Audit of Conformance with ISO 9001 Standard

Hello,

Thanks everyone for their help with my previous questions.

I have another question....

I have a hypothetical audit coming up....

the objective of my audit is the determine if the auditee's QMS is conforming with the requirements of the standard (not an audit to determine if they are complying with process).

I will be looking at all sections of the standard from 7.1 onwards.

Can someone provide me with examples of CARs they have issued where the QMS has not conformed with the requirements of the standard?

Thanks!

A hypothetical audit? Never done one of those...

Well, it's going to depend on what part of the QMS you are looking at, but an example might be:

ISO 9001:2008, section 6.2.2 states that the "organization shall blah, blah, blah..." A review of HR procedure HRXX revision 1 shows no indication of how competency is to be determined.

If you have had auditor training, your NCR is going to read pretty much as they taught you.

I will be looking at all sections of the standard from 7.1 onwards.

Click to expand...

Perhaps you are mentioning about a compliance audit to ISO9001 requirements. Why are you not looking at sections from 4 onwards, as there are vital 'shall' requirements there as well.
Are you meaning this to be a desktop ISO9001 documentation audit as well ?

If you're auditing for conformance and you're asking about CAR's then you lose on a couple counts

1. You're going into the audit biased, with a less than objective or impartial perspective and

2. You're looking for or expecting non-conformance and therefore in the act of creating nonconformance during the act of the audit...8.2.2 states "The organization shall conduct internal audits at planned intervals to determine whether the quality management system ...a) conforms to the planned arrangements"

As for the audit, don't waste time auditing 7.1 itself because evidence of fulfillment of everything after it is where you'll get the evidence of it being met (7.2-7.6)...... 7.1 is low hanging fruit and if any of its requirements aren't met you have major system related issues

AndyN said:

A hypothetical audit? Never done one of those...

Well, it's going to depend on what part of the QMS you are looking at, but an example might be:

ISO 9001:2008, section 6.2.2 states that the "organization shall blah, blah, blah..." A review of HR procedure HRXX revision 1 shows no indication of how competency is to be determined.

If you have had auditor training, your NCR is going to read pretty much as they taught you.

Click to expand...

1. "Hypothetical audits" - you remember, Andy, there used to be a certain registrar that offered "Hypothetical audits..."

2. Remember the audits should be done to the processes defined in the system, not just the clauses and sections.