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Quality manual for ISO 17025:2017

Discussion in 'ISO 17025 - Calibration and Test Laboratories' started by steve gill, Mar 12, 2018.

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will you have a QM next year?

  1. yes we still believe its good to have

    14 vote(s)
    100.0%

  2. no, we do not feel it is necessary

    0 vote(s)
    0.0%
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  1. steve gill

    steve gill Member

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    Hello I wanted to ask a question..... will you have a Quality manual once accredited to 17025:2017?
    it does not appear to be a requirement, so why would you need one?
     
    steve gill, Mar 12, 2018
    #1
  2. steve gill

    steve gill Member

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    no responses
     
    steve gill, Mar 15, 2018
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  3. Prabhu

    Prabhu New Member

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    I think it isa pre-requisite to have a quality manual at the time of applying for accredition
     
    Prabhu, Apr 24, 2018
    #3
  4. Saber Elwany

    Saber Elwany New Member

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    It is not mandatory to have, however, we still need such document to introduce the lab activities and to describe the management system and to fulfill the structural requirements as well.
     
    Saber Elwany, May 3, 2018
    #4
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  5. Paresh Patel

    Paresh Patel New Member

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    It is advisable to prepared Quality Manual.
     
    Paresh Patel, Jul 15, 2018
    #5
  6. Jerry Bambach

    Jerry Bambach New Member

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    A quality Manual is not required but the Quality system would have to have a Procedure for every element of the standard that would state the scope, policy and how it was accomplished is. this approach would replace some of the requirements that a manual would fulfill.
    Jerry Bambach
     
    Jerry Bambach, Jul 16, 2018
    #6
  7. Ameet Kulkarni

    Ameet Kulkarni New Member

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    Hello People,
    i agree with the view that it is advisable to have a Quality Manual in place as it is the basic document for introduction of the lab. secondly would also suggest that the Procedure manual (prepared in lieu of 2005 standard requirements) be kept intact or upgraded. this will ensure that the process is cascaded to all levels.
    in the recent interactions that i have had with a few auditors, it was evident that all audits will now be objective. irrespective whether you have a documented procedure or not, it has to be verified.

    now i wanted to enquire whether there are any templates available for preparing the Quality manual as per 2017 requirements.
     
    Ameet Kulkarni, Jul 20, 2018
    #7
    smijith vs likes this.
  8. smijith vs

    smijith vs New Member

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    Gents,

    Mee too looking for a dratft manual..If anybody have,,please help me.
    king
     
    smijith vs, Oct 14, 2018
    #8
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I'd steer clear of templates. Typically, they copy the content of the standard and, as such, are useless. Also, without knowing what should be in a QM, how will you know if the template is any good? So, if you find out what SHOULD be in a manual, it becomes easy to create one!
     
    Andy Nichols, Oct 14, 2018
    #9
  10. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I am sorry for the delay in this response.

    Do you have a copy of the standard? MFRP Alliance indicates no requirement for a Quality Manual exists in ISO/IEC 17025:2017.

    Why have a manual if none is required for accreditation? You can document procedures, scope, policy and anything else your lab and the standard requires. You could have a booklet-sized central source in which these documents are gathered. I have also seen them as tabs in a spreadsheet document.

    I have seen a table of contents essentially used as a Manual. If you use a process map, the procedure references could be listed there. I have also seen procedures referenced as part of actions to address risks, in documentation where risks are listed. There are many practical methods to replace a Manual that frankly was historically used by very few people.

    All of that said, if you must have a Manual, there are templates on the Internet. I agree with Andy that their usefulness is limited, hence my points above.
     
    Jennifer Kirley, Oct 14, 2018
    #10
  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Because that's not the only criterion on which to base a decision. Much as ISO 9001 doesn't require one, if you understand the "context of the organization" and the "needs and expectations of interested parties", one answer could be "Yes, we need a Lab Quality Manual" to meet some of these requirements. To fall for simply answering "it's not in the standard, so we don't need one" is to abdicate full understanding of why we have documentation.
     
    Andy Nichols, Oct 15, 2018
    #11
  12. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I think I may not have been clear. There is needed documentation for scope, policy etc., but these do not require a manual to maintain. An earlier posted said a manual is required for accreditation. I disagree, based on so many Manuals containing little more than a repeat of the clauses.
     
    Jennifer Kirley, Oct 17, 2018
    #12
  13. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Right, a manual isn't specified by ISO/IEC 17025 (I'm going off memory here) however, the ABs often have additional requirements, PLUS, when considering the context of the organization, there's likely some form of manual being identified as a customer or even internal need/expectation...
     
    Andy Nichols, Oct 17, 2018
    #13
  14. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    I have yet to see an AB ask for a Quality Manual when the standard does not require one. If a customer demands it, that is another matter.
     
    Jennifer Kirley, Oct 19, 2018
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  15. tony s

    tony s Well-Known Member

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    I believe so. UKAS actually has a tutorial for their assessment staff and has this powerpoint slide:
    upload_2018-10-20_16-37-1.png
     
    tony s, Oct 20, 2018
    #15
  16. MadMonk

    MadMonk New Member

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    Although it is not a requirement in the new standard it may be required by your customers, with that in mind after you have done all the hard work in complying to new standard, place everything together add a quality policy and hey presto. so you will find you will have one anyway. in my opinion :)
     
    MadMonk, Oct 18, 2019
    #16
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  17. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I agree! Plus, if anyone wants an effective lab (quality) manual, why not produce a simple "Quick-start" guide rather than one which simple spews the words of the standard at someone? It only needs to be a few pages to cover the basics, after all and can point to the other parts of the lab management system as a guide should, for those who want to know more.
     
    Andy Nichols, Oct 18, 2019
    #17
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  18. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Maybe, but it's common for ABs of labs to add requirements to the standard.
     
    Andy Nichols, Oct 18, 2019
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  19. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Which AB(s) require(s) labs to have a quality manual?
     
    Jennifer Kirley, Oct 19, 2019
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  20. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I think my point is being missed. Accreditation Bodies often add requirements in their contracts. I behooves a lab to read through these additions to see what they are. Being accredited isn't quite the same as being certified. ABs can and do add requirements. ISO Certification bodies have been known to add requirements, but there's more choice than with ABs - I offer a word of caution.
     
    Andy Nichols, Oct 20, 2019
    #20
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