target group
Employees in quality management and managing directors who want to independently check and document the conformity of their internal quality management system (1st party audit) and/or carry out professional supplier audits (2nd party audit).
content
The certificate course imparts the necessary know-how to audit a quality management system according to DIN EN ISO 13485:2016 and EU-MDR according to the guidelines of DIN EN ISO 19011:2018. The spectrum ranges from the systematic creation of an audit plan to the content and methodology of implementation and how to deal with difficult situations. Workshops deepen what has been learned: Using a case study, the participants can practice conception and communication in a simulated audit environment in order to be well prepared and confident when starting their new field of work.
Topic overview & dates
07/11/2022 Introduction to auditing: audit types, audit program and audit plan
07/12/2022 Audit preparation: dealing with lists of questions and/or checklists | Audit implementation: Audit methods
07/13/2022 Audit implementation: communication | Audit Reporting: Audit Report and Corrective Actions | Audit evaluation: Findings and evaluation systems for deviations
07/14/2022 Practical exercises: Audit analysis including video analysis
07/15/2022 Summary and review
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. After passing the exam, the participant receives a certificate issued by MedicalMountains GmbH.
a notice
Sound prior knowledge of DIN EN ISO 13485 is mandatory. We recommend attending the “Quality Manager Medical Technology” certificate course in advance.
Funding Opportunity
ESF funding is possible. More information can be found here .
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen
