Quality Manual vs. ISO9001:2000 Standard - Quality Manual doesn't address all of 9001

Although our registrar approved our quality manual there are distinct areas where it doesn't address the standard. Ok this is where I run into a problem. I want to ask some questions from the standard because our processes are affected or related to those areas of the ISO9001 standard, however, our quality manual does not address them, nor does our quality manual state those exceptions from the standard.
1. First question, is there something in the standard or 9004 guidelines (I couldn't find anything) that states "exceptions to the ISO9001 standard must be documented" in the quality manual or some other document?

2. What type of argument can I make to my fellow auditors to the effect that I can use the ISO standard, not just the quality manual in my audit checklist. (note they feel that only questions taken from the quality manual are fair game in an internal audit) I ran into this issue with Environmental and the 14000 standard as well.

3. Should I even challenge them since this is the company culture?


Thanks,

Jim

qualityboi said:

Although our registrar approved our quality manual there are distinct areas where it doesn't address the standard. Ok this is where I run into a problem. I want to ask some questions from the standard because our processes are affected or related to those areas of the ISO9001 standard, however, our quality manual does not address them, nor does our quality manual state those exceptions from the standard.

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This might sound like a weird question (forgive me, but I'm happily plugging away at work on DayQuil...non-drowsy?!?!...hah!) but...how doesn't it address the requirements of ISO 9001?

qualityboi said:

1. First question, is there something in the standard or 9004 guidelines (I couldn't find anything) that states "exceptions to the ISO9001 standard must be documented" in the quality manual or some other document?

Click to expand...

Read ISO 9001:2000 1.2 Application (3rd paragraph). "Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to the requirements within clause 7, and such exclusions do not affect the organziation's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements." Phew....what a mouthful!

In other words, just because you don't talk about that doesn't mean it doesn't apply. You need to indicate the "scope" of your ISO 9001 registration. For example, my site was ISO 9002...with the re-birth of ISO 9001:2000, we had to clearly state in our manual (because where else does it make sense to put this?) that we didn't do design and our lack of designing the product did not impact our ability to meet Stakeholder requirements.

qualityboi said:

2. What type of argument can I make to my fellow auditors to the effect that I can use the ISO standard, not just the quality manual in my audit checklist. (note they feel that only questions taken from the quality manual are fair game in an internal audit) I ran into this issue with Environmental and the 14000 standard as well.

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Try saying that you're doing a system audit...not a document audit. You do what you say, but you're going to audit if you say what you do....100%. If it's not applicable, using the checklist won't hurt anyone because you'll just indicate that a section (e.g., Design) is not applicable to the scope of your registration.

qualityboi said:

3. Should I even challenge them since this is the company culture?

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Challenge? No. Convince? Yes. One thing I have learned about Management Systems that that the 80-20 rule applies. 20% of time is actual work...the other 80% is selling my work.

qualityboi said:

2. What type of argument can I make to my fellow auditors to the effect that I can use the ISO standard, not just the quality manual in my audit checklist. (note they feel that only questions taken from the quality manual are fair game in an internal audit) I ran into this issue with Environmental and the 14000 standard as well.

Jim

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I believe your internal audit is supposed to be evaluating:
1. the effectiveness of your processes and
2. your system's compliance to the ISO standard.

In that case, you kind of have to use the ISO standard as well, because it is the standard to which you are comparing your system. However, the audit must still be process approach based, not element/clause based.

So, if you audit your procedures and work instructions, using the ISO standard as the satndard to which you compare, you may satisfy all parties.

This is why the internal audits are supposed to define the audit scope and criteria, which includes what documents are to be included.

Good Luck.

qualityboi said:

1. First question, is there something in the standard or 9004 guidelines (I couldn't find anything) that states "exceptions to the ISO9001 standard must be documented" in the quality manual or some other document?

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Well... I don't know if I misunderstood something, but: You don't have to look in ISO 9004 for that. ISO9001 says it all:

ISO 9001:2000 said:

The organization shall establish and maintain a quality manual that includes

a) the scope of the quality management system, including details of and justification for any exclusions (see 1.2),

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qualityboi said:

2. What type of argument can I make to my fellow auditors to the effect that I can use the ISO standard, not just the quality manual in my audit checklist. (note they feel that only questions taken from the quality manual are fair game in an internal audit) I ran into this issue with Environmental and the 14000 standard as well.

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I'll go to clause 8.2.2 for that one: :

ISO 9001:2000 said:

The organization shall conduct internal audits at planned intervals to determine whether the quality management system

a) conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the qualitym anagement system requirements established by the organization, and

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Of course you can use the standard to determine whether the QMS conforms to the standard...

/Claes

Still Thinking about this...

Roxanne mentioned the 20 / 80 rule, and that pretty much says it, however, I really really hate selling my work. Because of the other replies it probably was not clear as to what I was trying to say. Restated:
1. We have a quality manual that does not address all parts of the 9001:2000 standard (I will not go into length on which ones it does not address.)
2. Our registrar has approved it, even though we have listed zero or no, exclusionary provisions in the manual. Basically they said we are covered all sections even though when I do audits and comparisons agains the standard there are blatant gaps!
3. If I try to ask those questions from the standard that our manual does not cover, some managers get upset and tell me its not part of the quality manual and state that I should only be asking questions from the quality manual, not the ISO standard.

Based on 2 and 3 Roxanne had the best applicable answer that I needed to sell them on value of those questions taken from the standard. However selling is way out of my comfort zone, (otherwise I would be a salesman, right?).

Thanks for your thoughts on this, I will noodle my approach a bit more. Most managers do not corner me anyway because they are not familiar enough with the quality manual and do not realize I am asking a question not addressed, however, there is a small percentage that do know it and realize when I am asking a pointed question directly from the standard, and I just wanted to know how to deal with them. (see #3).

Again many thanks...

qualityboi said:

Roxanne mentioned the 20 / 80 rule, and that pretty much says it, however, I really really hate selling my work. Because of the other replies it probably was not clear as to what I was trying to say. Restated:
1. We have a quality manual that does not address all parts of the 9001:2000 standard (I will not go into length on which ones it does not address.)
2. Our registrar has approved it, even though we have listed zero or no, exclusionary provisions in the manual. Basically they said we are covered all sections even though when I do audits and comparisons agains the standard there are blatant gaps!
3. If I try to ask those questions from the standard that our manual does not cover, some managers get upset and tell me its not part of the quality manual and state that I should only be asking questions from the quality manual, not the ISO standard.

Based on 2 and 3 Roxanne had the best applicable answer that I needed to sell them on value of those questions taken from the standard. However selling is way out of my comfort zone, (otherwise I would be a salesman, right?).

Thanks for your thoughts on this, I will noodle my approach a bit more. Most managers do not corner me anyway because they are not familiar enough with the quality manual and do not realize I am asking a question not addressed, however, there is a small percentage that do know it and realize when I am asking a pointed question directly from the standard, and I just wanted to know how to deal with them. (see #3).

Again many thanks...

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Seems like the simplest solution (aside from ignoring the issue ) would be to fix the manual.

qualityboi said:

1. We have a quality manual that does not address all parts of the 9001:2000 standard (I will not go into length on which ones it does not address.)

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Think of this thread as being your attempt at preventive action - you are trying to fix the manual before someone identifies it is broke.

qualityboi said:

2. Our registrar has approved it, even though we have listed zero or no, exclusionary provisions in the manual. Basically they said we are covered all sections even though when I do audits and comparisons agains the standard there are blatant gaps!

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Begs the question as to what they were looking for - there is the usual get out clause that they only take a sample of the activity at each audit but it is unusual that someone has not carried out an adequacy assessment before offering you registration.

qualityboi said:

3. If I try to ask those questions from the standard that our manual does not cover, some managers get upset and tell me its not part of the quality manual and state that I should only be asking questions from the quality manual, not the ISO standard.

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Really this question is only appropriate for the person with overall responsibility for the Q Manual but it is a question that should be asked of them! Most "other" managers will not know what is in the manual - never mind what should be there. That is not a slight but it is unlikley they are familiar with the standard requirements.