Download To apply for A2LA accreditation under the mechanical field of testing

F312 – Scope of Accreditation Selection List: ISO 15189 Medical Testing Laboratories
To apply for A2LA accreditation under the medical field of testing, it is suggested that each
applicant identify the test type/test technology and associated test method(s) for which
accreditation is sought on table-A below. In addition, please identify the types of samples tested
in your laboratory on table-B below. This will help ensure that an assessor’s technical expertise
is correctly matched to the testing that your laboratory performs and enables A2LA staff to
generate the desired draft Scope of Accreditation.
Refer to the example proposed Scope of Accreditation (0000.01) on the next page when
entering the required information in tables A and B. Submission via electronic means is
preferred.
Table-A
Specialty
Microbiology:
Sub Specialty
Technology/Methodology
Bacteriology
Bacterial culture, complete ID
Bacterial culture
Genital cultures
Stool cultures
Urine cultures
Wound cultures
Chemistry
Routine Chemistry
Colorimeter and/or
spectrophotometer
Enzyme immunoassay (EMIT)
Enzyme-linked immunosorbent
assay (ELISA)
Immunoassay
Urinalysis
Microscopy, Urine Sediment
Urine Dipstick, Manual
Endocrinology
Chemiluminiscent Method
Table-B
Types of products, materials, and/or structures that the laboratory tests:
e.g. Whole blood, serum, plasma, urine, CSF, gastric contents, stool, other body fluids,
L:\Forms\F312 – Scope of Accreditation Selection List: ISO 15189 Medical Testing Laboratories (10/18/2007)
Page 1 of 2
PROPOSED SCOPE OF ACCREDITATION
SCOPE OF ACCREDITATION TO ISO 15189:2007
SCOPE EXAMPLE LABORATORY
12345 Main Street
Frederick, MD 21704
John Doe Phone: 555 555 5555
Identify the sample
types upon which you
perform testing.
MEDICAL
Valid To: May 31, 2007
Certificate Number: 0000.01
In recognition of the successful completion of the A2LA evaluation process, accreditation is
granted to this laboratory to perform the following types of testing on human samples, including:
Whole blood, serum, plasma, urine, CSF, gastric contents, stool, other body fluids
Specialty
Microbiology:
Sub Specialty
*Technology/Methodology
Bacteriology
Bacterial culture, complete ID
Bacterial culture
Genital cultures
Stool cultures
Urine cultures
Wound cultures
List the test Specialty and
Subspecialty(s) that the
laboratory is seeking
accreditation for.
Chemistry
Routine Chemistry
Colorimeter and/or
spectrophotometer
Enzyme immunoassay (EMIT)
Enzyme-linked immunosorbent
assay (ELISA)
Immunoassay
List the technologies or
methodologies to be
included on the Scope of
Accreditation
Urinalysis
Microscopy, Urine Sediment
Urine Dipstick, Manual
Endocrinology
Chemiluminiscent Method
* Please note that to be considered for accreditation, a copy of each selected test method and the
requisite equipment must be available at the laboratory.
L:\Forms\F312 – Scope of Accreditation Selection List: ISO 15189 Medical Testing Laboratories (10/18/2007)
Page 2 of 2