ISO 13485 - Antaris Consulting

Determining the Frequency of Management Review Meetings

The objective of management reviews is for top management to examine the effectiveness, appropriateness, applicability, and adequacy of the quality management system as well as safeguarding the products safety, effectiveness, and quality. ISO 13485:2016 ISO 13485:2016 requires management review meetings to be held at ‘planned intervals’, with no requirement for them to be held at […]

ISO 13485: Medical Devices – Quality Management Systems

ISO 13485: Medical devices – quality management systems was published in March 2016. This third edition cancels and replaces the second edition (ISO 13485:2003), which has been technically revised. Rather controversially, ISO 13485:2016 has not been revised in line with the high level structure, HLS, adopted by ISO 9001:2015, ISO 14001:2015 and 30 other management […]

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