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How to Handle Exclusions in ISO 9001:2015

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Jessica - EFC/Wesco, May 18, 2017.

  1. Jessica - EFC/Wesco

    Jessica - EFC/Wesco New Member

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    For ISO 9001:2008, my company cited Section 7.3 Design and development as an exclusion. Our reasoning was there are no capabilities to perform product design activities and there is no customer requirement to conduct product design activities. In other words, no orders are accepted that require us to conduct design and development activities. We also cited Section 7.5.2 Validation of processes for production and service as an exclusion, as all parts are monitored and measured at the point of fabrication. Also, Section 7.5.1.a Control of Production and Services, excluding services only as we do not perform after sales service. I can't tell for sure how to include this within the ISO 9001: 2015 standard. I've heard that the word 'exclusion' is not allowed in the new standard, but I've also seen quality manuals with a section still devoted to exclusions. I've even seen companies cite historical exclusions, citing ISO 9001:2008 directly. I'm not sure which is right, so I would appreciate any and all advice! Thank you!
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What you had is just fine (the only "other" time when design can't be excluded is when an organization does innovative design and enters the market. The customers' orders don't specify design). The exclusion word not being allowed is nonsense, frankly. Go ahead with your previously good statements.
     
  3. Jessica - EFC/Wesco

    Jessica - EFC/Wesco New Member

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    Thank you for your response Andy! It is very much appreciated!
     
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  4. tony s

    tony s Well-Known Member

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    Should you cite the clauses of the 2015 that are equivalent from your 2008's "exclusions", you can mention the following:
    2008 ----- 2015
    7.3 ------- 8.3
    7.5.2 ------ 8.5.1f
    7.5.1a ----- 8.5.1a.1
    7.5.1b ----- 8.5.1a.1
    7.5.1c ----- 8.5.1d
    7.5.1d ----- 8.5.1b
    7.5.1e ----- 8.5.1c
    7.5.1f ----- 8.5.1h

    IMHO 7.5.1 is applicable to both production and services and you can only exclude part/s of it.
     
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  5. Jessica - EFC/Wesco

    Jessica - EFC/Wesco New Member

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    Thank you for your help Tony!
     
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  6. Jacky_T

    Jacky_T Member

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    Can I understand in this way: in ISO9001:2008, the standard uses the term "exclusion"; in ISO9001:2015, we need to say which part is not applicable with justification. The justification could be the same as we used in 2008's? Is it just the interpretation differences?
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If nothing else has changed - scope, locations, products etc. then I'd say yes, you can keep the same scope.
     
  8. Jacky_T

    Jacky_T Member

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    Thanks Andy!
     

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