ISO 9001:2008 36-Hour Certified Lead Auditor with Medical Device Focus (ISO 13485:2016)

Who Should Attend

Those responsible for planning and scheduling an audit program for ISO 13485 and those who must perform audits to ISO 13485, Quality Assurance Managers, Quality Assurance Professionals, ISO Project Managers, ISO Project Team Members, Compliance Managers, Regulatory Personnel or anyone desiring an in-depth understanding of the ISO 13485 Audit Process. This course has been specifically designed to meet the needs of the Medical Device Industry.

Course Details

• 4 Days

• 3.6 CTUs

• $1995

This course will help you:

  • Fully understand and interpret the requirements of ISO 13485
  • Understand the differences between ISO 9001 and ISO 13485, including the critical differences in requirements for continual improvement and customer satisfaction
  • Understand the requirements contained in 21 CFR 820 and be able to compare these to the requirements in ISO 13485
  • Conduct a practical audit exercise to 21 CFR 820 to ensure understanding of these requirements
  • Understand how to apply the requirements of ISO 9001 and the ISO 13485 Standards during 5 practical audit exercises conducted during the class
  • Understand the terminology of the ISO 9001 and ISO 13485 and how these apply in a Medical Device Environment
  • Learn how to develop an ISO 9001 / ISO 13485 auditing system based on the ISO 19011 auditing requirements
  • Learn how to ask audit questions that get results
  • Learn how to conduct opening and closing meetings that have impact
  • Learn how to construct effective audit checklists
  • Learn how to generate effective corrective actions


  • Day One
    7:30am to 7:00pm
    • 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 Two
    7:30am to 7:00pm
    • 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 Three
    7:30am to 7:00pm
    • 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 Four
    7:30am to 5:30pm
    • 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 Five
    8:00am to 12:00pm
    • Review and Exam

Have questions? Contact us

DEKRA Audits

8990 Springbrook Dr. NW

Suite 210

Minneapolis , MN 55443

+1 800.633.2588
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