ISO/IEC 17025:2017 Clause 6.2.6
6.2.6
The laboratory shall have
structured process for granting authorization to individuals, allowing them to
undertake specific activities within the laboratory. The authorization is not
limited to a single task but extends to a range of laboratory activities.
Essentially, it implies that certain personnel will be officially sanctioned or
permitted to carry out designated functions or tasks within the laboratory. The
intent is to ensure that individuals with the requisite expertise, training,
and authority are entrusted with specific responsibilities, contributing to the
effective and controlled functioning of the laboratory.
a). Development, Modification, Verification, and
Validation of Methods
The accuracy and
reliability of laboratory testing processes hinge on the particular
development, modification, verification, and validation of methods. A
specialized group of authorized individuals with expertise in innovation and
validation are entrusted with this critical task.
Development of Methods: Authorized
personnel are responsible for crafting tailored methods that align with
specific testing requirements. This entails designing approaches to analyze
samples with the goal of achieving not only accuracy but also efficiency in
terms of time and resources.
Modification of Methods: As scientific
knowledge evolves or new technologies emerge, existing methods may require
modification. Authorized individuals possess the expertise to adapt methods,
ensuring they remain current, aligned with standards, and capable of delivering
precise results.
Verification and
Validation: Crucial steps in confirming method reliability, verification, and
validation involve systematic reviews and testing. Authorized individuals
ensure that methods are accurate, repeatable, and suitable for their intended
purpose, producing consistent and trustworthy results under varying conditions.
Ensuring Reliability: Authorization of
specific individuals to handle method-related tasks is paramount for
maintaining overall laboratory reliability. Rigorous oversight in the
development, modification, and validation of methods safeguards against
inaccuracies, contributing to the credibility of laboratory testing processes.
b). Analysis of Results, Including Statements of Conformity or Opinions and Interpretations
In the laboratory, a
designated process oversees the examination of test results, assigning distinct
responsibilities to various individuals. Their role is to accurately assess
whether the results align with required product standards (conforming or not
conforming) and to identify any potential issues. This thorough examination
ensures the accuracy and reliability of test results.
Moreover, certain
individuals possess the authority not only to evaluate results but also to
provide opinions or interpretations based on the test report. This may involve
offering insights into the meaning of results or their broader relevance,
providing valuable expertise to inform decision-making.
c) Report, review and authorization of results.
Within the laboratory,
specific individuals are assigned a crucial role in reviewing and approving
reports that document the outcomes of tests. These individuals possess the
authority to assess detailed reports, ensuring that the information accurately
reflects the test results. Their responsibilities extend to meticulous reviews
for clarity and, most importantly, accuracy.
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