ISO 13485 Lead Auditor Training

Modules Covered

1. 01Introduction to ISO 13485:2016
2. 02Medical Device Quality Management Systems
3. 03Quality Management System Requirements (Clause 4)
4. 04Management Responsibility (Clause 5)
5. 05Resource Management (Clause 6)
6. 06Product Realization (Clause 7)
7. 07Risk Management (ISO 14971)
8. 08Measurement, Analysis & Improvement (Clause 8)
9. 09ISO 19011 Audit Principles
10. 10Audit Planning & Preparation
11. 11Evidence Collection & Nonconformity Management
12. 12Audit Reporting & Follow-Up

Course Details

Why Take the ISO 13485 Lead Auditor Course?

The ISO 13485 Lead Auditor Course enables professionals to acquire the expertise required to audit Medical Device Quality Management Systems in accordance with ISO 13485:2016 and ISO 19011 guidelines. Participants gain a clear understanding of regulatory requirements, risk management, documentation, and auditing techniques, preparing them to confidently lead audit teams and ensure compliance within the medical device industry.

What the ISO 13485 Lead Auditor Course Covers

• ✓The structure of ISO 13485:2016 and its alignment with global regulatory requirements for medical devices.
• ✓Quality Management System requirements, documentation, and the Medical Device File (Clause 4).
• ✓Management responsibility, customer focus, regulatory compliance, quality policy, and quality objectives (Clause 5).
• ✓Resource Management including competence, training, infrastructure, work environment, and contamination control (Clause 6).
• ✓Product realization including planning, design and development controls, purchasing, production, service provision, validation, traceability, cleanliness, and sterile-device requirements (Clause 7).
• ✓Risk Management throughout the Medical Device Quality Management System in accordance with ISO 14971.
• ✓Measurement, analysis, and improvement including customer feedback, complaint handling, reporting to regulatory authorities, internal audit, CAPA, and control of nonconforming products (Clause 8).
• ✓Audit principles, audit planning, evidence collection, nonconformity grading, reporting, and follow-up activities based on ISO 19011.

Benefits of the Course

• ✓Develop a comprehensive understanding of ISO 13485:2016 Medical Device Quality Management System requirements.
• ✓Understand how ISO 13485 aligns with international medical device regulatory requirements.
• ✓Gain expertise in risk management, regulatory compliance, and Medical Device File documentation.
• ✓Develop practical skills to plan, conduct, report, and follow up Medical Device Quality Management System audits.
• ✓Understand product realization, design controls, validation, traceability, sterile-device requirements, and supplier controls.
• ✓Build confidence to successfully lead first-, second-, and third-party Medical Device Quality Management System audit teams.
• ✓Earn an internationally recognised CQI-IRCA ISO 13485 Lead Auditor qualification to strengthen your professional career.

Who Should Attend

• ✓Medical Device Manufacturers
• ✓Quality Assurance Managers
• ✓Regulatory Affairs Professionals
• ✓Lead Auditors
• ✓Internal Auditors
• ✓Medical Device Consultants
• ✓Quality Management Professionals

Prerequisites

• ✓Basic knowledge of Quality Management Systems and ISO 13485 concepts.
• ✓Understanding of medical device regulatory requirements is recommended.
• ✓Previous auditing experience is beneficial but not mandatory.

Frequently Asked Questions