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"Context of the Organization" in ISO 9001:2015 Clause 4.1 - Page 8

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4.1 - general requirements, context of the organization, definitions, iso 9001:2015
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  Post Number #57  
Old 19th August 2016, 04:13 PM
mogobadip's Avatar
mogobadip

 
 
Total Posts: 8
Re: "Context of the Organization" in 4.1 of ISO 9001

Sometimes if you cannot think risk based, think like a coward


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  Post Number #58  
Old 20th August 2016, 01:32 PM
charanjit singh

 
 
Total Posts: 112
Re: "Context of the Organization" in 4.1 of ISO 9001

Coming back once again to the "Context of the Organisation", I go by the clarification included in the standard (Annex.A.3 para 2) which says "There is no requirement....for the organisation to consider interested parties where it has decided that these parties are not relevant to its QMS. It is for the organisation to decide if a particular requirement of a relevant interested party is relevant to its QMS"". (emphasis is mine)

Thus there is no mention of any requirement calling for an organisation to record or otherwise offer a formal justification for their decision. My client is due for re-certification & up-gradation to the 2015 version in Oct/Nov. 2016. We have already identified the interested parties relevant to our QMS and do not expect any problem during the audit.
Thank You to charanjit singh for your informative Post and/or Attachment!
  Post Number #59  
Old 21st August 2016, 01:20 PM
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Jen Kirley

 
 
Total Posts: 6,159
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by JoShmo View Post

They "allow" a client to do one or two a year, is what I mean. I displike register auditors who have no clue what "effectiveness" looks like and use the CB process as a measure - asking for "all elements to be covered once a year/2 yers/cycle or whatevers. I don't dislike registers, I dilsike meaningless audits.
A CB auditor who asks that all elements be covered twice a year, or even once a year, is not correct. There is no requirement as such in any of the (5) standards/technical specifications I audit to.

Nor should a CB auditor "allow" a certain number of audits. Effectiveness of the internal audit process can be demonstrated by its functionality and finding conformance, nonconformities, and opportunities for improvement if finding such opportunities is part of the process's purpose.
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #60  
Old 21st August 2016, 01:28 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,159
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Mike S. View Post

This whole requirement sounds like fluff and a waste of time to me.
People are doing it already, just not realizing that's what the standard is asking for. LUV-d-4UM cracked the code; pointing out it is like the business plan was spot-on.

Does your organization have an Operating Plan or business plan? Chances are that document already has what you are asking about.

It is important to not overthink this standard.
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #61  
Old 21st August 2016, 01:32 PM
Jen Kirley's Avatar
Jen Kirley

 
 
Total Posts: 6,159
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Mike S. View Post

I look at it this way....how did we ever survive all these years without specifically listing the "context of the organization" in our QMS documents in exactly the way they are now asking for it?

Either it has been there in the QMS all along, but called something else, or it existed but was not specifically spelled out in the QMS documents.

Maybe I'm just grumpy this Monday morning, but I get tired of jumping through ISO/AS hoops when I do not see a clear benefit to it.
It has been there all along. Chances are good that you can simply trot out existing documentation. The standard's language has changed more than its actual requirements.
Thank You to Jen Kirley for your informative Post and/or Attachment!
  Post Number #62  
Old 22nd August 2016, 08:12 AM
Ganesh Raja L

 
 
Total Posts: n/a
Re: "Context of the Organization" in 4.1 of ISO 9001

I can't understand that whole concept of this process and it seems bit complicated. Can you please simplify it for me?

Thanks!
Thanks to for your informative Post and/or Attachment!
  Post Number #63  
Old 23rd August 2016, 08:00 AM
Mike S.

 
 
Total Posts: 2,267
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Jen Kirley View Post

People are doing it already, just not realizing that's what the standard is asking for.
Which means either the users (people) are not smart enough to figure this out or the standard is not written clearly enough for the average person to figure it out without someone else translating it into more simple language.

My vote is the latter.
  Post Number #64  
Old 23rd August 2016, 08:09 AM
LUV-d-4UM

 
 
Total Posts: 769
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Mike S. View Post

Which means either the users (people) are not smart enough to figure this out or the standard is not written clearly enough for the average person to figure it out without someone else translating it into more simple language.

My vote is the latter.
In ISO9001:2008 the process approach was only implied. So everyone tried to interpret the concept in their own way. The process approach has become explicit for ISO9001:2015.
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