Date: 13th & 14th of November 2019
Location: Germany, Frankfurt area
Costs: Regular € 1350.-
In this two-day course, Internal
auditor ISO 13485:2016, you will learn the insights of the audit
process, your role as internal auditor and how to use the Standard as the basis
for a Quality Management System audit.
During the course, key-concepts and requirements of internal auditing are
discussed, but moreover you will also have ample time to train your auditing
skills. The course will gain you an awareness and experience with all the
aspects of being an internal auditor.
Note: this training can also be provided in-house for
other organizations in the supply chain involved in one or more
stages of the life-cycle of a medical device, including design and development,
production, storage and distribution, installation, servicing or provision of
associated activities. The contents will be adapted to the specific role(s) of
Why should you
attend this course?
This training covers the key
concepts of internal auditing like the process approach, the risk-based
approach and the assessment of key requirements of ISO 13485:2016. The training
is a combination of gaining knowledge on the audit process and methods and obtaining
skills to translate this into pragmatic approaches auditing a Quality Management System for
organizations in the Medical
Device Industry. You will actually prepare, perform and report an
internal audit during this course!
the purpose of internal auditing according ISO 13485:2016 and how to challenge
ISO 13485 requirements in your audits
the typical audit activities and your role and responsibilities as internal
acquainted with different audit methods and he “process approach” and the
“risk-based approach” in internal auditing
how to use the concepts of audit objective, scope and criteria
the basic skills to prepare, execute and report an internal audit
how to write clear and unambiguous observations to initiate proper corrective
Key concepts of ISO 13485:2016
Introduction typical audit activities
Audit methods and approaches
Initiating the audit
Preparing the audit
Conducting the audit
Documenting the audit
Who should attend this course?
If you are (to be) involved as Internal auditors and anyone involved in the
implementation and maintenance of a Quality Management System in the Medical Device Industry.