Medical Device Auditing – Internal, External, Supplier Training Course

In this course, you will learn how to Internal Audit, and what to expect from external audits such as notified bodies for CE marking, and ISO 13485 audits. You will also learn how to perform supplier audits.

In this course you will learn:

The importance and need for auditing
The best way to perform auditing of your ISO 13485 system in planned intervals
The creation of an Internal Audit schedule
The Internal Audit Plan
The Internal Audit, the qualifications and experience required
Non-Conformances – Minor, Major, Recommendations
The Internal Audit Report
Opening and closing of audits – what to do, what to expect
External audits – the format and what to expect
How to perform a supplier audit – the plan, the audit and the report.

Course Duration: 0.5 to 2 days

Module 1: The importance and need for auditing

We will outline why having an audit schedule and performing an internal audit is so critical for the success of your medical device company.

Module 2: The best way to perform auditing of your ISO 13485 system in planned intervals and the creation of an Internal Audit schedule.

We will show you how to write an Internal audit schedule

Module 3: The Internal Audit Plan, The Internal Audit, the qualifications and experience required. We will explain the level of integrity required, experience and qualifications that may assist

We will show you how to write an Internal Audit plan.

Module 4: Non-Conformances – Minor, Major, Recommendations & The Internal Audit Report

We will explain what Non-Conformance is the levels and what they mean to you. We will explain how to write an internal audit report and what not to write.

Module 5: Opening and closing of audits – what to do, what to expect

We will explain what an opening audit and closing audit should involve.

Module 6: External audits – the format and what to expect

We will discuss what to expect from external audits.

Module 7: How to perform a supplier audit – the plan, the audit and the report.

We will discuss what you need to look for when evaluating a supplier, the evaluation process and scheduling an audit.

This course will benefit those who have not done an internal audit before and will provide an overview of your needs.

*Please note this is not an Internal Audit certification course. It is advised to do this with an accredited body.

Questions this course will answer:

Can I become an Internal auditor?
What do I need to do to become an auditor?
How many audits should I do to become qualified?
Can I audit my own area?
What are the benefits of auditing?