content
The certificate course imparts the necessary know-how to audit a quality management system according to DIN EN ISO 13485 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 able to start well prepared and confident in the new area of responsibility.
target group
Employees in quality management and managing directors who independently check and document the conformity of their internal quality management system (1st party audit) and/or want to carry out professional supplier audits (2nd party audit).
Topic overview & dates
06/24/2024
Introduction to auditing: audit types, audit program and audit plan
06/25/2024
Audit preparation: dealing with lists of questions and/or checklists | Audit implementation: Audit methods
06/26/2024
Audit implementation: Communication | Audit Reporting: Audit Report and Corrective Actions | Audit evaluation: Findings and evaluation systems for deviations
06/27/2024
Practical exercises: Audit analysis including video analysis
06/28/2024
Summary and Examination
exam and graduation
After the course, the technical knowledge and skills acquired are tested in writing. After passing the exam, the participants receive a certificate issued by MedicalMountains GmbH.
Notice
Sound prior knowledge of DIN EN ISO 13485 is mandatory.
Funding Opportunity
ESF funding is possible. More information can be found here
KONTAKT:
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