Evaluate your quality management system according to ISO 13485:2016 with these 365 routine questions, for internal audits or before your notified body audit. Find a list of expected documents for each question, as well as explanations for implementing each clause of ISO 13485:2016, illustrated with flowcharts. A must-have for evaluating your QMS. 155 pages, available for immediate download

Learn how to create a process for your QMS step by step, according to ISO 13485. This short guide will help you to properly document your processes in your quality management system.

How to write an effective procedure ? In this guide you'll find: The place of the procedure in document management and in a process; Where to start?; Strategies for writing a procedure; How to be clear and relevant; How to structure your procedure; My writing tips

Discover clear SWOT analysis guidance tailored to your QMS, effective strategies to boost compliance and product quality, expert tips for KPI management, and inspiring case studies to guide your quality management journey.

How to Integrate Risk Management Activities in Design & Development? This short guide, illustrated with concrete diagrams, will help you quickly understand how to place risk management at the heart of your Design & Development activities.