✔️Access 365 questions to evaluate your QMS
✔️Access the list of expected evidence to respond to each clause of the standard
✔️Be guided by +72 flowcharts to implement each clause
✔️Lifetime updates in case of standard evolution
155 pages, digital download
For each section of ISO 13485:2016, you will find:
✔️ Relevant questions to evaluate the clause
✔️The list of evidence expected to comply with the clause
✔️A guidance section with a flowchart to easily implement the clause
This book will enable you to:
Regularly assess your QMS or conduct an internal audit using the 365 questions that cover the 72 clauses of ISO 13485:2016.
Don't wait for your notified body to find non-conformities; anticipate them by asking the right questions.
For each clause, find a list of expected evidence and a guide to help you implement the clause
Improve the efficiency of your internal audits, detect non-conformities, and correct them.
Lead auditor ISO 13485; ISO 14971; EU MDR ; EU IVDR
"A pleasant-to-read book that has improved the quality of my ISO 13485 audits when I go to audit clients."
QARA Manager
"It allowed us to avoid potential non-conformities before our audit with the notified body."
"It allowed us to strengthen our internal audit process with ready-made questions from the book."
Regulatory Compliance Director | Consultant
"What a helpful tool."
Quality Manager
"An immediately actionnable book"
Senior Project Manager - Medical Devices
"Perfect fit with ISO TC 210 & ISO 13485; great tool"
The book may evolve based ISO 13485 requirements. Once in your possession, you will receive updates free of charge.