Discussion in 'Documentation Control, Procedures, Templates,...' started by Jellybean, Jan 24, 2018.
Does anyone have a procedure I could view to understand the concept of this new clause?
May I ask why you think a procedure will help? I have implemented this requirement many times and a procedure wasn't at all necessary.
I have added to our Quality Manual - Scope of products and services we provide. - External& Internal Interested parties, - Company overview, -Our mission(Strategic goal). I am not sure if this is enough to satisfy the requirement.
No, not even close. Please read the context of the organization again. Let me know what you think it's talking about.
This is what I get from this section.
Identifying internal and external issues. Identifying external & Internal Interested parties and there needs as it pertains to the QMS.
Document, monitor and review these as they relate to our strategic direction.
So, you didn't include anything about the internal and external issues which (and this is also missing from your description) are going to affect the ability of your QMS to deliver... These are going to be pretty "sensitive" to the organization and possibly shouldn't be shared in any manual (or in a procedure) which could go outside the organization. I've found that the management review requirements are, in many cases, addressing much of this - particularly the interested parties part.
I have verbiage in the QMS Manual that describes our procedure for handling internal and external issues as well as Interested parties, No actual issues are present in the manual.
I do call out interested parties in the management review procedure. For internal and external issues we do not call out this specific term "internal and external issues" We use corrective or preventive actions.
I think you are missing the point. The idea of this part of the context is to take a look - strategically - at issues which can impact (positively and negatively) the performance of your QMS. Please search on other posts on this subject where I expand on how the context leads to the section 6 planning and so on. I believe, based on what you've written regarding corrective and preventive actions, you're confusing "today's" issues with those of "tomorrow".
I am guessing a lot of what you need is part of the development of your strategic goals.
New here. To satisfy this clause - I wrote an exhaustive list of issues (good and bad) observed over the past year, plucked a few winners and listed them in my MRM for management to discuss. Identified/ Documented and will continue to review and update - help?
Check it out:
If your company is implementing ISO 9001:2015, the context of the orginazation should be documented. In this case you can refer to it or just copy it in your procedure related to Document Management.
I wouldn't agree. The requirements for the Context of the Org. have zero to do with document management.
The only subclause under clause 4 that requires a specific documented information that must be maintained is 4.3 i.e. scope of QMS. Many would create a list of internal/external issues or list of interested parties and their needs and expectations but these are not the intent of clauses 4.1 and 4.2. Refer to the statement under A.6 of the standard with the following statements:
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.
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