ISO 13485 - Medical Device Quality Management System Standard

Marc

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Standard Title: ISO 13485:2003 - Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485:2003 is a Quality Management System for medical devices, specifically for regulatory purposes. It is based on ISO 9001:2000 with some modifications. The standard includes a process model similar to that of ISO 9001:2000 but requires more documented procedures that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

The ISO 13485:2003 standard is an update and compilation of the older ISO 13485:1996 & ISO 13488:1996 standards. This update was in response to the publication of ISO 9001:2000.

The ISO 13485:2003 standard does not reference the requirements of ISO 9001 but does provide medical device manufacturers with a standalone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

Updates and additions/corrections welcomed by posting in this thread.
 

Sidney Vianna

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Re: ISO 13485 - Medical Devices Standard

The ISO 13485:2003 standard does not reference the requirements of ISO 9001 but does provide medical device manufacturers with a standalone standard for quality management systems that need to demonstrate compliance to regulatory requirements.

Updates and additions/corrections welcomed by posting in this thread.
For the uninitiated, that could be a little confusing. ISO 13485:2003 does not reference the requirements of ISO 9001, like the previous version of ISO 13485 used to. It does, however, includes MOST of the requirements from ISO 9001 in it's body, though.
 
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Wes Bucey

Prophet of Profit
Re: ISO 13485 - Medical Devices Standard

The notable exception being it specfically excludes "continual improvement." The primary concept here for medical device maufacturers is that many countries have chosen to "harmonize" their regulations for medical devices by requiring manufacturers to become registered to ISO 13485 as an entry into doing business in their country. Most countries, like Canada, for example, do not allow grandfathering - every manufacturer must qualify! Most countries also have very short lists of registrars they consider qualified to issue a certificate of registration to ISO13485.

The advantage for manufacturers is they only have one set of rules to follow (in addition to the USA FDA) instead of uneven rules in multiple countries where they opt to sell products.
 

Sidney Vianna

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Re: ISO 13485 - Medical Devices Standard

The notable exception being it specfically excludes "continual improvement."
In my opinion, the most notable difference is the missing monitoring of customer satisfaction requirement. Apparently the regulatory stakeholders behind the development of ISO 13485 believe that focus on customer satisfaction and continual improvement would detract from the goal of regulatory compliance.

As there are many medical device manufacturers that are dually certified to both ISO 9001 and 13485, the requirements associated with customer satisfaction and continual improvement don't impede regulatory compliance.

For those interested in learning more about the application of ISO 13485, they should read ISO/TR 14969:2004 - Medical devices -- Quality management systems -- Guidance on the application of ISO 13485: 2003
 

Marcelo

Inactive Registered Visitor
Re: ISO 13485 - Medical Devices Standard

There´s a technical corrigendum which was publisheds in 2009 and which links the standard to the 2000 version of ISO 9001 (instead of the 2008 version).

ISO 13485:2003/Cor 1:2009
 

Marcelo

Inactive Registered Visitor
Re: ISO 13485 - Medical Devices Standard

Apparently the regulatory stakeholders behind the development of ISO 13485 believe that focus on customer satisfaction and continual improvement would detract from the goal of regulatory compliance.

I think the main problem here is that the standard is to be used by manufacturers, and the regulations deal with safety of the patients and end users.

So, costumer satisfaction and continual improvement (of the manufacturer) could mean that the safety of the patient and user could be compromised.
 

Sidney Vianna

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Re: ISO 13485 - Medical Devices Standard

So, costumer satisfaction and continual improvement (of the manufacturer) could mean that the safety of the patient and user could be compromised.
Sorry, Marcelo, but I don't understand. The device designer and manufacturer has to balance product safety with all other expectations, such as cost reduction (via improvement) and customer satisfaction. Automakers do it, aircraft manufacturers do it, toy manufacturers do it. I don't understand what is so special about the medical device industry where a QMS should not be concerned with customer satisfaction and continual improvement. I don't see how a responsible medical device manufacturer would overlook patient safety in order to please a hospital or a doctor.

If you have a concrete example of how these would conflict, can you share?
 

Marcelo

Inactive Registered Visitor
Re: ISO 13485 - Medical Devices Standard

The device designer and manufacturer has to balance product safety with all other expectations, such as cost reduction (via improvement) and customer satisfaction...... I don't see how a responsible medical device manufacturer would overlook patient safety in order to please a hospital or a doctor.

Sidney, you are totally right in your statements, but i was thinking about the practical application of the standard; i can see that a manufacturer, for example, could be pushed by an auditor in fullfilling improvement and satisfaction requirements and thus forget this balance just to "pass the audit".

Please note that this is just my own opinion; the main justification of the writers of the standardon removing these requirements was that continuous improvement and customer satisfaction were too broad a requirement toincluding in regulations, and as the standard was made to harmonize with medical devices regulations, they would create problems in the harmonization should they be required.
 

xcanals_tecno-med.es

Involved In Discussions
Hi all
See the new list of harmonized standards for the medical devices directives published in the Official Journal of the European Union on 7 july 2010

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2010:183:0015:0044:EN:pDF

including the harmonization for the
EN ISO 13485:2003/AC:2009

So the quality manuals and certificates must refer now compliance to:

EN ISO 13485:2003 and EN ISO 13485:2003/AC:2009

or as usually abbreviated:

EN ISO 13485:2003+/AC:2009



Regards

Xavier
 
L

Leeshu

Re: ISO 13485 - Medical Devices Standard

I am beginning to work with a Medical Device company that will provide devices in kits for specific uses i.e ER, or Dr. offices. They will not manufactrue, only assemble in kits and sold. There is an ISO standard 1345. Does anyone have any specific experiences with this standard?
 
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