---
title: "ISO 13485 Lead Auditor | Standards Academy"
url: https://standards.academy/courses/iso-13485-lead-auditor
description: "Develop the expertise to plan, conduct and close ISO 13485 conformity assessment audits in this five-day PECB certification course. The course applies the…"
lang: en
---

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ISO 13485

Lead Auditor

PECB Certified

# ISO 13485 Lead Auditor

Develop the expertise to plan, conduct and close ISO 13485 conformity assessment audits in this five-day PECB certification course. The course applies the requirements of ISO/IEC 17021-1 and the guidelines of ISO 19011 to medical device quality management system audits. Earn the internationally recognized PECB Certified ISO 13485 Lead Auditor credential.

5 Days

31 CPD Credits

Exam Included

Back to All Courses (https://standards.academy/courses)

## About This Course

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.

## Learning Objectives

1

Understand the operations of a Medical Devices Quality Management System based on ISO 13485

2

Acknowledge the correlation between ISO 13485 and other standards and regulatory frameworks

3

Understand an auditor’s role to: plan, lead and follow-up on a management system audit in accordance with ISO 19011

4

Learn how to lead an audit and audit team

5

Learn how to interpret the requirements of ISO 13485 in the context of a MDQMS audit

6

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 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

## 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

## Prerequisites

No specific prerequisites required. Familiarity with management system concepts is helpful but not required.

## Frequently asked questions

### Do you offer discounts?

### Why is my price different from the list price?

1

Format and price

eLearning €1,195

All taxes included · Includes PECB exam voucher

2

Participant

Sign in (https://standards.academy/auth) to confirm the participant and to see your price.

Discounts and regional pricing are available. See which discounts apply (https://standards.academy/discounts)

3

Withdrawal

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### Quick Facts

Duration

5 days

CPD Credits

31

Language

English

Provider

PECB

Category

Quality & Management

### What's Included

- 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

### Downloads

Course Brochure: https://uqodmmmqsdvwwdqqtwqs.supabase.co/storage/v1/object/public/course-brochures/iso-13485-lead-auditor-4p.pdf
Promotional Flyer: https://pecb.com/pdf/brochures/1/iso-13485-lead-auditor_1p.pdf

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