EN ISO 13485:2012 supersedes EN ISO 13485:2003

Saturday, September 20, 2014

EN ISO 13485:2012 will soon be the harmonized standard for quality management systems under EC Directives 90/385/EEC (Active Implantable Medical devices), 93/42/EEC ( Medical Devices) and 98/79/EC (In Vitro Diagnostic Medical Devices). However as it contains no new requirements manufacturers that have been successfully audited by a Notified Body will not normally require any changes to their quality management system.

The Changes

The scope, terminology and the requirements contained in sections 4 to 8 of EN

ISO 13485:2012 are exactly the same as those in ISO 13485:2003. Thefore the ISO

13485 audit criteria being assessed by a certification body or Notified Body

have not changed.

The section that has been changed is the Foreword and in particular Annex

ZA, Annex ZB and Annex ZC. These annexes link the clauses in ISO 13485:2003

with the requirements of the conformity assessment annexes of Directives

90/395/EEC, 93/42/EEC and 98/79/EC respectively. What these annexes now make

clear is that the Directives have requirements which must be met by

manufacturers in addition to meeting all the generic requirements in ISO 13485.


As the requirements of ISO 13485 have not changed, certificates issued

against ISO 13485:2003 will remain valid and no change in any certificate is

strictly necessary. However for some time BVQA has been indicating both ISO

13485:2003 the international version and EN ISO 13485:2003 + AC 2009 the

European harmonized version on all their BoA accredited certificates. So when

EN ISO 13485:2012 is officially harmonized (expected before the end of 2012) BVQA

will start to reference ISO 13485:2003 and EN ISO 13485:2012 on all new or

amended certificates. The reference to ISO 13485 on CMDCAS certificates will

not change as this scheme is based only on ISO 13485:2003. It is expected that

other Notified Bodies will take similar action on certificates.


Manufacturers can check the

progress of the harmonization of this standard on the EC Commission website.