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The paper deals with the idea of validation of own application software related to data analysis in conditions of an accredited laboratory. Defined conditions require suitable approach to the chosen problem. While the accreditation process is directly connected with ISO/IEC 17025:2005 which refers to ISO 9001:2000 standards the quality management approach has been proposed in order to perform suitable requirements. Tensile testing method sets an example for the discussed topic as well as the application software supporting the method. Among various input data authors do mention i.e. environmental and organizational conditions, personnel qualifications or measurement equipment.
Czasopismo
Rocznik
Tom
Strony
159--165
Opis fizyczny
Bibliogr. 10 poz., rys., tab.
Twórcy
autor
autor
- Uniwersity of Technology and Life Sciences in Bydgoszcz ul. Prof. Kaliskiego 7 85-789 Bydgoszcz, Poland phone: +48 52 340 82 55, fax: +48 52 340 82 55, m.szczutkowski@utp.edu.pl
Bibliografia
- [1] AS 3563.1-1991 - Software Quality Management System, Part 1: Requirements.
- [2] ISO/IEC 17025:2005 - General requirements for the competence of testing and calibration laboratories.
- [3] ISO 9000:2005 - Quality management systems - Fundamentals and vocabulary.
- [4] ISO 9000-3:1997 - Quality management and quality assurance standards - Part 3: Guidelines for the application of ISO 9001:1994 to the development, supply, installation and maintenance of computer software.
- [5] ISO 6892-1:2009 - Metallic materials - Tensile testing - Part 1: Method of test at room temperature.
- [6] U.S. Department Of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health, Center for Biologics Evaluation and Research.: General Principles of Software Validation; Final Guidance for Industry and FDA Staff, 2002.
- [7] Czichos, H., Saito, T., Smith, L.: Springer Handbook of Materials Measurement Methods, Springer, 2006
- [8] Reinke, D.: Computer-aided standard test method for tensile strength – application software implementation, Graduation project, Univeristy of Technology and Life Sciences in Bydgoszcz, 2011.
- [9] http://computer.yourdictionary.com/validation, 06.2012
- [10] http://softwaretestingfundamentals.com/verification-vs-validation, 06.2012
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-article-BPG8-0082-0021