KATSUO KUBONO, Ph.DDeputy Director-General

Japan Accreditation Board

The 3rd GCC Laboratory Proficiency ConferenceMarch 24-25, 2015, Dubai

Medical Laboratory Accreditation and its utilization in Japan

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

Medical Laboratory Accreditation Scheme in Japan

Accreditation Activities for Medical Laboratories

Effectiveness and Application

CONTENTS

44

Mutual Recognition Arrangement

EA

APLAC

IAAC

SADCA

ＩＬＡＣ　ＭＲＡ　 69 economies 84 ABs

AFRAC

ARAC

55

Accredited Medical Laboratories in each economy As of Mar. 2015

Japan:82

6

Transition in the number of accredited medical

laboratories in Asian neighboring economies

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

Accredited Medical Laboratories in Japan.

23

26

20

31

University Hospital General Hospital

Registered Clinical Laboratory Health Check Laboratory

Clinical Trial Laboratory

9

Scope of AccreditatonGeneral Testing: 2005Biochemistry, Hematology, Immunology, Chromosome,

Gene, Biology, Urinalysis

Health Checkup: (Specified health checkup

testing ) 2007

Biochemistry, Hematology, UrinalysisPathology: 2009Processing of fixed specimens for histopathology, Cytodiagnosis, Histopahology

Physiology: 2015Echography, Electrocardiography, Electroencephalography,Spirometry

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 providedby JAB.

Participation Proficiency Testing

11

Improvement of proficiency test results

95

95.5

96

96.5

97

97.5

98

98.5

99

99.5

100

Initial Reassessment(1) Reassessment(2)

98.21±1.14

99.09±1.05 99.15±0.97

1212

July 1, 2013Pharmaceutical 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

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.. "

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

0.0

10.0

20.0

30.0

40.0

50.0

60.0

70.0Purpose ％

a Needs

of cust

omer

b Le

gal re

quest an

d resp

onse

c Improv

ement

of visib

ility

d Impro

vemen

t of p

erform

ance

e Deve

lopment

of hu

man resou

rce

f Impro

vement

of te

chnica

l capa

bilitie

s

g Social

respon

sibilit

y

h Vers

us co

nsumer

i Othe

rs NA

Purpose of accreditation Laboratory Survey

16

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1

Merit 3

Merit 2

Merit 1

Merit 0

N.A.

Survey result for Improvement of Technical Capability

Very Well Well

17

Effect of QMSEffect of technical

competenceReduction 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

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

ComplaintsNonconformities

19

Thank you for your attention !