The following words and terms, when used in this subchapter,
shall have the following meanings unless the context clearly indicates
otherwise.
(1) Conforming status--An official status granted by
the department to a laboratory. The official status permits the analysis
of shellfish samples in accordance with applicable rules based on
the process outlined in this subchapter. Conforming status means that
a laboratory has been found to be capable of correctly performing
the analyses for which it is approved.
(2) Critical nonconformity--A deviation of a laboratory
requirement which has the highest likelihood of adversely affecting
the quality of the analytical results.
(3) Department--The Department of State Health Services.
(4) Evaluation--A fact-finding process performed by
the department in which information and observations are collected
for the purpose of evaluating the laboratory's compliance with established
standards. Evaluation includes an onsite inspection but can, under
a certain circumstance, be conducted by desk audit.
(5) Key nonconformity--A deviation of laboratory requirement
that has a significant potential to adversely affect the quality of
the analytical results.
(6) Other nonconformity--A deviation of a laboratory
requirement which does not normally compromise the quality of the
analytical results, but generally serves to enhance the overall operation
of the laboratory.
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