Certified Medical Device Single Audit Program Internal Lead Auditor
Issued by
Exemplar Global
Professionals who hold this certification are competent to to conduct a medical device single lead audit that satisfies the requirements of multiple regulatory authorities, including the requirements of ISO 13485:2003 and Good Manufacturing Practice (GMP) requirements for each applicable regulatory authority. They have completed an Exemplar Global-certified training course (or equivalent) and have also completed the Exemplar Global Work Style Assessment for Lead Auditors.
- Type Certification
- Level Intermediate
- Time Days
- Cost Paid
Earning Criteria
Standards
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
This document provides guidance on auditing management systems, including auditing principles, managing an audit program, conducting management system audits, and guidance on the evaluation of competence of individuals involved in the audit process. These activities include the individual(s) managing the audit program, auditors and audit teams.