PECB Certified Course Mexico

ISO 13485 Lead Auditor Training

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.

Duration
5 Days
Duration
Delivery
Instructor-Led
Delivery
Next Session
Next Session
Location
Live Virtual
Mon - Fri
Official Accreditation Partner

Our Course ISO 13485 Lead Auditor is accredited by PECB

Starting from
$850
per participant
See upcoming dates

Choose Your Preferred Training Format

Training Options

Reserve Your Spot Today — Pay When You're Ready!

Live Online Training

Join from anywhere with interactive virtual sessions

Starts
Ends
Mon - Fri (5 Days)
USD 1,800
Starts
Ends
Mon - Fri (5 Days)
USD 1,800
Starts
Ends
Mon - Fri (5 Days)
USD 1,800
Starts
Ends
Mon - Fri (5 Days)
USD 1,800
Starts
Ends
Mon - Fri (5 Days)
USD 850

Classroom Training

In-person sessions at premier locations

Nairobi Kenya
Mon - Fri
5 Days
USD 2,750
Kigali Rwanda
Mon - Fri
5 Days
USD 2,950
Kampala Uganda
Mon - Fri
5 Days
USD 2,850

In-person training at our premier venues — pick a city and date that works for you.

Location Duration Fee Language
Nairobi, Kenya Mon - Fri (5 Days) USD 2,750 English See dates & reserve →
Kigali, Rwanda Mon - Fri (5 Days) USD 2,950 English See dates & reserve →
Kampala, Uganda Mon - Fri (5 Days) USD 2,850 English See dates & reserve →

Live, instructor-led sessions you can join from anywhere — pick the next start date below.

Code Start Date End Date Duration Fee
PQMS-02 Mon - Fri (5 Days) USD 1,800 Reserve my seat → Reserve team seats →
PQMS-02 Mon - Fri (5 Days) USD 1,800 Reserve my seat → Reserve team seats →
PQMS-02 Mon - Fri (5 Days) USD 1,800 Reserve my seat → Reserve team seats →
PQMS-02 Mon - Fri (5 Days) USD 1,800 Reserve my seat → Reserve team seats →
PQMS-02 Mon - Fri (5 Days) USD 850 Reserve my seat → Reserve team seats →

ISO 13485 Lead Auditor Overview

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.


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


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


Professional and Organizational Impact

None

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

Upcoming Sessions

Next available dates worldwide

Virtual

(Zoom) Training
USD 1,800
13th Jul-17th Jul 2026

Nairobi

Kenya
USD 2,750
13th Jul-17th Jul 2026

Kigali

Rwanda
USD 2,950
13th Jul-17th Jul 2026

Kampala

Uganda
USD 2,850
13th Jul-17th Jul 2026

Examination & Certification Information

Recognized credentials that advance your career

Participants who complete the ISO 13485 Lead Auditor Program earn a Trainingcred Certificate of Achievement, demonstrating professional competence and alignment with global standards in learning and development.

NITA Accredited

Accredited by the National Industrial Training Authority, ensuring programs meet nationally recognized standards of quality and relevance.

CPD Certified

Recognized by the CPD Certification Service, ensuring every program meets internationally benchmarked standards of professional excellence.

Real Results from Real Professionals

Thousands of professionals have transformed their careers through our training programs. Now, it's your turn.

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