This five-day course is certified by RABQSA under the TPECS scheme, and meets the
knowledge criteria requirements for Medical Device Management Systems and the Lead
Auditor grade or lower. This seminar fully covers the ISO 13485:2003 requirements.
Other topics include audit systems, the auditing process and audit instruments;
the documentation process, conducting an audit, writing the audit report, and taking
corrective action. Auditing case studies to develop skills for identifying nonconformities
will be used.
This class also covers the FDA 21 CFR 82030 for design control guidance for Medical
Device Manufacturers, the section of the Food, Drug and Cosmetic Act relating to
Medical Devices, Labeling for Medical Devices, US FDA QSR regulations and Good Manufacturing
Practices (GMP), Post Market Surveillance, and Human Factors in Medical Device Design.
Attendees who successfully demonstrate competence during this course will achieve
a Certificate of Attainment for the following competency units:
Who Should Attend
This seminar is designed for Management Representatives, ISO 13485:2003 Implementation
Teams, Internal Auditors and others who would like to develop judgment and decision-making
in ISO 13485:2003 and learn the auditing process for first, second, and third party
Recommended Training and/or Experience
An understanding of the ISO 13485:2003 requirements and/or work experience in applying
ISO 13485:2003 is recommended.
Each participant will receive a seminar manual and a breakout workbook that includes
auditing case studies.
- Understand the application of Quality Management Principles in the context of ISO
- Relate the quality management system to the organization’s medical devices, and
provision of related services.
- Understand the application of the principles, procedures and techniques of auditing.
- Understand the conduct of an effective audit in the context of the auditee’s organizational
- Understand the application of the regulations, and other considerations that are
relevant to the management system, and the conduct of the audit.
- Practice personal attributes necessary for the effective and efficient conduct of
a management system audit.
- Establish, plan and task the activities of an audit team.
- Communicate effectively with the auditee and audit client.
- Organize and direct audit team members.
- Prevent and resolve conflict with the auditee and/or within the audit team.
- Prepare and complete the audit report.
- Introduction and Welcome
- The Challenge for Top Management
- Overview of ISO 13485:2003 Requirements
- Breakout Exercise 1: Exclusions
- Overview of ISO 13485:2003 Requirements (continued)
- Introduction to ISO 13485:2003 Audit Trails
- Breakout Exercise 2: Documentation Review
- Management of Audit Programs
- Audit Planning and Preparation
- Breakout Exercise 3: Scope and Objectives
- Breakout Exercise 4: Audit Plan
- Performing the Audit
- Breakout Exercise 5: Opening Meeting
- Breakout Exercise 6: Conducting the Audit
- Writing Nonconformity Statements
- Breakout Exercise 7: Writing Nonconformities
- Closing Meeting
- Breakout Exercise 8: Summary Statement and Closing Meeting
- Completing the Audit Report
- Corrective Action and Closeout
- Breakout Exercise 9: Verification and Closeout
- Review of Audit Process and Audit Management Strategies
- Practical Application of Audit Principles and Instructor Interviews