ISO 13485 Lead Auditor Training (RABQSA Certified)
 

  1. Unit 1
    1. Terminology and Definitions
    2. Background, History and Rationale for Quality Assurance
    3. Introduction to the ISO Family of Documents
    4. Analysis of the Contents of ISO 13485
    5. Audit of Active Medical (Audit #1)
       
  1. Unit 2
    1. Quality System Requirements
    2. Analyzing Findings
    3. Audit of Active Medical to ISO 13485 (Audit #2)
    4. RABQSA and U.S. Certification System
    5. Auditor Qualifications
    6. Roles and Responsibility of Auditors
    7. Creation of Effective Audit Checklists
       
  2. Unit 3
    1. Audit of Active Medical - Document Audits (Audit #3)
    2. Tips for the Professional Auditor
    3. Audit of Active Medical - Department Audit (Audit #4)
    4. Compiling Audit Findings
    5. Documentation in the Quality System
    6. Planning and Conducting Effective Audits
    7. Refining Interview and Note-Taking Skills
    8. Applicability of the Elements to Company Situations
    9. Prevention vs. Detection
       
  1. Unit 4
    1. Audit of Active Medical - Department and System Auditing (#5)
    2. Corrective Action Initiation and Closure
    3. Refining Audit Interview and Note-Taking Skills
    4. Creation of an Audit Report
    5. Conducting the Audit
    6. Preparation and Presentation of a Closing Meeting
       
  2. Unit 5
    1. Review and Exam

 

Return to Course Description