Course Outline
Course Title: Lead Auditor – QMS Based on ISO 13485:2016
Offered By: Cosmos International Training Institute (CITI)
Duration: 5 Days (40 Hours)
Delivery Mode: Classroom / Virtual Live / Blended / Self-Paced
Assessment Method: Continuous Assessment + Final Examination
Certificate Type: Certificate of Completion issued by Cosmos International Training Institute (CITI)

Course Objectives
Participants will gain the competencies to:
• Understand the structure and requirements of ISO 13485:2016 for medical devices
• Learn how to assess a medical device QMS for compliance and effectiveness
• Plan, conduct, report, and follow up audits in accordance with ISO 19011:2018
• Lead QMS audit teams effectively in medical device environments
• Address regulatory requirements and risk-based thinking in audits

Course Content & Structure
Day 1: Introduction to ISO 13485 & Medical Device QMS
• Overview of Quality Management Systems for Medical Devices
• Introduction to ISO 13485:2016 – Structure, Scope, and Regulatory Framework
• Differences between ISO 9001 and ISO 13485
• High-Level Structure (Annex SL) – Overview
• Process Approach, PDCA Cycle, Risk-Based Thinking
• Summary of ISO 13485 Clauses
Day 2: ISO 13485:2016 Requirements in Detail
• Clause 4: Quality Management System
• Clause 5: Management Responsibility
• Clause 6: Resource Management
• Clause 7: Product Realization – Design, Purchasing, Production, and Servicing
• Clause 8: Measurement, Analysis, and Improvement
• Focus on Risk Management, Validation, and Regulatory Compliance
Day 3: Audit Concepts and Planning
• Types of audits: Internal, Supplier, External
• ISO 19011:2018 – Guidelines for auditing management systems
• Auditor Roles, Responsibilities, and Attributes
• Audit Planning – Scope, Criteria, Objectives
• Developing audit checklists and programs
• Considerations for medical device audits (regulatory requirements, traceability)
Day 4: Audit Execution & Reporting
• Conducting Opening Meetings
• Collecting and verifying audit evidence
• Auditing against documented QMS processes and controls
• Classifying nonconformities (Major/Minor/Observation)
• Conducting Closing Meetings
• Writing effective audit reports
• Corrective action follow-up and verification
Day 5: Mock Audit & Final Examination
• Mock audit activity using medical device scenarios
• Managing audit teams and resolving conflicts
• Recap of critical auditing steps and concepts
• Final Written Examination (MCQ + Case-based)
• Feedback and Closing Remarks

Assessment Criteria
• Formative: Continuous assessment through activities, discussions, exercises
• Summative: Written final examination (Pass required for certification)

Certification Details
• Certificate Title: QMS ISO 13485:2016 Lead Auditor – Certificate of Completion
• Issuing Body: Cosmos International Training Institute (CITI)
• Certificate Validity: Lifelong (Refresher recommended every 3–5 years)

Disclaimer on Recognition
This course is designed and delivered by Cosmos International Training Institute (CITI), aligned with the frameworks of ISO 13485:2016 and ISO 19011:2018.

Target Audience
• Quality Professionals in Medical Device Manufacturing
• Regulatory Affairs & Compliance Officers
• Internal Auditors and Supplier Auditors
• Consultants working with ISO 13485 QMS

Prerequisites
• Basic knowledge of ISO 13485:2016 and QMS principles
• Experience in medical device or related regulated industries is advantageous
• English proficiency for understanding technical content and exam completion