ISO 13485

Lead Auditor

PECB Certified

ISO 13485 Lead Auditor

Name: ISO 13485 Lead Auditor
Price: 945 EUR

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

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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

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 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

Format and price

eLearning€1,195

All taxes included · Includes PECB exam voucher

Participant

Discounts and regional pricing are available. See which discounts apply

Withdrawal

I ask Standards Academy to give me access to the course immediately. I understand and accept that once access has been given I lose my right to cancel within fourteen days and I will not be entitled to a refund. Where the course is treated as a service, I ask for it to begin immediately and I accept that my right to cancel ends once it has been fully delivered.

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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

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