Page 7 - 2015 A2LA AnnualReport

A2LA also offers an accreditation program for
clinical testing laboratories using ISO 15189:2012,
Medical Laboratories- Requirements for quality and
competence and the requirements of 42CFR493 under
the Clinical Laboratory Improvement Amendments
(CLIA).
A2LA is the only accreditation body in the world that
is both recognized by the International Laboratory
Accreditation Cooperation (ILAC) for the accreditation
of clinical laboratories to ISO 15189 and approved by
the U.S. Centers for Medicare and Medicaid Services
(CMS) (deemed status) for the accreditation of clinical
laboratories to the requirements of 42CFR493. A
description of the accreditation process is maintained
in A2LA’s document titled R901 – General Requirements:
Accreditation of Clinical Testing Laboratories Meeting
the ISO 15189 Requirements. The laboratory’s commit-
ment to A2LA in pursuing accreditation is documented
in R902 – Conditions for Accreditation for Clinical Testing staff competence and reporting. It is available to all
Laboratories Meeting the ISO 15189 Requirements.
Inspection Body Accreditation
For the purpose of accreditation, inspection is defined
as the examination of a product, process, service
or installation or their design and determination of
its conformity with specific requirements or, on the
basis of professional judgment, with general require-
ments. Inspection of processes includes personnel,
facilities, technology and methodology that make up
the process. The results of inspection may be used to
support certification.
A2LA recognizes the close relationship between
inspection, sampling, testing and measurement, yet
understands that inspection includes a variety of
activities not covered in testing laboratory accredita-
tion. Different but related requirements are needed.
A2LA is committed to using the latest international Table 2.
standards and so uses as the general requirements INSPECTION BODY
for this program ISO/IEC 17020:2012 Conformity ACCREDITATION FIELDS
assessment- Requirements for the operation of various AND SPECIAL PROGRAMS
types of bodies performing inspection. A descrip-
tion of the accreditation process is maintained in * Fields and special programs
A2LA’s document titled R301 - General Requirements: with additional requirements
Accreditation of ISO/IEC 17020 Inspection Bodies. The beyond ISO/IEC 17020
inspection body’s commitment to A2LA in pursuing
accreditation is documented in R102 - Conditions  Agricultural products
for Accreditation. Added requirements deemed  Bulk cargoes (e.g. coal, iron ore,
necessary to clarify issues related to the use of the
“A2LA Accredited” symbol on inspection reports and petroleum)
the relationship of inspections versus tests and measure-  Cargoes in containers and packages
ments that may be involved as part of the inspection  Cast products
process are also included.  Cranes
 Electrical Equipment
Accreditation is based on the assessment of the perfor-  Federal Risk and Authorization
mance of an inspection body including procedures,
Management Program (FedRAMP) *
types of inspection bodies including in-house services.
A2LA acknowledges that some user organizations  Field Evaluation Bodies (FEBs)
may choose to accept only inspections conducted by  Foods
third party (Type A) inspection bodies. It is up to such
organizations to decide which accredited inspection  Forensic Examination *
bodies they will accept.
 Forged products
An inspection body may be an organization, or part of  Gaming equipment
an organization, but must be discretely identifiable in  Information Technology and Cyber
order to be accredited. An inspection body engaged
in another conformity assessment activity, such as Security
testing, measurement or sampling work, may apply for  Mechanical equipment
accreditation for its work as a laboratory concurrently  Pipelines
with its application for accreditation for inspection.  Protective coatings
 Rolled products
A2LA welcomes applications for the accreditation of all  Special Inspection as defined in the
types of inspection work. See Table 2 for the programs
and types of materials included in the A2LA Inspection International Building Code *
Body Accreditation Program.
 Structures (e.g. concrete, steel,
timber)
 Textiles
 Welding
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