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Publication
Sistemas de gestão de qualidade em farmácia comunitária: visão sobre a realidade e viabilidade no contexto das farmácias em Portugal
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| 2.84 MB | Adobe PDF |
Abstract(s)
O trabalho teve como objectivo avaliar a possibilidade de uma farmácia comunitária portuguesa obter a certificação de qualidade pela norma ISO 9001, de forma expedita, através do potencial cumprimento parcial desses requisitos, resultantes da implementação de regras e regulamentações, exigidas por entidades reguladoras e actual legislação, que definem os termos para o seu estabelecimento, abertura e funcionamento. Pretendeu-se, através de um inquérito distribuído a farmácias comunitárias (FCs), entender o grau de conhecimento destas sobre qualidade e certificação, que informações recebem das entidades que as regulam, e o nível de pretensão em obter a certificação do Sistema de Gestão de Qualidade (SGQ) (caso ainda não a possuam). Através de um estudo de caso numa farmácia no distrito de Faro, foi testada a hipótese da implementação de um SGQ e sua certificação, tendo por base o seu funcionamento de acordo com as boas práticas de farmácia (BPF) e demais aspectos legais, necessários à sua habilitação e funcionamento. Aspectos Conclusivos: as FCs procuram melhorar a qualidade na oferta de produtos e serviços, buscam informação sobre SGQs, tendo a eficiência financeira como foco; no caso das farmácias certificadas, o foco é a satisfação do cliente; a certificação do SGQ é independente do sector; a maioria das farmácias não demonstra interesse na certificação ISO 9001, e apesar de familiarizada com aspectos da qualidade (Kaizen, SGQ, ISO 9001, BPF), consideram insuficiente/inexistente a informação divulgada por entidades reguladoras do sector, que deve ser melhorada; os motivos mais comuns apontados para a implementação de SGQ são a satisfação do cliente, a melhoria contínua e a redução de custos; as auditorias internas, previstas nas BPF, não são realizadas por entidades reguladoras do sector; no estudo de caso verificou-se que, por aplicação das BPF, parte dos requisitos exigidos pela norma ISO 9001 são cumpridos, estando outros em fase de implementação, prevêem-se condições para certificação num prazo de 10 meses; a implementação do requisito “procedimentos documentados” implicou maiores custos (tempo e recursos humanos); as BPF podem ser um manual de SGQ específico para FCs, adaptado à ISO 9001.
The objective of this work was to evaluate the possibility of a Portuguese community pharmacy to obtain quality certification by the ISO 9001 standard, in an expeditious way, through the potential partial fulfillment of these requirements, resulting from the implementation of rules and regulations, required by regulatory bodies and current legislation, which define the terms for its establishment, opening and operation. It was intended, through a survey distributed to community pharmacies (CPs), to understand their degree of knowledge about quality and certification, what information they receive from the entities that regulate them, and the level of intention to obtain certification of the Management System of Quality (QMS) (if they don't already have it). Through a case study in a pharmacy in the district of Faro, the hypothesis of the implementation of a QMS and its certification was tested, based on its operation in accordance with good pharmacy practices (GPP) and other legal aspects necessary for its authorization and operation. Concluding Aspects: FCs seek to improve the quality in the offer of products and services, seek information on QMS, focusing on financial efficiency; in the case of certified pharmacies, the focus is on customer satisfaction; QMS certification is sector-independent; most pharmacies do not show interest in ISO 9001 certification, and despite being familiar with aspects of quality (Kaizen, QMS, ISO 9001, GMP), they consider the information disclosed by regulatory bodies in the sector to be insufficient/non-existent, which should be improved; the most common reasons given for the implementation of QMS are customer satisfaction, continuous improvement and cost reduction; the internal audits, provided for in the GPP, are not carried out by regulatory bodies in the sector; in the case study it was found that, by application of GPP, part of the requirements demanded by the ISO 9001 standard are fulfilled, while others are in the implementation phase, conditions for certification are foreseen within a period of 10 months; the implementation of the “documented procedures” requirement implied higher costs (time and human resources); GPPs can be a specific QMS manual for CFs, adapted to ISO 9001.
The objective of this work was to evaluate the possibility of a Portuguese community pharmacy to obtain quality certification by the ISO 9001 standard, in an expeditious way, through the potential partial fulfillment of these requirements, resulting from the implementation of rules and regulations, required by regulatory bodies and current legislation, which define the terms for its establishment, opening and operation. It was intended, through a survey distributed to community pharmacies (CPs), to understand their degree of knowledge about quality and certification, what information they receive from the entities that regulate them, and the level of intention to obtain certification of the Management System of Quality (QMS) (if they don't already have it). Through a case study in a pharmacy in the district of Faro, the hypothesis of the implementation of a QMS and its certification was tested, based on its operation in accordance with good pharmacy practices (GPP) and other legal aspects necessary for its authorization and operation. Concluding Aspects: FCs seek to improve the quality in the offer of products and services, seek information on QMS, focusing on financial efficiency; in the case of certified pharmacies, the focus is on customer satisfaction; QMS certification is sector-independent; most pharmacies do not show interest in ISO 9001 certification, and despite being familiar with aspects of quality (Kaizen, QMS, ISO 9001, GMP), they consider the information disclosed by regulatory bodies in the sector to be insufficient/non-existent, which should be improved; the most common reasons given for the implementation of QMS are customer satisfaction, continuous improvement and cost reduction; the internal audits, provided for in the GPP, are not carried out by regulatory bodies in the sector; in the case study it was found that, by application of GPP, part of the requirements demanded by the ISO 9001 standard are fulfilled, while others are in the implementation phase, conditions for certification are foreseen within a period of 10 months; the implementation of the “documented procedures” requirement implied higher costs (time and human resources); GPPs can be a specific QMS manual for CFs, adapted to ISO 9001.
Description
Keywords
Gestão de qualidade sistemas de qualidade qualidade Certificação qualidade nas farmácias comunitárias.