Title

Validate all examination procedures performed in the laboratory

Why

In performing a specific examination you assume that the data provided by the examination is valid, true, reliable, reproducible, and provides you with information you expect. However, for accreditation the laboratory has to determine that what it assumes is indeed true. This is done through validation of the examinations.

What

In the previous activity the SOP for Validation of Examination Methods and Equipment has been written. Follow this SOP for validation of the examination methods used in the laboratory.

How & who

Quality Officer in collaboration with Heads of Sections and Technologists:

  1. When an examination method has to be validated by the laboratory itself, validate the methods according to the SOP for Validation of Examination Methods and Equipment (to determine whether an examination method must be validated by the laboratory itself: see previous activity).
  2. If a validation gives rise to changes in the method: make these changes until the method passes validation and adapt the SOP of that specific method. If necessary (the validation result leads to the need to make many changes), make a SMART action plan based on the validation report and monitor its implementation.
  3. Store the validation reports in a new folder called "Validation Reports". Insert two tabs named "Equipment validation" and "Examination Method Validation". Store the validation reports behind the tab "Examination Method Validation".
  4. If a method is changed, document the influence of the changes on the method and store this document also in the Validation Reports folder. When a change in the method could influence the outcome of this method, perform a new validation.
  5. Perform a validation each time a new examination method is introduced in the laboratory before using the method for routine practice. Make a validation report each time a new validation or re-validation is performed. Store each report in the folder Validation Reports.

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This activity belongs to the QSE Process Management

 

ISO15189:2007: 5.5.1 5.5.2 5.5.4
ISO15189:2012: 5.5.1.1 5.5.1.2 5.5.1.3 5.5.1.4
ISO15190:2003: