content
Process monitoring of your processes with QM key figures Quality management according to EN ISO 13485. This is how you can see whether the planned performance of your process monitoring and measurement has been achieved.
DIN EN ISO 13485 requires companies to define what needs to be monitored and measured and which methods are to be used to analyze and evaluate the performance and effectiveness of process monitoring in production.
When determining what needs to be monitored and/or measured, the organization should consider the actions required by the clauses of ISO 13485. Therefore, the company should determine how the monitoring and measurement, analysis and evaluation will be carried out and what resources will be required for this. The ISO 13485 lists a whole series of characteristics that can lead to meaningful QM indicators. For all characteristics, it is important to consider carefully whether they should be considered qualitatively and quantitatively. The basic requirement is always that a defined key figure is reliable and valid and can be collected without great effort. Furthermore, a company should also decide what documented information needs to be kept as evidence of the results of monitoring, measurement, analysis and evaluation.
topic overview
- Gauge management / gauge management
- Infrastructure – Maintenance of facilities/equipment
- Sampling procedure - determination of test level / test scope and AQL value
- SPC = Statistical Process Control - for monitoring and optimizing manufacturing processes
- Six Sigma level
- MFU – machine capability study
- Control of non-compliant products
- Examples of work and test instructions
target group
Representatives of top management (QMB), master craftsmen who are responsible for production, quality assurance employees.
previous knowledge
Basic knowledge of quality assurance is required.
KONTAKT:
MedicalMountains GmbH
