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Knudsen Plast Quality

One of the first to be ISO certified

Since our company’s beginnings in 1977, quality and the search for perfection have been our key concepts. We were one of the first companies in Denmark to obtain ISO 9001 certification. Since June 2017, we are solely certified to ISO 13485:2016. Our production fulfills also relevant sections of the FDA’s (US Food and Drug Administration) 21 CFR Part 820 Quality System Regulation and cGMP.

The scope covers:

  • Contract design and development
  • Development of injection moulds
  • Injection moulding of plastic products
  • Assembly of injection moulded plastic products
  • Sterile packaging

Our documentation gives you full traceability

Quality and documentation is a natural part of our work.

You can always find information on previous products. All processes are well-documented, and all documentation is archived and saved for a minimum of 10 years.

A control specification is created for all products, describing the scope of the control and the measuring equipment required.

All measurements and inspections are undertaken by our operators and by QA in our in-house measurement laboratory. All measuring equipment is checked regularly and calibrated, just as all items are subjected to regular process control. In addition, SPC is undertaken for shot weight.

You receive a certificate for each production. The certificate is your documentation that measurements and inspections are undertaken as arranged.

Want more information?

Download ISO13485


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