Transition training for 13485:2003 - Seeking Recommendations and Comments

[Dave-h]

I am just starting on moving my company from 13485:1996 & 9001:1994. I am familiar with ISO9001:2001, but 13485 is a different story because I am new to the medical world.

Has anyone found a short training course in 13485:2003 (in the UK) that they would describe as useful?

Or am I just best using my knowledge of 9k2k to update the existing 13485, and use this forum to help with the odd questions?


Many thanks,


Dave

[Cathy]

Hi Dave, welcome to the cove.

Do you manufacture finished medical devices? If yes, SGS run a course through the year and they take place all over the UK. Mail me if you want contact details.

Cathy

[SilverHawk]

Cathy, what's in for me? Our local SGS auditor is also going around recommending ISO 13485:2003 training course but openly refered to his consultant friend. Each time, we asked SGS for something related to the certification, this auditor wil keep asking us about the training course and never ever answer to our request related to certification.

Sincerely hope that Cathy should not make any recommendation.....

[Randy]

Silverhawk...........

Your auditor can't make recommendations, but Cathy can.

I recommend using BSI myself for training issues.

[Cathy]

Folks,

I have recommended this course because I have been on it myself. The BSI course was not available at the time for ISO13485: 2003 and I do have to say that a recent flyer for BSI details very good in-house customised course...this is also an option.

I chose the course I went on myself, our auditor did not influence my decision in any way. I refuse to be put the pocket of third party auditors and I will chose the best available at the time!

I enjoyed the course for the simple fact that it was (dare I say) Fun!!! It was very interactive, up-to-date, the course tutors were very knowledgeable, and they made time for open, questions and private one-to-one time for questions regarding your own business interest. I am only speaking from experience.

Apologies if offence was caused.

[liuyy]

If you are familiar with ISO 9001:2000,ISO 13485:2003 wouldn't be a problem.

[DannyK]

If you are familiar with ISO 13485:1996 and ISO 9001:2000, there should not be any problem for you to transition to the new standard. Annex B of ISO 13485:2003 clearly indicates the changes to the standard.

The only area that was new to me was in 7.1 which requires the organization to establish documented requirements for risk management throughout product realization.

If you have any specific questions, I am sure someone within the Cove would be able to answer you.

I have received my auditor interpretation training from Intertek for ISO 13485:2003 and I have completed documentation for one of my consulting contracts.

Danny

[wrodnigg]

Originally Posted by DannyK

The only area that was new to me was in 7.1 which requires the organization to establish documented requirements for risk management throughout product realization.

At this point I want to add the hint, that EN ISO 14971:2000 should be used for risk management because EN 1441:1997 will be void by the end of march 2004.