Course Overview

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.

Why Should You Attend?

During this training course, you will acquire the knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1 certification process.

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.

Who Should Attend?

Learning objectives

This training course will help you:

Download ISO 13485 Lead Auditor Brochure

Request More Information on Upcoming ISO 13485 Lead Auditor Training Classes and Sign up Now!

Educational approach

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.

Certification

After successfully completing the exam, you can apply for the credentials shown on the table below. You will receive a certificate once you comply with all the requirements related to the selected credential.

Note: PECB Certified Individuals who do possess the Lead Implementer and Lead Auditor Credentials are qualified for the respective PECB Master Credential, given they have taken 4 additional Foundation Exams which are related to this scheme. For more detailed information about the Foundation Exams and the overall Master Requirements, please go to the following link:  https://pecb.com/en/master-credentials.

To be considered valid, these audits should follow best audit practices and include the following activities:

1. Audit planning

2. Audit interview

3. Managing an audit program

4. Drafting audit reports

5. Drafting non-conformity reports

6. Drafting audit working documents

7. Documentation review

8. On-site audit

9. Follow-up on non-conformities

10. Leading an audit team