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.
Last edited by Jimmy Olson; 10th February 2004 at 11:58 PM.
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.
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
I greatly appreciate any information you (or anyone) can share, as the first time I even really heard about 13485/8 was yesterday.
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.
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.
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.
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