The “Quality” is the level in which a union of intrinsic features satisfy some requirements. It is a concept that was developed inside the standard ISO 9000 and ISO 9001. The present thesis project is a part of the certification path of the Supply Department Quality Management System (QMS) of ASST GOM Niguarda, based on UNI EN ISO 9001:2015 standard principles. During my internship, I could contribute to the QMS implementation. Starting with a general introduction to the work of the Supply Department staff, I was able to interact with them thanks to some interviews that allowed me to understand deeper the daily activities they carried out. An in-depth analysis of these first interviews has allowed me to model the Supply Department through the main processes in which work is being developed. Later, I also developed the organizational structure of the Supply Department, through organizational chart, “funzionigramma” and matrix of skills. Lastly, it was necessary a continuous support to the Supply Department staff during the preparation of the prescriptive documentation required by the standard UNI EN ISO 9001:2015, in order to define the basis of a good QMS. Prescriptive documentation means that the preparation of documented information (procedures, documents, operations instructions, forms, regulations, indicators, risk analysis, ...), required by the standard or deemed necessary for the Department. In order to face this path, they were of fundamental importance: • analysis of existing documentation to understand the notions of "Quality", QMS, standard ISO 9001; • analysis of the context in which are inserted the Supply Department and ASST GOM Niguarda; • support to the Supply Department staff, to understand a whole new job; • collaboration with QPRC, which manages everything that concerns Quality of ASST GOM Niguarda. The Certification of a Department is a long, articulate and continuous process. It was born from the intention of the Organization to analyze his own process and transform them into procedures and operations instructions which formulate as QMS, in order to realize an improving management efficiency. The certification path does not finish with the inspection visit of the certification body, scheduled for June 2018. The work will continue even after, with the aim to a continuous improvement. The activities done during the internship period have been articulated but very interesting, allowing me to know new worlds, that of Supply Department and Quality at the global level, with the difficulties and the resulting constraints. It is not easy to make clear to all colleagues involved that Quality should not be seen as a commitment in addition to the usual ones. It would be a good idea to look at Quality as an opportunity to standardize and improve their job, admitting that the way of working until now is not the most suitable one. It will take some time before using the Quality Management System implemented becomes daily routine, in order to optimize their work activities.
La “Qualità” è il grado in cui un insieme di caratteristiche intrinseche soddisfa dei requisiti, ed è un concetto approfondito all'interno delle normative ISO 9000 e ISO 9001. Il presente lavoro di tesi, quindi, si inserisce nell'ambito del percorso di certificazione del Sistema di Gestione della Qualità (SGQ) della Struttura Complessa (S.C.) Approvvigionamenti dell’Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (ASST GOMN), secondo i principi della norma UNI EN ISO 9001:2015. Durante il periodo di stage, ho potuto contribuire all'implementazione del SGQ. Partendo da un generale inserimento nelle attività di lavoro dei collaboratori della Struttura, ho potuto interagire con loro grazie ad alcune interviste che mi hanno permesso di comprendere più a fondo le attività quotidiane da loro svolte. Un'analisi approfondita di queste prime interviste, mi ha permesso di modellizzare la Struttura tramite i processi principali lungo i quali si sviluppano le attività lavorative. Successivamente, ho sviluppato anche l'assetto organizzativo della S.C. Approvvigionamenti, tramite la redazione di Organigramma, Funzionigramma e Matrice delle Competenze. Infine, è stato necessario un continuo affiancamento ai collaboratori della Struttura per la redazione della documentazione prescrittiva richiesta dalla norma UNI EN ISO 9001:2015, per definire le basi di un buon Sistema di Gestione della Qualità. Per documentazione prescrittiva si intende la redazione delle informazioni documentate (procedure, documenti, istruzioni operative, moduli, regolamenti, indicatori, analisi dei rischi...), richieste dalla Norma o ritenute necessarie per la Struttura. Per affrontare questo percorso, sono stati di fondamentale importanza: • analisi della documentazione esistente per comprendere le nozioni di "Qualità", Sistema di Gestione della Qualità, normativa ISO 9011; • analisi del contesto in cui si inserisce la S.C. Approvvigionamenti e ASST GOM Niguarda; • partecipazione ad un corso specifico sui contenuti e i principi della norma UNI EN ISO 9001:2015; • affiancamento ai collaboratori della Struttura, per comprendere un lavoro del tutto nuovo; • collaborazione con la S.C. Qualità, Privacy e Rischio Clinico (QPRC), che gestisce tutto ciò che riguarda la Qualità di ASST GOM Niguarda. Il percorso di certificazione di una Struttura è un processo lungo, articolato e continuo; nasce dalla volontà dell’Organizzazione di analizzare i propri processi e tradurli in procedure e istruzioni operative che concretizzino un SGQ, al fine di realizzare un miglioramento dell’efficienza gestionale. Il percorso non terminerà con la visita ispettiva dell'Ente di certificazione, prevista per Giugno 2018; il lavoro continuerà anche in seguito, nell'ottica del miglioramento continuo. Le attività affrontate durante il periodo di stage sono state articolate ma molto interessanti, mi hanno permesso di conoscere mondi nuovi, quello degli Approvvigionamenti e quello della Qualità a livello globale, con le difficoltà e i limiti che ne conseguono. Non è, infatti, semplice far comprendere a tutti i colleghi coinvolti che la Qualità non deve essere vista come un impegno in aggiunta a quelli abituali. Sarebbe opportuno guardare alla Qualità come un'opportunità per standardizzare e migliorare il proprio lavoro, ammettendo che il modo di operare utilizzato finora non sia proprio quello più adatto. Ci vorrà del tempo prima che diventi abitudine quotidiana utilizzare il Sistema di Gestione della Qualità implementato al fine di ottimizzare le proprie attività lavorative.
Certificazione qualità UNI EN ISO 9001-2015 nell'area approvvigionamenti di ASST Grande Ospedale Metropolitano Niguarda
LURAGO, ELISA
2016/2017
Abstract
The “Quality” is the level in which a union of intrinsic features satisfy some requirements. It is a concept that was developed inside the standard ISO 9000 and ISO 9001. The present thesis project is a part of the certification path of the Supply Department Quality Management System (QMS) of ASST GOM Niguarda, based on UNI EN ISO 9001:2015 standard principles. During my internship, I could contribute to the QMS implementation. Starting with a general introduction to the work of the Supply Department staff, I was able to interact with them thanks to some interviews that allowed me to understand deeper the daily activities they carried out. An in-depth analysis of these first interviews has allowed me to model the Supply Department through the main processes in which work is being developed. Later, I also developed the organizational structure of the Supply Department, through organizational chart, “funzionigramma” and matrix of skills. Lastly, it was necessary a continuous support to the Supply Department staff during the preparation of the prescriptive documentation required by the standard UNI EN ISO 9001:2015, in order to define the basis of a good QMS. Prescriptive documentation means that the preparation of documented information (procedures, documents, operations instructions, forms, regulations, indicators, risk analysis, ...), required by the standard or deemed necessary for the Department. In order to face this path, they were of fundamental importance: • analysis of existing documentation to understand the notions of "Quality", QMS, standard ISO 9001; • analysis of the context in which are inserted the Supply Department and ASST GOM Niguarda; • support to the Supply Department staff, to understand a whole new job; • collaboration with QPRC, which manages everything that concerns Quality of ASST GOM Niguarda. The Certification of a Department is a long, articulate and continuous process. It was born from the intention of the Organization to analyze his own process and transform them into procedures and operations instructions which formulate as QMS, in order to realize an improving management efficiency. The certification path does not finish with the inspection visit of the certification body, scheduled for June 2018. The work will continue even after, with the aim to a continuous improvement. The activities done during the internship period have been articulated but very interesting, allowing me to know new worlds, that of Supply Department and Quality at the global level, with the difficulties and the resulting constraints. It is not easy to make clear to all colleagues involved that Quality should not be seen as a commitment in addition to the usual ones. It would be a good idea to look at Quality as an opportunity to standardize and improve their job, admitting that the way of working until now is not the most suitable one. It will take some time before using the Quality Management System implemented becomes daily routine, in order to optimize their work activities.| File | Dimensione | Formato | |
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Descrizione: Testo della tesi
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https://hdl.handle.net/10589/137932