ISO 13485 Internal Auditor Training
- Understand the Quality Management Principles in the context of ISO 13485:2003.
- Relate the quality management system to the organization’s medical devices
- 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 situation.
- 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.
- Introduction and Welcome
- The Challenge for Top Management
- Overview of ISO 13485:2003 Requirements
- In Class Activity: Exclusions
- Overview of ISO 9001:2008 Requirements (cont.)
- Introduction to ISO 13485:2003 Audit Trails
- In Class Activity: Documentation Review
- Management of Audit Programs
- Audit Planning and Preparation
- In Class Activity: Scope and Objectives
- In Class Activity: Audit Plan
- Performing the Audit
- In Class Activity: Opening Meeting
- In Class Activity: Conducting the Audit
- Writing Nonconformity Statements
- In Class Activity: Writing Nonconformities
- Closing Meeting
- In Class Activity: Summary Statement and Closing Meeting
- Completing the Audit Report
- Corrective Action and Closeout
- In Class Activity: Verification and Closeout
- Individuals interested in conducting second- or third-party audits of QMS management systems based on ISO 13485
- Quality Management Representatives
- Quality Consultants
- Quality and Production Directors
- Cross-functional team members of a QMS implementation project
- Individuals who want to become an IRCA or RABQSA International Certified Provisional Auditor, Auditor, Principal Auditor, or Internal Auditor
Individuals who successfully display competence during these courses will receive a Certificate of Attainment stating that he or she has satisfied the ISO 13485 Foundations training requirements for Medical Devices through RABQSA
- RABQSA InternalAuditor Certificate
- TPECS – Some organizations have the ability to provide TPECS modular instruction. TPECS: Training Provider Examination Certification Scheme.
- TPECS Ensures:
- Improved assessment and evidence of competence;
- A more effective and efficient personnel certification process; and
- Greater involvement of training providers in the personnel certification process.
- Other Special Features may vary