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How much work to get to 13485 from ISO 9001:2015?

Discussion in 'ISO 13485 and ISO 14969 – Medical Devices QMS' started by Nikki, Dec 4, 2015.

  1. Nikki

    Nikki Well-Known Member

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    Hello All -

    I wanted to get all of your opinions on how much work you think it would take for my company to get to 13485.

    Yes, I will be buying the revised standard when it comes out, and yes I know this may be a little difficult to answer considering its still being worked on, but from what I see - I don't think I will have to do that much.

    Some background - We are a medical plastics compounder. We make the plastic pellets that are sold to medical device manufacturers. We do not make the device. We do not conduct sterilization.

    Because we sell our materials to the medical industry, we have been audited to 13485 regardless that we only hold ISO 9001:2008 certification.

    Because of those audits, we implemented a lot of the requirements such as preventive maintenance, incoming inspection, blah blah blah....

    I have and have read the current 13485 standard and from what I see, I would have to exclude a lot of the Section 7 requirements because we don't make the medical devices.

    It looks a little too simple to be true...

    Thoughts would be appreciated :)

    Thanks,
    Nikki
     
  2. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    The work would not be insignificant so from that perspective it is "too simple to be true". ISO 13485 will add a lot of overhead to a system that is probably not required of you now. If you are already being audited against it by your customers however it might be worth it.

    The bigger question is what is the benefit? Will your customers audit you less? Will it give you a competitive advantage in your market? Will you need to maintain both certifications? I'm a big fan of building strong quality systems because I truly believe they help the business ( as long as you can push out of the manufacturing centric view), I am not a big fan of certifications and certificates on the wall whoever, unless there is a larger goal than a piece of paper on the wall. There needs to be a business need for that cert IMHO.
     
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  3. Nikki

    Nikki Well-Known Member

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    Thanks Jim.

    We have several customers that are asking us (telling us) we need to be 13485 certified. I think that obtaining this certificate will also help us obtain more work. Right now, people see us as an ISO 9001:2008 certified company - and they don't realize that our system is the way it is - so close to 13485.

    Being certified to the medical standard, and us being a medical plastics manufacturer, I think, will make it more desirable to work with us.
     
  4. Andy Nichols

    Andy Nichols Moderator Staff Member

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    "A lot of overhead", is IMHO, a rather subjective statement when Nikki has provided little information on which to base it. I deal with a number of companies which have certification to both standards and they are mainly the lower end of the supply chain. There's a lot of similarity and many exclusions may be taken. I'd ask where the "overhead" comes from...
     
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  5. Jim Hagenbaugh

    Jim Hagenbaugh Member

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    I agree it is a bit subjective. With that said ISO 13485 goes fairly well beyond the ISO 9001 requirements in a number of areas. If the systems are in place because customers require them to be present you are absolutely correct their is no real impact. If not how is that certification making your system better taking "many exclusions" unless there is a business need for it. It sounds like Nikki has defined a business need so go for it.
     
  6. Ronen E

    Ronen E Well-Known Member

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    The business need often comes from customers requiring ISO 13485 without really understanding it or caring about any real added value. In short, I relate to those customers who seek a nice piece of paper (the certiicate) which they could file and feel good about it. For such, you could have as many exclusions as the standard / CB would allow, regardless of the real merit of what's left.
     
  7. Sidney Vianna

    Sidney Vianna Well-Known Member

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    Be prepared to pay SIGNIFICANTLY higher audit fees and have to deal with medical device auditor limited availability, which might mean having to have an auditor 3 time zones away and a couple of thousand dollars for travel fees.

    The IAF MD9 document stipulates 7 audit days (Stage 1 and 2) for an ISO 13485 audit for an organization with 50 employees (ANNEX D). As the new ISO 13485 has not taken the High Level Structure route that ISO 9001:2015 follows, it is very likely that you have to have additional days if you want to keep both certificates (9001 and 13485).

    Unless I knew (FOR A FACT) that my organization was losing business opportunities for the lack of an ISO 13485 certificate, I would avoid it like the plague :eek:
     
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  8. Andy Nichols

    Andy Nichols Moderator Staff Member

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    Not necessarily. If the services of CMDCAS accreditation are needed nor a NB, the costs of the audit may NOT be "significantly" higher.
     
  9. Ronen E

    Ronen E Well-Known Member

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    Why would CMDCAS or a NB be required if they don't make finished medical devices?
     
  10. Andy Nichols

    Andy Nichols Moderator Staff Member

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    What I meant to post was that if the CB is CMDCAS or is also an NB, the costs can be higher, regardless of if the client org. needs the approvals. Sorry for the confusion.
     
  11. QA Bee

    QA Bee Member

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    My company is small and we are currently ISO 9001:2008 certified.
    I am in the process of going towards ISO 13485 and I must say its not a lot of work but it takes the whole company to understand the importance of it, not only management.

    If you already 9001 complaint, there are only few more procedures need to be implemented for ISO 13485.
    I will let you know once our Stage 1 audit is completed in few weeks.

    Fingers Crossed:)
     
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  12. zac2944

    zac2944 New Member

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    Following this thread as I'm in the same boat as the OP. My company makes flexible packaging materials for Med Device companies and there is a push to switch from 9001 to 13485.
     
  13. Golfman25

    Golfman25 Well-Known Member

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    I would find out why your customers are asking/telling you to be 13485 certified. In a lot of cases it the easy way out of "supplier development." It may not provide any additional value. I would also survey your competitors to see if any of them are certified. That will tell you a lot. Seeing as you will try to exempt the medical device stuff, what's the point? In other words, make sure you do your research to make the decision. Good luck.
     
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  14. Nikki

    Nikki Well-Known Member

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    I have certainly done my homework on all of this. Years ago we were asked about going to 13485 - as you stated - we did not see the point as a lot of the additional stuff was going to be excluded. A lot of our competition is certified to 13485. We have one customer who is basically telling us that we need to be certified if we want to continue to work with them.
     
  15. Nikki

    Nikki Well-Known Member

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    Uhg... So I had an audit today - customer audit - and although everything went fine - I was informed, during said audit, that we are going to be setting a goal to be ISO 13485 certified by JUNE 2016. The newest revision of 13485 was just approved on 4-Jan-15, I just got my new revision of 9001:2015 - And this guy is saying I need to get our system to 13485 by June???

    :mad::eek:o_O:(
     
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  16. Sarasota Mike

    Sarasota Mike New Member

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    I am carious what you mean by “exclude a lot of the Section 7 requirements”?? A competent auditor may not agree as you go through Stage 1. I recommend a strong Risk Mitigation program. Is there any D&D? Who owns the patents on formulation, if any? As a compounder, sterilization may not be necessary but if the finished device is implantable or enters the body liability goes up. Anyone that is 13485 is automatically given the 9001. If top management is on board with expanding the resources, you shouldn’t have a problem.

    Best regards
     
  17. Nikki

    Nikki Well-Known Member

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    I shouldn't have used the work "a lot" but yes there were be several exclusions. We make plastic pellets - we do not make medical devices - we do not conduct sterialization - it is not required.
     
  18. Nikki

    Nikki Well-Known Member

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    Stage 1 audit scheduled..... October 2016 :eek::eek::eek:
     
  19. Candi1024

    Candi1024 Well-Known Member

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    Good luck!
     
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