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

Who should attend?

• Auditors seeking to perform and lead Medical Devices Quality Management System (MDQMS) certification audits
• Managers or consultants seeking to master a Medical Devices Quality Management System audit process
• Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements
• Technical experts seeking to prepare for a Medical Devices Quality Management System audit
• Expert advisors in Medical Devices Quality Management

Learning objectives

• Understand the operations of a Medical Devices Quality Management System based on ISO 13485
• Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks
• Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011
• Learn how to lead an audit and audit team
• Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit
• Acquire the competencies of an auditor to: plan an audit, lead an audit, draft reports, and follow-up on an audit in compliance with ISO 19011

Certification Details

• Certification and examination fees are included in the price of the training course
• Training material containing over 450 pages of information and practical examples will be distributed
• An attestation of course completion worth 31 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.
• In case of exam failure, you can retake the exam within 12 months for free