Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant
Keywords:
Indicators, ISO9001, 2008, Objectives, Quality systemAbstract
Aims: The aim of this work is the correct establishment and follow-up of quality objectives and indicators as the cornerstones of a quality assurance system, in this case focused on ISO9001.
Materials and methods: In this work, the authors present the criteria that, in their view, an organization must follow for a better selection and adaptation of the ISO9001:2008 quality system objectives and indicators applied to a university pharmaceutical pilot plant. The evolution of errors in setting objectives and indicators is assessed.
Results: Based on the experience of several years at the SDM (Service of Development of Medicines) at the Faculty of Pharmacy of the University of Barcelona, the results show that the establishing of appropriate objectives and indicators is not an easy task. A careful selection of both objectives and indicators must be a compulsory step prior to the establishment of a robust, reliable quality assurance system through years.
Conclusions: Experience over time proves to be a powerful tool to end up selecting the right quality objectives and indicators for such quality system. Since this task is not always easy to carry out, is necessary to set a selection of criteria in order to obtain useful information that contributes to the continuous improvement of the quality system.
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References
ISO 9001:2008 Quality management systems – Requirements. International Organization for Standardization (2008)
Fàbregas-Fernández A, García-Montoya E, Pérez-Lozano P, Suñé-Negre JM, Ticó JR, Miñarro M. Quality assurance in research: incorporating ISO9001:2000 into a GMP quality management
system in a pharmaceutical R+D+I center. Accred Qual Assur. 2009; 15:297-304.
Hexsel –Grochau I, Schwengber ten Caten C. A process approach to ISO/IEC 17025 in the implementation of a quality management system in testing laboratories. Accred Qual Assur. 2012; 5:519-527.
Hexsel –Grochau I, Ferreira CA, Zoppas-Ferreira J, Schwengber ten Caten C. Implementation of a quality management system in university test laboratories: a brief review and new proposals. Accred Qual Assur. 2010; 12:681-689.
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