ISO 13485:2016 Overview

1 day workshop

About ISO 13485
ISO 13485 represents requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 is evolving to keep up with the changes in the medical device industry. First released in 2003, a revised ISO 13485 was published on February 25, 2016. The revised standard comes with a large number of new requirements that better align it with FDA’s 21 CFR 820.

Your ability to recognize these changes and take appropriate, timely action will help you successfully comply with regulatory requirements (especially in the US).

Why was ISO 13485 revised?

All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to latest quality management system practices, including changes in technology and regulatory requirements and expectations. You will have three years to transition from ISO 13485:2003 and the associated European Standard EN ISO 13485:2012.

Some of the key changes to ISO 13485:2016 include:

  • Alignment of global regulatory requirements
  • Inclusion of risk management and risk based decision making throughout the quality management system
  • Additional requirements and clarity with regard to validation, verification, and design activities
  • Strengthening of supplier control processes
  • Increased focus regarding feedback mechanisms
  • More explicit requirements for software validation for different applications
  • Alignment of global regulatory requirements
  • Validation using pre-clinical and clinical evaluations
  • Validation of packaging and distribution requirements
  • A feedback section, including a new complaint-handling section and other guidance for customer communications
  • Additional improvement measures: adding the use of post-market surveillance, risk-based decisions, and timelines

QSG’s Overview of the Essentials of ISO 13485:2016
This 1 day workshop from QSG provides a comprehensive review/explanation of this standard.

ISO 13485:2016 is explained clause-by-clause with examples from various industries to illustrate individual concepts. This workshop provides a general understanding of the necessary concepts of the standard and its impact on day-to-day operations of organizations in the medical devices industry.

Learning Objectives:

  • Detailed review of ISO 13485:2016
  • Understand the purpose and concepts of ISO 13485:2016
  • Know the requirements of the standard and how they relate to your business
  • Review Risk Management requirements (with an overview of ISO 14971)
  • Understand the process-based and process effectiveness principles
  • Understand the PDCA model for Improvement
  • Learn the relationship between ISO 14971:2007 risk management and ISO 13485:2016
  • Understand how ISO 13485:2016 relates to regulatory requirements

Who Should Attend
Anyone who wishes to learn about the changes to ISO 13485:2016 standard or anyone beginning at the introductory level of ISO 13485:2016.

Location: Lavelle Machine, 485 Groton Road, Westford, MA


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