Internal Quality Audits and Contract Audits

D

db

It is YOUR system!

dr madhavan,

My experience is that auditors will always “read” into the standard. For example, your comment about the records kept for management review. The requirement is to keep records. There is no auditable guideline that says what kind of record, and how to maintain them (other than what is in 4.16/4.2.4). If I videotaped the management review, some auditor would undoubtedly state that the records must be in paper form, and because I don’t have a transcript of the tape I’m noncompliant.

Master lists are one of my favorites. Master lists are not required. Even in the old version, it stated “or equivalent…”. Yet many auditors demand that master lists are absolutely required, as are approved vendor lists.

The point is this. If your document control system works for YOU, and if your management review records provide YOU with enough information to know what went on, then tell the auditor to jump in the lake. Never….Never…..Never accept a nonconformance for any requirement that an auditor makes up, provided YOUR system works. Just explain to the auditor that YOUR system works, and the level of detail in the record, or list, or procedure, or whatever, meets YOUR needs. Also let them know you will replace THEM long before you replace YOUR system. They will promptly find some reason to allow it!

It is YOUR system.

I know this sounds harsh, but I ZERO tolerance for incompetence, unless it’s mine!:frust:

Dave B (the other Dave)
 

Marc

Fully vaccinated are you?
Leader
Re: Internal Quality Audits

Originally posted by dr madhavan

My observation is that there is always an element of subjective interpretation by these individuals and it puts lot of doubts in our various clients whether the Standard is really a 'Standard at all'.
This site exists because of subjective interpretations by auditors.

> One example is the way the Master List of documents is
> maintained. As long as the evidence is provided that there
> is a master list(document list, status, ID, holder details
> etc), the auditor should not mind 'how' it is maintained?

If you have a 'Master List', it (in my opinion and experience) must be controlled. How the company 'mantains' the list is up to them, but it must be controlled (let us be watchful of our word use here).

> Is it true that individual REgistrars provide guidelines
> for thier auditors(!)

Most do. The intent, typically, is to ensure the most consistent interpretations as possible within their organization.

> Is this problem only in India or others also face similar
> problems?

Interpretations are a problem everywhere. I heard there are calls for, or at least rumours of calls for, an interpretations document much like QS-9000 has. I do NOT know if this is true or not. See ISO 9001:2000 (& 2008) - Interpretations 101 for more thoughts on interpretations in ISO 9001.
 

Marc

Fully vaccinated are you?
Leader
Master List - Not Required

Originally posted by db

Master lists are one of my favorites. Master lists are not required. Even in the old version, it stated “or equivalent…”. Yet many auditors demand that master lists are absolutely required, as are approved vendor lists.
Excellent point. I'm mad at myself for not including it in my response. :frust: I have had many clients use the “...or equivalent…” 'out' - particularly those with distributed document control systms. Basic control requirements are defined in the company's level II document control flow chart. :thedeal:
 
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