Auditing Training Course

All auditing training courses use exercises, case studies and role-plays to make the learning experience enjoyable and informative. We guarantee that you will be able to substantially improve your management system using the knowledge and skills you develop on our auditing courses. Our auditing courses are suitable for those who are keen to develop best practice auditing skills.

ISO 13485 Internal Auditor Training

What is it?

This accelerated 2 day training course will give you the knowledge and skills necessary to conduct internal audits of your Medical Management System.

There are 3 main elements of this course:

  1. how to interpret the requirements of the ISO 13485 standard
  2. the structure and intent of a Medical Management System
  3. the tools and techniques of how to internally audit your companies Medical Management System

Content

  • Medical devices, quality and auditing terminology
  • Structure & intent of the medical devices standard ISO 13485 :2003
  • Types of audit
  • Internal audit objectives
  • Internal audit scope and criteria
  • The audit process
  • Roles and responsibilities of the internal auditor
  • Auditing skills
  • Planning, preparation and management of audits
  • Checklist development
  • Conducting process audits
  • Reporting audit findings
  • Verifying corrective action
  • Interviewing skills

Who's it for?

The are many different reasons why people chose to attend this internal audit course, a few examples are:

  • You may have been asked to internally audit your own companies management system and you need to know what it is all about
  • You may be a manager/supervisor who has been tasked with looking after the quality process within your department and you need to understand what everyone is talking about
  • You may have already had some training in the past, but as it was a long time ago you would like a refresher

Duration & format

Duration
2 days

Certificate
An Batalas approved certificate for those who successfully complete all elements of the course, including written and practical skills assessment.

Format of course

The ISO 13485 standard is a very detailed framework document, therefore we try to make the course as exciting as possible.

To explain the requirements of ISO 13485 we use a mixture of tutor led sessions and interactive exercises.

To teach the tools and techniques of how to audit your quality management system we use tutor led sessions and a comprehensive case study to simulate live audit scenarios. This case study approach means that you will actually conduct role play audits during the course to enable your skills to be developed.

Prior knowledge

If you already have a basic understanding of the requirements of ISO 13485 then that is great. But we do understand that the majority of delegates attending this course are doing so because they want to learn what it all means, therefore all we ask is that you complete a short pre-course exercise before you attend the course (this is sent to you via email 4 weeks before the course starts).

How much, where and when?

ISO 13485 internal training courses are scheduled approx. every 3 months in our Birmingham venue. The course fee below includes lunch, refreshments, comprehensive delegate manual and certificate.

Birmingham – £850 plus VAT

If you would like to stay over at the training venue, we can offer very competitive rates for accommodation at most of our venues.

To check dates and venues click here

ISO 13485 Lead Auditor Training

What is it?

This highly interactive 5 day Lead Auditor course for ISO 13485 will equip you with the knowledge and skills to successfully conduct audits against the requirements of ISO 13485 and medical / quality management systems.

In excess of 10,000 people have successfully completed our ISO Lead Auditor training courses worldwide. Since 1962 we have been providing unrivaled knowledge and experience for both the trainee and the more experienced auditor, enabling us to give you the best possible training. Our innovative training techniques and realistic role-plays will ensure you have the confidence to conduct effective ISO 13485 audits.

There are 3 main elements of this course:

  1. how to interpret the requirements of the ISO 13485 standard
  2. the structure and intent of a Medical and Quality Management System
  3. the tools and techniques of how to conduct 1st party (internally audit), 2nd party (supplier audit) and 3rd party (certification audit) of both your own companies Management System and that of your suppliers or external organisation

Content

  • Medical devices, quality and auditing terminology
  • Structure & intent of the medical devices standard ISO 13485 :2003
  • Types of audit
  • Internal audit objectives
  • Internal audit scope and criteria
  • The audit process – 1st Party (Internal), 2nd Party (Supplier) & 3rd Party (Certification)
  • Roles and responsibilities of the internal auditor
  • Auditing skills
  • Planning, preparation and management of audits
  • Checklist development
  • Conducting process audits
  • Reporting audit findings
  • Verifying corrective action
  • Interviewing skills
  • Team leader skills

Who's it for?

The are many different reasons why people chose to attend this lead audit course, a few examples are:

  • You are an internal auditor of your companies management system and you have now been asked to conduct audits of your suppliers
  • You are one of the companies internal auditors and have been tasked with designing the monthly audit programme
  • You are an internal auditor and you have been given more responsibility and need to lead a team of auditors
  • You have decided to have a change of career and you want to become an ISO consultant or auditor

Duration & format

Duration
5 days

Certificate
An Batalas approved certificate for those who successfully complete all elements of the course, including written and practical skills assessment.

Format of course

As a Senior Internal Auditor or Lead Auditor you will need to know the requirements of ISO 13485 in great detail, therefore to impart this knowledge to our delegates we use a mixture of tutor led sessions and interactive exercises.

Over the last 50 years as a leading ISO auditor training company, we have developed new and innovative ways to teach the tools and techniques of how to audit your quality management system, the way that achieve this is by using a small number of tutor led sessions and a very in-depth and comprehensive case study to simulate live audit scenarios. The use of a case study approach is by far the best way to learn how to audit, as it means that you will actually conduct role play audits during the course to enable your skills to be developed.

Prior knowledge

If you have done any management systems auditing before, then you probably have enough Prior knowledge to attend this course. A basic understanding of the requirements of ISO 13485 and management systems in general is a great start, but we do understand that some of the delegates attending this course are doing so because they want to learn what it all means, therefore all we ask is that you complete a short pre-course exercise before you attend the course (this is sent to you via email 4 weeks before the course starts).

How much, where and when?

ISO 13485 lead training courses are scheduled approx. every 3 months in our Birmingham venue. The course fee below includes lunch, refreshments, comprehensive delegate manual and certificate.

Birmingham – £1695 plus VAT

If you would like to stay over at the training venue, we can offer very competitive rates for accommodation at most of our venues.

To check dates and venues click here