Course Outline

Course Title: QMS Foundation Based on ISO 13485:2016
Duration: 1 Day (6–8 hours)
Delivery Mode: Classroom / Virtual Live / Self-paced
Assessment: Multiple-Choice Questions (MCQ) or Short Quiz
Certification: Certificate of Completion by Cosmos International Training Institute (CITI)

 

Course Objectives

This course will enable participants to:

• Understand the fundamentals of a Quality Management System specific to medical devices

• Gain insight into the requirements of ISO 13485:2016

• Understand the intent behind regulatory and customer requirements in the medical device sector

• Learn about risk-based thinking, documentation, and process approaches specific to ISO 13485

 

Course Modules

Module 1: Introduction to Medical Device Quality Management

• What is a Quality Management System (QMS)?

• The role of QMS in the medical device industry

• Overview of ISO 13485:2016 standard

• Importance of compliance and certification for regulatory markets

Module 2: ISO 13485:2016 Structure and Scope

• Overview of standard structure

• Explanation of process-based approach

• Key terms and definitions

• ISO 13485:2016 vs. ISO 9001:2015 – key differences

Module 3: Context of the Organization and Leadership (Clauses 4 & 5)

• Understanding the organization and its needs

• Documented information and QMS boundaries

• Management commitment and leadership responsibilities

• Quality Policy and organizational roles

Module 4: Risk Management and Planning (Clause 6)

• Risk-based approach to QMS

• Quality objectives and planning for product realization

• Planning of changes to the QMS

Module 5: Support and Resource Management (Clause 7)

• Competence, training, and awareness

• Infrastructure, environment, and contamination control

• Control of monitoring and measuring resources

• Documentation and medical device file

Module 6: Operational Requirements (Clause 8)

• Product realization planning

• Design and development controls

• Purchasing, production, and service provisions

• Product cleanliness, installation, and servicing

• Monitoring and traceability

• Handling nonconforming products

Module 7: Performance Evaluation & Improvement (Clauses 9 & 10)

• Internal audit and management review

• Complaint handling and reporting to regulatory authorities

• CAPA (Corrective and Preventive Actions)

• Continual improvement of the QMS

 

Assessment & Certification

• Short assessment (MCQ or quiz format)

• Certificate of Completion issued by Cosmos International Training Institute (CITI)

 

Target Audience

• New entrants to the medical device industry

• Regulatory, compliance, and QA professionals

• Internal auditors and management representatives

• Anyone planning to pursue advanced ISO 13485 training