Pursuing certification to ISO 13485 (actually 13488)

J

Jimmy Olson

#1
Help!!!

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.
 
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A

Aaron Lupo

#2
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.
 
J

Jimmy Olson

#3
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:
 
J

Jimmy Olson

#4
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.
 
J

Jimmy Olson

#7
Does anyone know if ISO 14969 is being updated with 13485? Is this document even worth having?
 
A

Aaron Lupo

#8
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.
 
J

Jimmy Olson

#9
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.
 
J

Jimmy Olson

#10
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:
 
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