This class addresses how quality management systems (QMS) and ISO 13485 apply to the medical device industry and how to develop a management system in conformity for ISO 13485 certification.
This ISO 13485 Lead Auditor Training is intended particularly for companies that produce or service medical devices or are part of an FDA regulated industry. It addresses the concerns specific to the medical device industry including risk management, software validation and supplier management.
This class may be run in conjunction with a ISO 13485 Lead Auditor Training Course.
Students successfully completing QMII’s 4-day ISO 13485 Lead Auditor training course and the TPECS examinations provided in conjunction with this course, receive a Certificate of Attainment for the following Exemplar Global (formerly RABQSA International) knowledge competency units:
MD – Medical Devices Management Systems
AU – Management Systems Auditing
TL – Leading Management Systems Audit Teams
The Certificate of Attainment provides evidence of knowledge competency defined by Exemplar Global in the competency units required for certification as a Medical Devices Management Systems Lead Auditor using ISO 13485:2016.
Successful course candidates can use these certifications as earned credit towards other certifications such as ISO 14001 Auditor and other similar standards under Exemplar Global’s Training Provider & Examiner Certification Scheme (TPECS).