BSI’s “ISO 13485:2003 and the QSRs Internal Quality Systems Auditor” course, designed for those with knowledge of medical device manufacturing, starts with one full day of review of ISO 13485:2003. Students gain a broad understanding of the ISO 13485:2003 quality management system requirements and their relationship with the FDA’s QSRs under Title 21 of the CFR, Part 820. In addition, the concepts of ISO 14971:2007, “Application of Risk Management to Medical Devices,” are introduced. Through small group activities, audit role-plays, lively discussions, and instructor-led lectures, students gain a thorough understanding of the principles of auditing. Students also learn how to apply the guidance of ISO 19011:2002, “Guidelines for Quality and/or Environmental Management Systems Auditing,” to implement effective internal audit programs for medical device manufacturing organizations.
Learning objectives
- Understand Quality Management Definitions, Concepts, and Guidelines
- Understand the Quality Management Principles
- Interpret All Clauses of ISO 13485:2003
- Apply Principles of ISO 14971:2007 for Risk Management
- Understand the Relationship between the QSRs (from title 21 of the CFR, Part 820) and ISO 13485:2003
- Understand the Linkage between ISO 13485:2003 and GMPs
- Apply Principles of ISO 19011:2002 to the Auditing Process
- Plan, Conduct, and Report Effective Internal Audits to ISO 13485:2003
- Understand the Registration Process
Course materials
Students receive comprehensive course manuals with reference materials.
Who should attend?
- Quality managers
- RA managers
- Auditors of medical device manufacturing firms (internal and external)
- Cross functional team members implementing the standard
Duration
Course times:
- Day 1: 8:00 am – 5:30 pm
- Day 2: 8:00 am – 5:30 pm
- Day 3: 8:00 am – 5:30 pm
Prerequisite
Participants should have a working knowledge of quality management systems, ISO 9001:2008, or ISO 13485:2003.
Course logistics
Certificates of attendance are provided at the conclusion of the course.
Student : Instructor Ratio – 20:1
