Pursuing certification to ISO 13485 (actually 13488)


Aaron Lupo

Richard one thing to think about is that ISO 13485:2003 will be a stand alone standard. It may take a little time but IMHO you may see companies in the Medical Industry drop 9001:2000 and go with only 13485:2003.

Where I work I plan on keeping both, I do not want to limit our company from looking at other markets in the future and it is not costing us any extra to maintain certification to both so we may as well reap the benifits from both.

Jimmy Olson

We will definately be keeping 9001:2000 since we are a contract manufacturer and that is more important to us. We are looking at 13485 as a marketing tool to be able to open up more doors for us.


DIS 13485:2XXX

Regards your query on 13488/5, I suggest you review the Global Harmonization Task Force website (GHTF.org) for perspectives on implementing and maintaining a harmonized (Global Medical Device Markets) QMS now that you have reviewed the DIS 13485:2XXX. There is some excellent guidance at the GHTF site.

Also, recommend you start thinking about the need to get your product CE marking compliant if your new business strategy will include the European business community.

The Medical Device Directive (regulation) describes the CE- marking process.

the fact that you mentioned bringing making your QMS ISO 13488 compliant does raise several questions. I understand 13488 will go away once the 13485: 2XXX standard is published. You'll probably need to apply only that portion of the new standard that is relevant to your company and rationales for non-relevant portion.

Your current registrar should be able to advise you on what steps are needed.

Best regards,

ASQ-CQA, Biomedical Auditing


Hi I was wondering what is the difference between ISO 13485 and ISO 13488

I know health canada medical device regulations state that class II medical devices should obtain iso13488 certification and
Class III and IV should obtain 13485.

but I am confused why the company I am currently writing a business plan for, states that they need iso 13485 certification. when infact the device to be licensed by that company falls under class II .

The person who started this thread/topic also just referred to it mainly as Iso 13485 with "actually 13488" in brackets. so my question is: is iso 13488 only a sub type of iso 13485? is it common practice to just refer to (any class ) medical device iso ceritification as just iso 13485?

and another question: lets say a company only thinks that thier device is class II, but they are not yet sure as they havent got health canada's opinion yet on classification for their particular device. it could fall under class III upon closer evaluation by health canada. should the company just get iso 13485 certification instead of iso 13488 ...because iso 13485 is sort of at a higher level...and once iso 13485 is recieved iso 13488 is not needed?

I would really appreciate clarification from iso experts here


Trusted Information Resource
You can only get registered to ISO 13485:2003. ISO 13488 does not exist.

If you are not sure about your device classification, contact Health Canada or check out their website.

The difference will be stated by the scope. If you have a class III or IV device, your scope will state :" Design & manufacture of..." If it is class II it will state: " Manufacture of...."

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