ISO 13485 Lead Auditor
Issued by
PECB
This certification is a benchmark for all individuals who have a high level of expertise and experience needed to audit a medical devices quality management system (MDMS) and to manage a team of auditors by applying widely recognized audit principles, procedures and techniques.
- Type Certification
Skills
Earning Criteria
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Pass the PECB Certified ISO 13485 Lead Auditor Exam or equivalent
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Submit evidence of 5 years of general work experience with a minimum of 2 years of work experience in medical devices quality management system as well as 300 hours of auditing experience
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Abide by the certification rules and policies
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Adhere to PECB's Code of Ethics
Standards
PECB is a Personnel Certification Body, accredited to ISO /IEC 17024:2012 to provide certification of persons by the International Accreditation Service (IAS-PCB-111), United Kingdom Accreditation Service (UKAS-No. 21923) and Korea Accreditation Board (KAB-PC-08). For the list of accreditation scopes, per accreditation body, click on the link above