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ISO 9001 2008 Statutory and Regulatory meaning

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Qualmx, Oct 7, 2015.

  1. Qualmx

    Qualmx Well-Known Member

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    Dear all
    Thanks to people who want to continue helping people.
    This is my first post.
    In iso 9001 2008? In section 1, scope, it says.
    d) aims to enhance customer satisfaction........... ...conformity to customer and applicable statutory and regulatory requirements.
    Question. In my case, do I have to comply fully with local regulations regarding,safety,enviromental,health,etc.? I have a print shop low production ,20 people and im just complying with that partially. I do this because i think iso focuses most on product that people. Im waiting my third audit toward the certification. Do you think auditors will check me local/nationals regulations or just a general checking?
    Could that be a reason to raise major ncs, which may delay my recommendation?
    May I prepare a defense (CA) in this issue? Avoiding the ncs?, i mean a ca mentioning that I will comply fully with regulations?, I appreciate too much your help
    Thanks
     
  2. Andy Nichols

    Andy Nichols Moderator Staff Member

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    The focus of the ISO 9001 requirements is on PRODUCT. You've listed things which aren't related to the product. The auditors won't be checking on regulations - they expect YOU to do that. If you have local workplace regulations you MUST comply with those, by law - NOT because you want to pass an ISO Certification audit.
     
  3. Miner

    Miner Moderator Staff Member

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    Examples of applicable (for ISO) regulatory requirements would be UL requirements and FMVSS (Federal Motor Vehicle Safety Standards). An example of statutory requirement would be Consumer Product Safety Commission requirement, such as the use of lead. The common thread here is, as Andy stated, that these apply to the product. In your business, are there any laws or regulations concerning prohibited chemicals (e.g., benzene) in the inks that you use? You would have to show compliance to those, but not, for example, compliance to regulations on VOC emissions.
     
  4. Qualmx

    Qualmx Well-Known Member

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    Thanks to Andy and Miner ,very useful your answers.
     

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