How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements

Descriptions

How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements By Stephanie L. Skipper

Product Information:

• Format: Hardcover
• Publisher: ASQ Quality Press (October 14, 2015)
• Language: English
• Print Length: 156 pages
• ISBN-10: 0873899172
• ISBN-13: 978-0873899178
• Item Weight: 1.09 pounds
• Dimensions: 7 x 0.44 x 10 inches
• Best Sellers Rank: #1,609,901 in Books (See Top 100 in Books)
• Customer Reviews: 4.3 out of 5 (10 ratings)

Description:

• Provides a methodology for compliance with FDA regulations and ISO standards (9001/13485) for documented information controls.
• Emphasizes the importance of a well-developed document control system (DCS) as the foundation of a quality management system.
• Discusses benefits to businesses, including improved knowledge retention, standardized processes, and enhanced customer communication.
• Offers a process-based approach for controlling all forms of documented information under the quality management system.
• Includes sample documents in the appendixes for clarification.

Pricing:

• Buy From Amazon Hard Cover:  $70.00+Additional costs of Shipping
• Buy Soft Copy from Booksbybb: $30.99 only

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Author Information:

• Stephanie L. Skipper:
  • No additional author details provided.

Customer Reviews:

• Rating: 4.3 out of 5 (10 global ratings)
• Review Examples:
  1. carla. (December 15, 2019): Describes the book as the most thorough discussion of document control, commending Stephanie Skipper for bringing logic to the topic.
  2. J.K.A.Kos (July 21, 2016): Criticizes the book as global, lacking understanding of the difference between revision and version. Suggests there are better books on the market for less money with more value.