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Clause 8.3 Design and development of products and services

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Kodirl, Jul 22, 2020.

  1. Kodirl

    Kodirl Member

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    Hi everyone- looking for your wisdom once again :)

    Our company has ISO 9001:2015 certification but clause 8.3 Design and development of products and services is currently excluded from our certification scope.

    We have now hired a subcontractor company to perform design engineering on our behalf on a Construction project. The subcontractor themselves are ISO 9001:2015 certified for all clauses of the standard.

    My questions are:

    As the company is a subcontractor and we are essentially responsible for them on the project how do we approach our next surveillance audit?

    Has our scope of certification changed?

    Do we now have to say clause 8.3 is not excluded from the certification audit and is something that we do?


    I appreciate any guidance you can provide on the above questions.
     
  2. Parag Kumar

    Parag Kumar Member

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    If the subcontractor company is working on your behalf, and you are responsible for them, in my opinion, yes, clause 8.3 ISO9001:2016 does become applicable and needs to be addressed. Now, since you are using this as an outsourced activity, you will also need to exercise control as stated in 8.4.1.
     
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  3. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @Kodirl ;
    @Parag Kumar is correct.

    There are two basic scenarios...

    1- The customer designs/is responsible for design, and "your" organization simply "builds to print".
    2- Your organization designs/is responsible for design.

    Based on your explanation, scenario "2" applies. In other words, regardless of whether your organization performs product design in -house or hires an external provider to do so,your organization is responsible for desgin.

    Hope this helps.
    Be well.
     
  4. Kodirl

    Kodirl Member

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    Thanks for your replies.

    So we need to update our QMS ......
     
  5. tony s

    tony s Well-Known Member

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    You can also consider the guidance provided by the Auditing Practices Group about Scope and Applicability. There is a statement there in page 8 that says: "A set of requirements or an entire clause cannot be considered non-applicable in the scope of the QMS (and the scope of the audit plan) only on the reason they are outsourced."

    Here's the link.
     
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  6. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Typically, a scope statement will include a description such as "Management of externally provided (or outsourced, or contracted) product design engineering", so that's it's clear the organization a) isn't actually designing the product and b) has management control of the process which is externally provided.
     
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  7. Kodirl

    Kodirl Member

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    thank you Tony!
     
  8. Brian Buss

    Brian Buss New Member

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    If your firm does not conduct any design and development activities and rely on your supplier to do it, then you can exclude 8.3 from your scope. Many companies who are "build to print" because their customers do all the design and development, suppliers can have this same sole Design and Development responsibility.

    Recently, one of my recent clients successfully excluded 8.5 Production and Service Provision from their ISO9001:2015 scope entirely because their suppliers do all the product manufacturing.
     
  9. Andy Nichols

    Andy Nichols Moderator Staff Member

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    It's not as simple as that Brian, trust me. Yes, if you only use contract manufacturing that may be excluded, however the scope must also reflect that.

    If organization X offers a product into the marketplace and all or even part of the design specification (like a software running on firm/hardware) is developed by a supplier, then organization X is still responsible and cannot exclude design. They own the specifications and they own the responsibility for the supplier relationship. Scopes are supposed to detail that.

    I'd offer a caution to anyone reading this thread. Do not be suckered into thinking scopes of certification are accurate or what is done is always correct. Only last week, I witnessed an organization with a current certificate, claiming product design who have neither a design process nor any design records, since they NEVER did design. The customer owns the specifications of the product. Changes cannot be made without customer approval. Auditors are frequently found to be incompetent when it comes to scopes. In this case, they were asleep at every audit since 2004...
     
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  10. John C. Abnet

    John C. Abnet Well-Known Member

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    @Andy Nichols is correct @Brian Buss .

    If the customer is not doing the design (i.e. the customer is wanting the provider/organization (x) to "take care of it"), then it does NOT matter if the organization (x) is doing this in-house or having one of their suppliers do the design, organization "x" still OWNS and controls the design.

    (Note the previous council provided to the OP earlier in this post.)

    Hope this helps.
    Be well.
     
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  11. tony s

    tony s Well-Known Member

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    Because of incompetence, the organization is paying more than what is necessary.:eek::mad:
     
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  12. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed, Tony! When I explain to business owners that, for years, they've overpaid for their Certificate, because it includes the word "design", that an incompetent auditor has never actually "tested" the scope and the CB who employed the auditor is blissfully (willfully?) ignorant of the fact the auditor doesn't actually know what they are auditing, those owners start to take an interest. IMHO, the accreditation of such CBs has failed those owners.
     
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