A registration auditor outlined ISO 9001:2000 section 1.0 in the audit report.
This section of the standard has no "SHALL" in it. Can this section be audited? Please Help!! Thanks in advance.

A registration auditor outlined ISO 9001:2000 section 1.0 in the audit report.
This section of the standard has no "SHALL" in it. Can this section be audited? Please Help!! Thanks in advance.I don't find a Section 1.0 - Requirements in my ISO 9001:2000 standard. What exactly did the auditor write up?

Remember, the quality of any answer is directly affected by the clarity of the question. Explain exactly what the auditor reported and we can TRY to help. Leaving a lot unsaid does not assist us in understanding the (potential) problem.

A registration auditor outlined ISO 9001:2000 section 1.0 in the audit report.
Welcome to the Cove!:bigwave:

What do you mean "outlined"? Do you mean he cited section 1.0 on a finding or nonconformance? What was the finding if so - can you post exactly what the auditor wrote?

ISO 9001:2000 Section 1 Scope; The auditors report stated that my companies Quality Manual does not comply with ISO 9001: 2000 Section 1, "does not describe the nature of work". I don't see where section 1 (scope) of the standard requires us to describe the nature of work.

Section 4.2.2 of ISO 9001:2000 contains the MINIMUM requirements for what a Quality Manual should contain. If the auditor can not identify a requirement you are "violating", he can not demand corrective action. It is THAT simple.

Wait a minute....

Did the auditor identify 1.2 referencing the "exclusion" requirements?

Did you claim exclusions other than in Clause 7 in accordance with 1.2 or did you fail to document and justify exclusions?

Even though all of ISO 9001:2000 is applicable the only auditable portions are the Clauses between 4 and 8.5.3

I find sections 1.1, 1.2, 2, and 3.

I think UV360 has asked an interesting question. If only the text from 4.0 to the end are auditable, why are we concerned about what can be excluded or defintions?

Regards,

Dirk

I think UV360 has asked an interesting question. If only the text from 4.0 to the end are auditable, why are we concerned about what can be excluded or defintions?

Regards,

DirkSections 1, 2 and 3 contain enforceable requirements, even though the word "shall" is not used. I disagree that sections 1, 2 and 3 are not auditable. For example, if an organization had a definition of corrective action that is not in line with ISO 9000, they should be written up for failure to enforce the definitions of ISO 9000, a NORMATIVE reference in ISO 9001.

Based on Sidney's posting, the auditor can site secions 1 - 3 as requirements. I guess the only other thing to be discussed is the validity of the content of the audit report. Meaning, whether or not section 1.0 is the proper reference and not whether section 1.0 can be used as a normative reference or requriements. Apparently it can be.

Regards,

Dirk

In the check list of the registrar I work for (a very large and International organization), we have to check requirement 1.2, in what concerns to exclusions.
Of course this can also be checked in 4.2.2 a).
In that 1.2 clause we also have to check this:
“Does the organization provide products or services that are out of the registration scope?”
“If so, what are they?”

I also have nonconformances written in this clause, when they refer to not well done exclusions. :(

AV

To expand on this subject...

1) Clause 3... An auditor is interpreting that one require a 'terms and definitions' section in the quality manual. I disagree. Those are terms and definitions of the standard not a QMS or QM requirement.

2) what about "Clause 0" or the introduction? Same auditor keeps referencing "Clause 0".
Seems to me "Clause 0" describes the philosophy behind the standard. There are no requirements.
I think he's trying use "Clause 0" like OSHA uses the General Duty Clause

thoughts?

To expand on this subject...

1) Clause 3... An auditor is interpreting that one require a 'terms and definitions' section in the quality manual. I disagree. Those are terms and definitions of the standard not a QMS or QM requirement.

2) what about "Clause 0" or the introduction? Same auditor keeps referencing "Clause 0".
Seems to me "Clause 0" describes the philosophy behind the standard. There are no requirements.
I think he's trying use "Clause 0" like OSHA uses the General Duty Clause

thoughts?

Hello ScottK,

The auditor is way off base. He/She is probably used to seeing quality manuals modeled after the ISO 9001 standard. That is not required and not necessary. The standard is pretty clear on the requirements, and that's it. It's OK to (professionally) push back!

Think for a moment what the purpose is of the quality manual. What are you trying to convey to existing and prospective customers? It should serve your company well, not the auditor.

Stijloor.

Hello ScottK,

The auditor is way off base. He/She is probably used to seeing quality manuals modeled after the ISO 9001 standard. That is not required and not necessary. The standard is pretty clear on the requirements, and that's it. It's OK to (professionally) push back!

Think for a moment what the purpose is of the quality manual. What are you trying to convey to existing and prospective customers? It should serve your company well, not the auditor.

Stijloor.


yes - I'm pushing back.
no doubt.
It just makes me doubt that the auditor understands the spirit of the standard.

yes - I'm pushing back.
no doubt.
It just makes me doubt that the auditor understands the spirit of the standard.

Hello ScottK,

I wonder too sometimes....not all companies understand that they do not have to agree with "audit conclusions." They do not push back because they are afraid that the auditor starts "looking" for more stuff.... Both parties want to be pleased, don't want to make waves, and as a result we've got the situation we're in right now. Many discussions on The Cove dealt with this very topic. Don't want to make waves myself right now....;)

Stijloor.

In my opinion, if I were to include "the spirit" of the standard in my efforts, I would absolutely include every word on every page in my thoughts.

I would not question if the auditor understands the spirit of the standard. Certainly the spirit would include sections 0, 1, 2, and 3. A pure conformity activity may not.

It would question if the auditor understand the conformity assessment strucuture, not the spirit.

Regards,

Dirk

Hello ScottK,

I wonder too sometimes....not all companies understand that they do not have to agree with "audit conclusions." They do not push back because they are afraid that the auditor starts "looking" for more stuff.... Both parties want to be pleased, don't want to make waves, and as a result we've got the situation we're in right now. Many discussions on The Cove dealt with this very topic. Don't want to make waves myself right now....;)

Stijloor.

I agree that most companies are afraid to question the CB/NB auditor, that is why when I do an audit I tell them if I have a finding and you don't agree let me know and I will be more than happy to discuss. If you can show me where I am wrong I will be more than happy to not write the finding. Please challenge me it keeps me honest and on my toes.