ISO 13485:2016 Pocket Guide – 2nd Edition



The ISO 13485:2016 Pocket Guide for Every Employee (2nd Edition) is your quick reference and helpful guide to implementing and maintaining the ISO 13485 quality standard.

– Pocket size and spiral bound for ease of use
– Explains the meaning and purpose of each clause of the standard
– Describes in detail the role and expectations for management and employees in each clause
– An easy reference and a quick reminder as to what to expect in an audit
– Captures the most likely actions of the auditor in each clause
– Enables employees to better perform their duties with more confidence and less concern

Each book contains a front end Q & A, a discussion of quality, and explains the value of being a registered company. Key points of the requirements for each clause are highlighted in yellow, while blue highlighting is used to quickly locate the likely actions of an auditor.

Quality Management System requirements impact every employee. This pocket guide will assist each employee in answering the multitude of questions that occur while implementing and maintaining a compliant medical devices/services quality system in the workplace. It will help them quickly understand the purpose of audits conducted against the standard and enable them to better fulfill their roles with clarity and confidence.

For orders of 25 or more books we can customize the front and back covers of this pocket guide to suit your company logo, colors, and message to employees.