Medical Devices ISO 13485:2016 Auditor Certification

The Qualification-Based (QB) Medical Device (ISO 13485:2016) Auditor Certification Program has been developed by Exemplar Global in liaison with industry representatives.

The program provides international recognition for auditors who conduct Medical Devices audits using national or international management system standards (eg. ISO 13485:2016), or other management system standards, normative and industry references that are recognized by Exemplar Global.

The purpose of this program is to develop and certify confident and reliable auditors for the Medical Device Industry. To achieve this detailed knowledge of the audit process and international standards are needed as well as direct auditing experience.
This personnel certification program has been developed to meet the following key objectives:

  • To achieve the requirements of the International Standard for personnel certification
    ISO/IEC 17024:2012;
  • To ensure that auditors meet or exceed the qualification guidelines for management system auditors described in ISO 19011:2011 and ISO 13485:2016 and are assessed as competent to perform medical device audits;
  • To assist organizations in identifying or documenting appropriately qualified auditors; and
  • To enhance the professional knowledge, reputation, and recognition of qualified auditors.
Grade Knowledge Competencies Education Work Experience Audit Experience
Medical Device Associate Auditor Exemplar Global-AU,
Exemplar Global-MD or
ISO 13485:2016 Auditor course
Associate Degree (2 year program) or higher 2 years industry experience within the last 4 years N/A
Medical Device Auditor Exemplar Global-AU,
Exemplar Global-MD or
ISO 13485:2016 Auditor course
Associate Degree (2 year program) or higher 4 years industry experience within the last 6 years 20 audit days, with at least 4 complete audits as member of audit team.
Medical Device Principal Auditor Exemplar Global-AU,
Exemplar Global-MD or
ISO 13485:2016 Auditor course
Associate Degree (2 year program) or higher 6 years industry experience within the last 8 years 20 audit days, with at least 4 complete audits. At least 10 days and 2 complete audits as a solo auditor.
Medical Device Lead Auditor Exemplar Global-AU,
Exemplar Global-MD or
ISO 13485:2016 Lead Auditor course
Associate Degree (2 year program) or higher 8 years industry experience within the last 10 years 35 audit days, with at least 7 complete audits. At least 15 days and 3 complete audits as Team Leader.
Medical Device Business Improvement Auditor Exemplar Global-AU,
Exemplar Global-MD or
ISO 13485:2016 Lead Auditor course plus
Exemplar Global-OI
Associate Degree (2 year program) or higher 8 years industry experience within the last 10 years 35 audit days, with at least 7 complete audits. A least 15 days and 3 complete audits as Team Leader.