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| MBIO2014 | Standardization and Quality | 3+0+0 | ECTS:4 | | Year / Semester | Spring Semester | | Level of Course | Short Cycle | | Status | Elective | | Department | DEPARTMENT of CHEMISTRY and CHEMICAL PROCESS TECHNOLOGY | | Prerequisites and co-requisites | None | | Mode of Delivery | | | Contact Hours | 14 weeks - 3 hours of lectures per week | | Lecturer | Prof. Dr. Hacer BAYRAK | | Co-Lecturer | Prof. Hacer BAYRAK | | Language of instruction | Turkish | | Professional practise ( internship ) | None | | | | The aim of the course: | | It is aimed to gain competencies by creating awareness about Standardization, Accreditation and Quality Management Systems. |
| Learning Outcomes | CTPO | TOA | | Upon successful completion of the course, the students will be able to : | | | | LO - 1 : | Will be able to have knowledge about Standard, Standardization, Accreditation and Quality Management processes and their importance. | 3,4,5 | 1, | | LO - 2 : | Will find the opportunity to apply all the processes that have been learned in professional / personal life | 3,4,5 | 1, | | LO - 3 : | Knows the documentation and accreditation studies. | 3,4,5 | 1, | | LO - 4 : | Know the steps of the standardization procedure. | 3,4,5 | 1, | | LO - 5 : | Knows the standardization and quality processes | 3,4,5 | 1, | | LO - 6 : | Know regional, international and national standardization organizations. | 3,4,5 | 1, | | LO - 7 : | Knows the requirements of calibration and verification methods. | 3,4,5 | 1, | | CTPO : Contribution to programme outcomes, TOA :Type of assessment (1: written exam, 2: Oral exam, 3: Homework assignment, 4: Laboratory exercise/exam, 5: Seminar / presentation, 6: Term paper), LO : Learning Outcome | | |
| Definition, purpose and benefits of standardization, Types of standards, Standardization Studies in our Country and in the World and Responsible National / International Institution / s, Revision-Amendment-Cancellation of Standards, Reading a standard within the framework of the competencies of standard preparation groups (regional / national / international standard organizations ), What is Accreditation and Certification? Importance ?, Accreditation Bodies and Its Importance in our Country and in the World, Contribution of Conformity Assessment Bodies (UDK) and Services to the Economy, Certification Activities, Validation and Calibration Concepts for the Reliability of Measurements, Definition ?, Calibration studies and necessity , Competence and Traceability of Calibration Service Providers, Determination of Verification Periods, Determination of Calibration Periods, Concept of Quality, PDCA cycle, Quality Approaches, Corrective and Preventive Activities, Quality Management System, Risk Management and Assessment (ax ions), The importance and necessity of documentation, Quality Policy, Quality Planning, Personnel Competence, Infrastructure and Resource Management, Management Review, Measurement and Evaluation, Internal and External Audit Activities and Their Importance, Control of Non-Compliant Work / Experiment / Analysis, Reason -Result Relations etc. |
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| Course Syllabus | | Week | Subject | Related Notes / Files | | Week 1 | Definition, purpose and benefits of standard and standardization | | | Week 2 | Definition, purpose and benefits of standard and standardization | | | Week 3 | Standardization Studies in our Country and in the World and National / International Institution (s) Responsibilities | | | Week 4 | Revision-Amendment-Cancellation concepts in the standards, Reading a standard within the framework of the activities of standard preparatory groups (regional / national / international standards organizations) | | | Week 5 | Revision-Amendment-Cancellation concepts in the standards, Reading a standard within the framework of the activities of standard preparatory groups (regional / national / international standards organizations) | | | Week 6 | What is Accreditation and Certification? Its Importance ?, Accreditation Bodies in our Country and in the World and Its Importance, Contribution of Conformity Assessment Bodies (UDK) and Services to the Economy, Certification Activities | | | Week 7 | Validation and Calibration Concepts, definition for Traceability / Reliability of Measurements?, Calibration studies and necessity, Competence and Traceability of organizations providing calibration services | | | Week 8 | Determination of Verification Periods, Determination of Calibration Periods | | | Week 9 | mid term exam | | | Week 10 | Quality Concept, PDCA cycle, Quality Approaches, Quality Costs, Corrective and Preventive Actions | | | Week 11 | Quality Management System, Risk Management and Assessment (taking actions, 5x5 risk matrix and monitoring) | | | Week 12 | The importance and necessity of documentation, Quality Policy, Quality Planning | | | Week 13 | quality control | | | Week 14 | Personnel Competence, Infrastructure and Resource Management, Management Review, Internal and External Audit Activities and Their Importance | | | Week 15 | Measurement and Evaluation, Control of Unsuitable Work / Experiment / Analysis, Cause-Result Relations etc. | | | Week 16 | Final exam | | | |
| 1 | Kölük, N., Dilsiz, İ., Kartal, S. C., 2015, Detay Yayıncılık, ANKARA | | | 2 | TS EN ISO / IEC 17025:2017 Deney Ve Kalibrasyon Laboratuvarlarının Yeterliliği İçin Genel Gereklilikler Standardı | | | 3 | TS EN ISO 15189 Tıbbi laboratuvarlar - Kalite ve yeterlilik için şartlar Standardı | | | 4 | TS EN ISO 9001 Kalite Yönetim Sistemleri - Şartlar | | | |
| Method of Assessment | | Type of assessment | Week No | Date | Duration (hours) | Weight (%) | | Mid-term exam | 9 | 06/05/2021 | 1 | 50 | | End-of-term exam | 16 | 02/07/2021 | 1 | 50 | | |
| Student Work Load and its Distribution | | Type of work | Duration (hours pw) | No of weeks / Number of activity | Hours in total per term | | Yüz yüze eğitim | 3 | 14 | 42 | | Sınıf dışı çalışma | 1 | 16 | 16 | | Arasınav için hazırlık | 1 | 9 | 9 | | Arasınav | 1 | 1 | 1 | | Dönem sonu sınavı için hazırlık | 1 | 15 | 15 | | Dönem sonu sınavı | 1 | 1 | 1 | | Total work load | | | 84 |
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