ISO 13485 Lead Auditor training enables you to develop the necessary expertise to perform a Medical Devices Quality Management System (MDQMS) audit by applying widely recognized audit principles, procedures and techniques. During this training course, you will acquire the necessary knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.
Based on practical exercises, you will be able to master audit techniques and become competent to manage an audit program, audit team, communication with customers, and conflict resolution.
After acquiring the necessary expertise to perform this audit, you can sit for the exam and apply for a "PECB Certified ISO 13485 Lead Auditor" credential. By holding a PECB Lead Auditor Certificate, you will demonstrate that you have the capabilities and competencies to audit organizations based on best practices.
Examination and Certification
The "Certified ISO 13485 Lead Auditor" exam fully meets the requirements of the Examination and Certification Program (ECP). The exam covers the following competence domains:
- Domain 1: Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
- Domain 2: Medical Devices Quality Management System (MDQMS)
- Domain 3: Fundamental audit concepts and principles
- Domain 4: Preparation of an ISO 13485 audit
- Domain 5: Conducting an ISO 13485 audit
- Domain 6: Closing an ISO 13485 audit
- Domain 7: Managing an ISO 13485 audit program
The "Certified ISO 13485 Lead Auditor" exam is available in different languages, including English, French, Spanish and Portuguese
For more information about the exam, refer to PECB Exam Preparation Guide
After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Lead Auditor, Certified ISO 13485 Auditor or Certified ISO 13485 Lead Auditor, depending on their level of experience.
A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential.
For more information about the certification process, refer to PECB section on ISO 13485 Lead Auditor