Content & Agenda
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.
Fee includes the cost of self-study training, as well as examination and certification by PECB ($700 Value!).
Delivery Format
Self-study at your desk, delivered through KATE training application. Participants will be provided with the training course material containing over 450 pages of explanatory information, examples, best practices, exercises, and quizzes.
Prerequisites
A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles.
Course Agenda
Day 1: Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485
Day 2: Audit principles, preparation and launching of an audit
Day 3: On-site audit activities
Day 4: Closing the audit
Day 5: Certification Exam
Examination
The “PECB Certified ISO 13485 Lead Auditor” exam fully meets the requirements of the PECB Examination and Certification Programme (ECP). The exam covers the following competency 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
General Information
1. Certification fees are included on the exam price.
2. Training material containing over 450 pages of information and practical examples will be distributed.
3. An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
4. In case of exam failure, you can retake the exam within 12 months for free.
Learn more on this course at ISO 13485 Lead Auditor Training
