Build a digital QMS for ISO13485…

…without QMS software Most people who want to start building a Quality Management System (QMS) look at dedicated QMS software first. So did I years ago. But after a thorough “Quest for Quality” I chose a more efficient ánd economical approach. I wrote a whitepaper to share the lessons learned while looking to implement an …

QMS structure

Procedures for ISO 13485 The image below shows a visual overview of the procedures (tier 1 and 2) and their interactions in a QMS based on ISO 13485. (Requirement 4.2.2c Quality Manual: “a description of the interaction between the processes of the quality management system“). NOTE: The structure shows how my QMS for ISO 13485 …