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 17025:2017 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