8

1 2556

QM-MSL

1 148

(Quality Manual)

(.
(.

(Quality Manager: QM)

(Technical Manager: TM)

............

QM-MSL

1 2556

2 148

(. )

Med Star Ltd. Manager

6 .

5 6

1 2556

QM-MSL

3 148

51
1

6 .

12

6 .

48

7.2

51

51

,
,

16 .

16 .

11

16 .

12

52
52
52

16 .

13

QM-MSL

1 2556

4 148

52
3

18 .

4.1.2
13

53
3

18 .

4.1.2
15

53

4.2

4.2.1.3

18 .

17

11

53
4

20
..53

20
. .
53

20

. .
53

20
. .
53

QM-MSL

1 2556

5 148

20

12

4.1

. .
53

20

. .

13

14

4.1.1

53
4

20
. .

53

4.1.2


4

20

16

. .
20

53
4

4.2.1.1

17

4.2.1.2

QM-MSL

1 2556

6 148

. .

53
5

10 .

10 .

13

54
54

10 .

14

54
5

10 .
54

30

4.13
6

12 .

12 .

54

30

54
54

..56

..2547

QM-MSL

1 2556

7 148

30

..56

1 ..

1 ..

ISO 15190:2003

1 ..

dot line Organization Chart

56
56

56

1 ..

1 ..

15

56
56

4.1.1
/

4.1.2
(Assistant Laboratory Manager :Assist.

QM-MSL

1 2556

8 148

LM)

4.1.3 (Quality
Manager :QM)

4.1.4 (Technical
Manager :TM)

4.1.5
(Document Control :DCC)

4.1.6 (Lab
Safety Officer :LSO)

4.1.7 (Medical
Technologist :MT)

4.1.8 (Assistant
Medical Technologist :Assist. LM)
4.1.9 -
(Messenger)
8

1 ..

20

56
8

1 ..

24

56

(MN-MSL-

001)

QM-MSL

1 2556

9 148

1 ..
56

51-53

6 7 WI

1.

2.

1 2556

QM-MSL

10
148

3.

10

4.

11

4.1

13

4.2

19

4.3

22

4.4

24

4.5

25

4.6

26

4.7

27

4.8

28

4.9

29

4.10

30

4.11

31

4.12

32

4.13

33

4.14

34

QM-MSL

1 2556

11
148

4.15
5.

35
37

5.1

37

5.2

40

5.3

41

5.4

43

5.5

45

5.6

48

5.7

49

5.8

50

6.

51

7.

53

54

54

55

56

1 2556

QM-MSL

12
148

57

- ..2547

58

QM-MSL

1 2556

13
148

ISO 15189: 2007, ISO 15190:2003

2551

1.

2.
ISO 15189: 2007, ISO
15190:2003 2551

1 2556

QM-MSL

14
148

3.

4.

ISO 15189: 2007, ISO 15190:2003
2551

5.

6.

2556

1 2556

QM-MSL

15
148

( )

1 2556

QM-MSL

16
148

1.

61/1 .

. . .

50 1 07 0004 51 4 2551

0503549003388 26 2549

(Quality Manual : QM)

ISO 15189:2007, ISO 15190:2003

1 2556

QM-MSL

17
148

2551

1 12

ISO 15189:2007, ISO
15190: , 2551

1 2556

QM-MSL

18
148

2.

1.

1 2556

QM-MSL

19
148

2.

3.

, ISO 15189 : 2007, ISO
15190:2003 2551

1 2556

QM-MSL

20
148

ISO 15189:2007,
ISO 15190:2003

2551

3.

ISO 15189:2007, ISO 15190:2003

2551

1 2556

QM-MSL

21
148

1 2556

QM-MSL

22
148

ISO 15189: 2007, ISO 15190:2003

2551

-
,

4.

1 2556

QM-MSL

23
148

ISO 15189: 2007,
ISO 15190:2003 2551

61/1 .

. . . 50200

1 2556

QM-MSL

24
148

61/1 . .

. . 50200
053-418969 053-418967-8

1 2556

QM-MSL

25
148

( )

ISO

15189:2007 2551

1 2556

QM-MSL

26
148

4.1

1 2556

QM-MSL

27
148

QM-MSL

1 2556

28
148

1 2556

QM-MSL

29
148

-
/

1 2556

QM-MSL

30
148

4.1.1 /
(Med Star Ltd.Manager/Laboratory Manager:LM)

.() 15

1 2556

QM-MSL

31
148

1 2556

QM-MSL

32
148

4.1.2 (Assistant Laboratory Manager

:Assist. LM)

.() 12

4.1.3 (Quality Manager :QM)

1 2556

QM-MSL

33
148

.() 10

ISO 15189 :
2007,ISO 15190:2003 2551
-

4.1.4 (Technical Manager :TM)

QM-MSL

1 2556

34
148

-
. 2
-

4.1.5 (Document Control :DCC)

1 2556

QM-MSL

35
148

4.1.6 (Lab Safety Officer :LSO)

-
. 2

(Lab Safety

Program) (Develop),
(Maintain), (Monitor)
-

(Effective of Lab Safety Program) (Education) ,

(Orientation), (Training) ,
(Audit and Evaluation)

4.1.7 (Medical Technologist :MT)

QM-MSL

1 2556

36
148

4.1.8 (Assistant Medical Technologist

:Assist. LM)

1 2556

QM-MSL

37
148

6 (.6)

, ,

4.1.9 - (Messenger)

3 (.3)

1 2556

QM-MSL

38
148

(QP-MSL-015)
4.2
4.2.1

4.2.1.1 (Quality Manager :QM)

QM-MSL

1 2556

39
148

ISO 15189
2551
-

QM-MSL

1 2556

40
148

4.2.1.2 (Technical Manager :TM)

QM-MSL

1 2556

41
148

ISO 15189
2551
-

(LM)

(Assist.LM)

(Assist.LM)

(QM)

1 2556

QM-MSL

42
148

(QM)
(TM)

(TM)

(MT)

1 2556

QM-MSL

43
148

4.3

4.3.1
-

(QP-MSL-002)

-
4

QM
QP

WI

SD
1. (Quality Manual : QM) QM-MSL
1

QM-MSL

1 2556

44
148

2. (Quality Procedure : QP) QP-

MSL-xxx 2

3. (Work Instruction : WI) WI-MSL-zzxxx 3

4. (Supporting Document : SD) 4

- (Manual) MN-MSL-xxx

- (Record)

RE-MSL-xxx

- (Form)

FM-MSL-xxx

IN-MSL-yy-xxx

QM-MSL

1 2556

45
148

- (Business

Register documents) BR-MSL-xxx

- (Text Book)

TB-MSL-xxx

- (Card File) CF- MSL- xxx

xxx
yy

zz

4.3.2

Quality Manual

Quality

1 2556

QM-MSL

46
148

Procedure

Work Instruction

Supporting

Document

4.3.3

QM-MSL

1 2556

47
148

4.4

1
12
(QP-MSL-003)

(MN-MSL-001)

1 2556

QM-MSL

48
148

1 2556

QM-MSL

49
148

4.5

1 2556

QM-MSL

50
148

(WI-MSL-00-027)

- Approved Subcontract/Referral Labs List

(QP-MSL-004)

1 2556

QM-MSL

51
148

4.6
4.6.1

(QP-MSL-005) Supplier (WIMSL-00-026)
4.6.2

(WI-MSL-00-020)

1 2556

QM-MSL

52
148

4.7

(QP-MSL-006)

1 2556

QM-MSL

53
148

4.8

(QP-MSL-011)

1 2556

QM-MSL

54
148

4.9

-
-

1 2556

QM-MSL

55
148

-

-

(QP-MSL-007)

1 2556

QM-MSL

56
148

4.10

(QP-MSL-008)

1 2556

QM-MSL

57
148

QM-MSL

1 2556

58
148

4.11

1.

2. 1 12

3. /
(FM-MSL-077)

1 2556

QM-MSL

59
148

4.

5. (Risk Profile)

(QP-MSL-009)

1 2556

QM-MSL

60
148

4.12

1 12

(QP-MSL-010)

1 2556

QM-MSL

61
148

1 2556

QM-MSL

62
148

4.13

(QP-MSL-012)

(Record)

1 2556

QM-MSL

63
148

IQC

External QC

,
*

,
*

,
*

,
*

*
*
*

1 2556

QM-MSL

64
148

*
*
5

,
,
*

,
*

,
*

4.14

1 2556

QM-MSL

65
148

ISO 15189: 2007, ISO 15190:2003

2551

check list

ISO 15189: 2007 , ISO 15190:2003

2551

1 12

(QP-MSL-013)

-
30 , 60

QM-MSL

1 2556

66
148

4.15

1 12
1.

2. (
, ,)
3.

1 2556

QM-MSL

67
148

4.

5.
6.
7.

8.

9.
10.
11.

12.

13.
14.

15.
16.
17.

18.
19.

20.

QM-MSL

1 2556

68
148

21.

22.
23.

24.
25.
26.

27.
28.

-
-
-
-

-
-

1 2556

QM-MSL

69
148

(Continuous Improvement)

(QP-MSL-014)
(FM-MSL-098)

1 2556

QM-MSL

70
148

5.
5.1

5.1.1

1. (
)

2.

3.

5.1.2

1 2556

QM-MSL

71
148

5.1.3

(QP-MSL-018)

QM-MSL

1 2556

72
148

5.1.4

(Job description)

(QP-MSL-018)
5.1.5

(QP-MSL-018)

5.1.6 (On the job training)

1 2556

QM-MSL

73
148

(QP-MSL-018)
ISO 15189: 2007

5.1.7
1)

2)

3)

4)

(QP-MSL-021)

1 2556

QM-MSL

74
148

5)

6)

5.1.8

(QP-MSL-018)

1 2556

QM-MSL

75
148

1 2556

QM-MSL

76
148

5.2

5.2.1
1)

2)

3)

4)

1 2556

QM-MSL

77
148

5)

6)
5.2.2

(QP-MSL-

009)

1 2556

QM-MSL

78
148

5.3
5.3.1

5.3.2

5.3.3

1 2556

QM-MSL

79
148

5.3.4

5.3.5
1)

2)
3)

QM-MSL

1 2556

80
148

5.3.6

(QP-MSL-019)

5.3.7

(WI-MSL-00-017)

1 2556

QM-MSL

81
148

1 2556

QM-MSL

82
148

5.4

5.4.1

(MN-MSL-001)

5.4.2

(WI-MSL00-008)

1 2556

QM-MSL

83
148

(WIMSL-00-008)

(QP-MSL-004)

1 2556

QM-MSL

84
148

(WI-MSL-00-028)

1 2556

QM-MSL

85
148

5.5
5.5.1

QM-MSL

1 2556

86
148

1 2556

QM-MSL

87
148

5.5.2

1 2556

QM-MSL

88
148

Text book, Journal

1 12

(MN-MSL001)

(QP-MSL-018)

(MN-MSL-001)

1 2556

QM-MSL

89
148

1 12

(WI-MSL-00-006)

(WIMSL-00-007)

1 2556

QM-MSL

90
148

QM-MSL

1 2556

91
148

5.6
5.6.1 Internal

Quality Control

(WI-MSL-00-011)

5.6.2

1 2556

QM-MSL

92
148

(Proficiency Testing)
(External Quality Assessment Scheme)

(WI-MSL-00-011)

(WI-MSL-00-011)
(WI-MSL-00-015)

5.6.3

Worksheet

5.6.4

(WI-MSL-00-016)

1 2556

QM-MSL

93
148

QM-MSL

1 2556

94
148

5.7

(QP-MSL-021)

(WI-MSL-00-028)

1 2556

QM-MSL

95
148

5.8

1 2556

QM-MSL

96
148

(QP-MSL-021)

1) ()

2)

(WI-MSL-00-023)

(QP-MSL-021)

1 2556

QM-MSL

97
148

3)

4)

/
5)

6)

7)

(QP-MSL-015)

6.

QM-MSL

1 2556

98
148

6.1

(WI-MSL-00-028)

-
-

-
-
6.2

(WI-MSL-00-001)

1)

QM-MSL

1 2556

99
148

2)
3)

6.3

1) (WI-MSL-00-029)

2)
(WI-MSL-00-028)
3)
(WI-MSL-00-030)

6.4
1)

1 2556

QM-MSL

100
148

2)

3) /

1 2556

QM-MSL

101
148

7.
7.1

QM-MSL

1 2556

102
148

7.2

(FM-MSL-080),

- (FM-MSL-081)

7.3
-

1 2556

QM-MSL

103
148

1 2556

QM-MSL

104
148

1 2556

QM-MSL

105
148

1. Reception
2.

3.

4.
CLINICAL CHEMISTRY 1
AND IMMUNOLOGY

5.
6.

7.
.

8.

9.

1 2556

QM-MSL

106
148

QM-MSL

1 2556

107
148

Co

Co

X9
Elecsy
D-

Elecsy
Co

10
FA

Co

VI

TROS
60 DT
II

QM-MSL

1 2556

108
148

PENTRA ES 60

Room
Temp.

Co

CX4

1 2556

QM-MSL

109
148

1 2556

QM-MSL

110
148

(QP-MSL-015)

QM-MSL

1 2556

111
148

.. 2547
..

12 .. 2547
59

1-5
:: 1 6-10
:: 2 11-13

:: 3 14-24

:: 4 25-27
:: 5

28-46

:: 6 47-49
:: 7 50-54
.

1 2556

QM-MSL

112
148

:: 55-59

29

31 35 39 48 50

1 "

.. 2547"

QM-MSL

1 2556

113
148

2[1]

" "

" "

" "

" "
" "

" "
" "

1 2556

QM-MSL

114
148

" "

" "
4

1
6

1 2556

QM-MSL

115
148

(1)
(2)

(3)

(4)

(5)

(6)

(7)

(8)

1 2556

QM-MSL

116
148

(1)

(2) 42
(3)

(4)

(5) (4)

(6)

(7)

(8)

QM-MSL

1 2556

117
148

(1)

(2)

(3)

(4)
(5) (1) (2) (3) (4)

10

2

11

(1)
(2)

QM-MSL

1 2556

118
148

(3)

(4)

(5)

12

(1)

(2)

(3)

1 2556

QM-MSL

119
148

(4)

13
(1)

(2)

(3) 11 (1) (2)

(5)

(4)

11 (3) (4)

14
(1)

(2)

1 2556

QM-MSL

120
148

(3)

(4)

(1) (2) (3)

15

14 (4)
16

14 (4)

1 2556

QM-MSL

121
148

14 (4)

17 14 (4)

15

16 22

18 14

(1)

QM-MSL

1 2556

122
148

(2)
(3)

19 14 (2) (4)

14 (4)

20

14 (2) (4)

(1) 13
(2) 18
(3)

(4)


14 (2)

1 2556

QM-MSL

123
148

21 14 (2)

14 (2)

22 14 (4)

18
14 (4)

1 2556

QM-MSL

124
148

23
(1)

7 8
(2)

(3)

(4)
()

1 2556

QM-MSL

125
148

() 11 (5)

()

()

16

()

15

()
()

16

()

32

()

1 2556

QM-MSL

126
148

()

()
()

()

32

()
()

()
()

1 2556

QM-MSL

127
148

27

24

(1)

()

()
()

(2)

1 2556

QM-MSL

128
148

(3)

(4)

()

()
()

()
()

(5)

1 2556

QM-MSL

129
148

(6)

(7)

(8) 15

(9) 16

4
25

QM-MSL

1 2556

130
148

13 (4)

26

27

(1)

(2)

(3) 13 (4)

1 2556

QM-MSL

131
148

(4)

42 (4) (5)

(1)
(2) (3) (4)

28

QM-MSL

1 2556

132
148

(1)

(2)

(3)

(4)

(5)

1 2556

QM-MSL

133
148

(6)

(7)

29

QM-MSL

1 2556

134
148

30

31

32

1 2556

QM-MSL

135
148

13

13 (2) (3) (4)

33

34

33

33

33

1 2556

QM-MSL

136
148

33
33

35

34
33

36

35

QM-MSL

1 2556

137
148

37

(1)

(2)

(3)

38

QM-MSL

1 2556

138
148

39

40

1 2556

QM-MSL

139
148

41

38

42

38

1 2556

QM-MSL

140
148

(1)
(2)
(3)

(4)
(5)

27

43

42

44 28

1 2556

QM-MSL

141
148

45

44
50

46

QM-MSL

1 2556

142
148

6
47

(1)

(2)

(3)

1 2556

QM-MSL

143
148

48

49

50 28 44

51 29 30

52 32

47

1 2556

QM-MSL

144
148

53

39

54 48

55

56

57

1 2556

QM-MSL

145
148

14 (4)

14 (1) (2) (3)

14 (1) (2)

(3)

16

14 (4)

58

QM-MSL

1 2556

146
148

59

(1)

5,000

1 2556

QM-MSL

147
148

(2) 2,500

(3)
500

(4)

3,000
(5) 500

:-

1 2556

QM-MSL

148
148

" "