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.

Grades

Medical Device Associate Auditor

Knowledge Competencies: Exemplar Global-AU, Exemplar Global-MD or ISO 13485:2016 Auditor course
Education: Associate Degree (2 year program) or higher
Work Experience: 2 years industry experience within the last 4 years
Audit Experience: N/A

Medical Device Auditor

Knowledge Competencies: Exemplar Global-AU, Exemplar Global-MD or ISO 13485:2016 Auditor course
Education: Associate Degree (2 year program) or higher
Work Experience: 4 years industry experience within the last 6 years
Audit Experience: 20 audit days, with at least 4 complete audits as member of audit team.

Medical Device Principal Auditor

Knowledge Competencies: Exemplar Global-AU, Exemplar Global-MD or ISO 13485:2016 Auditor course
Education: Associate Degree (2 year program) or higher
Work Experience: 6 years industry experience within the last 8 years
Audit Experience: 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

Knowledge Competencies: Exemplar Global-AU, Exemplar Global-MD or ISO 13485:2016 Lead Auditor course
Education: Associate Degree (2 year program) or higher
Work Experience: 8 years industry experience within the last 10 years
Audit Experience: 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

Knowledge Competencies: Exemplar Global-AU, Exemplar Global-MD or ISO 13485:2016 Lead Auditor course plus Exemplar Global-OI
Education: Associate Degree (2 year program) or higher
Work Experience: 8 years industry experience within the last 10 years
Audit Experience: 35 audit days, with at least 7 complete audits. A least 15 days and 3 complete audits as Team Leader.