PECB Certified
Quality and Management
Advanced Exam Included
PECB ISO 13485 Lead Auditor
Develop the competence required for PECB ISO 13485 Lead Auditor certification based on internationally recognized standards and best practices.
0
Hours of Video
5
Days
∞
Lifetime Access
2
Exam Attempts
About this course
PECB ISO 13485 Lead Auditor — Develop the competence required for PECB ISO 13485 Lead Auditor certification based on internationally recognized standards and best practices.
This is a Self-Study course — you receive all official PECB study materials and exam vouchers to learn at your own pace, without scheduled sessions or an instructor. Ideal for professionals who prefer independent study and flexible scheduling.
At MyISOCert, we work exclusively with PECB — one of the world's leading certification bodies — to bring you trusted, globally recognized ISO training at the best price guaranteed.
What you'll learn
✓ Explain the fundamental concepts and principles of ISO 13485*
✓ Interpret ISO 13485 requirements from the perspective of an auditor*
✓ Plan, conduct, and close a compliance audit in accordance with ISO 19011 and ISO/IEC 17021-1*
✓ Manage an audit program and lead an audit team effectively*
✓ Prepare comprehensive audit reports and communicate findings
Who is this course for?
Lead Auditors
Auditors seeking to perform and lead management system audits on behalf of certification bodies
Managers
Managers or consultants seeking to master the audit process
Responsible Individuals
Individuals responsible for maintaining conformity with management system requirements
Technical Experts
Technical experts seeking to prepare for a management system audit
Career Changers
Professionals wanting to pursue a career in conformity assessment
Course curriculum
1
Introduction to ISO 13485 and the management system*
Day 1
2
Audit principles and the preparation for and initiation of an audit*
Day 2
3
On-site audit activities*
Day 3
4
Closing the audit and continuous development of an auditor*
Day 4
5
Certification exam
Day 5
Student reviews
4.3
★★★★★
313 ratings
OF
Omar F.
Cyber Security Specialist · ★★★★★
"The practice exams in this ISO 13485 bundle are very close to the real thing. I felt fully prepared walking into the test centre."
June 2026
AP
Anna P.
Information Security Manager · ★★★★★
"Passed my ISO 13485 exam on the first attempt. The course content aligns perfectly with what actually comes up in the test."
June 2026
TX
Tom X.
Quality Assurance Lead · ★★★★★
"I have tried other ISO 13485 courses but this one is on another level. Clear, structured, and actually enjoyable to study."
May 2026
LK
Lena K.
Information Security Manager · ★★★★★
"Seamless experience from purchase to certification. The ISO 13485 course is organised, practical, and definitely worth the price."
May 2026
NE
Nina E.
Risk Manager · ★★★★★
"Best investment I made for my career. The ISO 13485 content is thorough, up-to-date, and the exam voucher is included — total no-brainer."
April 2026
PM
Patrick M.
Quality Assurance Lead · ★★★★★
"The practice exams in this ISO 13485 bundle are very close to the real thing. I felt fully prepared walking into the test centre."
April 2026
