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Las determinaciones de los laboratorios clínicos tienen un papel muy importante en la evaluación, diagnóstico, tratamiento y evolución del estado de salud de las personas. La confiabilidad de sus resultados se logra a través del aseguramiento de la calidad y mejora continua. El Programa de Evaluación Externa de la Calidad "Prof. Dr. Daniel Mazziotta" acompaña a los laboratorios de análisis clínicos desde hace 31 años brindando distintas herramientas para garantizar la calidad analítica. Ofrece los servicios de evaluación externa de la calidad, suministro de material para control de calidad interno para determinaciones en Química Clínica y soluciones para control de instrumental y pruebas de suficiencia. Desde la creación del programa se establecieron objetivos estratégicos a desarrollarse en tres etapas: establecimiento, consolidación y apoyo a la gestión de la calidad. Se genera ahora una nueva etapa, cuyo objetivo final es la acreditación. Como primer paso de este ciclo, se implementó un sistema de gestión de la calidad (SGC) de acuerdo a los requisitos establecidos en la norma argentina IRAM-ISO 9001:2015. En agosto de 2019, el Instituto Argentino de Normalización y Certificación (IRAM), representante en Argentina de la International Organization for Standarization (ISO), certificó que el SGC del programa cumple lo establecido en dicha norma. Su aplicación tiene como objetivo asegurar que los servicios ofrecidos satisfagan las necesidades de los laboratorios clínicos cumpliendo los requisitos legales requeridos y asegurando la mejora continua. El objetivo de este trabajo fue describir las acciones realizadas en la implementación del SGC y la posterior certificación de IRAM-ISO 9001:2015, por el IRAM.
Clinical laboratory determinations have a very important role in the evaluation, diagnosis, treatment and evolution of the health status of people. The reliability of their results is achieved through quality assurance and continuous improvement. The External Quality Assessment Programme Prof. Dr. Daniel Mazziotta has been accompanying clinical analysis laboratories for 31 years offering different tools to ensure analytical quality. It provides the services of external quality assessment, supply of material for internal quality control for determinations in Clinical Chemistry and solutions for instrumental control and sufficiency tests. Since the creation of the program, strategic objectives have been established to be developed in three stages: establishment, consolidation and support for quality management. A new stage is now being generated, whose final objective is accreditation. As a first step of this cycle, a quality management system (QMS) was implemented according to the requirements established in the IRAM Argentina standard-ISO 9001:2015. In August 2019, the Argentine Institute for Standardization and Certification (IRAM), representative in Argentina of the International Organization for Standardization (ISO), certified that the Programme's QMS complies with the provisions of said standard. Its application aims to ensure that the services offered meet the needs of clinical laboratories by fulfilling the legal requirements and ensuring continuous improvement. The objective of this work is to describe the actions carried out in the implementation of the QMS and the subsequent IRAM-ISO 9001: 2015 certification by the IRAM.
As determinações laboratoriais clínicas têm um papel muito importante na avaliação, diagnóstico, tratamento e evolução do estado de saúde das pessoas. A confiabilidade de seus resultados é alcançada através da garantia de qualidade e melhoria contínua. O Programa de Avaliação da Qualidade Externa "Prof. Dr. Daniel Mazziotta" apoia os laboratórios de análises clínicas há 31 anos, oferecendo diferentes ferramentas para garantir a qualidade analítica. Oferece os serviços de: avaliação externa de qualidade, fornecimento de material de controle interno de qualidade para determinações em Química Clínica e soluções para controle instrumental e testes de suficiência. Desde a criação do programa, os objetivos estratégicos foram estabelecidos para serem desenvolvidos em três etapas: estabelecimento, consolidação e suporte para a gestão da qualidade. Uma nova etapa é agora gerada, cujo objetivo final é a Acreditação. Como primeira etapa desse ciclo, um sistema de gestão da qualidade (SGQ) foi implementado de acordo com os requisitos estabelecidos na norma IRAM Argentina - ISO 9001:2015. Em agosto de 2019, o Instituto Argentino de Normalização e Certificação (IRAM), representante na Argentina da Organização Internacional de Normalização (ISO), certificou que o SGC do programa está em conformidade com as disposições da referida norma. Sua aplicação visa garantir que os serviços oferecidos satisfaçam as necessidades dos laboratórios clínicos, atendendo aos requisitos legais exigidos e garantindo a melhoria contínua. O objetivo deste trabalho é descrever as ações realizadas na implementação do SGQ e a subsequente certificação da IRAM-ISO 9001:2015, pela IRAM.
Subject(s)
Humans , Quality Control , Laboratories , Reference Standards , Certification , Chemistry, Clinical , Health , Health Status , Clinical Laboratory Techniques , Supply , State , Diagnosis , Laboratory Proficiency Testing/methods , Health Services Needs and Demand , AccreditationABSTRACT
Objective To identify the importance of ISO9001 in project management and explore the procedure of establishing it,to provide reference for further practice.Methods According to prior studies,the formation procedure of this quality management system was described in detail.Results Quality management system could improve project management in multiple aspects,such as explicit regulation,orderly implementation,effective supervision,timely feedback and effective reform.Conclusions As the unique national project management institution on medical science and health,it is crucial to establish a institutionalized,standardized and international scientific research management system,especially on medical science and health field.
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The external evaluation and management of hospital quality are two intimately related aspects of the same phenomenon: the need to improve the quality of health services and provide confidence of this quality to all stakeholders. The objective of this study is to analyze the hospital accreditation programs and ISO 9001 quality management and certification schemes of health institutions, as well as to identify the benefits of each of them, their similarities and differences. Hospital accreditations and ISO 9001 certifications are important instruments to improve the health service quality and to give confidence to the society about the health care provider. Both guide management strategies to improve service quality and patient safety. They differ in some aspects: accreditation is based on the best practices of the quality of the medical assistance and have a more technical character. The ISO 9001 standard is more process oriented and constitutes a suitable framework for incorporating the requirements of hospital accreditation programs and existing international methodologies for risk management in health institutions.
La evaluación externa y la gestión de la calidad hospitalaria son dos aspectos íntimamente relacionados del mismo fenómeno: la necesidad de mejorar la calidad de los servicios de salud y brindar confianza de esta calidad a todas las partes interesadas. El objetivo de este estudio es analizar los programas de acreditación hospitalaria y los sistemas de gestión y certificación de calidad ISO 9001 de las instituciones sanitarias, así como identificar los beneficios de cada uno de ellos, sus similitudes y diferencias. Las acreditaciones hospitalarias y las certificaciones ISO 9001 son instrumentos importantes para mejorar la calidad del servicio de salud y para dar confianza a la sociedad sobre el proveedor de atención médica. Ambos guían las estrategias de gestión para mejorar la calidad del servicio y la seguridad del paciente. Difieren en algunos aspectos: la acreditación se basa en las mejores prácticas de la calidad de la asistencia médica y tiene un carácter más técnico. La norma ISO 9001 está más orientada al proceso y constituye un marco adecuado para incorporar los requisitos de los programas de acreditación hospitalaria y las metodologías internacionales existentes para la gestión del riesgo en las instituciones de salud.
A avaliação externa e a gestão da qualidade hospitalar são dois aspectos intimamente relacionados do mesmo fenómeno: a necessidade de melhorar a qualidade dos serviços de saúde e brindar confiança desta qualidade a todas as partes interessadas. O objetivo deste estudo é analisar os programas de acreditação hospitalar e os sistemas de gestão e certificação de qualidade ISO 9001 das instituições sanitárias, bem como identificar os benefícios da cada um deles, seus similitudes e diferenças. As acreditações hospitalares e as certificações ISO 9001 são instrumentos importantes para melhorar a qualidade do serviço de saúde e para dar confiança à sociedade sobre o provedor de atenção médica. Ambos guiam as estratégias de gestão para melhorar a qualidade do serviço e a segurança do paciente. Diferem em alguns aspectos: a acreditação baseia-se nas melhores práticas da qualidade da assistência médica e tem um carácter mais técnico. A norma ISO 9001 está mais orientada ao processo e constitui um marco adequado para incorporar os requisitos dos programas de acreditação hospitalar e as metodologias internacionais existentes para a gestão do risco nas instituições de saúde.
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In Fertility Centers, quality should be measured by how well the organization complies with pre-defined requirements, and by how quality policies are implemented and quality objectives achieved. Having a quality management system (QMS) is a mandatory requirement for IVF centers established in most countries with regulatory guidelines, including Brazil. Nevertheless, none of the regulatory directives specify what a QMS must have in detail or how it should be implemented and/or maintained. ISO 9001 is the most important and widespread international requirement for quality management. ISO 9001 standards are generic and applicable to all organizations in any economic sector, including IVF centers. In this review, we discuss how we implemented QMS according to ISO 9001 and what we achieved 5 years later. In brief, with ISO we defined our structure, policies, procedures, processes and resources needed to implement quality management. In addition, we determined the quality orientation of our center and the quality objectives and indicators used to guarantee that a high-quality service is provided. Once measuring progress became part of our daily routine, quantifying and evaluating the organization's success and how much improvement has been achieved was an inevitable result of our well-established QMS. Several lessons were learned throughout our quality journey, but foremost among them was the creation of an internal environment with unity of purpose and direction; this has in fact been the key to achieving the organization's goals.
Na clínica de reprodução humana, a qualidade deve ser medida pela maneira como a organização cumpre os requisitos pré-definidos, e pela forma como as políticas de qualidade são implementadas e os objetivos de qualidade alcançados. Ter um sistema de gestão da qualidade (SGQ) é um requisito obrigatório para centros de fertilização in vitro estabelecidos na maioria dos países com diretrizes regulatórias, incluindo o Brasil. No entanto, nenhuma das diretivas regulamentares especifica o que um SGQ deve ter em detalhe ou como ele deve ser implementado e/ou mantido. A norma ISO 9001 é a exigência internacional mais importante e adotada mundialmente para a gestão da qualidade. Os conceitos da norma ISO 9001 são genéricos e aplicáveis a todas as organizações em qualquer setor económico, incluindo as clínicas de fertilização in vitro (ou bancos de células e tecidos germinativos tipo 2, como denominados no Brasil pela Agência Nacional de Vigilância Sanitária). Neste artigo, discutimos como implementamos um SGQ de acordo com a norma ISO 9001 e o que conseguimos 5 anos mais tarde. Em suma, com a norma ISO definimos nossa estrutura, políticas, procedimentos, processos e recursos necessários para implementar a gestão da qualidade. Além disso, determinamos a orientação da qualidade do nosso centro além dos objetivos de qualidade e indicadores utilizados para garantir que um serviço de alta qualidade seja fornecido para nossos clientes. A partir do momento que a mensuração do progresso tornou-se parte da nossa rotina diária, quantificar e avaliar o sucesso da organização e os resultados atingidos passou a ser uma consequência inevitável de um SGQ bem estabelecido. Várias lições foram aprendidas ao longo de nossa jornada de qualidade, mas o mais importante foi a criação de um ambiente interno com unidade de propósito e direção, que se tornou peça chave para alcançar os objetivos da organização.
Subject(s)
Humans , Reproductive Techniques/standards , Total Quality Management , Reproductive Health Services/standards , Total Quality Management , Fertilization in Vitro/standardsABSTRACT
The paper presented the thoughts and steps taken by the National Center for Cardiovascular Diseaes in biobank quality management system.By means ofprocess approach,the organizational structure,identification and analysis process were established,along with the management mechanism and normalized documentation.Centering onPlan,Do,Check and Act(PDCA),a complete set of quality management system was established.This system enables normalized management of biobanks in China,and provides practice guidelines for development industry standards of the country as well.
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Objective To observe the application effect of ISO9001 Quality Management System combined with level 3 general hospital evaluation standard (2011 version) in nursing management. Methods ISO9001 Quality Management System combined with nursing part of level 3 general hospital evaluation standard applied in nursing management; and data of nursing goals were collected before and after the implementation of nursing management system from 2011 to 2014. Results Nursing management system got more perfect, safety of blood transfusion, adverse event reports and so on were included. Both nursing quality target completion and satisfaction rate of hospitalized patients on nursing work increased year by year from 2011 to 2014. Satisfaction rate of doctors and nurses with high quality nursing service were both above 96%. Conclusions Nursing management system can promote can promote quality of nursing care, and provide comprehensive development guarantee to the whole hospital quality system, and offer reference for other hospital′s nursing management.
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According to the ISO 9001 quality management standardization,we build a new model by eight principles. Through implement the standardizations,we are benefited of the specification of the management and enhance the research reputation in the institute. We are also obtained the trust of the customers and optimize the research process and enhance the achievement quality.This system is rigorous and abundant.It is specific and manipulate easily.Through implement quality management standardization systems,it can also promote the achievement to transform the productivity in a forward step.
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El presente artículo expone los resultados de una investigación de tipo descriptivo, cuyo objetivo fuediseñar un sistema de gestión de la calidad en la prestación de servicios fonoaudiológicos, donde seconcibe al cliente como un ser humano integral. El método utilizado fue deductivo ya que partió de unmarco general de referencia para la formulación del sistema de gestión específico. Se tomó comoreferencia el Sistema Obligatorio de Garantía de Calidad en Salud y la norma ISO 9001. Los resultadosentregan un sistema de gestión de calidad para servicios fonoaudiológicos, que tras la validaciónhecha por jueces expertos, permitió la construcción de un instrumento valioso para la prestación deservicios fonoaudiológicos con calidad; de la misma manera, este instrumento facilita el seguimientopor parte de la profesión a la normatividad vigente del Ministerio de Protección Social en Colombiacon relación a la prestación de los servicios fonoaudiológicos, así como la implementación del Sistemade Gestión de Calidad ISO 9001, siempre con un enfoque integral del cliente.
This article presents the results of a descriptive research aim was to design a system of quality management in providing speech and language pathologist services, which takes into account the client as a whole human being. The deductive method was used because it came from a background reference for the formulation of specific management system. Were taken as reference the mandatory Health Quality Assurance and ISO 9001, the results deliver a quality management system for speech and language pathologist services and validation by expert judges in order to inquire about the degree of agreement between those. The data validate the system performed thrown as a valuable tool in providing speech favorer and language pathologist services for adoption by the profession to the regulations of the Ministry of Social Protection and the rise of implementing quality management system , while the approach to the user side when viewed from a holistic approach.
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Speech, Language and Hearing Sciences/organization & administration , Quality Assurance, Health Care/standards , Quality of Health CareABSTRACT
OBJECTIVE:To standardize the quality control of infusion solutions in each production process to guarantee the quality of the final products.METHODS:The process method in ISO9001 quality management system was adopted to standardize each production process of infusion solutions.RESULTS:Both the clarity and the eligible rate of the infusion solutions prepared in our hospital remained at above 97% and 96%,respectively.CONCLUSION:Applying process method in ISO9001 quality management system to standardize each production process of infusion solutions has helped guarantee the quality of final products as well as the clinical medication security.
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OBJECTIVE To explore the canonical management method to improve the control quality of hospital(infection).METHODS To induct the quality standard management system of ISO9001∶2000,carrying out a set of method which is systemic,standard,canonical,and scientific and continue to improve to hospital infection(mangament).RESULTS The control quality of hospital infection had been improved and standardized obviously.CONCLUSIONS Establishing the quality standard management system of ISO and persevering in the principle of plan,carry out, check,manage,feedback and continue to improve could advance canonical and sientific(managment) to the control of hospital infection,and improve the control quality of hospital infection.
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OBJECTIVE:To carry out the ISO9001standard quality control system in the department of pharmacy.METHODS:The procedures and methods of PDCA cycle(Plan-Do-Check-Action)were applied to our department's ISO9001quality authentication standardization.RESULTS:The application of PDCA cycle-based ISO9001standards proved to be successful in the standardization of our department.CONCLUTION:The ISO9001quality authentication following the PDCA cycle is effective.
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OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.
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OBJECTIVE:To study the general layout on the quality control of clinical pharmacy work of Xuzhou city during the period of2005～2008.METHODS:The problems appeared in hospital clinical pharmacy were analyzed by adopting ISO9001process control theory,i.e.PDAC cyclical quality management method,and suggestions on the corresponding scheme and practices were raised.RESULTS&CONCLUSIONS:Studying the general layout on the quality control of clinical pharmacy work by means of ISO9001process control theory is conducive to the development of clinical pharmacy of Xuzhou city.
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OBJECTIVE:To probe into the standardized administration in the public bid for drug purchase of medical institutions.METHODS:Experiences and understandings in carrying out ISO9001standards in the public bid for drug purchase of our hospital were introduced;problems involved in which were analyzed and some advices were put forward.RESULTS&CONCLUSION:The practice of ISO9001standards does good to the consummation and standardization of the public bid of drug purchase in Chinese medical institutions.
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The Hospital of Xinle Sector of Xuhui District in Shanghai started implementing the 2000 version of ISO9001 from September 2000. In doing so it highlighted respectively the following aspects: preparations for the implementation, intensified training, compilation of documents on the quality system, operation of the quality management system, examination and verification of the internal quality system, and examination and verification of attestation. As a result of conscientious implementation, the hospital was issued a certificate for its quality management system in May 2001 by the Quality Attestation Center of the Square & Round Mark Attestation Commission. The hospitals chief experience is that implementation of ISO9001 is a new means of constructing a model of modern medical quality management; it is a prerequisite for the sustained development of a hospital; and it guarantees organizationally the effective operation of medical quality management.
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OBJECTIVE:To establish quality control system by using modern scientific idea and advanced method in in?patient pharmacy.METHODS:Under the situation o f running authentication of ISO9001quality control system in our department,inpatient pharmacy should take the patients as focus to offer good and normative services to patients and clinical departments and continue to make our work better.RESULTS&CONCLUSION:Implementation of ISO9001quality control system has standardized the management of quality of inpatient pharmacy as well as increased the patients'satisfaction.And satisfactory social and economical benefits have been obtained and self-perfect and continuous improvement have been realized in the inpatient pharmacy.