An ISO 13485:2016 Pocket Guide for Every Employee - An Audit of the System not of the People (2nd Edition)

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An ISO 13485:2016 Pocket Guide for Every Employee - An Audit of the System not of the People (2nd Edition) By Edward P. Link

Product Information:

Description:

A quick reference and helpful guide for implementing and maintaining the ISO 13485 quality standard.
Pocket-sized and spiral-bound for ease of use.
Explains the meaning and purpose of each clause of the ISO 13485:2016 standard.
Details the role and expectations for management and employees in each clause.
Acts as a quick reminder for what to expect in an audit, highlighting key points and likely auditor actions.
Enables employees to better perform their duties with confidence and less concern.
Includes a front-end Q & A, a discussion of quality, and explains the value of being a registered company.

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Author Information:

Author: Edward P. Link
Background: More than 40 years of industrial experience as an Engineer, Manager, and Consultant.
Career: Devoted to Quality Engineering and Quality Management at Xerox Corporation and Eastman Kodak Company.
Audits: Conducted over two hundred quality system audits.
Consultancy: More than ten years of experience as a Quality Consultant.
Education: Holds a BS in electrical engineering and an MS in mathematical and applied statistics from Rochester Institute of Technology.

Customer Reviews:

Rating: 4.3 out of 5 (17 global ratings)
Distribution: 62% 5-star, 22% 4-star, 8% 3-star, 0% 2-star, 8% 1-star.
Top Review: Describes the product as awesome, fast delivery, and containing valuable information on the manager and employee responsibilities related to the standards.