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Go Back   The Elsmar Cove Forum > Medical Devices, Medical Information Technology, Medical Software and Health Informatics > Medical Device Related Standards > ISO 13485 and ISO 14969 - Medical Devices - Quality Management Systems
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Could we combine ISO 13485 and ISO 9001:2008?


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  Post Number #1  
Old 9th August 2009, 08:33 PM
toile

 
 
Total Posts: 2
Question Could we combine ISO 13485 and ISO 9001:2008?

Hi ,
I have been consulting the site since the end of june 2009, I realy like it, I found a lot of ansers to my questions. I have just got my first job in this field, I have a certificate in quality assurance. It was very simple for the Iso 9001 certification that i studied, but last week one of our major customers asked to be certified ISO 13485.
Could you plase tell me what do I have to do in our case, we are already certified Iso 9001. What ae the steps. Do I have to make an other manual, other procedures and other forms or just add things to the ISo 9001 documentation. It will be very apreciated if you give me some examples.

We are producting Titanium powders that are used for chirurgical implants by our customer. What is th class and regulation for our product (titanium powders)




Last edited by toile; 9th August 2009 at 08:38 PM.

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  Post Number #2  
Old 9th August 2009, 09:02 PM
Kales Veggie's Avatar
Kales Veggie

 
 
Total Posts: 1,001
Re: Could we combine ISO 13485 and ISO 9001:2008?

You will have to do a gap analysis between your current QMS and ISO13485 (probably also 11 CFR 820 if you export to the USA and Canadian medical device requirements), then augment your quality manual and procedures.

You will have to write several additional procedures and how you keep and maintain records might have to be changed.

There are several checklist published in the site here. Click on "post attachment list" and search for 13485.

If you have detailed questions, please ask.
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  Post Number #3  
Old 9th August 2009, 09:14 PM
MIREGMGR

 
 
Total Posts: 3,483
Re: Could we combine ISO 13485 and ISO 9001:2008?

Quote:
What is the class and regulation for our product (titanium powders)
I'm not aware of how powdered titanium could be considered a medical device under Canadian, EU or US rules. It would seem to me to be a raw material.

Note however in regard to your own regulatory stance that this standard:

ISO 5832-2:1999, Implants for surgery - Metallic materials - Part 2: Unalloyed titanium

would seem to be relevant, in that your customer(s) may have to cite it in their documentation of their device-products.

In case US regulation is relevant, the above standard is FDA Recognized Consensus Standard 8-57. More info is available at:

http://www.accessdata.fda.gov/script...ATION_NO=21827
  Post Number #4  
Old 9th August 2009, 09:46 PM
toile

 
 
Total Posts: 2
Re: Could we combine ISO 13485 and ISO 9001:2008?

Hi Kales and MIREGMGR

Thanks very much for your response.

Kales, could you please give me more informations about the several additional procedures that I have to write and what kind of changes that might be done to the way of how records are maintaind and kept. Do you have some examples



Last edited by Stijloor; 9th August 2009 at 09:59 PM.
  Post Number #5  
Old 9th August 2009, 10:49 PM
howste's Avatar
howste

 
 
Total Posts: 4,142
Re: Could we combine ISO 13485 and ISO 9001:2008?

First off, do you have a copy of ISO 13485? This may answer some of your questions. Look at all of the paragraphs in italics, as they have the differences from ISO 9001.

I've attached a file listing the different procedures and records required in ISO 13485 over and above what ISO 9001 requires.
Quote:
In Reply to Parent Post by Kales Veggie View Post

...probably also 11 CFR 820...
Did you mean 21 CFR 820?
Attached Files: 1. Scan for viruses before using, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf ISO 13485 vs. ISO 9001 (Required Docs).pdf (74.5 KB, 561 views)
Thank You to howste for your informative Post and/or Attachment!
  Post Number #6  
Old 10th August 2009, 01:51 AM
Roland Cooke

 
 
Total Posts: 612
Re: Could we combine ISO 13485 and ISO 9001:2008?

You will need to confirm if your Registrar can award ISO13485 registration, not all can. Potentially you will also need a Registrar that is accredited by Health Canada under the CMDCAS scheme.

If all of this is new to you, I would recommend hiring a consultant, even in addition to reviewing everything on the Cove.

Drop me a PM if you would like additional information.
  Post Number #7  
Old 17th December 2009, 08:24 AM
KCawley

 
 
Total Posts: 1
Please Help! Re: Could we combine ISO 13485 and ISO 9001:2008?

I also have been given the task of getting ISO13485 certification as our company are introducing a new medical device product (design will not be in scope).
We are currently certified to ISO 9001:2000 and the plan is to combine both standards so both 13485 & 9001 are combined in the same audit.
I just purchased the ISO13485 standard and Annex B gives a listing of the differences between 13485 & 9001 - in practical terms what would be the workload in getting certification to ISO13485 - what timeframe should I expect this to completed in?
I have limited knowledge of the ISO13485 requirements also
  Post Number #8  
Old 17th December 2009, 09:24 AM
Doug Tropf

 
 
Total Posts: 388
Re: Could we combine ISO 13485 and ISO 9001:2008?

Welcome. Preparation efforts for ISO 13485 shouldn't be too time consuming since you are already certified to ISO 9001. You can use ISO 13485's Annex B as a guide to complete a gap analysis - then go to work. I would recommend you obtain ISO 14969 (the guide for application of ISO 13485) as I found it very useful in our certification efforts.
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