Ateneo - UPO

Regulatory hints. Accreditation and certification. The ISO 9001-2015 standard.
The quality management system. Risk Management. Non-compliance.
The Audits.
Process indicators. Management review.
Analytical quality in the laboratory. Internal and external quality control.

Course slide

The module aims to allow the learning of the principles that allow the achievement and maintenance of quality in a laboratory

Vision of procedures and operating instructions during the internship in the first year of the course and first semester of the second

Power point presentations and films

none

Oral examination. The student must demonstrate that he has learned the principles governing the achievement and maintenance of quality in a laboratory

the course provides an introduction with reference to the regulatory hints, the differences between institutional accreditation and voluntary certification are taken into consideration. The contents of the ISO 9001-2015 standard are analyzed. Extensive discussion of the quality management system and type of documentation with explanatory examples. Risk definition and main methods used for risk management. Definition of non-conformities and their treatment with a view to continuous improvement, Importance of leadership, Management Review and user satisfaction. The audit mechanism and the main types of audits are illustrated. The importance of process indicators is referred to with explanatory examples. Definition of analytical quality in a Laboratory and its maintenance. definition of internal quality control and external quality control, significant differences and applications in the laboratory. The error in the laboratory and main categories of errors.

Knowledge and understanding of the principles that allow the achievement and maintenance of Quality in the laboratory.
Ability to differentiate process quality from analytical quality. Ability to discriminate and differentiate the errors present in an analytic process by connecting theory to practice.