Title

Validate all pieces of equipment used for examination in the laboratory, including software systems

Why

The laboratory has to keep a file with validation results for each piece of equipment, so that it is able to show that it knows that each piece of equipment performs the tasks the laboratory expects it to perform and that it delivers the results that the laboratory expects.

What

In phase 3 the SOP on Validation of Examinations and Equipment was written upon which all examination methods had to be validated. In phase 4 all equipment needs to be validated according to the procedure described in this SOP. Validate only those pieces of equipment that have a critical influence on the outcome of examinations, such as a PCR machine, a spectrophotometer, etc. (support equipment such as printers do not need to be validated). Also software used for examinations needs to be validated.

How & who

Equipment Officer:

  1. Validate all the pieces of equipment that have a critical influence on the outcome of an examination. Also validate software used for examinations.
  2. Make a validation report according to the procedure described in the SOP on Validation of Equipment and Examinations.
  3. Store the validation reports in the folder Validation Reports behind the tab Equipment Validation.
  4. Perform a validation each time a new piece of equipment is introduced in the laboratory to know from the start if the equipment is able to achieve the performance required and that it complies with specifications relevant to the examinations of which it is part. Also perform a validation each time a piece of equipment has been calibrated, serviced and/or repaired.
  5. Make a validation report each time a validation is performed.

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This activity belongs to the QSE Equipment

 

ISO15189:2007: 5.3.2
ISO15189:2012: 5.3.1.2
ISO15190:2003: