ISO 13485 Lead Auditor Course Outline
The following subjects will be taught during this course
Module 1: Introduction to ISO 13485:2016
- What is ISO 13485:2016?
- Importance of ISO 13485 for an organisation
Module 2: A Overview of ISO 13485:2016 Requirements
- General requirements
- Documentation requirements
- Management responsibility
- Resources
- Product realisation
- Infrastructure
- Risk management
Module 3: Implementation Phases of the ISO 13485 Frameworks
- Stages to implementation
- Gap analysis
- Process mapping
Module 4: Conducting an ISO 13485 Certification Audit
Module 5: The Relationship Between ISO 13485 and ISO 9001
- Scope
- Focus
- Continual improvement
- Terminology
- Differences between the standards
- Similarities between ISO 13485 and ISO 9001
Module 6: Internal Auditing
- Internal audit objectives
- Auditing skills
- Planning, preparation, and management of audits
- Internal audit – PDCA cycle
- Types of audit
- Audit techniques
Module 7: The Internal Audit Plan
Module 8: The Audit Process
- Conducting process audits
- Internal audit scope and criteria
- Reporting audit findings
Module 9: Internal Audit Evidence and Findings
- Classification
- The closing report
- Nonconformities
- Documented procedure
Module 10: Roles and Responsibilities
- Internal Auditor responsibilities
- Closing meeting
- Management responsibilities
Module 11: Resource Management and Product Realisation
- Provision of resources
- Infrastructure
- Planning and development of products
Module 12: ISO 13485 and Quality Management Systems
Module 13: Principles of Quality Management System
- Customer and regulatory focus
- Leadership
- Involvement
- The process approach
- Common tools
- Decision making
- Supplier management
- System management
- Continuous improvement
Module 14: The Fundamentals of Quality Management Systems
Module 15: Requirements and Quality Systems
Module 16: Measurement, Analysis, and Improvement
- Monitoring and measurement
- Control of non-conforming products
- The performance of the QMS
- Analysis of data
- Improvement of quality
- Corrective action
- Preventive action
- Identification of improvement opportunities
Module 17: Risk Management
- Risk management principles
- The risk management process
- Risk lifecycle
- Risk management tools
- Risk management culture
- Assessments and control of risk management
Module 18: Key Terms and Definitions of Lead Auditor
Module 19: Lead Auditor Responsibilities
- Roles, responsibilities, and authorities
Module 20: Team Leader Skills
Module 21: ISO 13485 Clauses 1 and 2
Module 22: ISO 13485 Clauses 3 and 4
Module 23: Structure and Intent of ISO 13485
Module 24: Medical Devices, Quality, and Auditing Terminology
Module 25: Processes, Procedures, and Records
Module 26: Checklist Development
Module 27: Planning, Preparation, and Management of Audits
Module 28: Interviewing Skills
Module 29: Corrective Action and Verification