Quality Management and Quality Assurance

Certified Processes for your safety.

Perfection in plastics will only be possible by a consequent quality management. There is a strong quality team working interdisciplinary with all divisions within, in order to assure the perfect product quality for you. This is also guaranteed by our certifications:

  • ISO 9001:2015 Quality Management System
  • ISO 14001:2015 Environmental Management System
  • ISO 13485:2016 Medical devices - Quality Management System
  • FSSC 22000 Business unit Consumer
  • SMETA 4-Pillars requirements N° SGS-212250

Our quality assurance measures are recorded throughout all stages of production. The certificates also show in-process controls and laboratory test results. For this purpose we are using the latest generation of software:

  • Software tool for examination and evaluation of the processes.
  • Integrated CAPA- and Change-Control-System.
  • Quality Management-System.

Flex Switzerland has at its disposal qualified product plants and clean rooms. Our qualification and validation policy includes risk assessment, qualification of the equipment as per the V-model and process validation. Re-qualification and re-validation in case of equipment alterations are an integrated part of our quality management.

The production processes at Flex Switzerland comply with the legal requirements of national and international authorities and guidelines of cGMP. At your request we establish Drug Master Files and CE-documents and undertake the submission to the authorities. Our quality management guarantees you the necessary safeness for a sustainably successful market presence.


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