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ISO 15189:2012 Medical laboratories-Requirements for Quality and competence. นางสุขใจ ผลอำไพสถิตย์ 30 กรกฎาคม 2557. เตรียมความพร้อมในการขอรับรอง ISO 15189:2012 ปี 2558. Summary of changes (2) Title : Medical laboratories-Requirements for quality and competence Definitions

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iso 15189 2012 medical laboratories requirements for quality and competence

ISO 15189:2012Medical laboratories-Requirements for Quality and competence

นางสุขใจ ผลอำไพสถิตย์

30 กรกฎาคม 2557

slide3

Summary of changes (2)

  • Title : Medical laboratories-Requirements for quality and competence
  • Definitions

- 19 (2007) and 27 (2012) definitions

- (7) removed: accuracy to measurement , uncertainty etc.

- Additional 15 definitions: alert interval, nonconformity, process etc.

slide4

ISO 15189: 2003, 2007, 2012

  • ISO 15189:2012
  • ข้อกำหนด 4.1-4.15
  • ข้อกำหนด5.1-5.10
  • ISO 15189:2007
  • ข้อกำหนด 4.1-4.15
  • ข้อกำหนด 5.1-5.8
slide12

5.3 Laboratory equipment

Lab equipment , reagent , consumables

slide20

5.4 Pre-examination procedure

Pre-examination processes

slide25

5.5 Examination procedure

Examination processes

slide29

5.6 Assuring quality of examination procedures

Ensuring quality of examination results

slide34

5.7 Post-examination procedures

Post- examination processes