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Information for external providers

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by David Howard, Nov 11, 2016.

  1. David Howard

    David Howard New Member

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    Am currently looking at the requirements for Section ISO9001 2015 - Section 8.4.3, and am struggling to determin the exact requirements. The context in which it is written suggests this should be applied to "Sub-Contracted" processes or activities, and not to the purchasing of for example raw materials for use in the process.
    As a business we do not outsource any process to an external provider am therefore wondering whether we need to include the provision within our procedures.
    If it should be applied to both outsourced processes and Purchased items, then any assistance as to how you can apply this to the suppliers of off the shelf suppliers would be appreciated.
    Any advice would be most welcome.
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    David:
    Welcome. The idea of external providers is to stop force fitting of the "purchasing" requirements to, say, sister organizations where purchasing (in the traditional sense) doesn't apply. So, raw materials come from "external providers" or suppliers. It's just terminology to stop another plant in the supply chain being forced into supplier selection and so on.
     
    Last edited: Nov 16, 2016
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  3. MCW8888

    MCW8888 Well-Known Member

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    One example of external provider which my company SHALL control is the DC that distributes our packed products to the dealer authorized by the automotive.
     
  4. Paul Simpson

    Paul Simpson Member

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    I'm sort of agreeing and disagreeing with my learned colleague at the same time. ;) He is right in that the whole of 8.4 was developed to reflect the broader requirements for outsourcing that were covered in a 'catch all' under clause 4.1.1 in the 2008 edition. So 8.4.3 covers similar requirements to the old 7.4.2 and says you need to provide suitable information to any external providers for processes, products and services you choose to buy in.

    Under the 2008 edition any purchasing organization was allowed to tailor the requirements based on the supplier they were planning to use. So a sister organization could be treated differently even before the 2015 edition.
     
  5. David Howard

    David Howard New Member

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    Many Thanks for the information provided, so in summary, we do not need to communicate our requirements for "Approval" (8.4.3 b) or the competence of the suppliers personnel (8.4.3 C) etc. for All purchased items / raw materials, only those "Out-Sourced" activities where we consider them relevant - perhaps sub-contract processes, or an on-site contracted service provider.:)
     
  6. tony s

    tony s Well-Known Member

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    Yes David. That's also my take on 8.4.3. You don't need to communicate ALL from a) to f) to every external provider. Only those that are relevant to their products and/or services that your organization needs.
     
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  7. David Howard

    David Howard New Member

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    Thanks Tony
     
  8. MCW8888

    MCW8888 Well-Known Member

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    IMHO the intent of this clause, is to be communicate to your suppliers including off the shelf products your requirements in order to avoid a negative impact to your operation and customer satisfaction. Maybe you can visit your supplier to view certain off-the shelf items that you normally purchase and how they handle some of your rush orders, etc...
     
  9. Phil Scott

    Phil Scott Member

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    I'm not sure an organization can say they have communicated their requirements for a) to f) if they've remained silent on those that don't apply. From the providers perspective, does silence mean "not required" or that the organization just forgot it?
     
  10. tony s

    tony s Well-Known Member

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    If I have to buy standard or replacement parts of production equipment from trading/distributor suppliers, do I have to communicate the requirements for competence or required qualification of persons (i.e. 8.4.3c) to such suppliers? I don't need to tell them "competence" is not my requirement.
     
  11. Artem

    Artem Member

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    Hi Tony,

    As for communicating requirements toward distributors - you can at lest communicate requirements towards communication competences, e.g. language skills. Theoretically, or in order to tick the box, this may be a small paragraph in the contract. However what is recommended in order not to make such requirements for 9001 certification sake only - is to conduct an ABC analysis or a Dutch Windmill analysis of the suppliers and based on this - a documented risk assessment. Your distributors will most probably fall into C category and will not represent any risk. In your documentation which describes supplier related quality processes you state that it is your rule to communicate detailed requirements towards A suppliers only, and only most critical to B and C
     
  12. Phil Scott

    Phil Scott Member

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    I completely understand your point Tony. However, some auditors may appeal to the literal wording. If that occurs or to prevent it occurring, consider posting your requirements for a-f, for example, on your website, in your Supplier Quality Manual, or hard coded into your PO's.
     
  13. tony s

    tony s Well-Known Member

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    If an auditor would impose to my organization to communicate ALL the requirements from 8.4.3a to 8.4.3f to ALL external providers of my organization, then I doubt that the auditor satisfies 8.4.3c - competence.

    8.4.3 started the requirement with these words "The organization shall ensure the adequacy of requirements prior to their communication to the external provider". Therefore, if I don't communicate the requirement on "competence" to trading/distributor of standard replacement parts such as bolts and nuts, then I believe I have already "ensured" the adequacy of my requirements as specified in our purchase order form.
     
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  14. Phil Scott

    Phil Scott Member

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    Thanks Tony. While I'm not prepared to call such auditors incompetent, I get that it seems unduly prescriptive.

    However, the sentence you cited is followed by "The organization shall communicate (underline mine) to external providers its requirements for:" and then lists a.- f. As I stated previously, some auditors argue that NOT communicating the fact that you have no requirement for one or more of a.-f. doesn't satisfy the "shall communicate" requirement. Silence is ambiguous at best.

    My experience is that most auditors don't cite it. Only rarely have I seen it cited, and then as a minor. When it is cited, if on organization chooses not to appeal, I offered some fairly simple ways to address that interpretation.
     

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