To book places on any of the courses detailed above, or to find out more, please complete the form below. If you would like to book more than one date, please add the number of places that you are interested in and choose the appropriate dates. One of our team will contact you to discuss dates and numbers with you.

Day 1

• Welcome, Introductions & Objectives
• Audit Types & ISO Guidelines
• Purpose & Structure of ISO 13485:2016
• ISO 19011: Terms & Definitions
• Audit Principles and the Audit Cycle
• Audit Preparation
• Case Study Introduction
• Audit Planning
• Audit Checklists

Day 2

• Review of Day 1
• Conducting the Audit
• The 6-Stage Approach
• Auditor Skills
• Identifying and Raising Nonconformities
• Case Study – Audit Role Play
• Compiling the Audit Report
• Corrective Action Process & Responsibilities
• Final Review and Q&A

This course is for anyone who is new to auditing or new to auditing ISO 13485 Quality Management Systems.

It is ideal for:

• Organisations implementing a new ISO 13485 quality management system which requires new internal auditors
• Organisations with an existing ISO 13485 certification who want to demonstrate their internal auditors are competent by completing a recognised training course
• Individuals who want to gain the knowledge and skills to become effective internal auditors
• Organisations that have an ongoing need to maintain a pool of internal auditors suitably qualified to audit ISO 13485 quality management systems
• Auditees awaiting ISO 13485 third-party certification audits

This is an interactive course developed and delivered by our experienced Medical Device Certification team and includes interactive exercises and workshops as well as a Medical device-based company case study and role play.

The course is comprehensive and covers all stages, including:

• Audit planning & preparation
• Audit checklists
• Audit skills
• Audit practice
• Correctly identifying and documenting non-conformances
• Compiling effective, clear and concise audit reports
• Guided by our experienced team, you will discuss every stage of the internal audit process using role-play, workshops and tutorials. You will also plan and conduct an audit and assess if it was done effectively.

At the end of the course, you will:

• Understand the principles of auditing, the audit cycle and the roles and responsibilities of the team involved with an internal audit program
• Have a clear awareness and understanding of the skills and attributes of an effective internal auditor
• Understand how to plan, prepare and conduct an effective internal audit
• Have undertaken a medical device-based internal audit via a case study role play
• Understand how to correctly identify and document non-conformances and compile effective, clear and concise audit reports