Quality Organisation and Management

Recommended Prerequisites

Relevant curricular units:

- Mathematics and Statistics (1^st Y/ 1^st S);

- Celular Biology (1^st Y/ 1^st S);

- Laboratory Methodologies (1^st Y/1^st S).

Recommended foundation knowledge: general biology and human biology, environment and health, adequate functioning of a laboratory.

Teaching Methods

- Lectures, with incentive to the students active participation, by stimulating critical thinking;

- Theoretical-practical lessons.

Learning Outcomes

To convey knowledge related to quality management and organization, according to certification norms (ISO 9001:2008 and ISO 14001:2021), analytical laboratory certification (ISO/IEC 17025; ISO/IEC 15189) and evaluation of their implementation (ISO 19011).

Acquisition of capability to:

- Have an active colaboration in process definition and management, in order to improve the efficacy and efficiency of an analytical labortory organization;

- Participate in process monitorization in a perspective of continuous improvement of the analytical laboratory through performance evaluation.

Work Placement(s)

No

Syllabus

- Introduction to quality management

- Quality concepts and their evolution

- Quality management principles

- Quality models

- Quality management system

- Process approach

- System documents

- Quality management standards and guidelines

- ISO/IEC 17025 and ISO/IEC 15189 and laboratory certification

- Environment management systems

- Guidelines for audits

Head Lecturer(s)

Patrícia Sofia Cabral Pires

Assessment Methods

Final assessment
Exam: 100.0%

Bibliography

ISO 14001: 2012 – Sistema de gestão ambiental. Requisitos e linhas de orientação para a sua utilização/ Guidelines for auditing management systems of quality and / or environmental management.

ISO 9000: 2005 - Sistemas de gestão da qualidade - Fundamentos e vocabulário/ Management systems quality - Fundamentals and vocabulary

ISO 9001: 2008 – Requisitos de sistemas de gestão da qualidade/ System requirements for quality management.

ISO/IEC 15189: 2014 – Laboratórios Clínicos. Requisitos particulares da qualidade e competência/ Clinical Laboratories. Particular quality and competence requirements

ISO/IEC 17025: 2005 – Requisitos gerais de competência para laboratórios de ensaio e calibração/ ISO / IEC 17025: 2005 - Requirements for the competence of testing and calibration.

Ramos Pires, A. - Qualidade. Sistemas de gestão da qualidade. 3ª ed. , Lisboa,: Sílabo, Lda. 2007/ The Quality. Systems of quality management. 3rd ed., Lisbon: Sílabo, Lda 2007.