ISO 13485 Lead Auditor Training Classes

Training for Other Standards


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ISO 13485 LEAD AUDITOR Training

ISO 13485 Lead Auditor Class Objectives:

  • Understand quality management definitions, concepts, and guidelines
  • Understand the purpose of the ISO 9000 series
  • Understand the requirements of the ISO 13485:2003 standard
  • Understand the roles and responsibilities of the auditor
  • Apply ISO 19011:2002 definitions, concepts, and guidelines
  • Recognize the principles, practices, and types of audits
  • Conduct all phases of an internal audit
  • Prepare and present effective reports
  • Understand RABQSA’s certification scheme
  • Understand the role of objectives, scope and criteria in the audit process
  • How to plan audits
  • Conduct audit team selection
  • Initiate the audit and conducting opening meetings
  • Understand audit team leader responsibilities
  • Communicate effectively during the audit
  • Conduct on-site activities
  • Prepare audit conclusions
  • Conduct closing meetings
  • Report audit results

Outline (Typical Agenda)

Day 1

  • Introduction
  • Accreditation / Certification/Registration
  • 8 Principles of Quality Management Systems
  • Process Management and the Plan Do Check Act (PDCA) Cycle
  • Introduction to the ISO 9000 Standard Series
  • Quality Management System Standard ISO 13485:2003
  • Day 1 Review

Day 2

  • Day 1 Review
  • Documentation of Management Systems
  • Processes and techniques for assessing the Quality Management Systems
  • Medical Devices Requirements
  • Intro to Auditing
  • Auditor Competence, Roles and Responsibilities
  • Sample Exams

Day 3

  • Day 2 Review
  • Starting the Audit and Preparing for on-site activities
  • Creating an Audit Plan
  • Creating Audit Checklists
  • Conducting on-site audit activities
  • Opening Meeting
  • Collecting and verifying information
  • Evidence and verifying information
  • Day 3 Learning Cycle Review

Day 4

  • Day 3 Review
  • Review of Case Study
  • QMS Simulated audit Interviews based upon QMS case study
  • Writing Audit Findings including classification
  • Audit Reporting
  • Writing the Audit Report
  • Day 4 Learning Cycle Review

Day 5

  • Day 4 Review
  • Completing the Audit
  • Evaluating Corrective and Preventive Actions
  • Audit Follow-Up Strategies
  • Analysing the audit results
  • Final Audit Team Meeting
  • Course Summary
  • Exam Instructions
  • Closing Meeting

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
  • Supplier Quality Engineers
  • Supply Chain Personnel
  • Regulatory Affairs Managers
  • Quality and Production Directors/VPs
  • Cross-functional team members of a QMS implementation project
  • Individuals who want to become an RABQSA International Certified Provisional Auditor, Auditor, Principal Auditor, or Lead Auditor

ISO 13485 Lead 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 Lead Auditor Certificate

Special Features

  • Online ISO 13485 Lead Auditor Training is not permissible. However, some courses combine an initial component over the Internet, and conclude with a 3-day classroom section under the guidance of an experienced trainer. (Online & Instructor Led)
  • 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