(Have a look at our infographics for more details about the differences existing between the two systems). In a nutshell, ISO 9001 is more customer oriented whereas ISO 13485 is more product oriented. Medical Device Quality Compliance (MDQC), LLC.įor more on this topic, please visit ASQ’s website. ISO 13485 was developed to ensure reliability, quality, trust and strong commitment to human safety. Many medical device companies today get ISO 13485:2003 registered and have dropped ISO 9001:2008 altogether as not being necessary.īy the way, TC 210 issued a technical corrigendum to ISO 13485:2003 in August of 2009 correcting its reference to “ISO 9001” to “ISO 9001:2000” to make this clear.
It is important to note that many governments such as Health Canada have adopted ISO 13485:2003 as their law or have their medical device law based on 13485:2003. La norme ISO 13485 est une norme indépendante, publiée pour la première fois par l’Organisation internationale de normalisation (ISO) en 1996.Elle constitue un jalon important dans le développement de l’industrie des dispositifs médicaux et une étape importante dans la fourniture d’une norme pour les entreprises opérant dans ce secteur. When TC 176 revised ISO 9001 in 2008, TC 210 decided not to make a change to ISO 13485 because ISO 9001 requirements didn’t change substantially. In other words, ISO 13485:2003 is ISO 9001:2000 (but with the requirement for “continual improvement” removed) and additional requirements for the medical device industry This was readily apparent in ISO 13485:2003 as much of the text. These two standards have always been very closely aligned, as the 19 versions of ISO 13485 were directly based on ISO 9001 (1994/2000). ISO 13485:2003 is founded on ISO 9001:2000, with additional requirements added for the medical device industry. Now, both ISO 9001 and ISO 13485 have been revised, with publication of the fifth edition of ISO 9001 in September 2015 and publication of the third edition of ISO 13485 in March 2016. They are two separate, independent technical committees that write and revise standards. Shouldn’t it be ISO 9001:2008 Quality management systems–Requirements?Ī: ISO 9001 is “controlled” by Technical Committee (TC) 176 while ISO 13485 is “controlled” by TC 210. Q: Why does Annex B of ISO 13485:2003: Medical devices - Quality management systems - Requirements for regulatory purposes address ISO 9001:2000?