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ISO 13485 Lead Auditor

ISO 13485 specifies requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory standards.

Description

 

During this training course, delegates 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 learn audit techniques and become competent to manage an audit program, audit team, communication with customers, and understand reporting requirements.

After acquiring the necessary expertise to perform this audit, you can sit for the exam and gain the "Certified ISO 13485 Lead Auditor” Certificate. By holding this Certificate, delegates can demonstrate that they have the competencies to audit organizations based on best practices.

About This Course

 

Learning Outcomes

 

  • Review 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 4Closing the audit and final exam.

 

Assessment

 

 

Delegates sit a combined exam, consisting of in-course quizzes and exercises, as well as a final essay style exam, consisting of 12 questions, on Day 4 of the course. The overall passing score is 70%, to be achieved within the 150 minute time allowance.

Exam results are provided within 24 hours, with both a Certificate and a digital badge provided as proof of success.

 

Prerequisites

 

An understanding of ISO 13485 requirements and knowledge of audit principles.

What's Included?

 

  • Certification fees are included on the exam price
  • Training material containing over 500 pages of information and practical examples will be distributed
  • An attestation of course completion worth 32 CPD (Continuing Professional Development) credits will be issued to the participants who have attended the training course.

Who Should Attend?

 

  • Auditors seeking to perform Medical Devices Quality Management System (MDQMS) certification audits 
  • Managers or consultants seeking to understand the Medical Devices Quality Management System audit requirements
  • Individuals responsible for maintaining conformance with Medical Devices Quality Management System requirements

Accreditation

Provided by

 

This course is Accredited by NACS and Administered by the IECB

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