ISO 9001 Quality Policy Manual vs. ISO 13485 Quality Policy Manual

I

ISO Learner-2006

Hi,

My name is Steve (ISO Learner) and I am working at a small (ISO 9001: 2000 certified) OEM company in California.

If my company wants to get ISO 13485: 2003 certified in the future, do I need to update or change some elements my company's ISO 9001 Quality Policy Manual?
If yes, could anyone give me some hint about updating the ISO 9001 Quality Policy Manual to meet ISO 13485 requirement?

Where can I download some samples of ISO 13485: 2003 Quality Policy Manul for reference?

Thanks,

Steve
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
ISO Learner said:
Hi,

My name is Steve (ISO Learner) and I am working at a small (ISO 9001: 2000 certified) OEM company in California.

If my company wants to get ISO 13485: 2003 certified in the future, do I need to update or change some elements my company's ISO 9001 Quality Policy Manual?
If yes, could anyone give me some hint about updating the ISO 9001 Quality Policy Manual to meet ISO 13485 requirement?

Where can I download some samples of ISO 13485: 2003 Quality Policy Manul for reference?

Thanks,

Steve


Steve, welcome to the cove.

You may want to check the "Post Attachment List" in the upper left corner of this forum. You may find something that you can review.

Secondly, you may want to perform a thread search, using the "search" pull down menu and see if there has been other questions/attachments already posted in previous threads.
 
D

Duke Okes

You should:
1. Get a copy of 13485
2. Study it to see what additions it has over 9001
3. Develop/modify QMS processes to meet the requirements
4. Update the manual to reflect those new/changed processes and compliance to 13484
 

Ajit Basrur

Leader
Admin
Hi Steve,

Welcome, yYou have come to the right place. If you search around the Cove, you will find lots of very useful informtaion.

Transitioning to ISO 13485 from ISO 9001 is bit easier and can be done. There are some posts whioch give the list of required procedures, reports etc. You will also find some training materials (Microsoft Powerpoint slides) which are very useful in imparting training.

All in all, this is one stop shop for all your queries. In case of any further queries, put it across and you will get answers.

Best Luck,

:bigwave:
 

Al Rosen

Leader
Super Moderator
ISO Learner said:
Hi,

My name is Steve (ISO Learner) and I am working at a small (ISO 9001: 2000 certified) OEM company in California.

If my company wants to get ISO 13485: 2003 certified in the future, do I need to update or change some elements my company's ISO 9001 Quality Policy Manual?
If yes, could anyone give me some hint about updating the ISO 9001 Quality Policy Manual to meet ISO 13485 requirement?

Where can I download some samples of ISO 13485: 2003 Quality Policy Manul for reference?

Thanks,

Steve
I found this ISO 13485 Quality Manual during my web travels. It's tailored for IVDs, so keep that in mind.
 

rmf180

Involved In Discussions
Will your company be producing medical devices in the future? If not, you may ask why seek ISO 13485. If you are looking to supply parts to the medical device industry, many times ISO 9001 is good enough. 13485 is set up for device manufacturers and does not translate very well to companies who only make components of a device. Will the added cost of 13485 be justified? Only your company can answer that!:confused:
 
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