as a guide to the implementation of ISO 9001”.

ISO 9004 is a very usefully document to help understand some of the clause of ISO 9001 but as clearly stated in Clause 1 it is not intended for certification and though a registrar may ask (remember you’re the customer who defines the terms of the contract with the registrar) for you to use or implement part of this document it is not required for certification.

 

[JRKH]

Back to the origional question.

We just went through a pre-assessment for ISO 9001:2000 and the auditor kept saying that 9004:2000 is the "interpretation" of 9K2K. We don't even have the initial ISO 9000 certification to prove that our baseline QMS is up to snuff and we are being audited to a much higher interpretation.

Is this what registrars are going to start doing?

Not that I mind. It's like an essay question in school...add more "fluff" and you may get a better grade. Sidney Vianna had an interesting post that triggered this question. I'd like to see what the more experienced folks have to say.

Anyway, we bought the 9004:2000 Standard and I'm revising the current procedures up to the new language.

You say that you have completed your pre-assessment. Has your auditor written any findings against your QMS based on 9004 sections? Or is he/she simply trying to point you at 9004 as a document to use in support of 9001?

It may be that the auditor is simply trying to make sure everyone is on the same page.

I think it is hard to argue that 9004 isn't the interpretation of 9001 since it was created at the same time. The only issue would be whether it is STILL the accepted interpretation.

If the auditor is trying to hold you to 9004 then I agree with the others who say you should fight any findings based on this. However he/she is using it as a reference for good practice, then look it over, use what you want and discard the rest.

James

 

[tazng00se]

Thanks again for everyone's professional input. "The boss" doesn't want to make any waves - he just wants the certificate in February/March. Because of the pre-assessment I have gone from 20 hrs/wk to 40 per week. After that I'll be pounding the pavement again. I have included a couple of things that I remember from the audit (14 CARs total).

Specific items paraphrased (from memory):

1) 9004 states...you need a management rep "appointed" and that means a letter from the president of the company. -- I still can't find a reference that states anything like an official letter/ceremony has to take place in order for the management rep to be officially recognized.

2) As stated in ISO 9004:2000 (the interpretation of ISO 9001:2000) the specific Inputs and Outputs of Management Review are not listed in QP 5.6 or fully listed in the Management Review Minutes form. -- I had combined some of the "listed" input/output items to keep the form on one page.

3) According to 9004, closure of preventive actions including follow-up is not defined when it occurs in this procedure. -- I can't find the need for follow-up to be defined in 8.5.2...there are only two items that include follow-up and they are 5.6.2 Review input (follow-up on previous mgmt. reviews) & 8.2.2 Internal Audits.

 

[Claes Gefvenberg]

After that I'll be pounding the pavement again.

Well, I hope that pavement takes you to a good employer.

I have included a couple of things that I remember from the audit (14 CARs total).

And they all begin with a reference to ISO 9004???? How quaint....

/Claes

 

[Rob Nix]

Sigh....

Bruce, I'm not sure you've absorbed much of what was posted throughout this thread, especially in regards to the purpose of ISO-9004.

Since your direction comes from the "boss", just do it that way. We can be of no further help.

 

[Craig H.]

1) Horse hockey. Show me the shall.
2) It is not our job to make the auditor's job easier. The requirements have been met. 'nuff said.
3) Will your certificate say 9004? Nooo. Where is the shall in 9001? Gee ITS NOT THERE!

This is a piece of work.

 

[Miner]

1) 9004 states...you need a management rep "appointed" and that means a letter from the president of the company. -- I still can't find a reference that states anything like an official letter/ceremony has to take place in order for the management rep to be officially recognized.

2) As stated in ISO 9004:2000 (the interpretation of ISO 9001:2000) the specific Inputs and Outputs of Management Review are not listed in QP 5.6 or fully listed in the Management Review Minutes form. -- I had combined some of the "listed" input/output items to keep the form on one page.

3) According to 9004, closure of preventive actions including follow-up is not defined when it occurs in this procedure. -- I can't find the need for follow-up to be defined in 8.5.2...there are only two items that include follow-up and they are 5.6.2 Review input (follow-up on previous mgmt. reviews) & 8.2.2 Internal Audits.

First off, I want to add my sentiments that the auditor is out-of-line to quote ISO 9004 as the source of the nonconformance. He may use it to show you a way to improve, but no more than that.

But to help in your examples:

1) ISO 9001, section 5.5.2 Management representative does state that "Top management shall appoint a member of management who, ..." You need to satisfy the following:

• Evidence that Top Management made the appointment
• The appointee is a member of management
• Appointee has defined responsibility and authority

You have options on how to satisfy this requirement. Your example is one such option. However, you can also define this in your Quality Manual, provided it has been approved by said Top Management.

2) The Inputs and Outputs of Management Review is a fairly simple matter. The auditor needs to see evidence that you have covered all of the manadatory I/Os (...the input shall include..., ...the output shall include...). It is a good idea to state the mandatory items in either the Quality Manual OR a Management Review procedure (if you need one). You can show evidence of meeting this by formatting your agenda, minutes or presentation to cover each mandatory item.

3) Section 8.5.2 refers to Corrective Actions, not Preventive, which is section 8.5.3. This probably refers to ISO 9001, section 8.5.2.f (or 8.5.3.e), which requires (...shall be established to define requirements for:...) the review (follow-up) of corrective (or preventive) actions taken.