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"Context of the Organization" in ISO 9001:2015 Clause 4.1 - Page 3


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4.1 - general requirements, context of the organization, definitions, iso 9001:2015
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  Post Number #17  
Old 28th June 2016, 08:05 AM
SATHYABALARAMAN's Avatar
SATHYABALARAMAN

 
 
Total Posts: 38
Re: "Context of the Organization" in 4.1 of ISO 9001

Context of the organization is the combination of relevant internal and external factors that affect an organization's ability and approach to providing products and services to its customer.

External factors can include, e,g. cultural, social, political, legal, regulatory, financial, technological, economic, and competitive environment, at the international, national, regional or local level.

Internal factors typically include the organization’s corporate culture, governance, organizational structure, technologies, information systems, and decision-making processes (both formal and informal).

The standard requires that an organization determine which of these factors could impact its purpose, direction and quality management system and accordingly monitor and review these factors and use this information in determining the scope of the quality management system.

(Copyright material askart solutions 2015)
Thank You to SATHYABALARAMAN for your informative Post and/or Attachment!

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  Post Number #18  
Old 2nd July 2016, 09:21 AM
tony s's Avatar
tony s

 
 
Total Posts: 128
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by drgnrider View Post

armani, you are correct, there is no "shall document this" "maintained as documented information". But how will you show some auditor who wants to see 'proof' that you have "monitored and reviewed this information" without documenting some form of it?
I find this guide in the Annex A of ISO 9001:2015 handy if an auditor insists on having a documented evidence to demonstrate conformity with 4.1. See below:
Quote:
A.6 Documented information
Where this International Standard refers to “information” rather than “documented information” (e.g. in 4.1: “The organization shall monitor and review the information about these external and internal issues”), there is no requirement that this information is to be documented. In such situations, the organization can decide whether or not it is necessary or appropriate to maintain documented information.
Thanks to tony s for your informative Post and/or Attachment!
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  Post Number #19  
Old 2nd July 2016, 12:02 PM
Joe Smith

 
 
Total Posts: 10
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by LUV-d-4UM View Post

Not quite right. How would you know how to define the scope if you do not understand the requirements of the parties that are interested in your QMS? You must first understand the business plan, determine what's needed to execute the plan.
Hello, new here.
Can the above really be right? The scope of our QMS, as stated on our certificate, is simply "The design, manufacture, supply and assembly of X, Y and Z". It's basically been unchanged for 22 years, and existed for several years before we even had a formal business plan. The only requirements relevant to this are those of our customers, namely we supply the products they want to buy - and that's it. I can guarantee that not a single member of our management knows that scope, and they don't need to. It will only ever come up if we change what we make.

Our company is more than 60 years old, very successful, No.1 and No.3 in the two markets we supply, with a stable, mature (but continually improving!) QMS. The idea that we have to show we understand our 'context' I find verging on patronizing. For new companies, or those new to ISO9001, fair enough. Frankly, if we didn't understand our markets and those we do business with already, we wouldn't even still be in business. And what are things like 'context of the organization', 'needs and expectations of interested parties' and 'risk-based thinking' - when they require no formal processes or documentation - even doing in a prescribed standard?

Sorry if this sounds a bit 'ranty', but like Mike S, I find it all "fluff, and a waste of time".
Thank You to Joe Smith for your informative Post and/or Attachment!
  Post Number #20  
Old 2nd July 2016, 02:03 PM
JoShmo

 
 
Total Posts: 156
Question Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Joe Smith View Post

Sorry if this sounds a bit 'ranty', but like Mike S, I find it all "fluff, and a waste of time".
What's your quality policy? Let's start there...
  Post Number #21  
Old 2nd July 2016, 05:42 PM
Joe Smith

 
 
Total Posts: 10
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by JoShmo View Post

What's your quality policy? Let's start there...
Quality Policy? It's the minimum we need to comply: "To maintain & continually improve the QMS, set & review quality objectives, to support our Mission, to achieve our Vision". It's the Mission, Vision and Values that define us, not a policy that we only have because of the standard. Our customers couldn't care less about our policy; I suspect that 99% of them have never even heard of ISO9001.
  Post Number #22  
Old 2nd July 2016, 08:58 PM
JoShmo

 
 
Total Posts: 156
Let Me Help You Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Joe Smith View Post

Quality Policy? It's the minimum we need to comply: "To maintain & continually improve the QMS, set & review quality objectives, to support our Mission, to achieve our Vision". It's the Mission, Vision and Values that define us, not a policy that we only have because of the standard. Our customers couldn't care less about our policy; I suspect that 99% of them have never even heard of ISO9001.
I mean verbatim...
  Post Number #23  
Old 3rd July 2016, 04:59 AM
Joe Smith

 
 
Total Posts: 10
Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by JoShmo View Post

I mean verbatim...
Er...that was verbatim, that's why it was in quotes (or at least, it was meant to be).
  Post Number #24  
Old 3rd July 2016, 10:41 AM
JoShmo

 
 
Total Posts: 156
Question Re: "Context of the Organization" in 4.1 of ISO 9001

Quote:
In Reply to Parent Post by Joe Smith View Post

Er...that was verbatim, that's why it was in quotes (or at least, it was meant to be).
So, it's NOT policy to comply with requirements? I think I see a problem...
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