SPECIFIC CRITERIA FOR

ACCREDITATION OF MEDICAL
LABORATORIES
 PREFACE
 SpecificCriteria for Accreditation of Medical
Laboratories was prepared by Ahmad Naeem
Sajed Microbiologist, in accordance with ISO
15189:2003. Thereafter, Issue No. : 02 has gone
through a few amendments. This document, has
been brought to the second edition of 15189,
version 2007. This document has gone through a
few amendments according to local Laboratory
requirements.
 CONTENTS
The scope of the accreditation is applicable to the following
medical laboratory services:
i. Clinical Biochemistry
ii. Clinical Pathology
iii. Microbiology and Serology
iv. Molecular Biology
v. Hematology and Immunohaematology
vi. Histopathology
Vii. Cytopathology
viii. Genetics
ix. Nuclear Medicine ( in-vitro tests only)
 DESCRIPTION AND TYPE OF
LABORATORY
 SmallLaboratory: A laboratory receiving up to 100
patients per day
 Medium Laboratory: A laboratory receiving up to 101-400
patients per day
 LargeLaboratory: A laboratory receiving above 400
patients per day
 MANAGEMENT REQUIREMENT
 (The
main text of this clause is the text of the same
clause of ISO 15189:2007)
A laboratory operating at more than one location within
a city having the same legal identity will be considered
as a single laboratory and will be issued a single
certificate. However, if the laboratory requires separate
certificates for individual locations, the application for
accreditation should be submitted separately for each
location. The laboratory operating at more than one
location having separate legal identities will be treated
as independent laboratories even though they are part
of same the organization
 TECHNICAL REQUIREMENT
 Personnel
 (The main text of this clause is the text of the same clause of ISO
15189:2007)
 The authorized signatories shall demonstrate knowledge and
competence in the concerned specialty.
 5.1.1.1 Qualification norms for Director/ Chairman/ Head
(howsoever named)
 Same qualifications as given in 5.1.1.2 with 5 years experience
 5.1.1.2 Qualification norms for authorized signatories (Refer Annex
– I for routine and special tests) are given in Table 1.
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

A Ph.D./M.D.F.C.P.S. Histopathology, Cytopathology, Clinical

(Pathology) Pathology, Haematology, Clinical
Biochemistry, Nuclear Medicine (in-vitro
tests), routine Microbiology and Serology,
Genetics, Flow Cytometry and Molecular
Biology .
B Ph.D./M.D F.C.P.S. Microbiology and Serology, Flow Cytometry,
(Microbiology) Molecular Biology, Clinical Pathology, routine
Haematology and routine Biochemistry
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

C Ph.D./M.D F.C.P.S. Histopathology, Routine Biochemistry,

(Histopathology) Clinical Pathology, Nuclear Medicine (in-
vitro tests), Flow Cytometry, Molecular
Biology, Routine Haematology, Routine
Microbiology and Serology
D Ph.D./M.D F.C.P.S. Clinical Biochemistry, Clinical Pathology,
(Biochemistry) Nuclear Medicine (in-vitro tests), Flow
Cytometry, Molecular Biology, Routine
Haematology, Routine Microbiology and
Serology
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

E Ph.D./M.D F.C.P.S. Molecular Biology, Clinical Biochemistry, Clinical

(Molecular Biology) Pathology, Nuclear Medicine (in-vitro tests), Flow
Cytometry, Routine Haematology, Routine
Microbiology and Serology

F M.Phil./M.S. (Anatomy)/ Genetics

Ph.D. with M.Sc.
(Human Anatomy)/
Ph.D. (Genetics)/ Ph.D.
(Applied Biology)
SR. Qualifications
Table 1Disciplines for being
No.
authorized signatory

G Medical Degree with specialized (post Nuclear Medicine.

graduate) qualification in nuclear
medicine such as Diploma in Radiation
Medicine (DRM), M.D./ Ph.D./ M.Sc. in
Nuclear Medicine
H Ph.D./M.D F.C.P.S. (Hematology)
Hematology, Clinical
Biochemistry, Clinical Pathology,
Nuclear Medicine (in-vitro tests),
Flow Cytometry, Molecular
Biology, Routine Haematology,
Routine Microbiology and
Serology
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

I Ph.D/M.D. in Clinical Pathology, Haematology, Clinical

Lab Medicine Biochemistry, Nuclear Medicine (in-vitro tests),
or Lab routine Microbiology and Serology
Technology

J M.Phil/M.S. Microbiology and Serology, Clinical Pathology,

(Microbiology)/ Clinical Biochemistry, Hematology, Molecular
(Biochemistry) Biology.
/(Molecular
Biology)/
(Hematology).
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

K DCP with 5 years Histopathology, Cytopathology, Clinical

experience Pathology, Hematology, Clinical
Biochemistry, Nuclear Medicine (in-vitro
tests), routine Microbiology and Serology

L M.Sc/BS./DMLS Microbiology and Serology, Clinical

(Microbiology) Pathology, routine Clinical Biochemistry,
routine Hematology , Molecular Biology
 Table 1
SR. Qualifications Disciplines for being authorized signatory
No.

M M.Sc/BS. Microbiology and Serology, Clinical

(Biochemistry) Pathology, routine Clinical Biochemistry,
routine Hematology , Molecular Biology

N MLT (Hon)/ BSc( 2 Routine Microbiology and Serology,,

Years) routine Biochemistry, routine Hematology
, Molecular Biology
 Qualification norms for technical staff
 The technical person performing the tests should have one of the following
qualifications:
 a. Graduate in Medical Laboratory Technology
 b. Diploma in Medical Laboratory Technology with the course of at least two
years duration
 c. Diploma/ certificate in Medical Laboratory Technology with the course of
at least one year duration and two years of experience in a medical
laboratory.
 d. Graduate in Science with one year experience in a medical laboratory.
 .
Qualification norms for technical staff
 e. Diploma in medical radiation and radioisotope technology
(DMRIT)
 f. Cytotechnologist – ‘a, b, c and d’ with additional
certification in cytotechnology
 g. A laboratory may employ up to 25 % of the staff with
science in matriculation having at least 10 years experience
in a medical laboratory
 GUIDELINES FOR OPERATING COLLECTION
CENTRE(S) OF THE MEDICAL LABORATORIES
 Collection centers are classified under three categories:
 (a) Ownership: Collection centers owned by the laboratory or its
parent
 (b) Management: Laboratory or its parent organization does not
own the collection centres but is entirely responsible for day to
day operations and its employees.
 (c) Franchisee: Laboratory or its parent company does not own the
collection centre but has an arrangement for sample collection
under a legal agreement with the franchisee. organization and
personnel are employees of the laboratory.
COMPOSITION OF TECHNICAL COMMITTEE
Sr. Name & Organization Capacity
No.
1 Chairman

2 Member

3 Member

4 Member

5 Member

6 Member
 COMPOSITION OF TECHNICAL COMMITTEE
Sr. Name & Capacity
No. Organization
7 Member

8 Member
9 Member
10 Member
11 Member
12 Member
Thanks