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Basic Documentation Question

Discussion in 'ISO 9001:2015 - Quality Management Systems' started by Vincent Aragon, Mar 23, 2018.

  1. Vincent Aragon

    Vincent Aragon New Member

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    Hello everyone. I am currently working for a startup med device company who is just now moving out of R&D and is trying to establish a functioning QMS. I am a document control specialist. This is the 3rd MD company I've run document control for. My question is very basic so I apologize for taking up space on the internet. So one thing I have never allowed my employees to do is submit documentation that has been printed front to back (on both sides of the paper) as I was trained this way early on by my QA Director. Its always been one side regardless of how many pages they have. Nobody has ever questioned me but now that I'm at a startup where most of the people here have never worked in an quality controlled environment, I am having to give explanations for even the most minor changes such as this. Can anyone confirm for me if this actually is a no no and if its states it anywhere in a standard or guideline? I dislike the idea of having both sides printed on documents so I'm hoping I can go back with cold hard evidence to support this. Thank you.
     
  2. John C. Abnet

    John C. Abnet Well-Known Member

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    Good afternoon Vincent;
    The simple answer is no. There is no requirement in the standard in regards to how documentation is created or printed. Sorry I can't give you some "...cold hard evidence..." to support your position.

    Be well.
     
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  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Agreed - in fact there are very simple controls which can be put into place to avoid "missing" the second side. No standard is going to dictate such a thing. Maybe, an auditor has their bias and this often become folklore.
     
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  4. Golfman25

    Golfman25 Well-Known Member

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    Maybe your QA Dir. had stock in a paper company. :)
     
  5. Candi1024

    Candi1024 Well-Known Member

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    When we print for FDA during an audit, our requirements say the FDA only wants 1-sided. This could be an old requirement though, or internal.
    Other than that, I'd say it's an old way of working based on copy machines that copy poorly (could see printing through the other side) or don't copy double sided very well. We now print double sided for everyone but the FDA.
     
  6. tony s

    tony s Well-Known Member

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    The entire clause of 7.5 - Documented Information - has no requirement that prescribes an organization to only print on one side. The standard only specifies WHAT not HOW.

    About being prescriptive:
    Annex A.4 of ISO 9001:2015 mentioned this statement:
    The risk-based thinking applied in this International Standard has enabled some reduction in prescriptive
    requirements and their replacement by performance-based requirements. There is greater flexibility
    than in ISO 9001:2008 in the requirements for processes, documented information and organizational
    responsibilities.
    Clause 7.5.1 of ISO/TS 9002:2016 (Guidelines for the Application of ISO 9001:2015) mentioned this statement:
    In general, ISO 9001 is not prescriptive in terms of the extent of documented information needed. This
    will vary from organization to organization depending on the size and complexity of the operations
    and processes; customer, statutory and regulatory requirements; and the competence of the persons
    involved. For example, documented information needed for a small bakery will be simpler and less
    extensive than that needed by an automotive parts manufacturer which has very specific customer
    (statutory and regulatory) requirements, including documented information of external origin, to be
    incorporated into the system.
     

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