| Multi-site
Laboratory Accreditation
Multi-site accreditation is used by L-A-B where more than one permanent
location is included in a single accreditation granted to a Laboratory. For
example, companies offering calibration service from technicians
individually located in their homes are “multi-site” laboratories.
Laboratories seeking multi-site accreditation must specifically apply for
it.
All locations of the
laboratory seeking accreditation must utilize the same quality system and
quality manual, which must comply in all respects with the requirements of
ISO/IEC 17025. One corporate quality contact should be allocated for the
laboratories.
Multi-site Laboratories must meet the
following requirements
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Document fully the relationships between
the locations and the extent of interaction (e.g. allocation of
testing/calibration work, transfer of samples between locations,
movement of technical staff and/or equipment and centralized or
otherwise rationalized reporting arrangements). The extent of
interaction possible will depend, among other factors, on the
commonality of test/calibration and/or sampling methods and of quality
control of performance.
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Have mechanisms in place to assure that
inquiries about work in progress are handled efficiently, regardless of
any transfer between locations.
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Assure that reviews of
requests, tenders and contracts include appropriate consideration of
clients’ or potential clients’ awareness of a multi-site accreditation
status and the implications of this for work undertaken.
Defining scopes of multi-site
accreditation
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For
laboratory accredited sites, each scope has to be separate and
applicable for the technical competence for that particular site. This
is necessary for the clients of organizations performing testing and/or
calibration and also for L-A-B assessment purposes. With multi-site
accreditation, each location involved in the provision of accredited
testing/calibration activities, or in providing support functions to
those activities, has to be identified with separate scopes.
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Scopes
issued by L-A-B state clearly that a multi-site accreditation is
involved via the numbering system for each scope. They detail the entire
scope of testing/calibration and/or sampling (whether performed in a
permanent laboratory or on site) and list the locations involved
together with the general activities and or support functions carried at
or by each.
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Separate
certificates of accreditation will be issued by L-A-B for each site with
a distinct suffix number.
- Similarly, separate scopes for
multi-site accreditation will be issued for each site when separate
certificates are issued.
Assessment and accreditation processes
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The normal
assessment and accreditation processes for laboratory accreditation
apply to multi-site accreditation. Each site shall be considered an
individual assessment to assure compliance to ISO / IEC 17025 and their
own quality system.
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At the
initial assessment all locations, key activities and individuals must be
reviewed to assure technical competence. The entire proposed scope is
covered with the appropriate technical evaluation thru a series of
observations, procedural review, interviews, and detailed equipment
evaluation.
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During
subsequent assessments; activities throughout the multi-site
organization will be covered during the surveillance and renewal
assessments to the extent necessary to form a reliable judgment about
compliance with ISO/IEC 17025. It is expected that all locations or
individuals would be visited or personally interviewed at least once in
the three year assessment cycle.
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When an
assessment involves sampling of individual sites, L-A-B, the assessor
and laboratory must agree to a sampling plan that must be approved by
L-A-B before the assessment is conducted. The sampling plan must be
documented, based on good statistical practice , and it must ensure that
a sufficient number of sites and technical personnel are sampled to
provide a firm basis for judgments of competence for the organization as
a whole.
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A technical
evaluation may constitute an evaluation at a central location
particularly if the calibration and/or test can be performed without the
requirement of technical competence of the particular laboratory
environment. (this would not constitute a “key activity for
accreditation) Additionally a representative number of technicians must
be witnessed performing calibrations and/or testing to further that
confidence for accreditation.
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In some
cases it may be feasible to have the various technicians and their
equipment, procedures and other requisite documentation brought to one
central location. In such cases, the assessor(s) may interview each of
the technicians involved in the multi-site accreditation. Otherwise, the
assessor will have to visit each of the individuals involved in the
multi-site accreditation to ensure that they have the proper equipment,
training, and documentation.
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An
accredited multi-site organization must notify L-A-B of any changes of
individuals or locations to the accreditation. Depending on the
significance of the change, an additional visit may have to be scheduled
to confirm continued conformance with ISO/IEC 17025 and L-A-B’s
requirements.
- In all cases it must be remembered
that accreditation of calibration services offered by a number of
individuals located in various parts of the country, or even
internationally, is a complex affair generally involving significant
time and effort on the part of the assessor to assure that each of the
individuals included in the assessment and subsequent accreditation is
competent.
Suspension, termination, and reduction
of accreditation
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Suspensions, terminations or reductions in scope at one location,
whether voluntary or imposed, will automatically involve a full
consideration of the implications for the multi-site as a whole. Where
associated activities at other locations are affected or where
distinction between affected and unaffected activities at different
locations is not feasible, the suspension, termination or reduction in
scope would apply across the multi-site. Specific locations may suspend,
have suspended, or terminate their participation in the multi-site
accreditation and the accreditation may be reduced permanently to
exclude the particular location.
- In the event of termination or
resignation of a location from a multi-site accreditation, any one or
more of the locations included in the multi-site that wishes to remain
accredited will be required to apply for individual accreditation, and
to pay an application fee. L-A-B will apply its full accreditation
processes to such applications.
L-A-B Policy 009 - Accreditations of Multiple-Site Laboratories
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