ISO 13485 Lead Auditor

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 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.

How this course works

Self-study means taking the training course at your own pace and in a place of your choice, for which all that is needed is access to the PECB training course materials. PECB describes this format as suitable for participants with considerable knowledge of the subject who do not require assisted lecturing.

• The complete PECB course material, digitally, through my PECB
• Work through it at your own pace, wherever you choose
• You direct your own studying — this format includes no taught sessions
• The same exam and the same credential as any other PECB format
• Around 450 pages of information and practical examples

You have 12 months from the date of purchase to work through the course and sit the exam — there are no fixed dates and nothing to schedule. Whichever format you take, PECB delivers the course material digitally through my PECB, and you sit the exam online from anywhere in the world once you are ready.

Your fee covers PECB’s full certification cycle:

• The first exam attempt
• One free retake
• The certification application fee
• The first year of PECB's Annual Maintenance Fee (AMF)

Both the 12-month window and what the fee covers are set by PECB’s Exam Rules and Policies. Note the last item: PECB covers the first year of its Annual Maintenance Fee, so keeping the credential current after that first year is paid to PECB directly.

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

What you’ll be able to do

• 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

PECB structures the course in 5 parts, covering 5days’ worth of material. You work through them in your own time.

1. Introduction to Medical Devices Quality Management Systems (MDQMS) and ISO 13485

2. Audit principles, preparation and launching of an audit

3. On-site audit activities

4. Closing the audit

5. Certification Exam

Prerequisites

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

Exam & certification

The course closes with the PECB Certified ISO 13485 Lead Auditor Exam, which meets the requirements of PECB’s Examination and Certification Programme and covers 7 competency domains:

1. Fundamental principles and concepts of a Medical Devices Quality Management System (MDQMS)
2. Medical Devices Quality Management System (MDQMS)
3. Fundamental audit concepts and principles
4. Preparation of an ISO 13485 audit
5. Conducting an ISO 13485 audit
6. Closing an ISO 13485 audit
7. Managing an ISO 13485 audit program

Pass it and you can apply for the PECB Certified ISO 13485 Lead Auditor credential. Passing the exam is only part of what PECB asks: each rung of the ladder adds experience, and every one of them requires signing the PECB Code of Ethics.