1. KATSUO KUBONO, Ph.D
Deputy Director-General
Japan Accreditation Board
The 3rd GCC Laboratory Proficiency Conference
March 24-25, 2015, Dubai
Medical Laboratory Accreditation
and its utilization in Japan

2. JAB and the Gulf Cooperation Center (GCC)
Accreditation Center (GAC) signed a
Memorandum of Communication (MOC) to provide
a framework for cooperation for accreditation.
MOU with the GCC Accreditation Center

3. 3
Medical Laboratory Accreditation
Scheme in Japan
Accreditation Activities for Medical
Laboratories
Effectiveness and Application
CONTENTS

4. 44
Mutual Recognition
Arrangement
EA
APLAC
IAAC
SADCA
ＩＬＡＣ ＭＲＡ 69 economies
84 ABs
AFRAC
ARAC

5. 55
Accredited Medical
Laboratories in each
economy As of Mar. 2015
Japan:82

6. 6
Transition in the number of accredited medical
laboratories in Asian neighboring economies

7. 7
JAB and the Japanese Committee for
Clinical Laboratory Standards (JCCLS)
jointly developed the accreditation scheme
for Japanese medical laboratories based on
the accreditation criteria of ISO 15189, and
JAB started its accreditation service in
August 2005.
Supported by both The Ministry of Health, Labor and Welfare and
Ministry of Economy, Trade and Industry
Medical Laboratory Accreditation

8. 8
Accredited Medical Laboratories
in Japan.
2
3
26
20
31
Unive rs ity Hos pital Ge ne ral Hos pital
Re gis te re d Clinic al Laboratory He alth Che c k Laboratory
Clinic al Trial Laboratory

9. 9
Scope of Accreditaton
General Testing: 2005
Biochemistry, Hematology, Immunology, Chromosome,
Gene, Biology, Urinalysis
Health Checkup: (Specified health checkup testing )
2007
Biochemistry, Hematology, Urinalysis
Pathology: 2009
Processing of fixed specimens for histopathology,
Cytodiagnosis, Histopahology
Physiology: 2015
Echography, Electrocardiography,
Electroencephalography,
Spirometry

10. Participation every year in proficiency
testing programs provided by at least
three associations.
NOTE: In the field of pathology, to
participate in a proficiency testing
program provided by Japan Association of
Medical Technologists.
At the time of on-site assessment, to
participate in an on-site practical
examination provided
Participation Proficiency Testing

11. 11
Improvement of proficiency test results
95
95.5
96
96.5
97
97.5
98
98.5
99
99.5
100
Init ia l Re a s s e s s me nt (1) Re a s s e s s me nt (2)
98.21±1.14
99.09±1.05 99.15±0.97

12. 1212
July 1, 2013
Pharmaceutical and
Food Safety Bureau,
Ministry of Health,
Labour and Welfare
Use the laboratory accreditation
(ISO 15189 accreditation) to the
quality control for medical
laboratory in clinical trial

13. Use the laboratory accreditation (ISO
15189) to the quality control of
medical testing in clinical trial
In the medical institutions that
actively conducted clinical research
or clinical trial beginning with the
physician-led clinical trials and
global clinical trials, in order to
ensure the testing accuracy of the
medical institution, medical
institution have to be accredited by
an external evaluation of ISO
15189, etc.. "

14. 4.1 組織とマネジメント
4.2 品質マネジメントシステム
4.3 文書管理
4.4 契約の内容の確認
4.5 委託検査室による検査
4.6 外部からのサ│ビス及び供給品
4.7 アドバイスサ│ビス
4.8 苦情処理
4.9 不適合の識別と管理
4.10 是正処置
4.11 予防処置
4.12 継続的改善
4.13 品質及び技術的記録
4.14 内部監査
4.15 マネジメントレビュ│
5.1 要員
5.2 施設及び環境条件
5.3 検査室の機材
5.4 検査前手順
5.5 検査手順
5.6 検査手順の品質保証
5.7 検査後手順
5.8 結果の報告
0.0
0.5
1.0
1.5
2.0
2.5
3.0
Continual Improvement
(Transition of findings)
Initial Assessment
First Surveillance
Second Surveillance
Re-assessment
Requirements

15. 15
0.0
1 0.0
20.0
30.0
40.0
50.0
60.0
70.0Pu rpo s e ％
a Ne e d s o f c us to me r
b
Le ga l re qu e s t a n d re s po n s e
c
Imp ro ve me nt o f vis ib ility
d
Impro ve me n t o f pe rf o rma n c e
e
De ve lop me n t of h uma n
re s o urc e
f
Imp ro ve me nt o f te c h nic a l c a p a bilitie s
g Soc ia l re s p on s ibility
h
Ve rs u s c o n s u me r
i Ot he rs NA
Purpose of accreditation
Laboratory Survey

16. 16
0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%
1
Me rit 3
Me rit 2
Me rit 1
Me rit 0
N.A.
Survey result for Improvement of
Technical Capability
Very Well Well

17. 17
Effect of QMS Effect of technical competence
Reduction of the incorrect frequency by
the standardization of work and the
promotion of organization /
documentation / the transparence.
Evaluation of value from a customer
(patients, doctors) improved by getting
third party evaluation.
Convergence of the human unevenness
by clarification of responsibility and
authority, documentation of operation
procedure.
Examination result report used in the
world wide by the ILAC/APLAC MRA.
Taking chance for international clinical
trial.
Certainty of setting up the work, rule
making, certifying, instructions, taking
over and investigation.
Improvement of the personnel
competence
Possibility of maintenance by
resignation, making change in the staff
Improvement of the evaluation result in
PT/EQA
Effectiveness after accreditation

18. 71
125
49
102
30
66
18
46
0
20
40
60
80
100
120
140
2005 2006 2007 2008
年
苦情
不適合
苦
情
／
不
適
合
の
件
数
Effectiveness in a accredited
Medical laboratory
Decreasing of Nonconformities/Complaints
Complaints
Nonconformities

19. 19
Thank you for your
attention !