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6.2.1 c) The organization shall establish quality objectives

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by OFDOBAIDI, Oct 2, 2018.

  1. OFDOBAIDI

    OFDOBAIDI Member

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    Dear all
    What does it mean that the quality objectives shall take into account applicable requirements?
    Regards,
     
  2. Artem

    Artem Member

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    Hi, I hope you are from a manufacturing company and my illustration attached will help. If you find it illustrative enough - ask your questions freely.

    Best regards
    Artem
     

    Attached File(s): 1. Scan for viruses before using. 2. Report any 'bad' files by reporting this post. 3. Use at your own Risk.:

  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It looks like a set of environmental system requirements, not quality...
     
  4. Serious Man

    Serious Man Active Member

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    My understanding is quality objectives shall be equal or more strict than related requirements of interested parties.
    When customer says that delivery performance ratio shall be >= 90%, organization shall not set quality objective >=88%.
     
  5. Artem

    Artem Member

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    Hi Andy,

    Please read the flow again - besides such environmental words as „toxic“ there are words like „purchasing process“, „line cleaning“, etc. which have all to do with quality

    By the way I am very excited that the topic remained unanswered for over a day and I thought that nobody has no opinion on that, but seems I am wrong :)

    Looking forward to your view on the subject
    Best regards
    Artem
     
  6. Artem

    Artem Member

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    Hi,

    As i was analyzing what to answer I also though about a collision of the word Objective with Tolerances, Targets, etc. if we consider a process to be less bound to specific product (after all, if you take 1 line - it can work for many customers each of them having own expectations expressed in values), but more generic, a company needs to say what is the generic objective of a process. Sure a customer X may have a target of delivery in 48 hours and you maybe need to aim 45 to be on the save side. But is it an objective of the process? It’s objective may be to assure 98,9% delivery on time. Which will come as an average of all deliveries - including those with 48 hours expectation and 120 hours expectation

    Best regards
    Artem
     
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  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Reading the flow again isn't going to change anything! The OP is asking about quality objectives. Quality is about conforming to (applicable) requirements, either customer specified, like a drawing of part number XYZ rev 2, a regulation such as EN 71 Safety of Toys, and/or an organization's requirement such as 96% FPY (first pass yield)
     
  8. judegu

    judegu Active Member

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    The book says that "take into account applicable requirements". So what we need, in my opinion, is just to think of the applicable requirement when you are setting up your quality objectives. That is all. It doesn`t state any requirement.
     
  9. tony s

    tony s Well-Known Member

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    If Clause 6.2.1 requires that quality objectives shall take into account applicable requirements, then an organization should determine what are the applicable requirements on each relevant function, level and process. Since requirement is defined by ISO 9000:2015 as "need or expectation that is stated, generally implied or obligatory", then the intent of clause 4.2 should also be considered. Objectives should be set based on the needs and expectation of the interested parties that can include customers, owners, employees, regulatory bodies, external providers,etc.
     
  10. judegu

    judegu Active Member

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    @tony s

    Hi, tony. Regarding Clause 6.2.1, the term "take into account" doesn`t imply any specific requiement, right? I think, during the process of determinig the quality objectives, it is quite natual to think about all the applicable requirements after all one of the ultimate goals of all the processes is to meet all applicable requirements. And due to the number of the applicable requirements (there will definitely be a lot), it is not necessary to assign a quality objective to each of them on paper. :)
     
  11. tony s

    tony s Well-Known Member

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    If there are various functions and processes needed for the QMS, each function/process may have some applicable requirements from interested parties. Example objectives set from interested parties' applicable requirements (i.e. needs and expectations) for the following functions/processes can include:
    upload_2018-10-6_15-7-38.png

    Not a requirement of ISO 9001:2015
     
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  12. OFDOBAIDI

    OFDOBAIDI Member

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    Thank to all
     

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