{"id":18507,"date":"2024-10-04T10:28:23","date_gmt":"2024-10-04T08:28:23","guid":{"rendered":"https:\/\/episkeymedical.com\/gestao-da-qualidade\/"},"modified":"2025-03-13T16:29:21","modified_gmt":"2025-03-13T15:29:21","slug":"gestao-da-qualidade","status":"publish","type":"page","link":"https:\/\/episkeymedical.com\/pt-pt\/gestao-da-qualidade\/","title":{"rendered":"Gest\u00e3o da qualidade"},"content":{"rendered":"

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Servi\u00e7os<\/span><\/h3>\n

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Gest\u00e3o da qualidade<\/span><\/strong><\/h1>\n

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A <\/span>gest\u00e3o da qualidade nos dispositivos m\u00e9dicos<\/b> \u00e9 um aspeto fundamental a ter em conta por todos os fabricantes de dispositivos m\u00e9dicos. A exist\u00eancia de um sistema de gest\u00e3o da qualidade adequado garante a seguran\u00e7a, a efic\u00e1cia e a conformidade dos dispositivos e produtos utilizados em ambientes m\u00e9dicos. Al\u00e9m disso, pode ser um pr\u00e9-requisito para a conformidade com regulamentos internacionais, como o <\/span>MDR 2017\/745<\/span><\/a>, <\/span>2017\/746<\/span><\/a> ou o <\/span>FD&C act cap\u00edtulo V: medicamentos e dispositivos<\/span><\/a>. Para garantir o correto funcionamento dos sistemas de gest\u00e3o da qualidade, \u00e9 aconselh\u00e1vel realizar regularmente auditorias internas de sa\u00fade. <\/span><\/p>\n

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Import\u00e2ncia da gest\u00e3o da qualidade nos dispositivos m\u00e9dicos<\/b><\/span><\/h3>\n

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A <\/span>gest\u00e3o da qualidade nos dispositivos m\u00e9dicos<\/b> abrange todos os processos relacionados com a conce\u00e7\u00e3o, o fabrico, a distribui\u00e7\u00e3o e a utiliza\u00e7\u00e3o de dispositivos m\u00e9dicos. O seu principal objetivo \u00e9 minimizar os riscos para os doentes e garantir a efic\u00e1cia dos dispositivos m\u00e9dicos. Para o conseguir, as empresas devem implementar sistemas de gest\u00e3o da qualidade baseados em normas internacionais como a ISO 9001 ou, no caso dos fabricantes de dispositivos m\u00e9dicos, a ISO 13485. <\/span><\/p>\n

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Uma qualidade <\/span>sistema de gest\u00e3o da qualidade para dispositivos m\u00e9dicos<\/b> estruturado na norma ISO 13485 permite:<\/span><\/p>\n

    \n
  • Reduzir as n\u00e3o conformidades relacionadas com os dispositivos m\u00e9dicos.<\/span><\/li>\n
  • Assegura a rastreabilidade dos dispositivos m\u00e9dicos.<\/span><\/li>\n
  • Respeita a regulamenta\u00e7\u00e3o sanit\u00e1ria em vigor.<\/span><\/li>\n
  • Aumenta a confian\u00e7a dos consumidores e dos profissionais de sa\u00fade.<\/span><\/li>\n
  • Optimiza os processos internos e reduz os custos associados a falhas ou recolhas de produtos.<\/span><\/li>\n<\/ul>\n

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    As auditorias internas de sa\u00fade como ferramenta de melhoria cont\u00ednua<\/b><\/span><\/strong><\/h3>\n

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    As <\/span>auditorias internas de sa\u00fade<\/b> s\u00e3o processos de avalia\u00e7\u00e3o interna para identificar \u00e1reas a melhorar no sistema de gest\u00e3o da qualidade dos dispositivos m\u00e9dicos. Estas auditorias s\u00e3o essenciais para detetar poss\u00edveis n\u00e3o-conformidades, ou as chamadas n\u00e3o-conformidades, e para implementar ac\u00e7\u00f5es corretivas antes de uma inspe\u00e7\u00e3o externa. <\/span><\/p>\n

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    As <\/span>auditorias internas de sa\u00fade<\/b> s\u00e3o processos de avalia\u00e7\u00e3o interna para identificar \u00e1reas a melhorar no sistema de gest\u00e3o da qualidade dos dispositivos m\u00e9dicos. Estas auditorias s\u00e3o essenciais para detetar poss\u00edveis n\u00e3o-conformidades, ou as chamadas n\u00e3o-conformidades, e para implementar ac\u00e7\u00f5es corretivas antes de uma inspe\u00e7\u00e3o externa. <\/span><\/p>\n

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    Benef\u00edcios das auditorias internas de sa\u00fade<\/b><\/span><\/strong><\/h3>\n

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      \n
    • Dete\u00e7\u00e3o precoce de problemas:<\/b> Permite a corre\u00e7\u00e3o de defici\u00eancias na gest\u00e3o da qualidade dos dispositivos m\u00e9dicos antes de se tornarem problemas graves.<\/span><\/li>\n
    • Melhoria dos processos:<\/b> Facilita a otimiza\u00e7\u00e3o dos procedimentos internos e promove uma cultura de melhoria cont\u00ednua.<\/span><\/li>\n
    • Conformidade regulamentar:<\/b> Ajuda a garantir que a organiza\u00e7\u00e3o cumpre os regulamentos, como o Regulamento (UE) 2017\/745 relativo aos dispositivos m\u00e9dicos.<\/span><\/li>\n
    • Prepara para auditorias externas:<\/b> Reduz o risco de n\u00e3o-conformidades nas inspec\u00e7\u00f5es das entidades reguladoras.<\/span><\/li>\n<\/ul>\n

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        \n
      • Dete\u00e7\u00e3o precoce de problemas:<\/b> Permite a corre\u00e7\u00e3o de defici\u00eancias na gest\u00e3o da qualidade dos dispositivos m\u00e9dicos antes de se tornarem problemas graves.<\/span><\/li>\n
      • Melhoria dos processos:<\/b> Facilita a otimiza\u00e7\u00e3o dos procedimentos internos e promove uma cultura de melhoria cont\u00ednua.<\/span><\/li>\n
      • Conformidade regulamentar:<\/b> Ajuda a garantir que a organiza\u00e7\u00e3o cumpre os regulamentos, como o Regulamento (UE) 2017\/745 relativo aos dispositivos m\u00e9dicos.<\/span><\/li>\n
      • Prepara para auditorias externas:<\/b> Reduz o risco de n\u00e3o-conformidades nas inspec\u00e7\u00f5es das entidades reguladoras.<\/span><\/li>\n<\/ul>\n

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        Elementos-chave na gest\u00e3o da qualidade dos dispositivos m\u00e9dicos<\/b><\/span><\/strong><\/h3>\n

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        A fim de assegurar um sistema de gest\u00e3o da qualidade <\/span>sistema de gest\u00e3o da qualidade para dispositivos m\u00e9dicos<\/b>as empresas devem considerar v\u00e1rios aspectos fundamentais:<\/span><\/span><\/p>\n

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        1<\/b><\/span><\/h2>\n

        Documenta\u00e7\u00e3o e rastreabilidade<\/b>Todos os dispositivos m\u00e9dicos devem ter registos detalhados do seu desenvolvimento, fabrico e distribui\u00e7\u00e3o. Isto permite um controlo adequado em caso de incidentes ou de retirada de produtos. <\/span><\/span><\/p>\n

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        2<\/strong><\/span><\/h2>\n

        Gest\u00e3o do risco<\/b>A identifica\u00e7\u00e3o e atenua\u00e7\u00e3o de perigos \u00e9 uma parte essencial da gest\u00e3o da qualidade em dispositivos m\u00e9dicos. A aplica\u00e7\u00e3o de metodologias como a An\u00e1lise de Perigos e Pontos de Controlo Cr\u00edticos (HACCP) ajuda a reduzir a possibilidade de falha. <\/span><\/p>\n

        <\/span><\/p>\n

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        3<\/b><\/span><\/h2>\n

        Forma\u00e7\u00e3o do pessoal<\/b>O pessoal envolvido no fabrico e no controlo de qualidade dos dispositivos m\u00e9dicos deve receber forma\u00e7\u00e3o cont\u00ednua sobre a regulamenta\u00e7\u00e3o e as boas pr\u00e1ticas.<\/span><\/p>\n

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        4<\/b><\/span><\/h2>\n

        Avalia\u00e7\u00f5es e auditorias sanit\u00e1rias internas<\/b>A implementa\u00e7\u00e3o de auditorias sanit\u00e1rias internas permite uma monitoriza\u00e7\u00e3o constante da qualidade e efici\u00eancia dos processos.<\/span><\/p>\n

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        5<\/b><\/span><\/h2>\n

        Gest\u00e3o de fornecedores<\/b>Gest\u00e3o de fornecedores: A sele\u00e7\u00e3o de fornecedores fi\u00e1veis com elevados padr\u00f5es de qualidade \u00e9 essencial para garantir a qualidade final dos dispositivos m\u00e9dicos.<\/span><\/p>\n

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        Como realizar auditorias internas de sa\u00fade eficazes<\/b><\/span><\/strong><\/h3>\n

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        1) Planeamento da auditoria interna sanit\u00e1ria<\/b><\/p>\n

        Antes de efetuar uma auditoria interna, \u00e9 essencial definir:<\/span><\/p>\n

          \n
        • Objectivos da auditoria<\/span><\/li>\n
        • \u00c2mbito e crit\u00e9rios de avalia\u00e7\u00e3o<\/span><\/li>\n
        • Normas e padr\u00f5es aplic\u00e1veis<\/span><\/li>\n
        • Equipas de auditoria e gestores de auditoria<\/span><\/li>\n<\/ul>\n

          [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_icon font_icon=”||divi||400″ icon_color=”#009ee3″ icon_width=”60px” align=”left” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_icon][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

          2. Planeamento da auditoria interna de sa\u00fade<\/b><\/p>\n

          Durante a auditoria, os auditores analisam os processos internos, entrevistam o pessoal e analisam a documenta\u00e7\u00e3o relevante sobre a gest\u00e3o da qualidade dos dispositivos m\u00e9dicos. As n\u00e3o-conformidades s\u00e3o identificadas e as conclus\u00f5es s\u00e3o registadas. <\/span><\/b><\/p>\n

            <\/ul>\n
              <\/ul>\n

              [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_icon font_icon=”||divi||400″ icon_color=”#009ee3″ icon_width=”60px” align=”left” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_icon][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

              3. Elabora o relat\u00f3rio da auditoria interna da sa\u00fade<\/b><\/p>\n

              Os resultados devem ser documentados num relat\u00f3rio pormenorizado que inclua:<\/span><\/p>\n

              Resumo das conclus\u00f5es<\/span><\/p>\n

              Identificou \u00e1reas de melhoria<\/span><\/p>\n

              Ac\u00e7\u00f5es corretivas recomendadas<\/span><\/p>\n

              Prazos para a implementa\u00e7\u00e3o de melhorias<\/span><\/p>\n

              [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,1_3,1_3″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_enable_image=”off” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_icon font_icon=”||divi||400″ icon_color=”#009ee3″ icon_width=”60px” align=”left” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_icon][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

              4. Aplica\u00e7\u00e3o de medidas corretivas<\/b><\/p>\n

              A organiza\u00e7\u00e3o deve tomar medidas corretivas e preventivas para corrigir as defici\u00eancias identificadas. O acompanhamento cont\u00ednuo assegurar\u00e1 a efic\u00e1cia das ac\u00e7\u00f5es implementadas. <\/span><\/p>\n

              [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_icon font_icon=”||divi||400″ icon_color=”#009ee3″ icon_width=”60px” align=”left” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_icon][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

              5. Revis\u00e3o e melhoria cont\u00ednua<\/b><\/p>\n

              As <\/span>auditorias internas <\/b>n\u00e3o s\u00f3 devem ser efectuadas com regularidade, como tamb\u00e9m devem fazer parte de um ciclo de melhoria cont\u00ednua no \u00e2mbito do sistema de gest\u00e3o da qualidade dos dispositivos m\u00e9dicos.<\/span><\/p>\n

              [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_3″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_divider color=”#009ee3″ divider_weight=”2px” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_divider][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.26.0″ _module_preset=”default” custom_margin=”0px||||false|false” custom_padding=”0px||||false|false” locked=”off” global_colors_info=”{}”][et_pb_row column_structure=”3_5,2_5″ disabled_on=”on|on|off” _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/02\/gestion-1.jpg” custom_padding=”0px||0px||false|false” global_colors_info=”{}”][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” background_color=”#FFFFFF” custom_padding=”40px|40px|40px||false|false” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

              A <\/span>gest\u00e3o da qualidade nos dispositivos m\u00e9dicos<\/b> e <\/span>auditorias sanit\u00e1rias internas<\/b> s\u00e3o essenciais para garantir a seguran\u00e7a, a efic\u00e1cia e a conformidade regulamentar dos dispositivos m\u00e9dicos. A implementa\u00e7\u00e3o de um sistema de gest\u00e3o da qualidade bem estruturado, juntamente com auditorias internas regulares, minimiza os riscos, optimiza os processos e aumenta a confian\u00e7a nos dispositivos m\u00e9dicos. <\/span><\/p>\n

              As organiza\u00e7\u00f5es que d\u00e3o prioridade \u00e0 <\/span>gest\u00e3o da qualidade em dispositivos m\u00e9dicos<\/b> n\u00e3o s\u00f3 cumprem a regulamenta\u00e7\u00e3o em vigor, mas tamb\u00e9m refor\u00e7am a sua competitividade no mercado e garantem a seguran\u00e7a dos doentes. Da mesma forma, a <\/span>auditorias internas de sa\u00fade<\/b> s\u00e3o ferramentas essenciais para avaliar e melhorar continuamente os processos, garantindo que a empresa opera sob os mais elevados padr\u00f5es de qualidade no sector da sa\u00fade.<\/span><\/p>\n

              [\/et_pb_text][\/et_pb_column][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”2_5,3_5″ disabled_on=”off|off|on” _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”2_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2024\/12\/back-img-over-2.png” title_text=”gest\u00e3o-1″ _builder_version=”4.26.0″ _module_preset=”default” background_image=”https:\/\/episkeymedical.com\/wp-content\/uploads\/2025\/02\/gestion-1.jpg” max_height=”200px” animation_style=”slide” animation_direction=”right” animation_delay=”100ms” global_colors_info=”{}”][\/et_pb_image][\/et_pb_column][et_pb_column type=”3_5″ _builder_version=”4.26.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.26.0″ _module_preset=”default” animation_style=”slide” animation_direction=”left” animation_delay=”150ms” global_colors_info=”{}”]<\/p>\n

              A <\/span>gest\u00e3o da qualidade nos dispositivos m\u00e9dicos<\/b> e <\/span>auditorias sanit\u00e1rias internas<\/b> s\u00e3o essenciais para garantir a seguran\u00e7a, a efic\u00e1cia e a conformidade regulamentar dos dispositivos m\u00e9dicos. A implementa\u00e7\u00e3o de um sistema de gest\u00e3o da qualidade bem estruturado, juntamente com auditorias internas regulares, minimiza os riscos, optimiza os processos e aumenta a confian\u00e7a nos dispositivos m\u00e9dicos. <\/span><\/p>\n

              As organiza\u00e7\u00f5es que d\u00e3o prioridade \u00e0 <\/span>gest\u00e3o da qualidade em dispositivos m\u00e9dicos<\/b> n\u00e3o s\u00f3 cumprem a regulamenta\u00e7\u00e3o em vigor, mas tamb\u00e9m refor\u00e7am a sua competitividade no mercado e garantem a seguran\u00e7a dos doentes. Da mesma forma, a <\/span>auditorias internas de sa\u00fade<\/b> s\u00e3o ferramentas essenciais para avaliar e melhorar continuamente os processos, garantindo que a empresa opera sob os mais elevados padr\u00f5es de qualidade no sector da sa\u00fade.<\/span><\/p>\n

              [\/et_pb_text][\/et_pb_column][\/et_pb_row][\/et_pb_section]<\/p>\n","protected":false},"excerpt":{"rendered":"

              Servi\u00e7osGest\u00e3o da qualidadeA gest\u00e3o da qualidade nos dispositivos m\u00e9dicos \u00e9 um aspeto fundamental a ter em conta por todos os fabricantes de dispositivos m\u00e9dicos. A exist\u00eancia de um sistema de gest\u00e3o da qualidade adequado garante a seguran\u00e7a, a efic\u00e1cia e a conformidade dos dispositivos e produtos utilizados em ambientes m\u00e9dicos. Al\u00e9m disso, pode ser um […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_et_pb_use_builder":"on","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"class_list":["post-18507","page","type-page","status-publish","hentry"],"yoast_head":"\nGest\u00e3o da qualidade - Episkey Medical<\/title>\n<meta name=\"description\" content=\"Gest\u00e3o da qualidade en Episkey Medical\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/episkeymedical.com\/pt-pt\/gestao-da-qualidade\/\" \/>\n<meta property=\"og:locale\" content=\"pt_PT\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Gest\u00e3o da qualidade - Episkey Medical\" \/>\n<meta property=\"og:description\" content=\"Gest\u00e3o da qualidade en Episkey Medical\" \/>\n<meta property=\"og:url\" content=\"https:\/\/episkeymedical.com\/pt-pt\/gestao-da-qualidade\/\" \/>\n<meta property=\"og:site_name\" content=\"Episkey Medical\" \/>\n<meta property=\"article:modified_time\" content=\"2025-03-13T15:29:21+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Tempo estimado de leitura\" \/>\n\t<meta name=\"twitter:data1\" content=\"18 minutos\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\/\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\/\/episkeymedical.com\/pt-pt\/gestao-da-qualidade\/\",\"url\":\"https:\/\/episkeymedical.com\/pt-pt\/gestao-da-qualidade\/\",\"name\":\"Gest\u00e3o da qualidade - 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