Laboratory Management and Quality System

Code:

Q4073

Acronym:

Q4073

Keywords
Classification	Keyword
OFICIAL	Chemistry

Instance: 2025/2026 - 1S

Active?	Yes
Responsible unit:	Department of Chemistry and Biochemistry
Course/CS Responsible:	Master in Advanced Methods and Accreditation in Chemical Analysis

Cycles of Study/Courses

Acronym	No. of Students	Study Plan	Curricular Years	Credits UCN	Credits ECTS	Contact hours	Total Time
M:MA3Q	7	Official study plan since 2025/2026	1	-	3	21	81

Teaching language

Portuguese

Objectives

This unit covers the recommendations and strategies for implementation of the quality management system in chemical testing laboratories according to NP EN ISO/IEC 17025.

Learning outcomes and competences

On completion of this course, students are expected to be able to:

1 Apply the concepts and processes that underpin quality management systems within a laboratory;
2 Recognize the roles and responsibilities of a quality manager and the importance of customer focus;
3 Be able to initiate the implementation of a quality management system within a laboratory that would meet the accreditation requirements undertaken according to the NP EN ISO / IEC 17025 standards;
4 Be able to monitor and evaluate quality performance for continuous improvement in a laboratory
5 Develop a quality manual.

Working method

Presencial

Pre-requirements (prior knowledge) and co-requirements (common knowledge)

No previous specific background is need, besides the basic knowledge in analytical chemistry and instrumental methods of analysis

Program

1 Key Components of the Quality Management System.
2 Organization and Management System.
3 Quality system establishment:
3.1 Organization and management;
3.2 chain of responsibilities;
3.3 Quality system.
4 Quality system control:
4.1 Document and records control;
4.2 Contract review;
4.3 Sub-contracting of tests;
4.4 Purchasing services and supplies.
5 Quality system review:
5.1 Customer complaints;
5.2 Control of nonconformities;
5.3 Internal audit and external assessment;
5.4 Management review.
6 Quality system improvement:
6.1 Service of customer;
6.2 Corrective and preventive actions.

Mandatory literature

ISO; NP EN ISO/IEC 17025 (2018). Requisitos gerais de competência para laboratórios de ensaio e calibração, 2018
ISO; NP EN ISO 9000 (2015). Sistemas de gestão da qualidade - Fundamentos e vocabulário, 2015

Complementary Bibliography

Ratliff, T. A; The Laboratory Quality Assurance System, John Wiley & Sons, Inc., 2003. ISBN: 978-0-471-26918-2
Funk, W., Dammann, V., Donnevert, G. ; Quality Assurance in Analytical Chemistry, Wiley-VCH Verlag GmbH & Co, 2007. ISBN: 978-0-470-01203-1
Reichenbacher, M., Einax, J. W. ; Challenges in Analytical Quality Assurance, Springer, 2011. ISBN: 978-3-642-16595-5

Teaching methods and learning activities

Program contents are introduced and developed through lectures supported by audiovisual tools available, but the context of the all thematic under study will be illustrated by students with study cases presentations and by guest lectures given by managers of external laboratories. Visits to external laboratories are planned

Evaluation Type

Distributed evaluation with final exam

Assessment Components

designation	Weight (%)
Exame	25,00
Trabalho escrito	75,00
Total:	100,00

Amount of time allocated to each course unit

designation	Time (hours)
Estudo autónomo	35,00
Frequência das aulas	21,00
Trabalho escrito	25,00
Total:	81,00

Eligibility for exams

In this course it is mandatory to comply with the attendance in classes.

The students must attend a minimum of 75% of the total number of classes and to obtain a positive mark in written works done during the semester.

Calculation formula of final grade

Final exam – individual evaluation - 25%: lowest mark 8.0/20 (round off to decimals)

Written Works performed in the context of classes: 35%: oral presentations, problems resolutions, homeworks. Lowest mark 9.5/20 (round off to decimals).

Presentation of a Quality Manual: 40%: lowest mark 8.0/20 (round off to decimals).

Final evaluation: 25% Exam + 35% written works+ 40% qquality manual.

For the students with final mark greater than 17, there will be an extra oral exam in order to confirm, or not, the final mark.

Examinations or Special Assignments

Are not provided

Internship work/project

Not applicable

Special assessment (TE, DA, ...)

The special assessment shall be a written examination

Classification improvement

Distributed evaluation can not be improved.

The final mark can be improved only by final exam.

Observations

UC jury
Cosme Moura
Carlos Melo Pereira
Paulo Almeida