How much "harder" is an ISO 13485 Registration Audit compared to ISO 9001

R

rdesmond

#1
Hello! Can anyone comment on how much "harder" a 13485 registration audit is compared to 9001 or is it literally that there are just more requirements & sections? I getting my company ready for a 13485 audit - considering BSI as the registrar. I have gone through a 9001 at another company. Some QMS sections are really strong, however some are relatively new so my main concern is how that will affect perceived effectiveness. I still have some time - early next year, however want to be adequately prepared. Thanks!!:bigwave:
 
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I

isoalchemist

#2
Re: ISO 13485 Registration

Having been through both my feeling is that ISO 13485 just requires more documentation and attention to detail not that it is "harder". The once exception is the risk management aspect that can lead to some wonderfully long and detailed meeting. Good Luck!
 
R

rdesmond

#3
Thank you! We are a contract manufacturer & produce no finished devices. We perform thorough PFMEAs for our whole product realization process. Any advice on additional Risk requirements? Thanks!
 

Ronen E

Problem Solver
Moderator
#4
Thank you! We are a contract manufacturer & produce no finished devices. We perform thorough PFMEAs for our whole product realization process. Any advice on additional Risk requirements? Thanks!
Hi,

Being "a contract manufacturer & produce no finished devices" I'm a bit puzzled as to how ISO 13485 would apply to you in the first place. Not necessarily to say that you can't get certified...

Anyway, if you follow ISO 14971:2007 carefully you should be fine with any ISO 13485-related aspects of risk management. Please be aware that it involves more than _FMEA or the likes.

Good luck,
Ronen.
 
J

JaxQC

#5
Dual certification is not hard. Since you’re talking ISO 13485 (medical), look up 21 CFR 820. These are your “customer specifics” who in this case is the FDA. Very little addition, I’d say more tweaks to get an ISO9000 system over to ISO 13485.

The link describes how the FDA views the various groups. Note that there are different groups for Contact Manufactures. While the list is actually for FDA registration, I would use it as a Rule of Thumb regarding if ISO 13485 may be useful for your particular company. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm

As to why, some Customers want their contract sources to have this certification & looking forward I foresee the FDA changing that to being required in the upcoming future.
 
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Mikishots

Trusted Information Resource
#6
Re: ISO 13485 Registration

Having been through both my feeling is that ISO 13485 just requires more documentation and attention to detail not that it is "harder". The once exception is the risk management aspect that can lead to some wonderfully long and detailed meeting. Good Luck!
Well, one advantage of ISO13485 over ISO9001 is that you won't have to worry about continual improvement. :)
 
W

William_55401

#7
Re: ISO 13485 Registration

Additional risk management? Ensure that your end to end PFMEAs are aligned with the Design FMEA of your customer. Are critical to quality / performance items from the customer fully explored and risks mitigated in your PFMEAs?
 
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