Conversion from ISO 9001:1994 to ISO 13485:2003

[Kristi]

Hi!
The company I work for is currently ISO 9001:1994 certified. We are in the process of converting to ISO 13485:2003.

The current quality system set up is quite complex and I would like to simplify it....
I would like some ideas on how others handle referencing SOPs or other documents. (I.e.: The current system here can have one SOP referencing 12 others; everything is very intertwined.)

Thank-you!

[Cathy]

Hi!
The company I work for is currently ISO 9001:1994 certified. We are in the process of converting to ISO 13485:2003.

Hi Kristi,
Welcome to the cove!
This is something that I would not like to do. Are you not going to upgrade to ISO9001:2000? I am sure you are aware that very few registrars (if any) certified to accredit ISO13485:2003.

One way you can simplify your system is to strip it back to the bare minimum. To start this the best thing for you to do is a GAP analysis of the current system and identify the areas where you must have a procedure and work from there - there will be quite a few differences. Have you implemented ISO13485:1996. If you have this may not be such a big jump.

This is the first time I have heard of a company converting from ISO9001:1994 to ISO13485:2003 have a look through the other threads in the section. There is some good advice!

Good luck,
Cathy

[Aaron Lupo]

Originally Posted by Kristi

Hi!
The company I work for is currently ISO 9001:1994 certified. We are in the process of converting to ISO 13485:2003.

The current quality system set up is quite complex and I would like to simplify it....
I would like some ideas on how others handle referencing SOPs or other documents. (I.e.: The current system here can have one SOP referencing 12 others; everything is very intertwined.)

Thank-you!

Kristi-

Welcome. When you say that your current system is complex, do you feel that it is because you have procedures referencing 12 others?? If that is the case when you revise your current procedures only reference what is necessary, there is no need to reference your training procedure in all your procedures (I am sure all employees are required to read your training procedure) so why restate the obvious same for document control etc...

Upgrading from ISO 9001:94 to 13485:2003 should not be that difficult have you looked at ISO 9001:2000 are you upgrading to 9001:2000 or as Cathy asked do you currently have 13485:1996 Certification? If not you do know that as of 12/15/03 your ISO 9001:1994 Certificate is no longer valid correct?

If you could provide a little more information we should be able to help you get past this.

[Kristi]

Thanks for the welcomes!

In reply to your questions:

We currently are not certified to ISO 13485:1996. However we do follow it.

Yes, we do know that as of 12/15/03 ISO 9001:1994 is no longer valid. We looked at going to the 9001: 2000, but have decided to convert only to the 13485:2003.

By "complex" I mean that we definitely do not have a simple to follow or user friendly system.

I have looked at several of the threads and have found them helpful!

[wrodnigg]

Hello Kristi,

...when you upgrade to 13485:2003 (from ISO 9001:1994), you have to do several things:

One of the first things, you have to switch to a process-oriented system. There is a lot of literature (and threads in this forum) which can guide you, how to establish processes in your company.
I think, this could also help you to simplify your system.

On the other hand you have to fulfill the requirements of 13485:2003 which are especially designed for manufacturers of medical devices.

If you already follow 13485:1996, there is less work to do, but you will have to establish ~30 documented procedures and implement a strong system for quality records.

In "Annex B" of 13485:2003, there you find a comparison between 9001:2000 and 13485:2003 which can help to find out the additional working-items you have to implement.

Another hint could be ISO/DTR14969 (you can buy it at www.aami.org), which is a "guidance on the application of ISO 13485:2003"

To the referencing thing:
You could try to use the index of the Standard and make a matrix (e.g. an Excel Sheet) in which you show which requirement of the standard is implemented in which SOP, and which SOPs belong to the same processes. Or you start on the process-landscape and start referencing top down from there.

regards~ghw