ISO 13485 Lead Auditor

★★★★★ 4.5/5

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.

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.

Training Options

Classroom Training

Online Instructor Led

Onsite Training

Course Information

Course Syllabus
Who It’s for
FAQs

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

General Information:

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

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

Educational approach:

This training is based on both theory and best practices used in MDQMS audits
Lecture sessions are illustrated with examples based on case studies
Practical exercises are based on a case study which includes role playing and discussions
Practice tests are similar to the Certification Exam

Audience Profile

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

100% Business Fulfilment

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Corporate Training Options

Online Instructor Led

Live, Online Training by top Instructors and practitioners across the globe.

Onsite
Training

Conduct training at the work location you desired.

Classroom Training

The Venue will be ideally located and easy to access with covid-19 SOP's.

Overseas Training

Travel to any desired location for your training.

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What People say?

Mohammed Aljbreen Operation Specialist, SAMA

The Clarity of the Content was very good. The explanation of the trainer with in-depth knowledge in a proper flow really impressed me to give 5 star rating.

Arindam Chakraborty Systems Specialist, King Abdullah University of Sciences & Technology

The Instructor was really impressive. Clear cut explanation of every topic he covered with real time scenarios.

Sher Afzal Khan Cloud Engineer, Cloud 9 Networks

The Trainer and the Course Material, both are good. Good flow of explanation with simple examples. The complete training was focused on current industry challenges.

Jawed Ahmad Siddiqui Sr. System Administrator, Saudi Ceramics

The Trainer’s presentation was impressed me to continue the course till end. Never feel bore till the entire sessions. She studied our mindset and follows.