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Where to include Scope and Context...

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by CarlosNS, Jan 21, 2022.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Welcome!

    Have you checked ISO 9004? Or ISO/TS 9002? ISO 9001 doesn't contain guidance.

    It's in there, you have to find it. Don't overlook there's "info" and "documented info", too. The ISO writers expect you to figure out what you need to know.

    There's no specified requirement for a Quality Manual, that might be part of the issue you're having. They are helpful to have, but really should be a "quick start guide" to the QMS. By that I mean, very short on details, really just pointing to the various process and other parts of the QMS.

    You may wish to check your understanding of what a documented QMS includes. It's rare to have all this documentation in a single Quality Manual. ISO 9001:2015 no longer mentions types of documents. Have you read ISO 9001:2015? The organization determines the need for documents beyond the required (few). There's no rigour to the structure as was implied by previous versions of ISO. Pyramids of documentation of different levels/types is 19th Century thinking about a QMS. You could do a lot with well designed checklists, for example.

    See the above comment. You may be more worried about what something is called than what it does. Fix that and the rest is simple.
     
    Last edited: Apr 9, 2022
  2. quality fan

    quality fan New Member

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    thanks for your comments, i am sorry, i am novice in ISO9001 writing, i was used to write test instructions for lab, not all this abstract centences.
    The ISO 9001 has 10 chapters and for some it seems you can/need to just copy paste the content into your own standard altough i think this is not the meaning. Even i just refer to each chapter, i have hundreds of other documents to include into the QMS i need to establish, SOP's, procedures, test instructions checklists, forms. I thought that a quality manual was sufficient to get certificated, but i think thats not true.
    I'm already struggling with the introduction part, other chapters are more clear. But thanks again for your remarks, i will need to take the blame if i didn't write it correctly
     
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Correct. These are requirements which must be present in the QMS your organization develops.

    Really? How big is the organization? Headcount? What do you make/do?
    Correct. There are some good books written about the process of setting up a QMS and being certified.
    I'm not sure I understand "chapters". A Quality Management System is made up of processes which have associated documentation to help plan, describe, control and record the associated activities. It's structured around those processes, not "chapters"...
     
    Last edited: Apr 9, 2022
  4. quality fan

    quality fan New Member

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    Thanks Andy, i meant the chapters from the ISO 9001 standard. i will try to fix the QMS structure first and from there try to make the ISO 9001 documentation.
    Sorry for bothering you
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    No bother!