ISO 13485 Internal Auditor Course Outline
The ISO 13485 Internal Auditor training course will cover the following topics
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