Biomedical Lab Sci

Quality Control in Laboratories2

Controlo de Qualidade Laboratorial

Course code:68207

Maria Gabriela Machado de Almeida

Learning outcomes of the curricular unit:

At the end of the teaching process, students should have acquired instrumental skills to identify the different terminology used in quality issue, dominate the definitions and concepts that enable them to address the technical issues. Should dominate the procedures necessary to follow the proper implementation of a quality system and know how to make a compromise between the acquired concepts and different types of organizations and laboratories.
They should also in this context, to interpret and apply the requirements of the different applicable referential.
At the level of interpersonal skills, students should be able to implement the requirements without interfering with other processes, harmonizing and optimizing the approach by processes, activities and tasks. They should also facilitate the communication and teamwork.

  1. Terminology applied in Quality Control
  2. Process approach to implementing a Quality Management System (QMS)
  3. Aim, application field, importance and impact of the Quality Control in a QMS
  4. QMS requirements: legislation; Portuguese, European and international standards
  5. Continuous quality improvement to ensure conformity with applicable regulatory requirements
  6. Laboratory certification and accreditation
  7. Audits
  8. Monitoring and measurement
  9. Control of product conformity
  10. Data analysis and improvement
  11. Quality control of laboratory assays
  12. Quality in laboratory context
  13. Analysis of the results conformity
  14. Handbook of good laboratory practice of Pathological Anatomy and Clinical Analysis – Quality methodologies for implementing quality in laboratories
  15. Product realization: implementation of a HACCP system
  16. Quality control and product conformity
Suggested Bibliography:
  • NP EN ISO 9001:2008, Quality management
  • NP EN ISO 19011:2012, Management systems auditing