Aug 3, 2008

ISO 13485/9000 is the baseline

This medical device company I know has finally wrapped up their ISO 13485 certification and they are pretty jazzed about it, even though doing so is probably going to end up delaying their project by several months due to pulling people off project work and putting them on paperwork. However, my thinking now is that certification is unimpressive and if you're making a big deal out of this, you might have bigger problems down the road. Ten years ago, maybe this was cause for celebration, but as it stands now, ISO 13485 and 9000 are pretty much the baseline and while you will undoubtedly run into some quirks (obviously more depending on the size of your company), it shouldn't be a major effort to get certification and if it is, then maybe you should think about adding, changing, or training personnel. There are something like 400,000 companies ISO 9000 certified now, I'm just saying, if you have a hard time joining that elite group perhaps some changes are needed.

UPDATE: Tom in the comments makes a similar point: "The big deal with 13485 is that it has to be done day by day as a normal part of medical device product development. If one has to stop and "catch up" with paperwork, not only are you doing it wrong, but missing a lot of the benefits that a great quality system can give you." If you don't have the resources to keep up ISO 13485 as Tom notes, then a rethinking is in order.

12 comments:

Anonymous said...

Manish
Use Do Follow Links Only
http://www.treatmentcenters.org/maine

Barb said...

Hi please contact me if you'd be interested in receiving press releases on new medical devices. (We have a new release due out 8/5/08.)

Thanks!

Barb

Michael Ben said...

Just wanted to drop a note to let you know how much I enjoy reading your blog!

Michael Ben said...

Just wanted to drop a note to let you know how much I enjoy reading your blog!

Tom Mariner said...

"Pull off projects to do paperwork"?

The big deal with 13485 is that it has to be done day by day as a normal part of medical device product development. If one has to stop and "catch up" with paperwork, not only are you doing it wrong, but missing a lot of the benefits that a great quality system can give you.

Andres said...

However much we think that 13485 shouldn't be a big deal, in my experience a lot of companies really do struggle with this. Case in point: Our 5-year old audio conference on 13485 and 14969 still gets requested on a regular basis.

Thanks,

Andres
http://fxconferences.blogspot.com/

David said...

Hi

I like this post very much. It help me to solve some my work under my director’s requirements.

Apart from that, below article also is the same meaning

ISO 13485 standard

Tks again and nice keep posting
Rgs

iso 9000 said...

Hey, very nice site. I came across this on Google, and I am stoked that I did. I will definately be coming back here more often. Wish I could add to the conversation and bring a bit more to the table, but am just taking in as much info as I can at the moment.
iso 9000

ISO 9001 said...

I appreciate your post. I also wrote that SMS advertising provides a cost effective method of targeting promotions to specific customer profiles. You might want to remind customers of specific events or promotions, but for whatever reasons, SMS allows you to pass information directly to the right customer at very affordable prices and fast delivery.
ISO 9001

JuliaSmith said...

Really nice and informative post. This is really an interesting blog......Thanks for sharing with us.
ISO 13485 Consultant bangalore

ISO 13485: 2003 Medical Devices said...

Great! As a medical device consultant, I'd like to suggest to outline and create medical devices to global quality benchmarks, guarantee smooth compliance, meet ISO 13485 norms, fulfill clients and keep in front of all administrative advancements..
Best luck~ Tanya H.

FenixSEO said...

Hi fellas,
Thank you so much for this wonderful article really!
If someone want to read more about that ISO13485 I think this is the right place for you!