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Application of Clause 8.5.1 control Production and service Provision

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Padym, Apr 18, 2016.

  1. Andy Nichols

    Andy Nichols Moderator Staff Member

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    I find these responses very odd. In IATF 16949, page 36, paragraph 8.4.2.3 Supplier quality management system development states:

    The organization shall require their suppliers of automotive products and services to develop, implement, and improve a quality management system certified to ISO 9001, unless otherwise authorized by the customer

    It then goes on to list a) compliance to ISO 9001 through 2nd party audits, b) certification to ISO 9001 through 3rd party audits... c) certification to ISO 9001 through MAQMSR d) certification to ISO 9001 and IATF 16949 through 2nd party audits

    In light of being mentioned no fewer than 5 times, I cannot fathom how this aligns with your post.
     
  2. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    Distributors are an interesting case. Too bad you did not originally state you were thinking of distributors when making the claim that ISO 9001:2015 does not require inspection.

    The revised standard made clear that service was to be included in 8.5.1: "The organization shall implement production and service provision under controlled conditions." In the case of distributors the "implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met" would be appropriate for the organization and its processes. I would never accept an RMA, complaint etc. as a substitution for such monitoring and measurement.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This is clearly non-sense.
     
  4. Jennifer Kirley

    Jennifer Kirley Moderator Staff Member

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    There has been a long-stated tongue-in-cheek claim that an ISO certified company could make cement life preservers. It has been pointed out in forums such as this one that such a claim is false because of regulations that life preservers remain buoyant. The same case can be made for boat design and building. You will therefore need to choose a different example to make your point valid.
     
  5. Andy Nichols

    Andy Nichols Moderator Staff Member

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    So, we audit by hear-say and innuendo and not specified requirements? Is that what you are saying? As a CB auditor?
     
  6. RoxaneB

    RoxaneB Moderator Staff Member

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    Let's go straight to the source, shall we? According to the International Organization for Standardization,

    For those that wish to read the full narrative, it is located here.

    Fairly safe to say that customers ordering boats would having "able to float on water" as a requirement (stated or otherwise) for acceptance - i.e., one of those quality requirements to be met prior to acceptance of the product by the customer.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, you are SO wrong! In actual fact, it's well know in the tire industry that the application to the Explorer was entirely wrong. Ford wanted a tire at a cost, not the one designed for the actual weight of the car. Furthermore the Explorer was shown in testing to have a tendency to roll over. Put the 2 together, you have problems. Please stop with these facile statements. (and the plant was QS-9000 certified, as it happens)
     
  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    If it was a question, where was the punctuation/query at the end of your sentence? < like this? If you make a statement and then claim it was a question, how will anyone know, when you don't follow the conventions of the language? It's not appropriate to then blame the reader for misunderstanding.
     
  9. tony s

    tony s Well-Known Member

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    Distributors, unlike with manufacturers, have a different set of criteria "needed to meet the requirements for the provision of products and services" (as per 8.1). They do perform inspection during receiving, while at the storage, at pre-delivery and at customer site. Criteria critical to distributors include quantity, visual criteria, packaging standards, identification and traceability. Sometimes they do perform testing to determine whether the supplied products are functioning during receiving, before delivery and upon delivery at destination.
     
  10. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    Hi everyone...

    just my two cents on the topic...

    from my understanding... ISO 9001 is a management system certification, it can be applied to numerous industries, inclusive of those that produce products. It does not certify the product, but it suggests that the company that the product was manufactured is in compliance with ISO 9001.

    I've worked in an ISO 9001 certified manufacturing company and an ISO 9001 certified distribution company and was very careful in how certification was communicated.
     
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  11. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Yes, indeed! Exactly so!
     
  12. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    In my experience we'd check for product conformance (which includes testing depending on the product) :
    - receiving
    - storage
    - dispatching
    - delivery
     
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  13. leyladonmez

    leyladonmez Member

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    Hello everybody,

    For traceability we put label on each part and on box of part. instead of this, if we put label on box of parts only do we meet the 16949 and CSR the traceability requirements?
     
  14. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @leyladonmez;
    Does your organization manufacture the parts?
    If yes, ...
    1- are any of the manufacturing processes outsourced?
    2- do your parts have content provided by a supplier?
     
  15. leyladonmez

    leyladonmez Member

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    Good day @John C. Abnet
    1- We don't have outsourced process.
    2- Yes our parts have contents provided by a supplier.
     
  16. John C. Abnet

    John C. Abnet Well-Known Member

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    Thanks for this feedback @leyladonmez ;
    The answer is -- it depends . Some customers, for some products, want "serial number" identification (each part unique identification). In other cases , the customer/product (your organization) may only require lot traceability.


    Example:
    1-

    A bolt manufacture will likely be required to have traceabiity to the "heat" of raw material that is used and within that heat of steel, may limit a lot size of bolts to 100k pieces. This may be dictated by the customer, or not. If not dictated by the customer it will likely be self imposed by the manufacturer to ensure they are protected by limiting their exposure to a quantity that they can track, get their hands around, and diagnose if something goes wrong.

    2-
    An airbag manufacture will be mandated to apply serial number (unique identification to each product) to ensure traceability to each and every manufacturing input in case their is a problem that needs recalled and/or diagnosed.


    You reference (IATF) 16949 [this post is under the ISO 9001 forum] . IATF 8.5.2.1 emphasizes that
    "...internal, customer, ...regulatory ....requirements...levels of risk..." are to be used to determine the necessary traceability.

    So, as you can see, your organization will need to analyze the aforementioned to determine the necessary level of traceability and whether or not your proposed method is acceptable.

    Hope this helps.
    Be well.
     
  17. leyladonmez

    leyladonmez Member

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    Thank you very much @John C. Abnet for your explanation. It is very detailed. In fact we track serial number traceability: a label for each product. We evaluate that can we do a lot size traceability for small parts in our company. But I think we must continue to track serial number traceability for them also because they are not as small as bolts and they are not like 100k pieces etc. and in technical drawing there is label.