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 13485:2016 and ISO 19011:2011 or want to add value to your organisation and improve the effectiveness of the QMS.
What you will learn
You will learn ...
an overview of the ISO 13485 requirements
the role management systems and internal audits play in helping businesses 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.