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ISO 13485:2016

Course Dates

To be verified

The new ISO 13485:2016 standard has been published in March 2016

Cost: €395 including course manual, lunch and refreshments.

The ISO 13485 standard “Quality Management Systems. Requirements for regulatory purposes”  is used globally by medical device manufacturers as a regulatory pathway to bring their medical devices onto some of largest worlds markets – Europe, Australia, Japan,  Canada, South Korea and Brazil, etc.

This standard provides the quality system architecture to demonstrate their compliance to strict regulatory requirements in these regions

Transition period

During the transition (co-existence) period, ISO 13485:2016 will co-exist with ISO13485:2003.

The transition period will last until February 2019, at which point the 2003 version will be withdrawn

Some of the key changes to ISO 13485 include:

  • Inclusion of risk management across all process activities
  • Additional requirements for design activities
  • Additional requirements for process validation and verification activities
  • Improvement in supplier control processes using a risk-based approach
  • Increased emphasis on feedback methodologies
  • Explicit requirements for quality system software
  • For outsourced processes control based on risk and ability to meet specifications and requirements
  • Detailed requirements in Technical file
  • Management Review frequency determination

Course Layout:

Module 1.          Background and History

Module 2.          Quality Management System

Module 3.          Management Responsibility

Module 4.          Resource Management

Module 5.          Product Realization

Module 6.           Improvement

Module 7.          Risk-Based Management

This course is designed for Senior Management, Quality Managers, Quality Engineers, QA and Regulatory personnel working on QMS’s in industry.

The successful completion of this programme by the learner does not lead to an award, but a certificate of attendance is issued to each participant.

Safety Shoes –Not Required on this course

Please be sure to view the details on our ISO 9001: 2015 training

7  Centre  Court, Blyry Business and Commercial Park, Athlone


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