Health Canada Releases Draft Guidance on QMS Audit Reports

Health Canada released a draft guidance document on the content of QMS audit reports. The document is open for comments until March 8, 2011. The document provides guidance to Health Canada recognized registrars on the content of quality management system (QMS) audit reports.

This guidance document uses the work of Study Group 4 of the Global Harmonization Task Force (GHTF), and in particular on the technical content of GHTF document SG4/N33R16:2007 Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 3: Regulatory Audit Reports.

You see the announcement, learn how to comment, and get a PDF copy of the draft guidance at