ISO 13485 QMS Lead Auditor (ISO13485-LA)

Mastering the Audit of a Quality Management System (QMS) based on ISO 13485

Course Description

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 necessary knowledge and skills to plan and carry out internal and external audits in compliance with ISO 19011 and the certification process according to ISO/IEC 17021-1.

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.

Audience

  • 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

Delivery and duration

  • Self-Training: Learn at your own speed, on your own schedule and on your favorite device. Click here for details

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

General Information

  • Exam and certification fees are included in the training price
  • Training material containing over 450 pages of information and practical examples will be distributed
  • A certificate of attendance will be issued to the participants
  • In case of failure of the exam, participants are allowed to retake it for free under certain conditions

Course Agenda

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

  • Course objectives and structure
  • Standards and regulatory frameworks
  • Certification process
  • Fundamental principles of Medical Devices Quality Management Systems
  • Medical Devices Quality Management System (QMS)

Day 2: Audit principles, preparation and launching of an audit

  • Fundamental audit concepts and principles
  • Audit approach based on evidence and risk
  • Initiating the audit
  • Stage 1 audit
  • Preparing the stage 2 audit (on-site audit)
  • Stage 2 audit (Part 1)

Day 3: On-site audit activities

  • Stage 2 audit (Part 2)
  • Communication during the audit
  • Audit procedures
  • Creating audit test plans
  • Drafting audit findings and non-conformity reports

Day 4: Closing the audit

  • Documentation of the audit and its review
  • Closing the audit
  • Evaluating action plans by the auditor
  • Beyond the initial audit
  • Managing an internal audit programme
  • Competence and evaluation of auditors
  • Closing the training

Day 5: Certification Exam

  • Duration: 3 hours

Examination and Certification

The "Certified ISO 13485 Lead Auditor" exam fully meets the requirements of the Examination and Certification Program (ECP). The exam covers the following competence 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

The "Certified ISO 13485 Lead Auditor" exam is available in different languages, including English, French, Spanish and Portuguese

For more information about the exam, refer to PECB Exam Preparation Guide

After successfully completing the exam, participants can apply for the credentials of Certified ISO 13485 Provisional Lead Auditor, Certified ISO 13485 Auditor or Certified ISO 13485 Lead Auditor, depending on their level of experience.

A certificate will be issued to participants who successfully passed the exam and comply with all the other requirements related to the selected credential.

For more information about the certification process, refer to PECB section on ISO 13485 Lead Auditor

Our next training activities

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Region Country City Language DateTrainerPrice Registration
Caribbean Self-Training Caribbean Self-Training Caribbean English 2014-08-01 to 2019-12-31 N/A 897.00 USD add to cart
Europe Self-Training Europe Self-Training EU English 2014-08-01 to 2019-12-31 N/A 947.00 EUR add to cart
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Americas Canada Self-Training CA English 2014-08-01 to 2019-12-31 N/A 1,297.00 CAD add to cart
Americas United States Self-Training US English 2014-08-01 to 2019-12-31 N/A 1,097.00 USD add to cart
Africa Self-Training Africa Self-Training Africa English 2018-08-20 to 2019-12-31 N/A 897.00 USD add to cart
Asia-Pacific Self-Training Asia-Pacific Self-Training APAC English 2018-08-20 to 2019-12-31 N/A 897.00 USD add to cart
Middle-East Self-Training Middle-East Self-Training ME English 2018-10-01 to 2019-12-31 N/A 1,097.00 USD add to cart