ISO 13485:2016 Internal Auditor
You need this course if ...
- you want to understand the best practices to conduct an effective internal QMS audit in accordance with the requirements of EN ISO 13485:2012 and ISO 19011:2011
- you want to add value to your organisation and improve the effectiveness of the QMS
You will learn ...
- an overview of the ISO 13485 requirements
- the role management systems and internal audits play in helping business manage their risks
- the roles and responsibilities of an Internal Auditor
- how to plan your audits and how to develop the effective checklists
- how to carry out effective audits using LRQA's 6 Stage Approach
- to gather objective evidence through observation, interviewing and sampling of documents
- to evaluate audit findings and determine conformity, nonconformity and effectiveness
- to report findings accurately, adding value to the business
- what is corrective action and who is responsible for implementation
- how to follow up and verify the effectiveness of corrective action taken
- how to address common internal audit weaknesses within the medical device industry
You will need …
- to have successfully completed the ISO 13485 Appreciation and Interpretation course
|28 - 29 Sep 2017||LRQA Birmingham - LRQA Birmingham - Birmingham West Midlands||
|07 - 08 Dec 2017||London||
|08 - 09 Mar 2018||LRQA Birmingham - LRQA Birmingham - Birmingham West Midlands||
|07 - 08 Jun 2018||London||
We also recommend these related courses to deepen your knowledge of this subject and take your skills up to the next level. Feel free to get in touch with our Client Service Team on 0800 328 6543 if you’d like more advice about which course is right for you or your team.