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 assessors 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,

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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.

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