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

Mike S.

An Early 'Cover'
#1
One of these days I am gonna have to delve into ISO9001-2015 and AS9100 D and help us get there. I have spent almost no time on this yet, but the first weird (to me) thing I came across in a quick scan was section 4 -- context of the organization. And I wondered, gee, how did I ever get along without that? :rolleyes:



I guess I am dense, but I read the words in 4.1 in the standard and it kinda registered to me as "blah, blah, blah...blah blah". Can someone please explain this section better than the standard did?

Thanks!
 

LUV-d-4UM

Quite Involved in Discussions
#4
Re: Context of the Organization

IT took me a long time to understand 4.1. I must have read it 100 times and after listening to our CEO's Business Plan a light came one.
 

BoardGuy

Quite Involved in Discussions
#6
Re: "Context of the Organization" in 4.1 of ISO 9001

Actually you cannot understand the organization and its context (4.1) without first understanding the needs and expectations of interested parties (4.2). The Standard writers got the order wrong but once you address 4.2 you will find 4.1 much easier to define.
 

somashekar

Super Moderator
Staff member
Super Moderator
#7
Re: "Context of the Organization" in 4.1 of ISO 9001

What is the purpose of your organization existing and sustaining over time... (be specific)
What environment are you operating in... (scale, geography, standard, custom, general, high precision, technology specialization ...)
Who are interested in your organization and what is the organization response to meet the requirement. >> The organization people, the share holders, the suppliers, the customers, the statutory and regulatory, associates, ..... may be you identify specific others.
A grip on this entirety commonly understood by the people who are the management and the decision makers, is your organization context.
This is not static, and changes that happens within or in the environment or in the interested parties have to be addressed as and when it comes up.
 
Last edited by a moderator:

LUV-d-4UM

Quite Involved in Discussions
#9
Re: "Context of the Organization" in 4.1 of ISO 9001

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.
 

Mike S.

An Early 'Cover'
#10
Re: "Context of the Organization" in 4.1 of ISO 9001

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.
 
Top