A Model Quality System for the Tranfusion Service
S Karger AG (Verlag)
978-3-8055-6751-0 (ISBN)
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This manual explains how to organize documentation of a quality programme and shows examples of how to document policies (a quality plan) for quality system essentials, and how to document quality system processes with accompanying flowcharts. It includes model procedures for reporting errors and accidents to the FDA and for conducting and documenting look-backs. Also included is a diskette providing text for a written quality plan, sample quality process descriptions and flowcharts and other sample forms.
Part 1 Model level 1 policies for essentials of the AABB quality system. Part 2 Model level 2 process descriptions for essentials of the AABB quality system: design and review of the quality programme; personnel selection; personnel training; competence assessment; continuing education; calibration process; maintenance programme; qualifying suppliers of critical equipment, supplies and services; supplier contracts; receipt and disposition of critical equipment, supplies and services; process control; quality control programme; process validation protocol; computer validation protocol; proficiency testing process; label control process; document change control; records management process; occurrence management; FDA-CBER notification; look-back protocol; quality indicator monitoring process; internal audit process; external assessments process; process improvement; safety programme.
| Erscheint lt. Verlag | 16.6.1998 |
|---|---|
| Zusatzinfo | 4, 4 fig. |
| Verlagsort | Basel |
| Sprache | englisch |
| Gewicht | 592 g |
| Themenwelt | Medizinische Fachgebiete ► Innere Medizin ► Hämatologie |
| Medizin / Pharmazie ► Medizinische Fachgebiete ► Pharmakologie / Pharmakotherapie | |
| ISBN-10 | 3-8055-6751-0 / 3805567510 |
| ISBN-13 | 978-3-8055-6751-0 / 9783805567510 |
| Zustand | Neuware |
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