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iso 19011 - quality (qms) and ems audits, processes (general), third party audits and auditing
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  #41  
Old 19th March 2012, 10:30 PM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

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In Reply to Parent Post by mrkjmg View Post

In ISO 9001:2008 a clause is there for purchase(7.4) process and even for audit.
If u refer ISO 19011 for audit then it calls for a schedule i.e. Audit plan and in that you have to mention audit plan as per the clauses. Because then only u will be able to complete and confirm that audit is done as per ISO 9001:2008.

Your all SOPs or QSPs should have reference clause no and the same should be mention in Quality manual. Even you will have cross reference checklist which gives you an idea about interrelated processes. So every where to keep record the reference will be a clause no of ISO 9001:2008.
Sorry to burst your bubble but you're incorrect, I've seen very good quality systems function and get certified without ever once mentioning ISO 9001 or any of its clauses. I've seen environmental systems do the same.

Your argument won't hold water

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  #42  
Old 19th March 2012, 10:55 PM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

Dont hold water.... refer clauses... Whether your QSP have covered entire clause or something is missing from it will be clarified only after referring a clause.
What u r saying can be followed but then there will be no unique tracing system like all QSPs and company will work in wag way. To make it systematic it should be as per clause and ref no should be there.
Compliance with any standard or directive will be done as per the clauses and u will understand that only if you have ever prepared a TCF of any product and the same is reviewed by any notify body.
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  #43  
Old 20th March 2012, 12:02 AM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

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In Reply to Parent Post by mrkjmg View Post

Dont hold water.... refer clauses... Whether your QSP have covered entire clause or something is missing from it will be clarified only after referring a clause.
What u r saying can be followed but then there will be no unique tracing system like all QSPs and company will work in wag way. To make it systematic it should be as per clause and ref no should be there.
Compliance with any standard or directive will be done as per the clauses and u will understand that only if you have ever prepared a TCF of any product and the same is reviewed by any notify body.
Cool, but seeing as I'm a full time management systems auditor for what you call a notified body I have a small bit of personal knowledge and hands on experience with this.

What you are saying may make it easy, but it does not make it eithr required or necessary for effectiveness and conformity to be achieved

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  #44  
Old 20th March 2012, 12:46 AM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

Completely agree with you sir,

- Only advantage of having clause no is systematic approach and will make cross verification easy.
- For new bee its easy way to understand and follow process as per standard.
  #45  
Old 20th March 2012, 04:03 AM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

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In Reply to Parent Post by mrkjmg View Post

Completely agree with you sir,

- Only advantage of having clause no is systematic approach and will make cross verification easy.
- For new bee its easy way to understand and follow process as per standard.
I'd just like to support Randy with a general point.

If you start off with a 'systematic approach' that adds no value you end up with a bureaucratic nightmare. The purpose of an audit programme is to cover all of the management system. If (for example) you use a process audit methodology then you will identify all the processes you want audited and cover those. During each audit you will cover a whole range of clauses and, so long as you can demonstrate that all the requirements are covered then you are not obliged to list all the clauses.

As a newbie if you start off following the standard (and not the organization's processes) it is a sure fire way of having a system that is unusable by the people that need to know - the users.

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  #46  
Old 20th March 2012, 07:05 PM
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Re: 3rd Party Audit Comment - Identify ISO Clauses/Sub Clauses to each Process

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In Reply to Parent Post by Ron tollett View Post

Hi, it was brought up in our last audit to "Identify ISO clauses/Sub clauses to each process" I understand this i.e. 7.4 Purchasing, but was wondering if there was a process model that would identify all ISO clauses and sub clauses so I do not miss anything.
Check this one out...

http://www.sae.org/servlets/registra...GE=getSCMHBOOK
Thanks to dsanabria for your informative Post and/or Attachment!
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