Re: Please review my ISO-9001 QM and registrar comments
A few observations:
Your quality manual is not conform with the requirements of the ISO 9001.
We don't find:
The process approach
4.2.2(c) of the standards says that the quality manual must include "a description of the interaction between processes of the quality management system." While your 4.1 and 4.2 indicate that your QMS addresses the identification of processes and interactions, there's no reference to where the evidence might be found. The standard is pretty unambiguous about the requirement for description of interactions to be included in the manual.
Scope of certification is not clearly defined, Normative reference is missing (TPED?,....), design according ASME B31.3?
The "scope of certification" isn't called for in the standard; what
is called for is "...the scope of the quality management system..." Those are two different things. Nonetheless, while you do have an initial section alleging to include a scope, I don't see one. What you need is a simple statement that explains who and what the QMS applies to.
There is no requirement in the standard for normative references, but even so, you cite some, so I have no idea what they think is missing. Just ask for the specific language of the standard they're referencing.
You work follow EN stadards?
I think this must be related to normative references, but who knows? The fact that the auditors might be Belgian is no excuse for lack of clarity and misspelling.
Term and definitions are missing
No requirement.
You don't follow the structure prescribed in the ISO standard.
There
is no "structure prescribed."
The quality policy is not in accordance with §5.3 of ISO 9001 and is not signed by the President
Except for the signature part, I tend to agree. I don't see "...a commitment to comply with requirements and continually improve the effectiveness..." of the QMS. Your policy has a "belief" statement (We believe that...") which is not the same as a
commitment. We don't always do what we believe in. I also don't see how the policy "...provides a framework for establishing and reviewing quality objectives." We don't see the policy until page 5 of the manual, which is a little curious, as the policy should be the foundation of the QMS, and not an afterthought intended to satisfy the requirement for the existence of a policy.
As far as a response is concerned, I wouldn't waste a lot of explanation at the outset; you should just reject their findings and demand something that (A) cites the specific clause(s) in the standard allegedly violated, (B) cites the specific findings that they object to and precisely how they fail to conform and (C) is devoid of anything made up, such as the requirement for a signature on the quality policy.