ISO 13485 Internal Auditor - Australia

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

• Certification audits

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

• The audit plan
• Criteria

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