ISO 13485 Lead Auditor (Self-study)

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?

• 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

Course outline: 5 days for classroom and 30 days for self-study

• 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

Educational approach

• This training is based on both theory and best practices used in MDQMS audits  
• Lecture sessions are illustrated with examples based on case studies
• Practical exercises are based on a case study which includes role playing and discussions
• Practice tests are similar to the Certification Exam

Prerequisites

A fundamental understanding of ISO 13485 and comprehensive knowledge of audit principles

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

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.

The requirements for PECB Auditor Certifications are:

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