ISO 13485 Lead Auditor
ISO 13485 Lead Auditor Training Course
The ISO 13485 Lead Auditor training equips you with essential skills to conduct audits of a Medical Devices Quality Management System (MDQMS) following recognized audit standards and practices.
Why Attend?
This training provides in-depth knowledge to plan and execute internal and external audits in compliance with ISO 19011 and ISO/IEC 17021-1. Through practical exercises, you’ll gain expertise in audit planning, conducting audit activities, managing an audit team, engaging in customer communications, and resolving conflicts effectively. By the end of the course, you’ll be prepared to sit for the certification exam and apply for a “PECB Certified ISO 13485 Lead Auditor” credential, demonstrating your competency in auditing MDQMS in alignment with industry best practices.
Who Should Attend?
- Auditors: Those looking to conduct and lead MDQMS certification audits.
- Managers/Consultants: Individuals seeking mastery of the MDQMS audit process.
- Compliance Officers: Those responsible for MDQMS conformance.
- Technical Experts: Professionals preparing for MDQMS audits.
- Expert Advisors: Specialists in MDQMS implementation and auditing.
Learning Objectives
- Understand MDQMS operations per ISO 13485.
- Recognize the correlation between ISO 13485 and other regulatory standards.
- Comprehend an auditor’s role in planning, leading, and following up on audits.
- Learn to lead audits and manage audit teams.
- Interpret ISO 13485 requirements in the context of MDQMS auditing.
- Develop audit planning, reporting, and follow-up skills as per ISO 19011.
Educational Approach
- Theory and Practice: Integrates theoretical learning with practical audit techniques.
- Case Studies: Real-world scenarios and role-playing activities.
- Mock Exams: Practice tests that mirror the certification exam.
Prerequisites
Participants should have a basic understanding of ISO 13485 and knowledge of audit principles.
Course Agenda
- Day 1: Introduction to MDQMS and ISO 13485.
- Day 2: Audit principles, preparation, and audit initiation.
- Day 3: On-site audit activities.
- Day 4: Audit closure.
- Day 5: Certification Exam.
Examination
The “PECB Certified ISO 13485 Lead Auditor” exam complies with the PECB Examination and Certification Program, covering:
- Fundamental MDQMS principles
- ISO 13485 audit planning and execution
- Performance evaluation and audit closure
For exam formats, available languages, and other details, contact us .
Certification Requirements
| Credential | Exam | Professional Experience | MS Audit Experience | Additional Requirements |
|---|---|---|---|---|
| PECB Certified ISO 13485 Provisional Auditor | Lead Auditor Exam | None | None | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Auditor | Lead Auditor Exam | 2 years (1 in MDQMS) | 200 hours | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Lead Auditor | Lead Auditor Exam | 5 years (2 in MDQMS) | 300 hours | Sign the PECB Code of Ethics |
| PECB Certified ISO 13485 Senior Lead Auditor | Lead Auditor Exam | 10 years (7 in MDQMS) | 1,000 hours | Sign the PECB Code of Ethics |
PECB Master Credential holders must complete four additional Foundation exams. contact us
Certification Validity Requirements
Audit activities should align with best practices, encompassing:
- Audit planning and interviews
- Program management and team leadership
- Audit reporting, including non-conformity documentation
- On-site audits and follow-up procedures
General Information
- Fees: Certification and exam fees included.
- Materials: 450+ pages of training content.
- Credits: Completion worth 31 CPD credits.
- Retake Policy: Free retake available within 12 months if necessary.
For more information, contact us .
