ISO 13485 Changes
ISO 13485:2012 has now been issued which will supersede the current version ISO 13485:2003. However, it is the European version that has been updated and other countries outside of Europe therefore still use ISO 13485:2003.
Why was the change made?
The European standard EN ISO 13485:2012 Medical Devices, Quality Management Systems, Requirements for Regulatory Purposes, has been published, after approval by CEN on 24 January 2012. This replaces EN ISO 13485: 2003. The change was made as a number of European countries objected to the inference that ISO 13485 inferred compliance to the Medical Device Directive (MDD). To solve this problem, annexes at the beginning of the new standard have now been expanded to link the clauses of ISO 13485 to the Medical Device Directive.
It is important to note that the text of the global standard ISO 13485:2003 is unchanged. Only the foreword and annexes in the European version have been revised.
During 2011, the European Commission raised an objection to the harmonization status and the implied Presumption of Conformity of a number of European standards including EN ISO 13485. Sweden also raised a formal objection to the European Commission in February 2011 on the link between adhering to the standard and compliance to the Medical Device Directives (MDD).
To restore confidence and bring back the presumption of compliance indicated by the harmonized status of the standard, Annexes ZA, ZB and ZC were revised and add further details on the link between standards and the three Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
Our Notified Body (SAI Global) states that once EN ISO 13485:2012 is harmonized there will be no need for existing customers with ISO 13485 certificates to undergo an automatic update or re-issue of certification. This is because there is no change in the requirements of the standard. Any existing certificates being renewed or reissued to support changes after this date will be updated at the point of reissue to also refer to ISO 13485:2012.
How do the changes affect Crescent Industries?
Practically they don’t really affect the standard. However, there have been changes to the on-site audit days required for re-registration audits according to the IAF (International Accreditation Forum). The days required for Crescent’s re-registration audit is now 4.5 audit days on site (previously it was 3 days). There are no new requirements, in fact there are no changes at all in the main text of the standard, and so it is expected that Certification Bodies will just issue a new certificate once the standard is harmonized.
--Written by Victor Gurany, Quality Assurance Manager