My solo consultancy is geared towards startup medical device companies preparing for quality system lift-off.
Category Archives: ISO 13485
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”
Quality Policy and Objectives
Does your organization’s Quality Policy inspire you, or tire you? First, let’s review US FDA and ISO 13485 requirements and ISO 14969 guidance. After that, I am sharing my current “state of the art” model for a Quality Policy and corresponding Quality Objectives. Quality Policy Definitions ISO 9000:2005 – Overall intentions and direction of anContinue reading “Quality Policy and Objectives”
Independence Matters
Independence is the basis for judicial systems and sporting matches. And for quality systems, it is generally accepted that personnel who are independent of an activity are more objective (impartial) than persons who are directly responsible for the success of the work.
