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Technical Files required for CE marked, EU origin products that we private label?

Discussion in 'ISO 9001:2008 - Quality Management Systems' started by Kate Gardiner, Feb 4, 2016.

  1. Kate Gardiner

    Kate Gardiner New Member

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    Hi,

    My first ISO 9001:2008 audit is happening in 5 weeks...scary!

    Quick question...

    We buy a product from the EU that we then private label.
    The product has CE marking from origin.
    If that is in place, do we then also need full technical files or will the fact that it is CE marked already satisfy this?

    Many thanks,

    Kate
     
  2. rob73@work

    rob73@work New Member

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    When you say "private label" do you mean to show you as the "manufacturer" or "distributed by"?
    If you are rebranding the product in your own name then you will need some sort of tech file covered by an agreement with the original manufacturer to share technical and safety information.
    The attached is guidance for own brand labelling in the EU, if you are outside the rules may be slightly different.
    It might be good practice to have a basic tech file even if you are just "distributing" with your name in the packaging.
    This really falls under ISO 13485 more than 9001 though. You may get better answers in that forum.
     

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  3. Pancho

    Pancho Active Member

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    Hi Kate,

    What kind of product do you private-label? And are you selling it within the EU?

    If yours were a construction product and you were selling it within the EU, then your case is governed by Reg 305/2011, specifically articles 11 to 15. Article 15 says that "An importer or distributor shall be considered a manufacturer...where he places a product on the market under his name or trademark...". Article 11.8 says that "Manufacturers shall, further to a reasoned request from a competent national authority...provide... all information and documentation necessary to demonstrate the conformity of the construction product."

    Of course, other types of products may have different requirements.

    Best wishes for your audit!
     
  4. Nick1

    Nick1 Member

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    Hi Kate,

    Based on the relative limited information your provided (do you modify the goods at all?), I would always go for the safest route here and make sure you create your own documentation. Complications with the CE marking can leave you exposed to some serious legal issues and financial implications.

    I don't know what kind of goods you are buying but the EU machine directives might give you some goof insight:
    http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32006L0042

    With respect to your ISO there is only just one point that really matters. Somewhere in the very beginning the ISO9001 states that the company complies with every law that applies to it.

    I would recommend you to make sure everything is compliant and create your own documents to be sure. Do keep in mind that you have to provide this documentation in the language of the country you are selling the goods. This become very tedious when you sell in multiple countries.

    All the best!
     

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