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