Quality Assurance and Accreditation in Laboratory Practice

NAME OF THE COURSE Quality Assurance and Accreditation in Laboratory Practice

Code

KTH215

Year of study

2.

Course teacher

Assoc Prof Josipa Giljanović

Credits (ECTS)

6.5

Associate teachers

Type of instruction (number of hours)

P S V T

30

15

28

2

Status of the course

Elective

Percentage of application of e-learning

30 %

COURSE DESCRIPTION

Course objectives

Acquisition of basic knowledge about basic concepts and principles of quality management, requirements and criteria of testing laboratories according to the requirements of EN ISO / IEC 17025 standard.

Course enrolment requirements and entry competences required for the course

Completed appropriate undergraduate study

Learning outcomes expected at the level of the course (4 to 10 learning outcomes)

1. Understanding the quality menagement system in the laboratory including accreditation process laws and standards for accreditation
2. Apply laboratory tests, methods, the process of mesurements, uncertainty, quality control and documentation of the laboratory
3. Understand evaluation off laboratories tests, accreditation of laboratories, the system of authorization and accreditation in Europe and Croatia.
4. Apply knowledge in practice and link the theoretical knolidge with real problems in the laboratorywork.

Course content broken down in detail by weekly class schedule (syllabus)

1st week: Analytical system. Sampling from the environment. Seminar: Solving problems.
2nd week: Preparation of the sample for analysis. Seminar: Solving problems.
3rd week: Method of isolation of the analyte from the nuts: solid phase extraction, microwave ultrasonic extraction. Seminar: Solving problems.
4th week: Spectroscopic methods. Molecular Spectroscopy. Seminar: Solving problems.
5th week: Atomic absorption spectroscopy, mass spectroscopy. Seminar: Solving problems.
6th week: Chromatographic methods: gas, ion, thin layer chromatography. Seminar: Solving problems.
7th Week : 1st. partial exam, solving the test
8th week: The standard methods and reference materials, validation. Seminar: Solving problems
9th week: sample for analysis, records, process evaluation and report, Seminar: Solving problems
10th week: subcontracting, external services and procurement; appeal. Seminar: Solving problems
11th week: GLP-principles, and procedures. Seminar: Solving problems
12th week: A system of authorization and accreditation in Europe and Croatia, principles and rules. Seminar: Solving problems
13th week:. The requirements of EN ISO / IEC 17025 (current edition). Seminar: Solving problems
14th week: The requirements of EN ISO / IEC 17025 (current edition). Seminar: Solving problems
15th week : 2nd partial exam , solving the test
List of Exercises
documentation of good laboratory practice
individual documentation for ISO / IEC 17025: 2005
Development of manual quality
internal audits
visit to the Veterinary Institute Split

Format of instruction:

Student responsibilities

Lectures attendance - at least 80% and completing exercises

Screening student work (name the proportion of ECTS credits for eachactivity so that the total number of ECTS credits is equal to the ECTS value of the course):

Class attendance

0.5

Research

0.0

Practical training

1.0

Experimental work

0.0

Report

0.0

 

 

Essay

0.0

Seminar essay

1.5

 

 

Tests

0.0

Oral exam

1.0

 

 

Written exam

1.0

Project

1.0

 

 

Grading and evaluating student work in class and at the final exam

The entire test can be applied over two partial tests during the semester. Passing threshold is 60%. Each test in assessing participates with 50%. Lectures presence of 80 to 100% is 10% marks. The examination periods there is a written and oral exam. Passing threshold is 60%. Passing one partial test of any part (previous activity) is valid throughout current academic year. Written exam has a share of 50% and oral examination also 50%. Students who have not passed the partial tests will have oral examination in the regular examination period. Passing threshold is 60% and the examination form to participate in the evaluation by 50%.
Rating: 60% -69% - satisfactory, 70% -79% - good, 80% -89% very good, 90% -100% - excellent.

Required literature (available in the library and via other media)

Title

Number of copies in the library

Availability via other media

HRN EN ISO/IEC 17025:2005 - Opći zahtjevi za osposobljenost ispitnih i umjernih laboratorija; , zakoni, propisi; Guide to Quality in Analytical Chemistry, CITAC/EURACHEMGUIDE Edition (2002)

3

Na web stranici Zavoda http://www.eurachem.ul.pt/guides/val

M.Kaštelan-Macan, Kemijska analiza u sustavu kvalitete, Školska knjiga, Zagreb (2003)

4

Optional literature (at the time of submission of study programme proposal)

 

Quality assurance methods that ensure the acquisition of exit competences

- registration of student’s presence in class
- annual analysis of students success in this course
- student’s survey in order to evaluate the professor
- professor’s self-evaluation

Other (as the proposer wishes to add)