Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant
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 mu...
Main Authors: | , , , , , |
---|---|
Format: | Article |
Language: | English |
Published: |
Facultad de Farmacia, Universidad de Granada
2015-01-01
|
Series: | Ars Pharmaceutica |
Subjects: | |
Online Access: | http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S2340-98942015000100003&lng=en&tlng=en |
id |
doaj-d74580582d61429face12d794213f11a |
---|---|
record_format |
Article |
spelling |
doaj-d74580582d61429face12d794213f11a2020-11-25T00:57:23ZengFacultad de Farmacia, Universidad de GranadaArs Pharmaceutica2340-98942015-01-015611723S2340-98942015000100003Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plantAnna Fàbregas-Fernández0Encarnación García-Montoya1Pilar Pérez-Lozano2Montserrat Miñarro-Carmona3Josep Ramon Ticó-Grau4Josep Maria Suñé-Negre5University of BarcelonaUniversity of BarcelonaUniversity of BarcelonaUniversity of BarcelonaUniversity of BarcelonaUniversity of BarcelonaAims: 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.http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S2340-98942015000100003&lng=en&tlng=enIndicadoresISO9001:2008ObjetivosSistema de calidad |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Anna Fàbregas-Fernández Encarnación García-Montoya Pilar Pérez-Lozano Montserrat Miñarro-Carmona Josep Ramon Ticó-Grau Josep Maria Suñé-Negre |
spellingShingle |
Anna Fàbregas-Fernández Encarnación García-Montoya Pilar Pérez-Lozano Montserrat Miñarro-Carmona Josep Ramon Ticó-Grau Josep Maria Suñé-Negre Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant Ars Pharmaceutica Indicadores ISO9001:2008 Objetivos Sistema de calidad |
author_facet |
Anna Fàbregas-Fernández Encarnación García-Montoya Pilar Pérez-Lozano Montserrat Miñarro-Carmona Josep Ramon Ticó-Grau Josep Maria Suñé-Negre |
author_sort |
Anna Fàbregas-Fernández |
title |
Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant |
title_short |
Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant |
title_full |
Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant |
title_fullStr |
Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant |
title_full_unstemmed |
Establishment of criteria for the selection and adaptation of objectives and indicators in ISO9001:2008 quality system in a university pharmaceutical pilot plant |
title_sort |
establishment of criteria for the selection and adaptation of objectives and indicators in iso9001:2008 quality system in a university pharmaceutical pilot plant |
publisher |
Facultad de Farmacia, Universidad de Granada |
series |
Ars Pharmaceutica |
issn |
2340-9894 |
publishDate |
2015-01-01 |
description |
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. |
topic |
Indicadores ISO9001:2008 Objetivos Sistema de calidad |
url |
http://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S2340-98942015000100003&lng=en&tlng=en |
work_keys_str_mv |
AT annafabregasfernandez establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant AT encarnaciongarciamontoya establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant AT pilarperezlozano establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant AT montserratminarrocarmona establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant AT josepramonticograu establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant AT josepmariasunenegre establishmentofcriteriafortheselectionandadaptationofobjectivesandindicatorsiniso90012008qualitysysteminauniversitypharmaceuticalpilotplant |
_version_ |
1725224497544429568 |