ISO 13485 Internal Auditor Training Courses

Training for Other Standards


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ISO 13485 Internal Auditor Training

ISO 13485 Internal Auditor Class Objectives:

  • 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.

Outline (Typical Agenda)

Day 1

  • Introduction and Welcome
  • The Challenge for Top Management
  • Overview of ISO 13485:2003 Requirements
    • In Class Activity: Exclusions

Day 2

  • 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

Day 3

  • 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

Who Should Attend?

  • 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

ISO 13485 Internal Auditor Certification

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

Special Features

  • 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.
  • AATT
  • Other Special Features may vary