ISO 13485 Consultant Recommendations

[Wesley]

We are considering moving forward with ISO certifications and were wondering if anyone could recommend a good consultant company to assist us with the process. We are a small company (14 employees) and money will definitely play a factor in any decision we make. If you have any recommendations for us it would be greatly appreciated. Information about our company can be found at our web site (see my profile).

Thank you,

Wesley
QA Manager

[Coury Ferguson]

Wesley,

A consultant will run your company anywhere from $250.00-$1000.00 per day. If you are familar with QMS and ISO9001:2000 you would be better off trying to accomplish the documented system with the help of your fellow workers.

The Registration process can be expensive. The Registrar will run you anywhere from $1000.00 to $2500.00 per audit day.

I would suggest that you get some quotes for Registration. I would suggest American Systems Registrar (ASR) located in MI for your Registrar, just because I have worked with them before and they are very personable with their clients. The President's name is Richelle Kinzie and their Marketing Manger is Tom Droog. Their website is: www.asrworldwide.com

Coury Ferguson

[Helmut Jilling]

Originally Posted by Coury Ferguson

Wesley,

A consultant will run your company anywhere from $250.00-$1000.00 per day. If you are familar with QMS and ISO9001:2000 you would be better off trying to accomplish the documented system with the help of your fellow workers.

The role of a consultant can be varied. Some are capable of helping a company get a system in place. Some can help a company excel and reach the top of their field. It all depends on what kind of consultant one hires.

For example, I can play a sport without a coach. But if I am serious about winning money in professional sports, it will almost certainly require that I find a great coach.

[Marc]

This was moved from the ISO 13485 forum. Because of that I also retitled the thread.

Question: Wesley - What certification are you referring to?

[AndyN]

that very rarely does the organization know or have competencies on the whole '9 yards' of any requirement like ISO 9001, ISO 14001, etc. My experience has been you can get a shot at many things, read guidance here, ask your local ASQ membership etc., but (paradoxically) unless you pay for help, it's generally not (perceived) as much good...........Furthermore, you could spend so much time yourself researching a number of options that the cost may actually be the same or higher than the investment in an outside helper!! Your management will also want action, not someone to be 'finding out' about what might work, plus which options work and can anyone internally justify why that option works or identify what to fix, if it doesn't

Yes, all these sound like reasons to use a consultant - sure! They are also realistic issues to consider before you end up with a poorly designed, half heartedly implemented system which then needs external help to sort out........

Andy

[Wesley]

Originally Posted by Marc

This was moved from the ISO 13485 forum. Because of that I also retitled the thread.

Question: Wesley - What certification are you referring to?

No problem, sorry for posting in the wrong forum! I was assuming we would need certification for 13485, and maybe 9001 (I'm not completely sure yet though). Our product is a biologic implantable medical device, and we hope to eventually sell them worldwide (initially in the US and Canada).

Thank you for your assistance,

Wesley

[Al Rosen]

Originally Posted by Wesley

No problem, sorry for posting in the wrong forum! I was assuming we would need certification for 13485, and maybe 9001 (I'm not completely sure yet though). Our product is a biologic implantable medical device, and we hope to eventually sell them worldwide (initially in the US and Canada).

Thank you for your assistance,

Wesley

If you are marketing worldwide you will need ISO 13485, otherwise you must meet FDA Quality System Regulation if you are only marketing in the US.

[JanJohn]

Hi Westley,

I'd like to suggest you consider Kristine King at QPA, Inc. She has huge experience in quality management system development, for systems ranging from automotive to medical device manufacturers. She also brings her experience with lean process development into her guidance for QMS development.

Phone: 763.561.2428
www.qpa.com

Best regards,

SAI Global Lady