Curricular Unit:			Code:
Accreditation and Safety of Laboratories			1100ACLB
Year:	Level:	Course:	Credits:
2	CTSP	Laboratory Analyses	3 ects
Learning Period:		Language of Instruction:	Total Hours:
Winter Semester		Portuguese/English	39
Learning Outcomes of the Curricular Unit:
The aim of the course unit is to provide the knowledge to implement a quality management system according to 9001/2015 and NP EN ISO/IEC 17025:2005 standards especially regarding the validation of test methods.
Syllabus:
1. Introduction to laboratory accreditation 1.1. Objectives 1.2. Advantages and obstacles 1.3. Quality systems 2. Technical requirements of ISO 9001/2015 2.1. Responsibilities of a quality management office 2.2. Quality manual and work instructions and procedures 2.3. SWOT analysis 3. Technical requirements of ISO 17025/2018 3.1. Accreditation of testing laboratories 3.2. Accreditation of calibration laboratories 3.3. Clinical laboratory accreditation (ISO 15189) 4. Laboratory test methods 4.1. Procedures for testing 4.2. Most frequent errors in tests 4.3. Interlaboratory comparison tests 5. Validation of assay methods 5.1. Standard method and internal method 5.2. Working range 5.3. Analytical thresholds of the methods 5.4. Precision and accuracy 5.5. Repeatability and reproducibility 5.6. Method robustness 5.7. Calculation of uncertainties
Demonstration of the Syllabus Coherence with the Curricular Unit's Objectives:
Through the course contents, the student should be able to recognise and apply, when necessary, the normative references
Teaching Methodologies (Including Evaluation):
The classes are of a Theoretical-Practical nature, in which a theoretical exposition of the have the opportunity to take a guided tour of one or more various contents is made, allowing, however, a frequent teacher/student interaction. Students will have the possibility to visit one or more laboratories in the campus. The evaluation to this UC is done with the use of quizzes during classes. The minimum score for the exam is 9.5; below which the students will be sent to exam.
Demonstration of the Coherence between the Teaching Methodologies and the Learning Outcomes:
During the expository classes several examples are given of current and realistic situations about the various subjects, in which the students themselves can also intervene. Students are encouraged to talk about their experiences on the appropriate subjects. By being able to visit some laboratories on campus, students have the opportunity to verify in practice some of the concepts exposed.
Reading:
ISO 9001: 2015 e NP EN ISO/IEC 17025:2017. Procedimentos para Acreditação laboratórios-Guia 2019. Apcer Guia ISO 9001_2015. Despacho 10009_2019-Aprova manual boas práticas. Guia aplicação da 17025_2018-Acred.lab ensaio e calibração. GuiaAplicacao15189_2017-Acreditação Laboratórios Clínicos Requisitos gerais de competência para laboratórios de ensaio e calibração. IPQ. 2005 Guia 3 - Validação de Resultados em Laboratórios Químicos. Relacre. 1990 Guia 6 - Acreditação de laboratórios de ensaio microbiológico. Relacre 2007 Guia 7 - Ensaios Inter laboratoriais em Química. Relacre.1996 Guia 13 - Validação de métodos Internos de ensaio em análise química. 2000
Lecturer (* Responsible):
Cristina Almeida (calmeida@ufp.edu.pt)