Is ISO 9001 necessary if ISO 13485 certified?

Kary13 · Apr 28, 2009

Hi all!

Ok, my company recently got certified for both ISO 9001:2008 and ISO 13485:2003. However, as I am now reviewing standards and other documents, I can't help but thinking why we wanted ISO 9001 in the first place (as opposed to strictly ISO 13485)? What I mean is that when I started working here, the process for QMS implementation had already started and a consultant was hired. Therefore, I followed the lead... but now I wonder why... :bonk:

I understand that the focus of both standards are slightly different with regards to customer focus and that it is not because you comply to ISO 13485 that you automatically comply with ISO 9001. But then, what is the purpose of getting ISO 9001 if the company only produces medical device???

Thanks for your help!

Doug Tropf · Apr 28, 2009

You might have a look at the similar discussion threads listed below.

Kary13 · Apr 28, 2009

Doug,

Haven't seen the info I am looking for... maybe I was not clear enough...???

All the other post seems to talk about the differences between the standards, how to upgrade from 9001 to 13485... However, what I am wondering is what is the advantage of getting ISO 9001 if we already comply with ISO 13485?

Doug Tropf · Apr 28, 2009

I'm not aware of any advantages with maintaining both certificates if you operate exclusively in the medical device world. Maybe some others will chime in with some insight.

Kary13 said:
Doug,

Haven't seen the info I am looking for... maybe I was not clear enough...???

All the other post seems to talk about the differences between the standards, how to upgrade from 9001 to 13485... However, what I am wondering is what is the advantage of getting ISO 9001 if we already comply with ISO 13485?

DannyK · Apr 28, 2009

If the scope of your ISO 13485 certificate is the same as your ISo 9001 certificate, then it may be a good idea to drop the ISO 9001 certificate.

If it is different it may serve a purpose. Ask your marketing department if there is any customer requirements for ISO 9001.

Kary13 · Apr 29, 2009

Hum... No customer so far so no "requirements" regarding certification as yet! ;-) It is our initial certification actually! Could it be related to the product certification somehow (CE, 510k, Health Canada)?

P.S. Scopes of both certificates are the same...

Ajit Basrur · Apr 29, 2009

kary13,

If you are manufacturing only medical devices, certification to ISO 13485 would be sufficient but if you have any other types of products, certification to ISO 13485 may be required to meet the "Customer Satsifaction" and "Continuous Improvement" as these sections are not included in ISO 13485.

Crimson · Apr 29, 2009

Only 13485 is required if you are manufacturing - suppliers will probably want 9001/13485 because manufacturers (i.e. clients) will want to see "continous improvement"...

db · Apr 29, 2009

The focus of the two documents are slightly different. 9001 has a much stronger customer satisfaction and continual improvement slant, whereas 13485 is more focused on regulatory compliance. Although the two are compatible, registration to one does not equate to compliance to the other.
If you desire your customers (or potential customers) to get a feel for your commitment to customer satisfaction, or continual improvement, you might want to keep both. Registration to both might also lead to more flexibility in looking at new customers or markets.

Chris Ford · Apr 29, 2009

Kary13 said:
Hi all!

Ok, my company recently got certified for both ISO 9001:2008 and ISO 13485:2003. However, as I am now reviewing standards and other documents, I can't help but thinking why we wanted ISO 9001 in the first place (as opposed to strictly ISO 13485)? What I mean is that when I started working here, the process for QMS implementation had already started and a consultant was hired. Therefore, I followed the lead... but now I wonder why...

I understand that the focus of both standards are slightly different with regards to customer focus and that it is not because you comply to ISO 13485 that you automatically comply with ISO 9001. But then, what is the purpose of getting ISO 9001 if the company only produces medical device???

Thanks for your help!

In the old days, before 13485 became a stand-alone standard in 2003, you couldn't be certified to 13485 unless you were 9001 certified. 13485 was an add-on certification. If you're company manufactures only medical devices, it isn't advantageous to have both certifications. I've seen contract manufacturers with multiple certifications and multiple quality systems to manage the specific needs and requirements of the various industries they serve. So, it's not uncommon to see a company with a "ISO 9001 side and a Medical side". In your case, the company is wasting money certifying to both standards, in my opinion.

Is ISO 9001 necessary if ISO 13485 certified?

Kary13

Doug Tropf

Quite Involved in Discussions

Kary13

Doug Tropf

Quite Involved in Discussions

DannyK

Kary13

Ajit Basrur

Crimson

db

Chris Ford

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