IT Quality Management
Major: Quality, Standardization and Certification
Code of subject: 7.152.06.M.015
Department: Measuring Information Technologies
Lecturer: Alla Vasylivna Ivanyshyn, associate professor of the Department of МIT
Semester: 2 семестр
Mode of study: денна
Завдання: The study of an academic discipline involves the formation and development of students' competencies: general: The ability to generate new ideas and non-standard approaches to their implementation (creativity); The ability to make management decisions, assess their possible consequences and take responsibility for the results of one's own and one's team's activities; Ability to manage projects, organize teamwork, take the initiative to improve activities; Ability to investigate problems using system analysis, synthesis and other methods; The ability to analyze, verify, assess the completeness of information in the course of professional activity, if necessary, supplement and synthesize missing information and work in conditions of uncertainty; Ability to conduct professional, including scientific research activities in an international environment; professional: The ability to use modern research methods and software to develop working hypotheses, build theoretical models of the object of research, and substantiate accepted assumptions; Ability to apply quality engineering methods to control and diagnose technological processes, provide technical control of production. Ability to develop and implement regulatory documents for quality
Learning outcomes: PH1 (Knowledge of domestic and foreign quality management experience) RN2 (Knowledge of the principles of ISMS development and implementation in various industries, features of a risk-oriented approach to managing the quality of IT services) PH3 (Ability to describe the processes of IT companies) PH4 (Ability to identify and assess project and other risks in IT companies)
Required prior and related subjects: Quality management systems according to ISO 9000
Summary of the subject: During the study of the academic discipline, the basic principles of quality management in the field of IT and their application in international and domestic practice, the procedure for the development and implementation of information security management systems in IT companies, methods of identification and description of business processes, risk management, quality management tools in accordance with requirements of international standards.
Опис: Introduction. The purpose and objectives of the course. Terms and their definitions in relation to quality management in the IT sphere Standardization. Standards - types, categories. Standards for the IT industry. ZU "On standardization" Components of quality management in IT Principles of TQM quality management Modeling of business processes. Description of processes Software life cycle processes. Project management processes Requirements for the quality of systems and software tools and their evaluation. Overview of ISO 2500n ISO/IEC 25010 requirements Overview of requirements of DSTU EN ISO 13485:2018 (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) Medical devices. Quality management system. Regulatory requirements Overview of the requirements of DSTU EN 62304:2014/Change No. 1:2019 (EN 62304:2006/A1:2015, IDT; IEC 62304:2006/A1:2015, IDT) Software for medical devices. Software life cycle processes Risk management. Configuration management. Risk-oriented approach to product (service) quality management. An overview of the requirements of the ISO 31000 series of standards General requirements for the implementation of quality management systems in IT companies in accordance with the requirements of the ISO 9000 series Features of the implementation of information security management systems in IT companies in accordance with the requirements of ISO 27001 Quality management methods and tools. FMEA, HAZOP, 5 why, Ishikawa, Pareto Certification (certification marks). Compliance assessment. Declaration of conformity General information about licensing and accreditation in the field of IT
Assessment methods and criteria: Current control - performance of practical works, tests, selective oral survey; assessment of activity, submitted proposals, original decisions, clarifications and definitions, etc. Exam - test control, oral component
Критерії оцінювання результатів навчання: Together on Current control 50 points Examination control 50 points Together for discipline 100 points
Recommended books: Synopsis of lectures. Electronic NMC "Quality Management in the IT Sphere" ISO 9000:2015 Quality management systems. Basic provisions and glossary of terms ISO 9001:2015 Quality management systems. Requirements ISO 2500n series of standards. Systems and software engineering. Requirements for the quality of systems and software tools and their evaluation (SQuaRE) DSTU EN ISO 13485:2018 (EN ISO 13485:2016, IDT; ISO 13485:2016, IDT) Medical devices. Quality management system. Regulatory requirements DSTU EN 62304:2014/Change No. 1:2019 (EN 62304:2006/A1:2015, IDT; IEC 62304:2006/A1:2015, IDT) Software for medical devices. Software life cycle processes ISO 31000 series of standards. Risk management methods ISO 27000 series of standards. Information security management systems DSTU ISO 19011:2019 (ISO 19011:2018, IDT) Guidelines for conducting audits of management systems DSTU ISO Guide 73:2013 Risk management. Glossary of terms (ISO Guide 73:2009, IDT).