BSI's "ISO 9001:2008 Lead Auditor Course with Emphasis on ISO 13485:2003" course begins with a review of ISO 13485:2003 and continues to teach the principles of process auditing in accordance with quality management system standards and ISO 19011:2002, "Guidelines for Quality and/or Environmental Management Systems Auditing." In addition, the concepts of ISO/TR 14971:2001, "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 and how to apply the guidance of ISO 19011:2002 to implement effective audit programs for medical device manufacturing organizations. 
This course is certified by the RABQSA. Students successfully completing this course (by passing the continual evaluation and the written examination) fulfill the RABQSA training requirements for QMS Auditor and QMS Lead Auditor certification.
Learning Objectives
- Understand Quality Management Definitions, Concepts, and Guidelines
- Understand the Quality Management Principles
- Interpret All Clauses of ISO 13485:2003
- Apply Principles of PD ISO/TR 14969:2004 and ISO 14971:2001
- Apply ISO 19011:2002 Definitions, Concepts, and Guidelines
- Apply Principles of ISO 19011:2002 to the Auditing Process
- Manage an Audit Program
- Initiate the Audit and Conduct Opening and Closing Meetings
- Conduct On-site Activities
- Communicate Effectively During the Audit
- Generate Audit Findings
- Prepare Audit Conclusions
- Report Audit Results
- Conduct an Audit Follow-up
- Understand the Registration Process
Course Materials Provided
Students receive comprehensive course manuals with reference materials.
Who Should Attend
- Management Representatives
- Quality Directors
- Auditors of Medical Device Manufacturing Firms (internal and external)
- Managers
- Engineers
- Consultants
Prerequisite
A pre-course assignment must be completed before the first day of the course. A prior review of the ISO 13485:2003 standard and internal audit experience are strongly recommended for this course.
Next Steps
