ISO IEC EN Standards Hacks, Tips, Tricks

Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS) EVS is the national standards body in Estonia. Since Estonia is a member of the European Union they will publish ISO / IEC and CEN / CENELEC standards with the “EVS-” prefix added to the front of the designation See examples below. Example A – ISO Standards (the standard identification number 12345 and the EuroContinue reading “ISO IEC EN Standards Hacks, Tips, Tricks”

ISO 13485:2016 Quality System Process Risk Management

ISO 13485:2016 has a broader view of risk management than in the past. Risks are to be considered in terms of the impact on medical device safety and performance, and in terms of meeting regulatory requirements. For managing quality system process risks, rather than adding a “Risk” section to each Standard Operating Procedure (SOP) as some haveContinue reading “ISO 13485:2016 Quality System Process Risk Management”