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ISO 9001:2015: Need the List of documents required

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Darren, Sep 20, 2016.

  1. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    An auditor should be able to listen to you describe how your processes work, perhaps observe in action, talk with responsible people and review documentation when you, the customer, and/or the standard requires it. An auditor can recognize the "shall" is being met without asking you how you address shalls, and may even be able to do all this without a documented procedure where none is required.

    You are right about the roadmap bit. That is the way the standard was intended. Your organization and/or interested parties determines what processes need documented procedures in order for specific things to be done or produced correctly and consistently, to help manage knowledge and/or for some other valid (and hopefully value-added) reason.
     
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  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Let's not overlook, either, that ISO 9001 isn't and never was an auditing standard and that it can be implemented WITHOUT being certified, in which case the whole "do it to please an auditor goes away. The auditors are supposed to audit the organization's QMS, which, in turn, is supposed to be designed to comply - as needed - with the requirements (customer, regulatory and ISO 9001). Trouble is, some CB auditor got the wrong message in their LA corse and some just can't deal with anything but documents... Sad, really...
     
  3. tony s

    tony s Well-Known Member

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    I really agree on this.

    I recall when I was one of the resource persons that assisted a bank in their efforts for setting up a QMS that conforms to ISO 9001:2000 version. During their certification audit, I was an observer then, the CB auditor ask straightforwardly his auditee this question "How did you satisfy the requirements on clause 7.5.2?" The auditee, of course, stammered in answering such "alien" question. I cannot remember how did the auditee answered the question but I noticed that the auditor was not satisfied with the answer. I was surprised to hear that from a CB auditor. CB auditors should know better. They should not expect their auditees are well-versed on the clauses and statements of the standard.
     
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  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, Tony! I forget how many times I've heard auditors speaking about requirements and everyone looks at them as if they're speaking a different language...
     
  5. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Tony, of course that auditor is not here to defend himself, but I would be appalled if I saw that happen. It just suggests the auditor did not know what 7.5.2 said.

    I don't like to ask about elements anyway. Especially now that they are changing, but it's always supposed to have been about the processes and the system.
     
  6. tony s

    tony s Well-Known Member

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    I also agree on this.

    Even the Guidance on Documented Information (ISO/TC 176/SC2/N1286) mentioned in the last two paragraphs the following:
    • Objective evidence does not necessarily depend on the existence of documented information, except where specifically mentioned in ISO 9001:2015. In some cases, (for example, in clause 8.1 (e) Operational planning and control, it is up to the organization to determine what documented information is necessary in order to provide this objective evidence.
    • Where the organization has no specific documented information for a particular activity, and this is not required by the standard, it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2015. In these situations, both internal and external audits may use the text of ISO 9001:2015 for conformity assessment purposes.
     
  7. pearl

    pearl New Member

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    hello. your advice is great but not good enough for someone who is not very clear with the Standard and does not have much experience with auditors and more. if you are new at this, you need to document what you can and as soon as everyone in your company understands ISO and what is expected of them,then you can drop documentation since they will then know how to deal with the auditor when asked question. so first timers just have to stick to documenting the "important" documents.
    this are not not facts but that is how i dealt with everything when i started since i had not done Quality before at school and had no experience on it.
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'm sorry to disagree, but this ISN'T what "doing ISO" is about and is at the core of why there's so much mythology. If the issue is not being experienced with the standard or dealing with auditors, then address those issues - the root cause. To create documentation for the purpose of surviving an audit is a corruption of the purpose behind the standard and, fundamentally, strikes against the reasons why less documentation is now mandated! My advice is become more experienced with the standard. Surviving an audit (or) will then take care of itself. Trust me, 40 years of doing this is behind these comments.
     
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  9. Che Promubol

    Che Promubol Member

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    Dont forget something on 6.3 Planning for Change. CB's (from my experience and having also just been audited on 2015 & AS Rev D) want to see that changes are not being carried out 'ad'hoc'.
     
  10. Charu Tyagi

    Charu Tyagi New Member

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    Hi..I am new to this platform and iso9001:2015. Can someone share this standard. I have old version of it.


    Regards,
    Charu Tyagi
     
  11. Atul Khandekar

    Atul Khandekar Administrator Staff Member

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    Welcome to the forums !

    You will need to purchase your copy from iso.org or Bureau of Indian Standards or some agency that is authorized to sell ISO standards.

    Please do not ask for any copyrighted standards or documents. It would be a violation of copyright to request or share such a document on this website.

    Thanks.
     
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  12. Qualitypro99

    Qualitypro99 New Member

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    Here's your list of required documents:



    Got it? The standard no longer REQUIRES documents. It leaves that up to the discretion of the organization. Document what you feel is needed for your organization. Considering and evaluation interested parties (internal or external), for example, can be satisfied with a statement to the auditor. You don't need to prove this in writing. It can, however, be documented in Management Review minutes if you like to have something to show an auditor.