Quality Organisation and Management

Recommended Prerequisites

Chemistry, Biology and Statistics.

Teaching Methods

Lectures and theoretical-practical are taught to enable students to grasp selective and integrated scientific knowledge. The lectures have lasting sixty minutes and follow the model of masterful lesson. In the exhibition uses the data "show." and at the end of each lesson are highlighted the most relevant concepts and provided material support teaching. Simultaneously, the classes are available in Nónio. The practical classes lasting 1 hour to allow analysis and discussion of case studies.

Learning Outcomes

The intention of this course is to impart knowledge to students concerning the organization and quality management in accordance with the requirements of certification standards (ISO 9001:2008 and ISO 14001:2012), the accreditation of analytical laboratories (ISO / IEC 17025, ISO / IEC 15189) and even with the evaluation of its implementation (ISO 19011).

Skills to:

 - Active collaboration in defining and managing processes to improve the effectiveness and efficiency of the organization of an analytical laboratory;

- Participation in the monitoring process towards continuous improvement of the analytical laboratory by measuring their performance.

Work Placement(s)

No

Syllabus

Plenary lectures

I - Introduction to Quality Management

2. Concepts of Quality and its evolution

3. Principles of quality management

4. Quality Models

5. System quality management

6. The process approach

7. Documents system

8. Standards of Quality Management

9. Total quality

10. Future prospects

II - Formalization of a quality system

III - The ISO / IEC 17025 and ISO / IEC 15189 and Accreditation of Laboratory

1. Purpose and scope of the Standards

2. Characterization of the requirements of the Standards

3. The importance of the technical activity in laboratory

4. Methodology for the implementation of the standards

IV - Environmental Management Systems

V - Guidelines for auditing.

Theoretical and Practical

- Presentation and discussion of documents (examples)

- Presentation of practical cases

- Visits to laboratories where the standards are applied.

Head Lecturer(s)

Maria Eugénia Soares Rodrigues Tavares de Pina

Assessment Methods

Assessment
Mini Tests: 20.0%
Exam: 80.0%

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.