Author Description

The ISO 13485:2016 Memory Jogger is a quick reference guide, full of actionable information to give you only what you need, when you need it, for establishing, auditing, working in, and maintaining a medical device Quality Management System (QMS). It is intentionally written in plain English and indexed by section of the standard to help you get to the answer you need in the shortest time. The Memory Jogger is packed full of techniques, templates, and links to communicate the ISO 13485 standard in the language your organization will connect with, leading to quicker adoption and increased comprehension and buy in. It is specifically formatted using the GOAL/QPC exclusive framework to see each section from every angle including: Objective To make sure you are focused on the most important things What it is? A no-frills approach to understand what the ISO 13485 standard is asking you to do How to do it? Step-by-step guidance on how to implement what the ISO 13485 standard is asking for Tools and Techniques to achieve it A whole toolbox of options to achieve each element Documents to prove it A list of audit verifiable evidence to prove that you did what was asked and that your QMS is performing effectively Questions to assure you know it A list of audit questions for each section to assure your organization understands the ISO 13485 standard and for the auditees to know how to answer How can you fail at it? Covering the most common ways to fail for each of the elements (based on 20 years of Quality Management Systems experience and hundreds of audits) This book is designed to give useful guidance to every person in an organization operating in an ISO 13485 QMS. From the associates to the executives, including the quality professionals, the auditors, the auditees, the trainers and those being trained, this Memory Jogger will help them find the information they need quickly. This Memory Jogger will help you jumpstart or optimize yo