人員訓練及能力評估 -檢驗作業指引 · tslm 管2-08 b-01 頁次：第 1 頁共18 頁...
TRANSCRIPT
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Taiwan Society of Laboratory Medicine www.labmed.org.tw
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TSLM 2-08B-01
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2008
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10643 16 12 1 http://www.labmed.org.tw TEL : 886-2-23697497 / 886-2-23697463 FAX : 886-2-23698363 E-mail : [email protected]
Copyright Taiwan Society of Laboratory Medicine. All Right Reserved.
TSLM 2-08B-01
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1 1. 1 2. 1 3. 1 4. 1~2 5. 2~5 6. 5~6 7. 6 7~18
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TSLM 2-08 B-01 1 18
- 2007/11/10
2008/07/15
1.
2.
2.1 / 2.2
3. 3.1 QSEs
QSEs
4.
4.1
4.2
4.3
4.3.1
4.3.2
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TSLM 2-08 B-01 2 18
4.4 4.4.1
4.4.2 HISLISPC
4.4.3
4.4.4 4.4.5
4.5 4.5.1
4.5.2 4.5.3
4.6 4.6.1
4.6.2 4.6.3
5.
5.1 5.1.1 SOP
5.1.2
5.1.3
5.2 5.2.1
5.2.1.1 () 5.2.1.2 ()
(linearity checks)
5.2.2 -
5.2.3
()
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TSLM 2-08 B-01 3 18
()
5.2.4
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5.3
5.3.1 ()
5.3.2 5.3.2.1
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TSLM 2-08 B-01 4 18
5.3.2.2 5.3.2.3
5.3.2.4
- - - - DOCL
5.3.3 5.3.3.1
SOP
5.3.3.2 5.3.3.3
SOP DOCL
5.3.3.4 - - DOCL - - -
5.3.4 5.3.5 3 800 5 /
5.4 ()
5.4.1
5.4.2 5.4.2.1
5.4.2.2
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TSLM 2-08 B-01 5 18
5.4.2.3 5.4.3
5.4.3.1 5.4.3.2 5.4.4.3 5.4.3.3 5.4.3.4 5.4.3.5 .
5.4.4
5.4.5
5.4.6 SOP
5.4.7 5.4.7.1 5.4.7.2 5.4.7.3
6.
6.1 6.1.1
()
6.1.2 6.2
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TSLM 2-08 B-01 6 18
6.3
6.4 (who) (where) (who) (when )
7.
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TSLM 2-08 B-01 7 18
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TSLM 2-08 B-01 8 18
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TSLM 2-08 B-01 9 18
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TSLM 2-08 B-01 1018
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TSLM 2-08 B-01 1118
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TSLM 2-08 B-01 1218
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TSLM 2-08 B-01 1518
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TSLM 2-08 B-01 1618
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TSLM 2-08 B-01 1718
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TSLM 2-08 B-01 1818