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ISO 15189:2012 Sistemas De Calidad En ISO 14001:2004 Laboratorios Clínicos SGI Presentación Autora: Lorena Sánchez Gancedo (Rev.03 Agosto 2016) OHSAS 18001:2007

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ISO 15189:2012 Sistemas De Calidad En ISO 14001:2004 Laboratorios Clínicos SGI Presentación Autora: Lorena Sánchez Gancedo (Rev.03 Agosto 2016) OHSAS 18001:2007 Nuestra Estrategia, SGIEL DESARROLLO- Sistema de Gestión COMPETITIVO. de la Calidad INTEGRAR: Fusionar N partes, obteniendo un todo, que incluye partes comunes y partes específicas de cada norma. ISO 15189:2012 Sistemas de Calidad en ISO 14001:2004 Laboratorios Clínicos SGI Presentación Autora: Lorena Sánchez Gancedo (Rev.03 Agosto_2016) OHSAS 18001:2007 www.intedya.com Intedya es una entidad internacional presente en más de 16 países de 3 continentes competente en la consultoría, auditoría y formación en el ámbito de la gestión de la Calidad, el Medio Ambiente, la Seguridad e Inocuidad Alimentaria, Laboral y de la Información, en organizaciones públicas y privadas de cualquier tipo de actividad y dimensión. Nuestra estrategia del “Desarrollo Competitivo” se basa en nuestra experiencia y capacidad para ayudar a los clientes a rendir al máximo nivel y, de esta forma, crear valor sostenible para sus clientes, proveedores, accionistas y la sociedad de la que forman parte. DIMENSIÓN Y PRESENCIA ESTADOS UNIDOS ESPAÑA MÉXICO ANDORRA REPÚBLICA DOMINICANA PORTUGAL GUATEMALA ANGOLA COLOMBIA PERÚ ECUADOR BOLIVIA BRASIL PARAGUAY ARGENTINA URUGUAY CHILE DESARROLLO COMPETITIVO Con presencia directa en 16 países de 3 continentes, disponemos de la capacidad para dar servicio en cualquier país de la Unión Europea, América y África, formando una de las mayores redes internacionales en nuestra especialidad. Áreas de conocimiento Calidad y Excelencia Salud y Seguridad Seguridad Alimentaria . ISO 9001 - Sistemas de Gestión de la Calidad . OHSAS 18001 - Sistema de Gestión de Seguridad y Salud en el . ISO 22000 - Sistemas de Gestión de la Inocuidad Alimentaria . ISO 9001. Sistemas de Gestión de la Calidad Trabajo . Protocolos BRC y BRC-IOP . Transición ISO 9001:2015 . ISO 22320 - Gestión de Emergencias . Protocolo IFS . ISO/TS 16949. Sistemas de Gestión de la Calidad en el Sector de la . ISO 39001 - Seguridad Vial . Protocolo Global GAP Automoción . Asesoramiento en Cumplimiento de Leyes Nacionales en materia de . Esquema FSSC 22000 - Sistemas de Gestión de la Inocuidad . EN 9100. Sistemas de Gestión de la Calidad en el Sector Aeroespacial Riesgos Laborales y Salud Ocupacional Alimentaria . ISO 13485. Sistemas de Gestión de la Calidad para Productos . Servicios de Coordinación de Seguridad y Salud . HACCP Análisis de Peligros y Puntos Críticos de Control Sanitarios . Asistencia Técnica Integral en PRL . Producción Controlada de Frutas y Hortalizas . ISO 18091. Directrices para la aplicación de la Norma ISO 9001:2008 . Coordinación de Actividades Empresariales . EN 15593 - Gestión de Higiene en la Producción de Envases en el Gobierno Local . Estudios de Seguridad y Salud . Buenas Prácticas de Manufactura (BPM) . RtQ . Road to Quality . Elaboración e Implantación de Planes de Seguridad y Salud . Buenas Prácticas de Almacenamiento (BPA) . EFQM. Modelo de Excelencia y Calidad . Elaboración e Implantación de Planes Específicos de Seguridad . Distintivo H (México) . ISO 9004. Sistemas de Gestión Avanzada . Elaboración de Planes de Trabajo para Empresas con Riesgo de . Industria Limpia (México) . Metodología 5´s Exposición al Amianto . NOM 251 (México) . Lean Manufacturing . Elaboración y Mantenimiento del Documento de Protección contra . México GAP (México) . ISO 15189. Sistemas de Gestión de la Calidad en Laboratorios Clínicos Explosiones (ATEX) . ISO/IEC 17025. Laboratorios de ensayo y de calibración . Informes Técnicos Especializados . ISO 22716. Guía de Buenas Prácticas de Fabricación de Cosméticos . Planes de Autoprotección Riesgos y Seguridad . ISO/IEC 20000-1. Gestión del Servicio . Estudios Específicos. Mediciones de contaminación física, química y . UNE 166002. Sistemas de Gestión de la I+D+i biológica . ISO 31000. Gestión del Riesgo . Normas de Calidad Sectoriales . Informes Periciales para Juicios, relacionados con la Prevención de . ISO/IEC 27001. Sistemas de Gestión de la Seguridad de la Información Riesgos Laborales . ISO 22301. Sistemas de Continuidad del Negocio Sostenibilidad . ISO 14298. Gestión de Procesos de Impresión de Seguridad Directivas Europeas . ISO 28000. Especificación para Sistemas de Gestión de la Cadena de . ISO 14001. Sistemas de Gestión Ambiental Suministro . Transición ISO 14001:2015 . Directiva Baja Tensión 2014/35/UE. Material Eléctrico . ISO 28001. Sistemas de Gestión de la Cadena de Suministro . ISO 50001. Sistemas de Gestión Energética . Directiva 2014/30/UE. Compatibilidad Electromagnética (CEM) . Estándares Nacionales de la Cadena de Suministro . Verificación EMAS . Directiva 2014/68/UE. Equipos a Presión . BASC. Comercio Seguro . ISO 14006. Gestión del Ecodiseño . Directiva 2010/35/UE. Equipos a Presión transportables . ISO 19600. Sistemas de Gestión de Compliance . ISO 14067. Huella de Carbono de Productos . Directiva 2009/142/CE. Aparatos de Gas . ISO 37001. Sistemas de Gestión Antisoborno . ISO 14064. Huella de Carbono de Organizaciones . Directiva 2000/1/CE. Instalaciones de transporte de personas por cable . Leyes Nacionales en Materia de Protección de Datos . ISO 14046. Huella de Agua . Directiva 89/686/CEE. Equipos de Protección Individual . Plan de Prevención de Delitos Penales . PEFC y FSC. Cadena de Custodia de Productos Forestales . Directiva 2006/42/CE. Máquinas . RSPO. Cadena de Custodia del Aceite de Palma . Directiva 2014/33/UE. Ascensores *Normas y referenciales más relevantes consulte a su . LEED. Estándar de Edificación Sostenible . Directiva 2009/48/CE. Juguetes asesor o en www.intedya.com el catálogo completo de . Industria Limpia, Calidad Ambiental y Calidad Ambiental Turística . Directiva 93/42/CEE. Productos Sanitarios . ISO 26000. Guía sobre Responsabilidad Social soluciones . SGE21. Gestión Ética y Responsabilidad Empresarial . SA 8000. Responsabilidad Social Internacional . Sistemas de Gestión de Igualdad de Género . Distintivo ESR ISO 15189:2012 ¿Por qué es importante? LA CUENTA ATRÁS PARA QUE LA ACREDITACIÓN SEA EXIGIDA A LOS LABORATORIOS CLÍNICOS, POR LAS AUTORIDADES REGLAMENTARIAS HA COMENZADO!! ISO 15189:2012 ¿Por qué es importante? . EL NÚMERO DE PAÍSES EN LOS QUE LAS AUTORIDADES SANITARIAS EXIGEN LA ACREDITACIÓN DE LABORATORIOS CLÍNICOS SIGUE UNA TENDENCIA CRECIENTE, ya sea para toda su actividad o para algunas especialidades o pruebas específicas (Genética y Cribado prenatal, principalmente) . Actualmente, la acreditación es el CAMINO QUE ELIGEN LA MAYORÍA DE LOS LABORATORIOS CLÍNICOS PARA IMPLEMENTAR UN SISTEMA DE GESTIÓN DE LA CALIDAD, lo que se deduce por el ELEVADO NÚMERO DE PUBLICACIONES acerca de la experiencia en la implantación de la acreditación en las diferentes disciplinas del laboratorio clínico, concretamente en los ÚLTIMOS SEIS AÑOS A NIVEL EUROPEO E INTERNACIONAL. ISO 15189:2012 ¿Por qué es importante? Nº Laboratorios acreditados y en proceso. 90 80 70 60 50 40 Acreditadas 30 En proceso 20 10 0 …Y EL NÚMERO DE LABORATORIOS ACREDITADOS SIGUE SUBIENDO!!! ISO 15189:2012 ¿Por qué es importante? Certificado ISO 15189 EXIGENCIA En la actualidad, la acreditación de los laboratorios clínicos según el estándar ISO 15189, se está convirtiendo rápidamente en la norma mundial de excelencia para los laboratorios clínicos. Los laboratorios que ostentan la acreditación en ISO 15189 disfrutan de un reconocido prestigio en su sector. No ostentar un certificado de calidad es una limitación para trabajar en mercados tan exigentes como el SANITARIO, para optar a trabajos con la ADMINISTRACIÓN PÚBLICA o colaborar con ESTUDIOS MULTICÉNTRICOS con otros hospitales, universidades, sociedades científicas…etc. ISO 15189:2012 ¿En qué puede ayudar INTEDYA a las organizaciones? En INTEDYA tenemos la solución para, . Asesorar al laboratorio, en la realización de una AUTOEVALUACIÓN OBJETIVA del correcto funcionamiento del proceso global y avanzar hacia la excelencia del servicio ofrecido. IDENTIFICAR SUS PROCESOS (PREANALÍTICOS, ANALÍTICOS Y POSTANALÍTICOS), E IMPLEMENTAR INDICADORES EFICACES para evaluar el desempeño de los mismos. IMPLEMENTAR UN SISTEMA DE GESTIÓN BASADO EN FICHAS DE PROCESO ADAPTADAS A SU ORGANIZACIÓN, y de fácil comprensión para todo el personal. GESTIONAR DE FORMA ADECUADA SUS RIESGOS Y AYUDAR A ASEGURAR LA SEGURIDAD DEL PACIENTE. En las fases extraanalíticas, es donde suceden el mayor número de errores y más concretamente en la preanalítica (45-71%). FACILITAR LA LABOR DEL FACULTATIVO CLÍNICO aportándole una confianza añadida en la fiabilidad del resultado que obtiene. La Acreditación de un sistema de Gestión basado en ISO 15189, se considera el camino hacia la excelencia de los laboratorios clínicos ISO 15189:2012 ¿En qué puede ayudar INTEDYA a las organizaciones? En INTEDYA tenemos la solución para, . Facilitar la aplicación y el mantenimiento de un sistema efectivo de la calidad, DAR CONFIANZA AL USUARIO EN LA UTILIZACIÓN DEL SERVICIO. PROVEER DE RECONOCIMIENTO NACIONAL/INTERNACIONAL DE LA COMPETENCIA TÉCNICA, y ayudar al laboratorio clínico frente a las controversias legales relativas a los resultados. EVALUAR A SUS PROVEEDORES, una de las partes interesadas más relevantes de cualquier laboratorio, y cuya falta de rigor o mal servicio origina pérdidas económicas muy importantes, y disminución de la calidad del servicio ofrecido. ASESORARLES EN ACCIONES DE MEJORA en base al análisis del contexto de su laboratorio y de las expectativas de sus partes interesadas. La Acreditación de un sistema de Gestión basado en ISO 15189, se considera el camino hacia la excelencia de los laboratorios clínicos ISO 15189:2012 ¿Qué es? La norma ISO 15189 fue elaborada por el Comité
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