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Potential Issues for Auditing ISO 9001:2015 - Page 2


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audits and auditing, iso 9001 - quality management systems, iso 9001:2015
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  Post Number #9  
Old 22nd January 2014, 01:45 PM
Reg Morrison

 
 
Total Posts: 433
Re: Potential Issues for Auditing ISO 9001:2015

Quote:
In Reply to Parent Post by Randy View Post

As an auditor I'm not going to waste my time trying to interpret anything
I am surprised with that statement. When anyone assesses if evidence shows that audit criteria is being complied with, or not, and the requirements are generic in nature, interpretation is always required.

The thrust of making conformity assessment personnel competent for their functions, via documents such as ISO 17021-3:2013 is exactly to ensure that interpretations are meaningful.

Interpreting generic standards is at the core of auditing.
Thanks to Reg Morrison for your informative Post and/or Attachment!

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  Post Number #10  
Old 22nd January 2014, 06:25 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,456
Re: Potential Issues for Auditing ISO 9001:2015

Reg,

But we are wasting our time interpreting a CD. I see some people even sell training on the CD!

We used to wait for the FDIS but let's at least wait for the DIS before we waste time wondering if we will have to audit "risk management thinking"

John
Thanks to John Broomfield for your informative Post and/or Attachment!
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  Post Number #11  
Old 22nd January 2014, 07:06 PM
Randy's Avatar
Randy

 
 
Total Posts: 8,461
Re: Potential Issues for Auditing ISO 9001:2015

Absolutely John, I agree with you, until the FDIS comes out the CD is really nothing more than "who cares?"

As for my "interpretation", I don't waste my time with it, I apply and use available definitions to words and phrases from the guidance documents or pay attention to what the standard in question is stating. In this case we're referencing the organization realization that they may need to document or record something beyond what is specifically "required" in the standard itself and what might be required by customer, law, or whatever else. When an organization makes the decision that they want or need to document something to allow for better, understanding, control, or "recording" then appropriate doc or record controls are to be applied and I, the auditor have to make sure that the documentation is in fact being created and is being controlled....This is basically what 4.2.1d is calling out to be done....No interpretation necessary
  Post Number #12  
Old 23rd January 2014, 02:07 AM
JaneB's Avatar
JaneB

 
 
Total Posts: 3,518
Caution Re: Potential Issues for Auditing ISO 9001:2015

Ah, but I suspect that if all the auditors out there were cut from the same cloth as you Randy, then there would be far fewer problems (or questions posted).
  Post Number #13  
Old 22nd May 2014, 07:25 AM
Paul Simpson

 
 
Total Posts: 1,765
Re: Potential Issues for Auditing ISO 9001:2015

Thanks for the prompt to this thread, Marc. I'd agree with some that the move to 'documented information' to cover both documented procedures and records is likely to create a lot of confusion - just look at the discussions on here about the need for documents to describe processes when they aren't one of the '6'. Perhaps we can get people to think more generally about what they need before they set their system up in future?

The simple distinction I make is:
  • Is the documented information there to describe what you plan to do - equivalent to a (documented) procedure
  • Is the documented information evidence of what has happened - equivalent to a record

The change is as a result of the TMB's work on Annex SL - pretty much no other technical committee required a procedure or manual (unless the organisation decided it was necessary) and they didn't all get hung up on document vs. record.

I remember going through the transition auditor training for the 2000 edition of ISO 9001 and spent a lot of time on the question of how you would audit a process without a documented procedure .... perhaps all the trainers can dust that down again, replace document / procedure / record with documented information and have another go?
Thanks to Paul Simpson for your informative Post and/or Attachment!
  Post Number #14  
Old 22nd May 2014, 10:02 AM
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Colin

 
 
Total Posts: 1,472
Re: Potential Issues for Auditing ISO 9001:2015

Some good points in there Paul. I was browsing the DIS this morning and I wonder whether this statement in clause 4.4:

The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned.

has a similar intent to the existing 4.2.1 d)?
  Post Number #15  
Old 22nd May 2014, 01:38 PM
John Broomfield's Avatar
John Broomfield

 
 
Total Posts: 2,456
Yin Yang Re: Potential Issues for Auditing ISO 9001:2015

Colin,

I would agree that it has. The absence of a specified requirement for any procedures, undocumented or otherwise, may though cause a lot of confusion for newbies.

John
  Post Number #16  
Old 10th June 2015, 08:51 AM
CBAL08

 
 
Total Posts: 165
Re: Potential Issues for Auditing ISO 9001:2015

What happens when a Company has both ISO 9001 and 13485? Will ISO 13485 be updated as well soon or within its Transition period of ISO 9001:2015 which is 2018?
Thanks to CBAL08 for your informative Post and/or Attachment!
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