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8 Analytical Chemistry and Quality
attached to the laboratory or its technical management. There are two types of
external assessment activities. External-internal assessment is carried out by
staff affiliated with the body of which the laboratory is a part but not with the
laboratory itself. Such staff may belong to the QAU established within the
framework of GLPs when this is the system adopted or to the body's quality
department otherwise.
The functions of this quality assessment group are the orientation, management and surveillance, not only of the quality control systems, but also of the rest
of the laboratory. Using the established protocols and SOPs or the contents of the
Quality Manual as guidelines, this personnel conducts a visual, documentary
and, occasionally, also quantitative, inspection of the laboratory activities. Their
work is similar to that involved in an internal audit; its institution raises major
personal problems that eventually disappear as the laboratory staff gradually
accept having their activities systematically examined on a routine basis. Incentives are very important in this context.
External-external assessment is conducted by experienced personnel from
other bodies, so it is doubly external to the laboratory. In the quality domain,
these activities are known as audits. Their targets can be systems (which are
examined in a purely qualitative manner by visual and documentary inspection), performance (assessment of which is exclusively quantitative) or both
(integrated assessment). There are two main types of analytical audits, namely:
(a) direct audits, which materialize in laboratory accreditation; and (b) indirect
audits, represented by proficiency testing. Both are commented on below.
8.6.2 Laboratory Accreditation
Laboratory accreditation is an external-external type of systems audit of
laboratory quality. It is defined as the formal written acknowledgement that a
laboratory is fit and competent to perform one or more given types of analysis.
Accreditation is provided by a public or private national organization and relies
on internationally established standards issued by institutions such as EU,
OECD, ISO, ILAC, WELAC, etc. Laboratory accreditation is voluntary (conducted
at the laboratory's request), temporary (it holds over a definite length of time)
and partial (it refers to a specific activity rather than to the laboratory's whole
work).
The accreditation process is started if the laboratory already possesses a
quality system materialized in a Quality Manual. The auditor conducts a
qualitative (visual and documentary) inspection and generates a report that can
be appealed by the laboratory. If the report is eventually favourable, an Accreditation Certificate is issued that must be paid for by the laboratory and
carries the twofold commitment of maintaining the existing quality systems and
granting the auditor free access to the laboratory in order to conduct periodic
controls over the period where accreditation is to hold. Renewing the accreditation (e.g. after the previous one has expired or the laboratory has undergone
some change) theoretically entails reconducting the whole accreditation
8 Analytical Chemistry and Quality
attached to the laboratory or its technical management. There are two types of
external assessment activities. External-internal assessment is carried out by
staff affiliated with the body of which the laboratory is a part but not with the
laboratory itself. Such staff may belong to the QAU established within the
framework of GLPs when this is the system adopted or to the body's quality
department otherwise.
The functions of this quality assessment group are the orientation, management and surveillance, not only of the quality control systems, but also of the rest
of the laboratory. Using the established protocols and SOPs or the contents of the
Quality Manual as guidelines, this personnel conducts a visual, documentary
and, occasionally, also quantitative, inspection of the laboratory activities. Their
work is similar to that involved in an internal audit; its institution raises major
personal problems that eventually disappear as the laboratory staff gradually
accept having their activities systematically examined on a routine basis. Incentives are very important in this context.
External-external assessment is conducted by experienced personnel from
other bodies, so it is doubly external to the laboratory. In the quality domain,
these activities are known as audits. Their targets can be systems (which are
examined in a purely qualitative manner by visual and documentary inspection), performance (assessment of which is exclusively quantitative) or both
(integrated assessment). There are two main types of analytical audits, namely:
(a) direct audits, which materialize in laboratory accreditation; and (b) indirect
audits, represented by proficiency testing. Both are commented on below.
8.6.2 Laboratory Accreditation
Laboratory accreditation is an external-external type of systems audit of
laboratory quality. It is defined as the formal written acknowledgement that a
laboratory is fit and competent to perform one or more given types of analysis.
Accreditation is provided by a public or private national organization and relies
on internationally established standards issued by institutions such as EU,
OECD, ISO, ILAC, WELAC, etc. Laboratory accreditation is voluntary (conducted
at the laboratory's request), temporary (it holds over a definite length of time)
and partial (it refers to a specific activity rather than to the laboratory's whole
work).
The accreditation process is started if the laboratory already possesses a
quality system materialized in a Quality Manual. The auditor conducts a
qualitative (visual and documentary) inspection and generates a report that can
be appealed by the laboratory. If the report is eventually favourable, an Accreditation Certificate is issued that must be paid for by the laboratory and
carries the twofold commitment of maintaining the existing quality systems and
granting the auditor free access to the laboratory in order to conduct periodic
controls over the period where accreditation is to hold. Renewing the accreditation (e.g. after the previous one has expired or the laboratory has undergone
some change) theoretically entails reconducting the whole accreditation