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Quality Management

Quality Assurance System
HTL has a well established quality management system. First ISO 9001 certificate was acquired by the company in 1998. In May 2004, PZ HTL S.A. qualified, as one of the first enterprises in Poland, for the ISO 9001:2000 certification. Since the beginning of our work within the ISO guidelines, our certifying body, KEMA Quality B.V. (DEKRA Certification since 2010), has been respected. Our sophisticated quality management system ensures that all vital processes in the company such as product development, purchase and quality control of the raw materials, component manufacturing, product assembly and quality control, logistics, sales and marketing are described, recorded and strictly controlled.

 

HTL manufactures its products in conformity with GMP guidelines and the European Medical Device Directive. Since mid 2004 all pipettes manufactured by HTL are CE marked. 

 

Quality Control Procedure
Stringent quality control is the key of the success of HTL’s products. Within many years of manufacturing manual liquid handling systems we have worked out the control procedures allowing us to ensure that only 100% reliable product reaches the end users. Thanks to the harsh durability tests and precise accuracy and precision verification performed on all of our products our equipment is renowned for its sturdiness and long lasting reproducibility.

 

 

The control of the quality of HTL manufactured equipment is performed at the following stages of the production process:

  • Statistical control of incoming raw materials and metal components
  • Statistical control of the injected parts including shaft durability test
  • Individual control of the components during assembly
  • Individual post production control.

After assembly every product manufactured at HTL is subject to strict individual control performed in accordance with

EN ISO 8655

standards. Testing is performed by highly experienced staff in state of the art, fully computerized laboratory. Accuracy and precision tests are conducted with distilled water by gravimetric method under stabilized temperature (20°C ± 1°C). Standard quality control procedure involves the following tests:

 

  • Evaluation of product aesthetics (colors, imprints, etc.)
  • Pipetting smoothness and pipetting force tests
  • Air tightness test
  • Accuracy and precision verification.

The testing results automatically enter computer control system which independently qualifies if the certain pipette meets company standards. Only once all tests are passed the Quality Control Certificate stating the performance of the product is being printed.

 

Quality Control Certificate presents true accuracy and precision results obtained during the control procedure of the certain pipette. The certificate is included in pipette box.



 



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