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Setting up a Quality control Lab

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Guest user Created:   Sep 15, 2020 Last commented:   Sep 15, 2020

Setting up a Quality control Lab

Our company is planning to set up a Quality control lab for medical textiles. I have been assigned to design it using minimum specifications. I would like to know if there are any guidelines regarding layout and design as suggested by the IEC 17025.

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Tracey Evans Sep 15, 2020

ISO 17025:2017 does not provide specific guidelines for laboratory layout. The requirements for facilities and environmental conditions are covered in clause 6.3. As the facilities and environmental conditions can have a major impact on consistent operation and result validity, the standard requires laboratories to:

  • Ensure suitable separation of incompatible activities (eg vibrations near a weighing room is not suitable).
  • Document requirements depending on the work to be performed.
  • Control, record, and monitor any applicable environmental conditions as specified in methods, procedures, and specifications.

I recommend you document all the equipment you need, then look at their placement and a logical workflow. If you are not familiar with laboratory workflow and needs, it will be beneficial to contact a supplier that outfits laboratories.

For more information, see the ISO 17025 toolkit document template: Facilities and Environmental Condition Procedure at https://advisera.com/17025academy/documentation/facilities-and-environmental-condition-procedure/

and the  whitepaper Clause-by-clause explanation of ISO 17025:2017 at https://info.advisera.com/17025academy/free-download/clause-by-clause-explanation-of-iso-17025/

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Sep 15, 2020

Sep 15, 2020