Howdy everyone.

I have just found out that we will be pursuing certification to ISO 13485 (actually 13488). Can anyone recommend any good resources for information so I can get up to speed on this standard. I have a very good understanding of 9001:2000 (which I've heard is similar), but know nothing about the medical side of things. I need to find out what the major differences are, and what extra steps need to be taken (we are certified to 9001:2000). Thank you in advance for all your help.

Richard, I don't have a lot of time this morning but just a qucik note. There is not really a major difference between 13485:96 and 9001:94, now with that said are you aware that the revised 13485 is set to be released in the first part of 2003? It is similar to 9001:00, however there are more requirments for procedures that 9K2K requires. A couple questions you need to ask is does your company sell in Canada, and is your registrar qualifed to audit you to 13485?

I will try and give you more details in the next day or two, in the mean time feel free to e-mail me or send me a private message.

ISO GUY,

Thanks for your response. I look forward to hearing more details from you.

To answer your questions real quick, I have heard that there is a new version coming out soon, we don't sell anything in Canada, and our registrar does cover 13484/8 (I have requested some information from them).

We haven't been asked to meet any standards (even though we do manufacture on a small scale for a medical device company). It is mostly being considered as a marketing tool since there are a number of medical device companies in the area. Actually what started the whole thing yesterday was our marketing director noticed that on a competitors brochure :vfunny:

I greatly appreciate any information you (or anyone) can share, as the first time I even really heard about 13485/8 was yesterday. :confused:

I don't know what kind of timeframe we're looking at, but it seems to be picking up a lot of steam around here, so I'm thinking it is going to become a priority soon.

Thanks :bigwave:

Does anyone know where I can obtain a copy of the draft version of the new 13485? I've tried searching, but can only find the older versions available. Thanks.

Here you go

Thank you so very much. Words can not express my appreciation.:D

Does anyone know if ISO 14969 is being updated with 13485? Is this document even worth having?

Yes, ISO/TS 14969 is being updated as well. Is it worth having at this point IMHO I would say no.

Too bad you didn't live close by, I am giving a presentation on this topic in a couple weeks for our local ASQ. The same one I gave for the IMDMC - Indiania Medical Device Manufacturers Council.

I think we pretty much decided that 14969 probably wasn't essential.

We are going to be looking at training for this, so if you have any information please send it and I will pass it on to my training coordinator.

Have you seen or heard of any companies that have been 9001:2000 and then added 13485 later? Looking at the standard, it doesn't look too difficult to do.

I would like to retract my previous statement. At a quick glance it looked like it wouldn't be difficult adding 13485 to 9001:2000. But after reading it in detail I realized that there is a lot more involved to it. :bonk:

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.

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.

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,

JCouncil
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
thanks!

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...."

Danny