ISO 13485 Lead Implementer Training Course Outline
Module 1: Introduction to ISO 13485:2016
- Introduction
- What is ISO 13485:2016?
- Benefits of Implementing ISO 13485
- Applications of ISO 13485
- First Steps to ISO 13485:2016 Compliance
- What is a Medical Device?
- Purpose of a Quality Management System
- Importance of ISO 13485
- Basic Principles of ISO 13485
- Exercise
Module 2: ISO 13485 Clauses 1 and 2
- Clause 1 – Scope
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 2 - Normative References
Module 3: ISO 13485 Clauses 3 and 4
- Clause 3 - Terms and Definitions
- Clause 4 - Quality Management System
- Clause 4.1 General Requirements
- Clause 4.2 Document Requirements
- Exercise
Module 4: Requirements and Quality Systems
- Requirements and Quality Systems
- Clause 5 - Management Responsibilities
- Clause 6 - Resource Management
- Clause 7 - Product Realisation
- Clause 8 - Measurement, Analysis, and Improvement
- Exercise
Module 5: Overview of ISO 13485:2016 Requirements
- Requirements of ISO 13485:2016
- General Requirements
- Documentation Requirements
- Management Responsibility
- Resources
- Product Realisation
- Infrastructure
- Risk Management
Module 6: Implementation Phases of the ISO 13485 Frameworks
- Stages to Implementation
- Gap Analysis
- Process Mapping
Module 7: Conducting an ISO 13485 Certification Audit
- Certification Audits
- Exercise
Module 8: Relationship Between ISO 13485 and ISO 9001
- Scope
- Focus
- Continual Improvement
- Terminology
- Differences Between the Standards
- Similarities Between the Standards
Module 9: Internal Auditing
- Internal Auditing
- Internal Audit Objectives
- Auditing Skills
- Steps in Internal Auditing
- Planning, Preparation, and Management of Audits
- Internal Audit – PDCA Cycle
- Types of Audit
- Audit Techniques
- Exercise
Module 10: Internal Audit Plan
Module 11: Audit Process
- Audit Process
- Conducting Process Audits
- Scope
- Criteria
- Reporting Audit Findings
Module 12: Internal Audit Evidence and Findings
- Internal Audit Evidence and Findings
- Classification
- Closing Report
- Nonconformities
- Documented Procedure
- Exercise
Module 13: Roles and Responsibilities
- Internal Auditor Responsibilities
- Closing Meetings
Module 14: Resource Management and Product Realisation
- Provision of Resources
- Infrastructure
- Planning and Development of Products
Module 15: ISO 13485 and Quality Management Systems
- ISO 13485
- Quality Management Systems (QMS)
- Exercise
Module 16: Principles of Quality Management System
- Principles of QMS
- Exercise
Module 17: Fundamentals of Quality Management Systems
- Fundamentals of Quality Management Systems
Module 18: Measurement, Analysis, and Improvement
- Measurement, Analysis, and Improvement
- General Requirements
- Monitoring and Measurement
- Control of Nonconforming Product
- Performance of QMS
- Analysis of Data
- Improvement
- Corrective Action
- Preventive Action
- Identification of Improvement Opportunities
Module 19: Risk Management
- Risk Management
- Risk Management Principle
- Risk Management Process
- Risk Lifecycle
- Risk Management Tools
- Risk Management Culture
- Assessments and Control of Risk Management
- Exercise