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LEARNING OUTCOMES
- Students at the end of the lesson will be familiar with the:
- quality terms such as certification, accreditation, uncertainty, total quality management, quality control
- accreditation with the ISO 15189 in clinical laboratories,
- basic principles of ISO 17025 and ISO 9001.
SYLLABUS
1. Τhe meaning of quality. The certification and accreditation procedures. Which organizations provide accreditation certificates?
2. Introduction to the ISO 9001 standard. What is its application in the field of health. Implementation of Directive CEN / TS 15224.
3. The quality documents. What are they? What are their similarities and differences? Individual work: the writing of a quality document with the quality policy of a laboratory.
4. The general requirements of the standards ISO 9001, ISO 17025, ISO 15189 (I). What are the similarities and what are the differences. The role of the laboratory manager, the quality manager and the staff members.
5. The general requirements of the standards ISO 9001, ISO 17025, ISO 15189 (II). Equipment maintenance. The evaluation of suppliers and super contractors. Individual work: creation of a quality system for the maintenance of household equipment.
6. The general requirements of the standards ISO 9001, ISO 17025, ISO 15189 (III). The requirements of the standards for the environmental conditions, the use of the records, the quality of life of the staff. Individual work: write a document/guideline for the monitoring and improvement of the environmental conditions of a biomedical laboratory.
7. The calibration of the measuring equipment. The concept of calibration. Which instruments are calibrated and by which method. The concept of random, systematic error and uncertainty.
8. The requirements of ISO 15189, ISO 17025 for pre-analytical procedures. What requirements must be met at the pre-analytical stage of clinical or other trials. Individual work: to write a work instruction for the collection of samples and their processing.
9. Internal operation control of pipettes, cylinders, scales and thermometers. Practice exercise in the laboratory.
10. The quality control of the analysis. The differences between internal and external quality control. The control diagrams. Individual work: creating control charts and calculating type A uncertainty.
11. The concept of uncertainty. Calculation of type B uncertainty and extended uncertainty using calibration and quality control data. Individual work: calculation of the extended uncertainty of certain given data.
12. The requirements of ISO 15189, ISO 17025 for meta-analytical processes. What requirements must be met at the post-clinical stage of clinical or other trials? Individual work: to write a work instruction for the secretarial support of a laboratory.
13. The basic principles of audit. Internal and external audit.