Course Description
BSI's ISO 13485:2003 Lead Auditor Training course begins with a review of requirements of ISO 13485:2003. This course then 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 instructorled 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.
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
Students receive comprehensive course manuals with reference materials, including loan copy of :
- Copy of ISO 13485:2003
- Copy of ISO 14971:2001
- Copy of ISO 19011:2002
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
For more information, please contact BSI India or complete our training enquiry form.
