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 13485:2016 standard
  • Understand the roles and responsibilities of the auditor
  • Apply ISO 19011 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 Exemplar Global’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

  • Terminology and Definitions
  • Background, History and Rationale for Quality Assurance
  • Introduction to the ISO Family of Documents
  • Analysis of the Contents of ISO 13485
  • Audit of Active Medical (Audit #1)

Day 2

  • Quality System Requirements
  • Analyzing Findings
  • Audit of Active Medical to ISO 13485 (Audit #2)
  • Exemplar Global and U.S. Certification System
  • Auditor Qualifications
  • Roles and Responsibility of Auditors
  • Creation of Effective Audit Checklists

Day 3

  • Audit of Active Medical – Document Audits (Audit #3)
  • Tips for the Professional Auditor
  • Audit of Active Medical – Department Audit (Audit #4)
  • Compiling Audit Findings
  • Documentation in the Quality System
  • Planning and Conducting Effective Audits
  • Refining Interview and Note-Taking Skills
  • Applicability of the Elements to Company Situations
  • Prevention vs. Detection

Day 4

  • Audit of Active Medical – Department and System Auditing (#5)
  • Corrective Action Initiation and Closure
  • Refining Audit Interview and Note-Taking Skills
  • Creation of an Audit Report
  • Conducting the Audit
  • Preparation and Presentation of a Closing Meeting

Day 5

  • Review and Exam

Who Should Attend?

  • Individuals interested in conducting first-party, second-party, and third-party audits
  • Management Representatives
  • Quality Directors in Medical Device
  • Managers
  • Engineers
  • Consultants

ISO 13485 Lead Auditor Certification

This course comprises the following three Exemplar Global TPECS Competency Units whose outcomes are certified by Exemplar Global:

  • MD – Medical Device Systems
  • AU – Management Systems Auditing
  • TL – Leading Management Systems Audit Teams

Attendees successfully completing this course receive a Certificate of Attainment for each of Exemplar Global Competency Units listed above.

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.