Course Description
This three day course, designed for those with a knowledge of medical device manufacturing, starts with a review of ISO 13485. Students will gain a broad understanding of the ISO 13485 Quality Management Systems requirements, including the proposed revisions. In addition, the concepts of ISO 14971 - The Medical Device Risk Management Standard - will be introduced. This program uses an interactive approach to learning. Students will participate in small group activities and lively debate, along with instructor led segments to gain the knowledge needed to effectively manage changes to the new standard. Students will learn how to apply these principles to produce effective internal audits of medical device manufacturing firms.
Who Should Attend?
- Quality managers
- Regulatory Affairs managers
- Auditors of Medical Device manufacturing firms (internal and external)
- Cross functional team members of implementation project
Benefits to Your Business
This course empowers staff to identify any gaps that threaten the effectiveness of your Medical Devices management systems. Auditors gain self-confidence through hands-on experience.
Course Structure
- Interpret all clauses of ISO 13485:2003
- Understand differences between ISO 13485:1996 and 2003 version
- Apply principles of ISO 14969
- Understand quality management principles
- Apply principles of ISO 19011:2002 in auditing process
- Plan, conduct, and report effective internal audits to ISO 13485
- Understand the essentials of ISO 14971 – The Medical Device Risk Management Standard
Duration
3 days
Prerequisite
Knowledge of medical device manufacturing is a prerequisite to attending this course.
Next steps
View available course dates and book now.
For more information, please contact BSI India or complete our training enquiry form.
