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How to get ISO 13485

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by KD Shah, Dec 6, 2019.

  1. KD Shah

    KD Shah New Member

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    Hello everyone,
    I am currently working as an Industrial Engineer at an injection molding plant. The company wants to venture in to new waters and produce injection molded parts for medical clients.
    Is there anyone who can help me walk through step by step process on what do I need to do in order to get the certification ?
    I would really appreciate the help.
     
    KD Shah, Dec 6, 2019
    #1
  2. yodon

    yodon Well-Known Member

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    There's just too much detail to implementing a QMS than can be posted in a forum like this.

    Are you already certified to, say, ISO 9001? That is a higher jumping-off point than starting completely from scratch.

    If you haven't already, purchase the standard (that's always step 1!). There are also documents like this link that might be helpful (not endorsing it, don't know anything about it, just letting you know there are other resources available).

    Start documenting how you meet the requirements. When you bump into specific issues, post here again and the folks will gladly offer advice and suggestions.
     
    yodon, Dec 7, 2019
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    John C. Abnet likes this.
  3. Andy Nichols

    Andy Nichols Moderator Staff Member

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    This kind of question is almost unanswerable, plus, to get an answer you can practically use, isn't likely to be given freely. There are people who have done it once or twice, which may not actually help you. What you require is an "expert" and that's usually costs. It might be the cost of a book, the cost of a training course, the cost of a consultant. Help which has a value isn't usually free.
     
    Andy Nichols, Dec 7, 2019
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    Parag Kumar likes this.
  4. John C. Abnet

    John C. Abnet Well-Known Member

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    Good day @KD Shah, and welcome to the site. As @yodon and @Andy Nichols mentioned, it would not be possible via a simple forum discussion to comprehensively reply to your broad question. If you are seeking "step by step" assistance, it will require someone who is willing to spend time getting to know your current business and processes. I always recommend reverse engineering the QMS. In otherwords, instead of looking at your organization through the lens of the standard, look at the standard through the lens of your organization. It is likely your organization is already doing many of the "things" required by standard. Be careful not to put in place a bunch of "do this" burden on the organization because of overthinking or possibly mis-interpreting the intent of the standard. May I inquire as to where you are located geographically?
     
    John C. Abnet, Aug 12, 2020
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    Parag Kumar likes this.
  5. ValeriaGar

    ValeriaGar Member

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    Hi everyone,
    I agree you should start with the standard, but not only the purchase but also to understand it well. Believe me, it's not that simple at all. After that, an implementation plan is made, etc. To make your job easier, I would suggest that you implement QMS using software because it can make your job a lot easier (everything is automated). You do not have to invest a lot of money to buy, there are also affordable software for all sized company.
    And one more thing, it is not only important to implement, but also to maintain the standard, and for that, I suggest a very strict internal audit.
     
    ValeriaGar, Nov 3, 2020
    #5