84939 - Quality systems in the laboratory and management of experimental protocols

Academic Year 2021/2022

  • Docente: Piera Versura
  • Credits: 6
  • SSD: BIO/13
  • Language: Italian
  • Moduli: Piera Versura (Modulo 1) Juri Monducci (Modulo 2)
  • Teaching Mode: Traditional lectures (Modulo 1) Traditional lectures (Modulo 2)
  • Campus: Bologna
  • Corso: Second cycle degree programme (LM) in Health Biology (cod. 5729)

Learning outcomes

The student acquires the knowledge regarding quality control and certification procedures in the biological laboratory. In particular, the student is able to: - use the methods, techniques and procedures to operate in a Quality System within a biological laboratory; - manage the control of the data obtained in the biological laboratory. The management of clinical protocols, preparing information on informed consent and data processing are also discussed.

Course contents

The topics of the program are hereby summarized:

- Quality System: history, evolution and models. The ISO system and its basic principles

- Analysis of UNI EN ISO 9001 and 14001 standards, rationale and novelty.

- Certifications and Accreditation

- ISO standards, specific techniques for laboratories in the Healthcare and Agri-food sectors

- The HACCP system

- Audit according to the ISO model: Guidelines for conducting the Audit and explanatory cases

- The Clinical Assistance Audit: definition, management method and explanatory cases

- Ethics in conducting clinical research studies

- Guided case study to be submitted to the requests of the Ethics Committees

- Conducting and Monitoring the clinical studies - explanatory cases

- Big data analytics and privacy issues


Materials provided by the teacher, and references from the Literature, available on the IoL platform

Teaching methods

Frontal teaching, team working

Assessment methods

Speech based on a presentation developed on a topic chosen by the student. Test with multiple choice quiz on topics from the program. Grades for each module will be valid for eight months.

Teaching tools

Video projector, PC, mobile app for interactive teaching.

Office hours

See the website of Piera Versura

See the website of Juri Monducci


Good health and well-being

This teaching activity contributes to the achievement of the Sustainable Development Goals of the UN 2030 Agenda.