实验室质量管理系统-handbook

hisun，sanofi

Table of contents
Acknowledgements  ........................................................................................................p 4
Foreword ...........................................................................................................................p 5
Key words ..........................................................................................................................p 6
1. Introduction to quality ................................................................................................p 7
1-1: The importance of laboratory quality ...............................................................................................p 8
1-2: Overview of the quality management system  ...............................................................................p 9
1-3: The quality management system model .........................................................................................p 11
1-4: History of laboratory quality management  ..................................................................................p 14
1-5: International laboratory standards ..................................................................................................p 15
1-6: Summary ...............................................................................................................................................p 16
2. Facilities and safety ................................................................................................... p 17
2-1: Overview ..............................................................................................................................................p 18
2-2: Laboratory design  ..............................................................................................................................p 20
2-3: Geographic or spatial organization  ................................................................................................p 21
2-4: Physical aspects of premises and rooms ........................................................................................p 22
2-5: Safety management programme  .....................................................................................................p 23
2-6: Identifi cation of risks  .........................................................................................................................p 25
2-7: Personal protective equipment ........................................................................................................p 29
2-8: Emergency management and fi rst aid .............................................................................................p 30
2-9: Summary ...............................................................................................................................................p 32
3. Equipment ................................................................................................................... p 33
3-1: Overview  .............................................................................................................................................p 34
3-2: Selecting and acquiring equipment  .................................................................................................p 36
3-3: Getting equipment ready for service  ............................................................................................p 38
3-4: Implementing an equipment maintenance programme ..............................................................p 40
3-5: Troubleshooting, service, repair and retiring equipment  ...........................................................p 42
3-6: Equipment maintenance documentation  ......................................................................................p 44
3-7: Summary ...............................................................................................................................................p 46
4. Purchasing and inventory .................................................................................. p 47
4-1: Overview  .............................................................................................................................................p 48
4-2: Purchasing  ............................................................................................................................................p 50
4-3: Implementing an inventory management programme  ...............................................................p 51
4-4: Quantifi cation ......................................................................................................................................p 52
4-5: Forms and logs  ...................................................................................................................................p 54
4-6: Receipt and storage of supplies .......................................................................................................p 55
4-7: Monitoring inventory  ........................................................................................................................p 57
4-8: Summary ...............................................................................................................................................p 58
5. Process control—sample management .............................................................. p 59
5-1: Overview ..............................................................................................................................................p 60
5-2: The laboratory handbook ..................................................................................................................p 61
5-3: Collection and preservation  ............................................................................................................p 62
5-4: Sample processing ...............................................................................................................................p 64
5-5: Sample storage, retention and disposal  .........................................................................................p 66
5-6: Sample transport ................................................................................................................................p 67
5-7: Summary ...............................................................................................................................................p 70


2 Laboratory Quality Management System

6. Process control—introduction to quality control ............................................. p 71
6-1: Introduction  ........................................................................................................................................p 72
7. Process control—quality control for quantitative tests ................................... p 75
7-1: Overview  .............................................................................................................................................p 76
7-2: Control materials  ...............................................................................................................................p 77
7-3: Establishing the value range for the control material .................................................................p 79
7-4: Graphically representing control ranges ........................................................................................p 84
7-5: Interpreting quality control data  ....................................................................................................p 85
7-6: Using quality control information  ..................................................................................................p 87
7-7: Summary ...............................................................................................................................................p 88
8.  Process control—quality control for qualitative and
semiquantitative procedures .................................................................................. p 89
8-1: Overview ..............................................................................................................................................p 90
8-2: Quality control materials  .................................................................................................................p 92
8-3: Quality control of stains ....................................................................................................................p 94
8-4: Quality control of microbiological media ......................................................................................p 96
8-5: Summary ...............................................................................................................................................p 98
9. Assessment—audits .................................................................................................. p 99
9-1: Overview .......................................................................................................................................... p 100
9-2: External audit .................................................................................................................................... p 103
9-3: Internal audit ..................................................................................................................................... p 105
9-4: Internal audit programme .............................................................................................................. p 106
9-5: Actions as result of audit ............................................................................................................... p 108
9-6: Summary ........................................................................................................................................... p 109
10. Assessment—external quality assessment ..................................................... p 111
10-1: Overview ......................................................................................................................................... p 112
10-2: Profi ciency testing .......................................................................................................................... p 115
10-3: Other external quality assessment methods ......................................................................... p 117
10-4: Comparison of external quality assessment methods........................................................... p 119
10-5: Managing external quality assessment in the laboratory ..................................................... p 120
10-6: Summary .......................................................................................................................................... p 122
11. Assessment—norms and accreditation ........................................................... p 123
11-1: Overview ......................................................................................................................................... p 124
11-2: International standards and standardization bodies ............................................................. p 125
11-3: National standards and technical guidelines ........................................................................... p 127
11-4: Certifi cation and accreditation ................................................................................................... p 129
11-5: Process of accreditation ............................................................................................................... p 132
11-6: Benefi ts of accreditation ............................................................................................................. p 133
11-7: Summary .......................................................................................................................................... p 134
12. Personnel ............................................................................................................... p 135
12-1: Overview ........................................................................................................................................ p 136
12-2: Recruitment and orientation ..................................................................................................... p 138
12-3: Competency and competency assessment ............................................................................. p 140
12-4: Training and continuing education .............................................................................................. p 143
12-5: Employee performance appraisal .............................................................................................. p 145
12-6: Personnel records .......................................................................................................................... p 147
12-7: Summary .......................................................................................................................................... p 148


Laboratory Quality Management System   3

13. Customer service ................................................................................................. p 149
13-1: Overview ........................................................................................................................................ p 150
13-2: The laboratory clients—the customers ................................................................................... p 152
13-3: Assessing and monitoring customer satisfaction ................................................................... p 155
13-4: Customer satisfaction surveys .................................................................................................... p 156
13-5: Summary .......................................................................................................................................... p 158
14. Occurrence management .................................................................................. p 159
14-1: Overview ......................................................................................................................................... p 160
14-2: Sources and consequences of laboratory error ..................................................................... p 161
14-3: Investigation of occurrences

........................................................................................................ p 163
14-4: Rectifying and managing occurrences ........................................................................................ p 164
14-5: Summary .......................................................................................................................................... p 166
15. Process improvement ......................................................................................... p 167
15-1: Continual improvement concept ............................................................................................... p 168
15-2: Tools for process improvement .................................................................................................. p 170
15-3: Quality indicators .......................................................................................................................... p 172
15-4: Selecting quality indicators .......................................................................................................... p 173
15-5: Implementing process improvement ......................................................................................... p 176
15-6: Summary ......................................................................................................................................... p 178
16. Documents and records ..................................................................................... p 179
16-1: Introduction .................................................................................................................................... p 180
16-2: Overview of documents ............................................................................................................... p 181
16-3: The quality manual ......................................................................................................................... p 184
16-4: Standard operating procedures (SOPs) .................................................................................... p 185
16-5: Document control ......................................................................................................................... p 188
16-6: Overview of records ..................................................................................................................... p 191
16-7: Storing documents and records ................................................................................................. p 193
16-8: Summary .......................................................................................................................................... p 194
17. Information management .................................................................................... p 195
17-1: Overview ......................................................................................................................................... p 196
17-2: Elements of information management ...................................................................................... p 197
17-3: Manual paper-based systems ....................................................................................................... p 200
17-4: Computerized laboratory information systems ..................................................................... p 202
17-5: Summary .......................................................................................................................................... p 205
18. Organization .......................................................................................................... p 207
18-1: Organizational requirements for a quality management system ......................................... p 208
18-2: Management role ........................................................................................................................... p 210
18-3: Organizational structure .............................................................................................................. p 212
18-4: Organizational functions: planning .............................................................................................. p 214
18-5: Organizational functions: implementation ................................................................................ p 216
18-6: The laboratory quality manual .................................................................................................... p 218
18-7: Summary .......................................................................................................................................... p 220
Glossary ....................................................................................................................... p 221
Acronyms ...................................................................................................................... p 233
References and resources by chapter .................................................................... p 235
Notes ............................................................................................................................. p 243

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