ISO 13485:2016 Medical Devices Internal Auditor

SAI Global
Training overview
Professional Course
3 days

Course description

ISO 13485:2016 Medical Devices Internal Auditor

This 3 day course is designed to provide participants with the knowledge and skills required to perform an internal audit of a quality management system based on ISO 13485. It will also provide a hands-on approach to planning, conducting and reporting on internal audits in accordance with ISO 19011 and meets the training requirements for Exemplar Global (TPECS) Auditor Certification for Quality Auditors.

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Who should attend?

  • Quality coordinators/QMS management representatives
  • Quality professionals
  • Any personnel who will act as internal auditors

Training content

At the end of the course, participants will understand how to:

  • Explain the purpose of a Quality Management System
  • Explain the purpose of the ISO 9000 Standards
  • Explain the audit process - plan, conduct, report and follow-up in accordance with ISO 19011
  • Undertake an audit of a Quality Management System against the requirements of the ISO 13485 Standard

Modules

  • Module 1: Quality Management Systems
  • Module 2: Audit Fundamentals
  • Module 3: ISO 13485:2016 Standard
  • Module 4: Managing an Audit Program
  • Module 5: Audit Planning and Preparation
  • Module 6: Conducting Audit Activities
  • Module 7: Preparing and Distributing the Audit Report
  • Module 8: Completing the Audit and Conducting Follow-up

About SAI Global

sai global

SAI Global

At SAI Global, we understand the challenges of building stakeholder trust and confidence for companies at all stages of maturity. We work with organizations to help them meet stakeholder expectations for quality, safety, sustainability, integrity and desirability in any market...


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