7 Validation of the Measurement Procedure
89
Validation: verification, where the specified requirements are adequate for an
intended use
**
Clause 2.45
In order to make those definitions suited to laboratory practice, several examples
were added.
*This could be understood as confirmation that a given reference material as
claimed is homogeneous for the quality value and measurement procedure concerned,
down to a measurement portion with a mass of 10 mg.
**A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may also be validated for measurement in human
serum.
The terms verification and validation and their definitions given in the VIM 3
both caused a lot of discussion among professionals dealing with measurements.
First of all, it was essential to compare the definitions given in the VIM 3 with
those on validation given in ISO/IEC 17025. Very briefly, the definition of the term
‘verification’ in VIM 3, “to provide objective evidence that an object meets specific
requirements,” covers the requirements set out in ISO/IEC 17025 for validation.
The term ‘verification’ (or ‘confirmation’) was widely used in laboratories for the
procedure used when confirming that analytical parameters of previously validated
measurement procedures, for example, standardized procedures, can be achieved
in a given laboratory environment. Owing to the extensive discussion around the
distinction between the meaning of the two terms verification and validation, the
following interpretation of the above definitions has been proposed:
Suppose a laboratory bought a new instrument, and after its installation, the laboratory planned a series of measurements to confirm whether the instrument fulfilled
its specification. This process could be considered to be verification—the laboratory
would be obtaining measurement data (objective evidence) to confirm the proper
operation of the instrument. The next step would be to use the new instrument (which
had previously undergone verification) with the analytical procedure, for which the
laboratory identified the earlier analytical requirements, in line with those agreed
with the customer, for the intended use of the procedure. As a result, the laboratory has planned a series of measurements aimed at obtaining confirmation that the
measurement parameters are consistent with the requirements. This process could
be considered as validation.
7.1 Techniques, Methods and Measurement Procedures
In the literature, various descriptions of the process used in chemical measurements
can be found. In this work, terms are used that relate to the individual steps or rather
89
Validation: verification, where the specified requirements are adequate for an
intended use
**
Clause 2.45
In order to make those definitions suited to laboratory practice, several examples
were added.
*This could be understood as confirmation that a given reference material as
claimed is homogeneous for the quality value and measurement procedure concerned,
down to a measurement portion with a mass of 10 mg.
**A measurement procedure, ordinarily used for the measurement of mass concentration of nitrogen in water, may also be validated for measurement in human
serum.
The terms verification and validation and their definitions given in the VIM 3
both caused a lot of discussion among professionals dealing with measurements.
First of all, it was essential to compare the definitions given in the VIM 3 with
those on validation given in ISO/IEC 17025. Very briefly, the definition of the term
‘verification’ in VIM 3, “to provide objective evidence that an object meets specific
requirements,” covers the requirements set out in ISO/IEC 17025 for validation.
The term ‘verification’ (or ‘confirmation’) was widely used in laboratories for the
procedure used when confirming that analytical parameters of previously validated
measurement procedures, for example, standardized procedures, can be achieved
in a given laboratory environment. Owing to the extensive discussion around the
distinction between the meaning of the two terms verification and validation, the
following interpretation of the above definitions has been proposed:
Suppose a laboratory bought a new instrument, and after its installation, the laboratory planned a series of measurements to confirm whether the instrument fulfilled
its specification. This process could be considered to be verification—the laboratory
would be obtaining measurement data (objective evidence) to confirm the proper
operation of the instrument. The next step would be to use the new instrument (which
had previously undergone verification) with the analytical procedure, for which the
laboratory identified the earlier analytical requirements, in line with those agreed
with the customer, for the intended use of the procedure. As a result, the laboratory has planned a series of measurements aimed at obtaining confirmation that the
measurement parameters are consistent with the requirements. This process could
be considered as validation.
7.1 Techniques, Methods and Measurement Procedures
In the literature, various descriptions of the process used in chemical measurements
can be found. In this work, terms are used that relate to the individual steps or rather