MS ISO15189

7/26/2019 MS ISO15189

1/6

Schedule

lssue date: 09

December 2015

Valid until:

29

October

2016

NO: SAMM

480

Lab 6

of 10

(lssue

2,

09

December

2015 replacement

of SAMM

480

dated

19 February

2014)

Page:

1

of 6

LABORATORY

LOCATTON: MEDTCAL

LABORATORIES

(PERMANENT

LABORATORY)

HEMATOLOGY & TRANSFUSION

MEDICINE

LABORATORY

HOSPTTAL

UNIVERSII

SAINS MALAYSIA

(HUSM)

JALAN RAJA PEREMPUAN

ZAINAB II

16150

KUBANG

KERIAN

KELANTAN, MALAYSIA

A

medical laboratory's

fulfillment of

the

requirements

of

ISO

15189:2012

means

the

laboratory

meets both the technical

competence requirements

and

the

management system

requirements

necessary

for it

to consistently

deliver technically

valid test

results.

The

management system

requirements

in ISO 15189

(Section

4) are

written

in a

language

relevant to

a medical

laboratory's operations

and meet the

principles

of

ISO

9001:2008

Quality

management systems

-

Requirement and

are

aligned

with

its pertinent requirements

(Joint

IAF-ILAC-ISO Communiqud

issued in 2015)

FIELD

OF MEDTCAL

TESTING:

HAEMATOLOGY

SCOPE OF

ACCREDITATION :

sKlM AKREDTTAST MAKMAL MALAYS|A

(SAMM)

LABORATORY ACCREDITATION

SCHEME OF

MALAYSIA

MS tSO 15189

Specimen

Tested

Type

of

Tests/

Properties Measured

Test Method, Specification/

EquipmenUTechniques

Used

Routine Haematology

EDTA Blood

Dried Blood

EDTA Blood

Routine

Haematology

EDTA Blood

FBC

ESR

GOPD Screening

Reticulocyte

Count

FBP

o

FBC

Manual

Sysmex

XE500O / DC

Detection Method as

Documented

in

HUSM/HEMA-UPT/STM-R1

Sysmex l

7/26/2019 MS ISO15189

2/6

Schedule

NO:

SAMM 480

Lab

6

of

10

(lssue

2,

09 December

2015 replacement

of SAMM 480

dated 19 February

2014)

FIELD

OF

MEDTCAL

TESTING:

HAEMATOLOGY

SCOPE OF ACCREDITATION:

lssue

date: 09 December

2015

Valid

unti :

29

October

2016

Page:

2

of 6

MS rSO

'15189

Specimen

Tested

Type

of Tests/

Properties

Measured

Test Method,

Specification/

EquipmenUTechniques

Used

Molecular

EDTA B|ood/

EDTA

Bone Marrow

Coagulation

Plasma

Molecular

APTT

PT

/ INR

Fibrinogen

Factor

Assay:

Factor

Vlll:C &

Factor lX

D-Dimer

Lupus

Anticoagulant

Polymerase

Chain

Reaction

(PCR).

BCR-ABL

Fusion

transcript

using

Multiplex

RT-PCR

as

documented in

HUSM/HEMA-UPT/STM-M1


Polymerase

Chain

Reaction

(PCR).

JAK

2

Mutation

V617F

as

documented

in


HUSM/HEMA.UPT/STM-M4


Coag

u

lometric

Test-Mechan

ical

Clot

Detection

Method

on

STA CompacUSTA-R

EVOLUTION

as Documented

in

HUSM/HEMA-UPT/STM-C1

MechanicalClot

Detection

Method

on STA

Compact

/STA-R

EVOLUTION

as

Documented

in


MechanicalClot

Detection

Method

on

STA

CompacU

STA-R

EVOLUTION

as

Documented

in HUSM/H

EMA-U PT/STM-C2

MechanicalClot

Detection

Method

on

STA

Compact as Documented

in


lmmunoassay

Tests

-

Mechanical

Clot

Detection

on

STA CompacV STA-R

EVOLUTION Method

as

Documented in


STA Compact

/

Mechanical clot detection

method

as

documented in


HUSM/HEMA-UPT/STM.C7

ST

art

4

/

Mechanical

clot detection

method

as

documented

in

H

USM/H EMA-U PT/STM-C8

7/26/2019 MS ISO15189

3/6

Schedule

NO:

SAMM 480

Lab 6

of

10

(lssue

2,

09 December 2015 replacement

of

SAMM

480

dated 19 February 2014)

FIELD

OF

MEDICAL

TESTING: HAEMATOLOGY

SCOPE OF

ACCREDITATION:

lssue

date: 09 December

2015

Valid

until:

29

October 2016

@

S tSO 15189

Page:

4

of

6

Specimen Tested Type

of

T.ests/

Properties

Measured

Test Method,

Specification/

EquipmenUTechniques

Used

Flow

Cytometry

EDTA Blood

Haemopoetic

Progenitor

Cell-

Apheresis

(HPC-A)

anticoagulated with

ACDA; Peripheralblood

stem

cell

in

EDTA

container

(2mll3ml).

Haemoglobin

Analysis

EDTA Blood

lmmunophenotyping

Quantitation of CD34

Positive

Cells

For Stem

Cell

Transplantation

Haemoglobin

Electrophoresis

Hb

Analysis

Flow

Cytometry

FACS

CANTO llas

documented

in

HUSM/H

EMA-U

PT/STM-F1

FACS

Calibur

Flowcytometer

Single Platform ISHAGE

Gating Strategy

using

Flowcytometry

as documented in

HUSM/HEMA-UPT/STM-F2

Agarose

Gel

/

System Electrophoresis

lnterlab G26

as

Documented in

HUSM/HEMA.U

PT/STM-SH2

HUSM/HEMA.U PT/STM-SH3

HPLC

/

Bio-Rad

Variant ll

as documented

in HUSM/HEMA-UPT/STM/SH-1

sKlM

AKREDTTAST

MAKMAL

MALAYSTA

(SAMM)


SCHEME OF

MALAYSIA

7/26/2019 MS ISO15189

4/6

Schedule

NO: SAMM

480

Lab 6 of 10

(lssue

2, 09

December

2015 replacement

ofSAMM

480 dated

19 February

2014)

FIELD

OF

MEDICAL

TESTING:

HAEMATOLOGY

SCOPE

OF

ACCREDTTATION:

lssue date:

09 December

2015

Valid until:

29 October

2016

Page:

3 of6

MS tSO

15189

Specimen

Tested

Type of Tests/

Properties

Measured

Test

Method,

Specifi

cation/

EquipmenUTechniques

Used

lmmunohaematology

EDTA B|ood

Transfusion

Microbiology

Serum/Plasma

Bone

Marrow

Aspirated

Bone

Marrow

ABO/Rh

Grouping

Antibody

Screen

(lndirect

Coombs

Test)

Cross Match

Rhesus Genotyping

Direct

Antiglobulin Test

RBC Phenotyping

Antibody

ldentification

HlV,

HCV

and

HBsAg

Screening

for

Blood

Donor

Bone marrow

examination

and

cytochemical

staining

Tile/Tube

Method

/ Gel Card

(Techno

Twin

Station)

(Antibody-Antigen

Reaction)

as

documented

in

HUSM/HEMA-UPT/STM.T1

HUSM/HEMA-UPT/STM-T2

Gel

Card

(Antigen-Antibody

Reaction) as

documented

in

H

USM/H

EMA-U

PT/STM-T3

Gel

Card

(Antigen-Antibody

Reaction)

Tube

Method

(lmmediate

Spin)

as documented

in HUSM/HEMA-UPT/STM-T4

Gel Card/

Tube

Method

(Antibody-Antigen

Reaction) as

documented

in

HUSM/HEMA-UPT/STM-Ts

Gel

Card

(Antigen-Antibody Reaction) as

documented

in

H

USM/H EMA-U

PT/STM-T6

Gel

Card/

Tube

Method

(Antigen-Antibody

Reaction) as

documented

in

HUSM/HEMA-UPT/STM-T7

Gel

Card

(Antigen-Antibody

Reaction)

as

documentEd

iN

HUSM/HEMA-U

PT/STM-T8

Abbott

Architect

(Chemiluminescent

Microparticle

lmmunoassay

(CMIA)

as

documented

in

H

USM/H

EMA-U

PT/STM-SI

Manual

Smear

&

Staining

Method

as

documented

in

H

USM/H

EMA-U

PT/STM-BM

1

H USM/H

EMA-U

PT/STM-BM2

H

USM/H

EMA-U

PT/STM-BM3

HUSM/H

EMA-U

PT/STM-BM4

HUSM/HEMA.U

PT/STM-BM5

H

USM/H

EMA-U

PT/STM-BM6

HUSM/H

EMA-U

PT/STM-BM7

7/26/2019 MS ISO15189

5/6

Schedule

NO:

SAMM

480

Lab

6

of

10

(lssue

2,

09

December

2015

replacement

ofSAMM

480

dated

19

Febryary

2014)

Key

Personnel:

lssue

date:

09 December

2015

Valid

until:

29

October

20{6

ns

6-rsrag

Page:5

of6

No.

Name

Designation

1.

Assoc.

Prof.

Dr. Rapiaah

Mustaffa

Laboratory

Director

2.

Assoc.

Prof. Dr.

Wan

Zaidah

Abdullah

Deputy

Laboratory

Director

Haematology

3. Assoc.

Prof.

Dr.

Wan

Zaidah

Abdullah

Quality

Manager

4.

Mdm.

Norizah

Tumin

Deputy

Quality

Manager

5.

Mdm. Maseta lsmail

Technical

Manager

6.

Mdm.

Narishah

Sharif

Deputy

Technical

Manager

7.

Mdm. Norizah

Tumin

Document

Controller

8. Ms.

Wan

NorAziemah

Wan

Zainulddin

Deputy

Document

Controller

9

Mdm.

Roazliana

Ramli

Technical

Officer

Routine

Haematology

10.

Mr. Muhammad

Ashraf

Zulkarnain

Technical

Officer

Routine

Coagulation

11.

Mr.

Saharim

Osman

Technical

Officer

Routine

Flowcytometry

12.

Mdm.

Salwana

Ahmad

Technical

Officer

Routine

Molecular

13.

Mdm.

SuryatiAbdullah

Technical

Officer

Routine

-Hb Analysis

14.

Ms.

Ang

Cheng

Yong

Technical

Officer

Routine

Bone Marrow

Transfusion

Medicine

15.

Assoc.

Prof. Noor

Haslina

Mohd Noor

Quality

Manager

16.

Mdm

Khairiah

Yazid

Deputy

Quality

Manager

17.

Mdm.

Salamah

Ahmad

Sukri

Technical

Manager

18.

Mdm.

Rohana

Yusof

Deputy

Technical

Manager

19.

Mdm. Khairiah

Yazid

Document

Controller

20.

Mr.

Muhamad

FakhriMohd

Azmi

Deputy

Document

Controller

21.

Mdm.

Suzana Abu

Technical

Officer lmmunohematology

22. Mr.

Abu

Salam Mohamed

Nor

Technical

Officer

Transfusion

Microbiology

23.

Mr.

Ahmad

Zaki

ldris

Technical

Officer Stem Cell

24.

Mdm Wan

RosniWan

Yakob

Technical

Officer

Donor

Section

sKtM

AKREDTTAST MAKMAL MALAYSTA

(SAMM)


SCHEME OF

MALAYSIA

7/26/2019 MS ISO15189

6/6

Schedule

ffiL

Y

MS rSO

15189

lssue

date:

09 December 2015

Valid

until:

29

October 2016

NO:

SAMM 480

Lab 6 of 10

(lssue

2,

09

December

2015

replacement

of SAMM 480

dated

19 February

2014)

Clinical

Personnel:

Page:

6

of

6

No. Name

Discipline

1

Assoc.

Prof.

Dr. Rapiaah

Mustaffa

Haematology/Transfusion

Med

icine/Molecu

lar

2

Prof.

Dr. Rosline Hassan


Med

icine/Molecu

lar

3 Assoc.

Prof. Dr.

Wan

Zaidah Abdullah


Medicine/Molecu

lar

4

Assoc.

Prof.

Dr.

Suhair Abbas

Ahmed

Al-Salih Haematology/Transfusion

Medicine

5

Dr.

Wan HaslindawaniWan

Mahmood

Haematologyff

ransfusion

Medicine

6

Dr. Shafini Mohamed

Yusoff


Med

icine

7

Assoc.

Prof.

Dr.

Rosnah

Bahar

Haematologyff

ransfusion

Medicine

I Assoc.

Prof.

Dr.

Noor

Haslina Mohd.

Noor


Med

icine

I

Dr.

MariniRamli


Medicine

10

Dr. Mohd

Nazri Hassan


Med

icine

11 Dr. Muhamad

Farid

Johan

Molecular

12 Dr

Salfarina

lberahim


Med icine

13

Dr. Marne

Abdullah


Medicine

sKtM

AKREDTTAST

MAKMAL MALAYSIA

(SAMM)


SCHEME

OF MALAYSIA

MS ISO15189

Documents

Transcript of MS ISO15189