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ISO9001-2015 Terms relating to Organization

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Matteo, Jul 22, 2016.

  1. Matteo

    Matteo New Member

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    Goodmorning,
    I have a questions about the definitions of the responsabilities referred to chapter 8.3 "Project & development of products and services".

    In sub.chap. 8.3.3 is written that the organization must satisfy the essential requirements, including statutory and regulatory requirements (regulations, directives, legislative decrees).

    My question is, those persons shall mean Organisation? Only the technical designer? O's most prominent figures with high technical responsibility?

    As an example, if I'm a simple electrical engineering designer, I have to define the applicable legislative decrees, directives and standards?

    Thank you
    BR
     
    normzone likes this.
  2. normzone

    normzone Well-Known Member

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    I'm pretty sure there's no such thing as a simple electrical engineering designer. But the organization must do those things, and who gets to do that depends on who knows the most about it.

    When in doubt, push the responsibility uphill, usually until such time as clearly defined roles, responsibilities and resources are provided. At that time the responsibility may come back down to the appropriate person(s).
     
  3. Pondo

    Pondo Member

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    This is where a good cross functional team involved in the design/development process is helpful.
     
  4. Matteo

    Matteo New Member

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    Thank you, i agree with your opinion

    Best regards