Regulatory changes ahead for ISO 13485 certified organizations
19 December 2011
If your organization is certified to ISO 13485, your audits may increase in duration due to changes in industry requirements.
Effective January 1, 2012, Health Canada will be imposing new mandatory requirements on CMDCAS registrars related to the content of their audit reports. In the European Union, the Notified Body Operations Group (NBOG) previously published a similar guidance document on the content of audit reports.
In addition, a new mandatory document published by the International Accreditation Forum (IAF) containing specific requirements related to audit duration will become effective on July 15, 2012 as a criterion for accreditation of ISO 13485 registrars.
These mandatory documents are available online:
- Health Canada's "Guidance Document GD211: Guidance on the Content of Quality Management System audit reports"
As an ISO 13485 registrar accredited by the Standards Council of Canada (SCC) and recognized by Health Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) program, and as a Notified Body under the Medical Device Directive 93/42/EEC, Intertek shall implement the new mandatory documents by their respective effective dates.
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