Course Dates3rd September, 2018 - 3rd September, 2018 (1 days)
The new ISO 13485:2016 standard has been published in March 2016
Cost: €395 (10% discount for Plastic Ireland/Ibec members) 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
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The transition period will last until February 2019, at which point the 2003 version will be withdrawn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
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
WHO SHOULD ATTEND
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