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Applicable requirments (Exclusions) 8.3 Design and development

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by SEGKnight, Feb 28, 2018.

  1. SEGKnight

    SEGKnight Member

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    Hello,

    I work with a transportation company that ships cargo via road/rail/vessels.

    Currently we have an exclusion to 8.3 Design and development. However, I don't know how we were able to justify this.

    We own some of our shipping containers and retrofit them depending on the season (heated/dry/refrigerated) and carry out this work our self or sub contract this out. In addition, some of our containers are specifically designed based on the commodity for specific clients, we work with the client to determine the requirements and would contract the build out.

    Also, the movement of some of the cargo is completely dependent on the customer requirements, we may make different arrangements to satisfy the needs of the customer or consignee. Wouldn't design and development be applicable to our processes?

    I have only been with this company as their Quality Management Coordinator for half a year. I am currently rewriting the scope of our QMS to make it more applicable to the current QMS. I am not sure if we can really justify the exclusion/applicability of 8.3.

    Comments are greatly appreciated!
     
  2. Golfman25

    Golfman25 Well-Known Member

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    I think you can. It is generally thought of as product design and development -- something you produce and sell. The stuff you do, sounds more like tooling and fixtures to accomplish the making of the product. Most places exclude those. However, if you want to be cutting edge, you could apply the requirement to your process design -- which would encompass what you are doing.
     
  3. SEGKnight

    SEGKnight Member

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    I understand your reasoning, I agree as well but then overthink it. When I read most of the information on this, it is heavily related to product design but I replace it with service which is what is ultimately confusing me. The last company I worked for was an engineering company, no question, their products were designed.

    Thank you for your input!
     
  4. tony s

    tony s Well-Known Member

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    I've seen a logistics company quality manual with a statement like this for justifying the exclusion:
    "Since shipping, warehousing, transport of goods and other logistical operations are industry accepted trade practice and the types of services offered only deviate in rates offered to clients and organizations, our company claims exclusion for satisfying the requirements in Clause 8.3 - Design and Development of Products and Services. Most of the inputs required in the realization of our services are already pre-determined by clients as well as regulatory bodies and government agencies."
     
  5. SEGKnight

    SEGKnight Member

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    Great reference statement Tony, that's excellent. Thanks for sharing.
     
  6. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    This is helpful, thank you.

    I am also struggling with justifying 8.3 not begin applicable to my company.

    We do fire suppression systems, but we basically resell the parts and just plug the customer's dimensions into a spreadsheet provided by the supplier and the design is generated based on NFPA standards etc.
     
  7. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Why? It's a simple issue to resolve, by asking yourself the question: Do we have authority to make changes to product specifications, without customer approvals? If the answer is "no", then you aren't design responsible. There are other questions which may also be asked, such as "do our customers' orders/contracts, request us to design?"
     
  8. Suraiya Ramkissoon

    Suraiya Ramkissoon Active Member

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    1. in a way yes, under specific constraints, but i'll definitely run these two questions by the manager directly responsible!
    2. Yes, but we do it based on our supplier's specifications.
     
  9. Neo113016

    Neo113016 Member

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    Please use "does not apply" instead of "exclusion" based on Clause 4.3 of the standard.

    For additional information, please read Annex 5 Applicability.
     

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