target group

Quality management officers (QMB) and employees in general quality assurance.

content

A well-structured test equipment management is essential to meet the requirements of DIN EN ISO 13485:2016 in order to be able to meet the high quality requirements in medical technology. In this seminar, the participants are given the tools to set up, maintain and continuously improve an effective system in accordance with DIN EN ISO 13485:2016 "7.6 Control of monitoring and measuring equipment". This is particularly important with regard to compliance with the basic requirements - according to Directive 93/42/EEC relating to ensuring patient safety.

topic overview

  • Basics of test equipment monitoring
  • Calibration - Return to Normal
  • Organization of test equipment management audits
  • Selection of test equipment and costs
  • gage capability
  • Importance of testing in production - test methods
  • Definition of test level and AQL value

previous knowledge

Basic knowledge of quality management and/or quality assurance is an advantage.

KONTAKT:
Max-Planck-Straße 17,  Tuttlingen
Beruflichen Bildungsstätte Tuttlingen & Online

 

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