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

Re: "Context of the Organization" in 4.1 of ISO 9001

Mike S. said:

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.

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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.

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!

Re: "Context of the Organization" in 4.1 of ISO 9001

Jen Kirley said:

People are doing it already, just not realizing that's what the standard is asking for.

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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.

Re: "Context of the Organization" in 4.1 of ISO 9001

Mike S. said:

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.

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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.

Re: "Context of the Organization" in 4.1 of ISO 9001

And the best wording this esteemed group of gurus could come up with is the "context of the organization" and the rest of the crud they put in 4.1?

I think they often try to impress each other with their prose instead of making the complex understandable, which IMO is the mark of a true professional.

Re: "Context of the Organization" in 4.1 of ISO 9001

Has anybody in a publicly traded company reviewed the SEC required, publicly available 10-k document that is filed annually by your company? At least for my company, it basically contains the requirements for context of the organization.

I am debating creating a summary as an addendum to our Quality Manual vs pointing to the 10k document. It doesn't make sense to copy/paste into a QMS document. There are already business processes that review and update this information on an annual basis.

On some level though, I believe it may be helpful to have a document, or section of the QMS to define or map the scope/boundaries of the QMS as required by 4.3.

Any thoughts?

Re: "Context of the Organization" in 4.1 of ISO 9001

JoShmo said:

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.

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Actually you can do internal audits as often as you want to. And, you may do some more frequently than others such as in problem areas. This has always been the case.

See Status and Importance. Note the focus on effectiveness.

scottwal404 said:

Has anybody in a publicly traded company reviewed the SEC required, publicly available 10-k document that is filed annually by your company? At least for my company, it basically contains the requirements for context of the organization.

I am debating creating a summary as an addendum to our Quality Manual vs pointing to the 10k document. It doesn't make sense to copy/paste into a QMS document. There are already business processes that review and update this information on an annual basis.

On some level though, I believe it may be helpful to have a document, or section of the QMS to define or map the scope/boundaries of the QMS as required by 4.3.

Any thoughts?

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Sounds reasonable to me. Of course most companies aren't publically traded so they won't have a 10 k.

Re: "Context of the Organization" in 4.1 of ISO 9001

Mike S. said:

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.

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The standard is carefully avoiding the kind of detail that would have made it more obvious. After all, a business plan could work better for a small organization while a really big complex place might need a more detailed approach.

Our job is to get used to the idea of this being a business document instead of a bunch of "shalls." This transition has left a lot of uncertainty and discomfort. Maybe that is why the technical committee put out all these guidance documents.

Re: "Context of the Organization" in 4.1 of ISO 9001

I read many times as well and still not really understand what the standard actually require. How to documented all these?

Re: "Context of the Organization" in 4.1 of ISO 9001

Jen Kirley said:

The standard is carefully avoiding the kind of detail that would have made it more obvious. After all, a business plan could work better for a small organization while a really big complex place might need a more detailed approach.

Our job is to get used to the idea of this being a business document instead of a bunch of "shalls." This transition has left a lot of uncertainty and discomfort. Maybe that is why the technical committee put out all these guidance documents.

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IMO they could make a requirement more clear without making it more prescriptive. When you need a bunch of guidance documents to explain the main document, IMO that is a clue you did not do a good job writing the main document. Sorta like the tax code......even the so-called experts who wrote it can't understand it or agree on the meaning.