Comparación entre ISO 13485:2016 y China Nuevo dispositivo médico GMP
Un mapeo técnico detallado basado en los últimos Principios de Inspección NMPA para fabricantes internacionales.
| y determinar el diseño y desarrollo de cada departamentoActividades e interfaz,claroResponsabilidades y división del trabajo. | |||
| Al revisar los documentos de planificación de diseño y desarrollo., Las actividades de diseño y desarrollo deben planificarse de acuerdo con las características del producto., y los resultados de la planificación deben documentarse. Esto debe incluir al menos lo siguiente:contenido: | |||
| 1.Proyectos de diseño y desarrolloObjetivo yDescripción de significado | |||
| Narrativo,Análisis de indicadores técnicos.; | |||
| 2.ConfirmadoFases de diseño y desarrolloY adecuado para cada etapa de diseño y desarrollo.Revisión, verificación, validación y transferencia de diseñoActividad; | |||
| 3.Se debe identificar y determinar el diseño y desarrollo de cada departamento.Actividades e Interfaces,claroResponsabilidades del personal u organizaciones en cada etapa,Composición del panel de revisión,así como los resultados de salida esperados en cada etapa.; | |||
| 4.Planificar y organizar las tareas principales y las tareas por fases en relación con todo el proyecto. Consistente; | |||
| 5.Requisitos técnicos del producto seguro de Formulate, verificar, ConfirmarDispositivos de medición necesarios para las actividades de producción.; | |||
| 6.Gestión de RiesgosActividad. | |||
| El diseño y desarrollo deben implementarse de acuerdo con el plan. Desviación del plan Cuando es necesario modificar el plan, se debe hacer de la siguiente manera:El plan será revisado y aprobado nuevamente.. | |||
| 7.3.3 Aportes de diseño y desarrollo. | 5.3.1 | 1)13485Énfasis en usabilidadSolicitar, y requieren que cumpla con las siguientes condiciones. Requisitos IEC 62366-1; and inspectionThe principle was not explicitly emphasized. | |
| The requirements related to the product should be determined.enterand maintainRecord(See4.2.5)These inputs should include: | Design and development inputs should includeIntended Use SpecificationSpecific functional, performance, and safety requirements, and regulatory requirements.,Risk management and control measuresandOther requirements. | 2)13485When appropriate, designThe development inputs include information provided by previous similar designs, while the inspection principles are not proposed. | |
| a)in accordance withIntended Use,Functions, performance,AvailabilityandSafetyRequire; | 5.3.2 | ||
| b)ApplicableRegulatory requirementsandstandard; | Design and development inputs should be analyzed.Reviewand obtainedarriveapprove,KeepRelated records. | ||
| c)ApplicableRisk management output; | |||
| d)When appropriate, previouslySimilar designInformation provided; | |||
| e)The design and development of products and processes are necessaryOther requirements; | |||
| Requirements shouldComplete and clear, can beVerify or confirm, | |||
| And it cannot be self-contradictory. | |||
| Nota: Further information can be found at [link/reference].IEC 62366-1. | |||
| 7.3.4 Design and development outputDesign and development outputs should: | *5.4.1 | Inspection principles are relatively13485 More detailedbody | |
| a)satisfyDesign and development inputRequirements; | Design and development outputs shouldMeets input requirements,includeProcurement, production and serviceRequired relevant informationProduct Technical Requirementswait. | ||
| b)GiveProcurement and productionandService providedAppropriate | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| information; | Review the design and development output materials; they should at least meet the following requirements.The following requirements are made: | ||
| c)Include or referenceProduct Acceptance Criteria; | 1.Procurement Information,likeRaw materials, materiales de embalaje, assembly | ||
| d)Regulations on productsSafe and normal useRequiredProduct Features; | Technical requirements for parts and components; | ||
| Design and development outputformShould be suitable for designand development inputverifyAnd should be before publicationbatchallow. | 2.Production and service needsInformation, such asProduct drawings | ||
| The design and development outputs should be maintained.Record(See | (including component drawings))Process formulation, work instructions, environmental requirementswait; | ||
| 4.2.5). | 3.Product Technical Requirements; | ||
| 4.productInspection procedures or instructions; | |||
| 5.Specified productsProduct characteristics necessary for safety and normal usesuch as productsInstruction Manual,Packaging and labeling requirementsEtc. Does the product instruction manual match the notes? | |||
| The registration application and approval are consistent; | |||
| 6.Identification and traceabilityRequire; | |||
| 7.Submit toRegistration and approval departmentFiles, such asResearch data, product technical requirements, registration test reports, clinical evaluation data (if any))List of basic requirements for the safety and effectiveness of medical deviceswait; | |||
| 8.prototype or sample; | |||
| 9.Biological evaluation results and records,includeMain performance requirements of materials. | |||
| 5.4.2 | |||
| The design and development outputs should be receivedapproveMaintain phasecloseRecord. | |||
| 7.3.5 Design and development review | 5.6.1 | 13485 Emphasis was placed on design and development reviewsThe participants. | |
| existAppropriate stageThe design and development should be systematically carried out in accordance with the planned and documented arrangements.Review,so that: | It should be arranged at an appropriate stage of design and development.CommentsTrial,KeepReview resultsand anyNecessary measuresThe recordrecord. | ||
| a)Evaluation of design and developmentThe results meet the requirements.ofability; | Review relevant documents and records, ensuring at least the following requirements are met.beg: | ||
| b)Identify and proposeNecessary measures. | 1.It should be based on the results of the design, development, and planning.suitable | ||
| ReviewParticipantsThis should include the design and development phases being reviewed.Representatives of relevant functionsOtherofexpert. | stageConduct design and development reviews; | ||
| ReviewResults and any necessary measuresofRecordShould be | 2.Design and development reviews should be maintained.Record,includeReviewresultand the review adoptedNecessary measuresThe recordrecord. | ||
| Keep(See4.2.5). | |||
| 7.3.6 Design and development verification | 5.6.1 | 1)13485Emphasis was placed on the method and reception.Criteria, and the statistical techniques and principles used to determine the sample size; | |
| To ensure that the design and development outputs meet the design and development requirements | Design and development should be carried outverifyTo ensure that the design and development outputs meet the input requirements and maintainVerification resultsand anyNecessary measuresShi’s records. | 2)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined; | |
| Input requirements should be based on the planned and documented arrangements for design and development.verify. | Review relevant documents and records, ensuring at least the following requirements are met.beg: | 3)The inspection principle emphasizes the availability of options. | |
| The organization should include a validation plan.Create document,includesquare | 1.The results of the planning should be considered in conjunction with the actual situation.Appropriate stage | ||
| Law, Acceptance CriteriaWhen appropriate, to determineSampling sizeThe adoptedStatistical Techniques and Principles. | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementThe verification should include the following:Connection or engagementAt that time, it was confirmedThe design output satisfies the design input.The content. | Conduct design and development verification to ensure that the design and development outputs meet the input requirements; | The calculation method or the method of comparison with the proven design should be used.Appropriateness of the methods used in the reviewSexuality, whether the confirmation method is scientific andefficient. | |
| Verification resultsandin conclusionas well asNecessary measuresofRecord | 2.Design and development verification should be maintained.Record,verificar | ||
| It should be maintained.(See4.2.4 and4.2.5). | resultand anyNecessary measuresRecords; | ||
| 3.If the design and development verification usesAvailableCalculation methodorComparison of proven designsMethodThe methods used should be reviewed.suitablesexTo confirm whether the method is scientific and effective. | |||
| 7.3.7 Design and development confirmation | 5.8.1 | 1)13485Emphasis on methods and receiving accuracyTherefore, when appropriate, the statistical techniques used to determine the sample size should be consistent with the original principles.reason; | |
| To ensure the product canMeets the applicable requirementsor requirements for intended useIt should be based on the planned and writtenComponent-based arrangements for design and developmentconfirm.The organization should confirm the plan.Create document,includesquareLaw, Acceptance CriteriaWhen appropriate, forDetermine the sample sizeStatistical techniques and principles employed. | Design and development should be carried outconfirmTo ensure productionProduct satisfactionSpecified usage requirements or intended useRequirementsAnd keep confirmingresultand anyNecessary measuresofRecord. | 2)13485Clearly require representative samplesProduct design confirmation; | |
| responseRepresentative productsDesign confirmation was conducted, with representative products includingThe initial production unit, batch, or other equivalentThe information used for confirmation should be recorded.Product Combinationreason(See4.2.5). | Review relevant documents and records, ensuring at least the following requirements are met.beg: | 3)13485Explicitly require recording forVerify the product’s suitability; | |
| As part of design and development verification, the organization shouldaccording toApplicable laws and regulationsRequired to conductClinical evaluation orPerformance Evaluation. | 1.Should be inSuitable stageDesign and development | 4)13485Clearly for clinical evaluationMedical devices that have undergone performance evaluation should not be considered as released for customer use. | |
| ForClinical evaluation or performance evaluationofmedical devices | Recognize and ensure product quality.Requirements for meeting the specified usage or intended use; | 5)13485Emphasizing other medical devicesSpecial validation requirements for medical devices that are mechanically connected or joined. | |
| This should not be considered as permission for customers to use.. | 2.Design and development validation activities should be conducted during product development.Before delivery and implementationconduct; | ||
| If the intended use requires medical devices to be used in other medical fieldsMedical devicesConnection or engagementConfirmation should include this linkWhen connecting or joining, confirm the applicable requirements or pre-defined conditions. | 3.Design and development verification records should be maintained, includingClinical evaluation or clinical trialRecord the results and any necessary actions taken. | ||
| The intended use has been fulfilled. | 5.9.1 | ||
| Confirmation should be made on the productBefore delivery to the customeroverbecome. | Confirm that clinical or performance evaluation methods are suitable.When conducting clinical trials,Compliant with medical device clinical trialsTesting regulationsRequirements. | ||
| confirmresultandNecessary measuresofRecordShould be maintained | CheckClinical evaluation reportand its supporting materials. If open | ||
| (See4.2.4 and4.2.5). | For clinical trials to be conducted, the clinical trials must comply with the law.The regulations require and corresponding supporting documentation must be provided. For those requiring… | ||
| Medical devices requiring clinical or performance evaluationThe equipment should be able to provide an evaluation.Reports and/or materialsmaterial. | |||
| 7.3.8 Design and development conversion | 5.5.1 | 1)The inspection principles have further refined the specific content of design and development transformation activities.Allow; | |
| Organizations should transfer design and development outputs to manufacturing.changeChangeThe procedures are documented. These procedures should ensure the design… | Design should be carried out during the design and development process.From development to productionConversionActivities to enable design and developmentThe output was developed before becoming the final product specification.Verification ensures that the design and development outputs are validated.Suitable for life | 2)The inspection principles emphasize product technology.beg. | |
| The output of development becomes the final production specification.PreviouslySuitable for productionthroughverify,andProduction capacity can meet product requirements. | Produce. | ||
| Transformedresultandin conclusionIt should be recorded.(See | The relevant documents must meet at least the following requirements: | ||
| 4.2.5). | 1.Design should be carried out during the design and development process.conversionActivityTo solveManufacturability, Componentsand the availability of materials, the required production facilities | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Training of equipment and operatorswait; | |||
| 2.Design transformation activities should incorporate the product’s…Each technical requirementCorrectly translate into product realizationRelatedSpecific process or procedure; | |||
| 3.Records of design conversion activities should indicate that the design conversion activities were completed.Design and development output in becomingFinal product specificationsFan Qian’s statement has been verified.and retainVerification records,To ensure the design and developmentOutput suitable for lifeProduce; | |||
| 4.Special processes should be addressed.Confirm conversionIndeed | |||
| Ensure the results are applicable to production and retain confirmation records.record. | |||
| 7.3.9 Control of design and development changes | 5.10.1 | The inspection principles have been further refined in design and development.The revised review record requirements. | |
| The organization should control design and development changes.programCreate documentThe organization should determine the relationship with medical devices.Functionality, performance, usability, securityandApplicable medicalMedical device regulations requireand itsIntended use relatedofHeavyTo change. | The design and development should beChangePerform identification andKeep a record. | ||
| Design and developmentchangeIt should be identified before implementation.,thisThese changes should be: | 5.10.2 | ||
| a)go throughReview; | Design and development changes should be made when necessary.CommentsReview, verification and confirmationand obtained before implementationapproveView design and development.ChangeofReview Record,At least | ||
| b)go throughverify; | The following requirements must be met: | ||
| c)When appropriate,confirmar; | 1.Debe incluir cambios en los componentes del producto y el impacto de los productos entregados.; | ||
| d)pasar por aprobar. | 2.La implementación de cambios de diseño y desarrollo debe cumplir con los requisitos médicos. Registro de productos de dispositivos médicos. Las regulaciones pertinentes.; | ||
| La revisión de los cambios de diseño y desarrollo debe incluirDurante el procesoO ya entregadodeComponentes y productosCambios yGestión del riesgo eólicoyProceso de realización del productode | 3.El contenido y los resultados de los cambios de diseño implican modificar…Cambiar certificado de registro de producto de dispositivo médico (Certificado de presentaciónEl certificado indicaAl discutir el contenido, las empresas deben realizar…Análisis de RiesgosY de acuerdo con la normativa pertinente., solicitar un cambio de registro (presentación) para cumplir con los requisitos. | ||
| Evaluación del impacto de los cambios en los insumos y productos., and modification.ofReview resultsand anyNecessary measuresofRecordShould be maintained(See4.2.5). | It meets the requirements of the regulations. | ||
| Design and development changesReviewIt should include evaluations.Modify product components and work-in-process or delivered | *5.10.3 | ||
| The impact on the product, and the evaluation changes.Risk ManagementInput/Output andProduct realizationThe impact of the process. | When selectedMaterials, parts, or product functionsChanges may affect medical device products.Safety and effectivenessWhen making changes, the potential consequences should be evaluated.riskTake measures to mitigate risks when necessary.Reduce to acceptableSubject to levelAt the same time, shouldCompliant with relevant regulationsThebeg. | ||
| 7.3.10 Design and development documents | none | Aunque los principios de inspección no enfatizan explícitamente el mantenimiento de la documentación de diseño y desarrollo para cada tipo o familia de dispositivos médicos en este capítulo., El proceso regulatorio real en China requiere…Debería cubrir todos los modelos de productos.. | |
| La organización debe mantener cada tipo de dispositivo médico o familia de máquinas médicas. Los documentos de diseño y desarrollo., Este documento debe incluir Incluir o citar para demostrar el cumplimiento de los requisitos de diseño y desarrollo. | |||
| Los registros resultantes, así como cambios de diseño y desarrolloRecord. | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| none | 5.11.1 | Aunque13485 El estilo no se definió claramente en un capítulo separado. Requisitos de gestión de riesgos, pero en la sección anterior “7.1”Planificación de la realización del producto” requiere claramente:”Durante el proceso de realización del producto., la organización debería…”One or more processes of risk management”Create a document”. | |
| Product implementation, including design and development, should be included.Throughout the entire process, the following was formulated.Risk ManagementThe requirements should be documented and relevant records maintained. | |||
| CheckRisk Management DocumentsandRecordAt least meet the following requirementsThe following requirements are made: | |||
| 1.Risk management should cover the realization of the products developed by the enterprise.The whole process; | |||
| 2.Documentation for risk management of medical devices should be established and relevant records should be maintained.RecordTo determine the certificate of implementationaccording to; | |||
| 3.The risks of medical device products should be controlled withinAcceptable level. | |||
| 7.4 purchase | 7.4.1 Procurement process | *6.1.1 | Los principios de inspección son más detallados dentro del proceso de adquisición. Requisitos para el contenido y la revisión de proveedores.. |
| Las organizaciones deberíanProcedimiento de documentación(Ver 4.2.4),medianteAsegurar que los productos adquiridosInformación de adquisiciones cumpla con los requisitosLas organizaciones deben establecer mecanismos de evaluación y selección.Directrices para proveedores,permitir | Se deben establecer procedimientos de control de adquisiciones.. | ||
| Entonces debería ser: | El proceso de adquisición debe incluir al menos lo siguiente:Procurement process, selección, evaluación y reevaluación de proveedores calificados, Requisitos para la inspección o verificación de los artículos adquiridos., registros de adquisicionesRequisitos. | ||
| a)Basado en el proveedorProporcionar productos que cumplan con los requisitos de la organizacióncapacidad; | *6.1.2 | ||
| b)Basado en el rendimiento del proveedor; | Es necesario garantizar la adquisición de bienesCumpleLos requisitos, y No menos de Disposiciones pertinentes de leyes y reglamentos y Fortaleza nacional Requisitos pertinentes de normas reglamentarias. | ||
| c)basado enEl impacto de la adquisición de productos en la calidad de los dispositivos médicos.; | 6.2.1 | ||
| d)Relacionado con dispositivos médicosriesgoConsistente. | deberíaBasado en el impacto de los artículos comprados en el producto,SeguroPara artículos comprados. Los métodos y el alcance del control. Examinar los métodos y el alcance del control implementado sobre los artículos adquiridos. De acuerdo con las regulaciones., Los métodos de control de verificación y el alcance pueden cumplir con los requisitos. Requisitos del producto. | ||
| Las organizaciones deben responder a la política de conducta de Vigilancia y Reevaluación de los proveedores. Plan de Proveedores cuyos productos adquiridos cumplan con los requisitos. Desempeño Se debe dar Vigilancia Los resultados de la vigilancia deben servir como base para el proveedor. [recurso/recurso].Aportes al proceso de reevaluación. | 6.3.1 | ||
| Debe indicarse los requisitos de adquisiciones no cumplidos y, en consecuencia, existen proveedores de productos que corresponden a los riesgos y en cumplimiento de los requisitos reglamentarios aplicables.. | Se debe establecer un sistema de auditoría de proveedores. Los proveedores deben ser auditados y evaluados.. Se deben realizar auditorías in situ cuando sea necesario.nuclear. | ||
| Evaluación de proveedoresResultados, selección, escucha, y reevaluaciónprecioRegistros o acciones tomadas como resultado de estas actividadescualquierMedidas necesariasSe deben mantener registros. | ¿Cumple con los requisitos??Directrices para la auditoría de proveedores de fabricantes de dispositivos médicosRequisitos. | ||
| (See4.2.5). | 6.3.2 | ||
| Cuando se retiene el resultado de la evaluación del proveedor y el registro del proceso de evaluación. | |||
| 7.4.2 Procurement Information | 6.5.1 | Sin diferencias significativas | |
| La información de adquisiciones debe describir o hacer referencia a los productos que se adquirirán., y, cuando corresponda, incluir: | al adquirir, La información sobre adquisiciones debe indicarse claramente y los detalles de la adquisición deben describirse claramente. Requisitos de compra, incluyendoCategorías de artículos comprados, criterios de aceptación,Presupuesto, procedimientos, y dibujosContenido como… | ||
| a)especificación del producto; | Verificar aleatoriamente la adquisición de artículos relevantes de la lista de adquisiciones.. | ||
| b)Directrices de aceptación del producto, procedimientos, procesos y equipos | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Requisitos; | Requisitos de compra, y confirmar si cumplen con los requisitos de esta cláusula. | ||
| c)Cualificaciones del personal del proveedorRequisitos; | 6.5.2 | ||
| d)Requisitos del sistema de gestión de calidad. | Se deben establecer registros de adquisiciones., incluyendo contrato de compra, lista de materias primas, documentos de calificación de proveedores, estándares de calidad, informes de inspección y criterios de aceptaciónesperar. | ||
| Antes de comunicarse con proveedores, la organización debe garantizar que…Regulations on procurement requirementsIt is sufficient and appropriate. | *6.5.3 | ||
| Where appropriate, any actions that affect the ability of purchased products to meet the prescribed procurement requirements.changeBefore implementation, procurement information should be…Includes a written agreementThe supplier shall inform you. | Procurement records should meet the following requirementsTraceableRequire. | ||
| Changes in the organization’s procurement of products. | *6.4.1 | ||
| according to7.5.9 RegulationsTraceabilityRequired process | Should be withMajor raw material suppliersSignQuality AssociationDiscussionClearly define the quality responsibilities undertaken by both parties. | ||
| The organization should use documents to determine the degree of organization.(Ver 4.2.4)and records(See4.2.5)To maintain relevant procurement information in a specific format. | |||
| 7.4.3 Verification of purchased products | 6.6.1 | 13485 Requisitos de verificación para productos compradosPor favor sea más específico. | |
| La organización debe establecer e implementar pruebas u otras actividades necesarias para garantizar que los productos cumplan con los requisitos de adquisición especificados. Actividades de verificación Alcance y extensión Deben basarse en los resultados de la evaluación del proveedor y la compra de productos riesgo Consistente. | Los artículos adquiridos deben ser inspeccionados. Inspección o verificación,asegúrese de cumplir con los requisitos de producción. | ||
| Cuando una organización tiene conocimiento de cualquier cambio en los productos que adquiere.…En ese tiempo, la organización debe determinar estos: ¿Afecta el cambio al proceso de realización del producto o al dispositivo médico??. | Consultar los artículos adquiridos. Registros de inspección o verificación.. | ||
| Cuando una organización o sus clientes pretenden utilizar el proveedorImplementación in situ | |||
| verificar en ese momento, the organization should include this in the procurement information.Proposed VerificationArrangementsandProduct release methodRegulations should be established. This should be maintained.verifyRecord(See4.2.5). | |||
| 7.5product Servicefor | 7.5.1 Control of production and service provision | *7.1.1 | 1)The inspection principles emphasize ensuring that products comply with mandatory standards and are registered.Or the product technology to be registeredbeg; |
| To ensure product compliance with regulations, [the following measures should be taken]Provision of production and servicesconductPlanning, implementation, monitoring and controlWhere appropriate, production control should include, but is not limited to, [the following].: | Production should be carried out in accordance with the established quality management system.Production to ensure product complianceMandatory standardsand registered or filedProduct Technical Requirements. | 2)The inspection principles emphasize the need to clearly identify key processes and special procedures; | |
| a)Used for production controlprogram/Method files | *7.2.1 | 3)The inspection principles have further refined the specific content of production records. | |
| (Ver 4.2.4); | Production should be preparedProcess specifications and work instructionswait,clearKey processesandSpecial process. | ||
| b)FoundInfrastructure; | Review relevant documents to see if key processes and special procedures are clearly defined, and whether there are provisions for verifying or confirming important parameters of key processes and special procedures. | ||
| c)derechoParámetros de procesoyCaracterísticas del productorealizarvigilanciaymedición; | 2.1.1 | ||
| d)Adquisición y usoDispositivo de vigilancia y medición; | Edificios e instalaciones de fábricaDebe ajustarse al productoRequisitos de producción. | ||
| e)De acuerdo con la normativa LabelandPackageoperate; | 5.2.1 | ||
| F)Liberar,entregaryDespués de la entregaImplementación de la actividad. La organización debe establecer y mantener [los procedimientos necesarios].Cada (o lote) de instrumento médico de registro(See4.2.5)para proporcionar7.5.9 medioRegulacionestrazabilidadRegistrar el alcance y extensión, e indicarCantidad de producciónyAprobado para la ventaLa cantidad.RegistroDebe pasar porValidación y aprobación. | 5.Determinar los requisitos técnicos del productoFormular, verificar, confirmarreconoceryActividades de producciónRequeridoDispositivo de medición; | ||
| *5.4.1 | |||
| 5.Normativas necesarias para la seguridad y buen uso del producto.. | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Características del producto, como productos Manual de instrucciones,Paquetey | |||
| Requisitos de etiquetado, etc.. Does the product instruction manual match the notes? | |||
| The registration application and approval are consistent. | |||
| 8.3.2 | |||
| Inspección entrante que requiere control de rutinaInspección del procesoy | |||
| En principio, Los elementos de inspección del producto terminado no deben subcontratarse.. | |||
| Pruebas. Para condiciones de prueba y equipos con altos requisitos., [lo siguiente es necesario]: | |||
| Para artículos que requieren subcontratación de pruebas, se puede contratar una agencia de pruebas calificada. | |||
| La agencia realiza inspecciones para demostrar que el producto cumple con las normas obligatorias.. | |||
| Estándares y tecnologías de productos registrados o archivados. | |||
| mendigar. | |||
| *8.5.1 | |||
| Se deben especificar los productosProcedimiento de liberación,lote de condición y liberación | |||
| Requisitos estándar. | |||
| Verifique el procedimiento de lanzamiento del producto para ver si el proceso de lanzamiento está claramente definido.. | |||
| Condiciones y requisitos para la aprobación de la liberación.. Se debe especificar la autoridad.. | |||
| Se debe proteger al personal autorizado para liberar productos y sus responsabilidades y autoridad.. | |||
| Mantener registros aprobados. | |||
| *9.1.1 | |||
| Los productos deben establecerseVentaRegistro y satisfacerTrazable | |||
| Requerir | |||
| 9.3.1 | |||
| Debe poseer las capacidades necesarias y adecuadas a los productos que produce. Servicio postventa | |||
| Capacidades de servicioEstablecer y mejorar el sistema de servicio postventa.. | |||
| *7.6.1 | |||
| Cada lote (unidades) de productosTodos deben tener registros de producción,y | |||
| satisfacer los requisitos rastreables. | |||
| 7.6.2 | |||
| Registros de producción Debe incluir:Nombre del producto, Presupuesto | |||
| Número, número de lote de materia prima, número de lote de producción o número de producto | |||
| fecha de producción, cantidad, equipo principal, parámetros del proceso, | |||
| Operadores, etc.contenido. | |||
| *8.4.1 | |||
| Cada lote (unidades) de productosTodos deben tenerRegistro de inspección de lotes, | |||
| y satisfacerTraceableRequire. | |||
| 7.5.2 Limpieza del producto | 7.3.1 | 13485 Más detalles sobre qué situaciones requieren | |
| La organización debe hacer que el producto sea limpio o controle la contaminación del producto. | Durante el proceso de producción, es necesario…Materias primas, productos intermedios, etc.. | Product cleaning or product contamination control requirements | |
| RequireCreate document,if: | conductcleanThose that are handled should be clearly defined.Cleaning methodsand | Please create a document. | |
| a) existSterilization and/or before useProducts manufactured by the organization | Requireand toCleaning effectconductverify. | ||
| clean; | |||
| b) byNon-sterile formProvided and inSterilization or | |||
| Cleaning should be performed first.Products; | |||
| c)existProducts that cannot be sterilized or cleaned before use | |||
| Taste,Clean during use.yesImportantof; | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| d)byNon-sterile formThe products provided, theirCleaning is essential.of; | |||
| e)From the product during the manufacturing processRemove processing aidsAgent. | |||
| If the product is as described abovea)orb)If cleaning is required, then before cleaning treatment.No need to satisfy6.4.1Require. | |||
| 7.5.3 Installation activities | 9.4.1 | No major differences, inspection principles are slightly more detailedSpecific requirements for installation and maintenance by the user or other enterprise. | |
| When appropriate, the organization should include medical devicesInstallandInstallation Verification Acceptance CriteriaThe requirements are documented. | Need to beEnterprise installationMedical devices should be determinedInstallRequirements andInstallation verificationofAcceptance Standard,EstablishInstallandAcceptance Record. | ||
| If the customer requests permission, except…organization orOther than its suppliersofExternal installation of medical deviceshour, | 9.4.2 | ||
| The organization should handle the installation and installation verification of medical devices.Provide documented requirements. | Depend onUser unitorOther companiesFor installation and repair, the following should be provided:Installation requirements, estándares, maintenance parts, documentation, passwords, etc.and conductguide. | ||
| It should be maintained that the work is done by the organization or its supplier.Installand | |||
| Verification records(See4.2.5). | |||
| 7.5.4 Service Activities | 9.3.1 | 13485 The service records have been further refined.Requirements for tolerance. | |
| Where service requirements are specified, and when necessary,Organizations should establish [equipment/systems] forService provision activitiesandverifyDocumentation confirming whether the service meets the specified requirements.ofProcedures and Reference MaterialsandMeasurement Procedure. | It should possess the necessary capabilities appropriate to the products it produces.After-sales serviceService capabilitiesEstablish and improveAfter-sales service system. | ||
| The organization should analyzeThe organization or its suppliersImplement service activities | 9.3.2 | ||
| movingRecord: | debeRequisitos de servicio posventayEstablecer registros de servicio de servicio posventay satisfacerRequisitos rastreables. | ||
| a)Determinar si la información se utiliza como se manejan las quejas.; | |||
| b)When appropriate,Como proceso de mejora entramos. Debe mantenerse La organización o sus proveedores Las actividades de servicio realizadas En movimiento Registro(See4.2.5). | |||
| 7.5.5 Requisitos específicos para dispositivos médicos estériles | 《Guía GMP para la inspección in situ de dispositivos médicos estériles, pero”: | 1)Sin diferencias significativas. Se encuentran disponibles requisitos específicos detallados para dispositivos médicos estériles. Consulte”GMP Dispositivos médicos estérilesRegulaciones pertinentes, documentos, y estándares, como el “Directrices para la inspección in situ”; | |
| La organización debe mantener el registro de los parámetros del proceso de esterilización de cada lote de esterilización.(See4.2.5),Registro de esterilizaciónRespuestaRastreablellegarDispositivos médicosCada lote de producción. | 7.21.1 | 2)《Dispositivos médicos estériles GMPEl “Directrices para la inspección in situ” perfecciona aún más los documentos de control del proceso de esterilización.. | |
| Es necesario formular documentos de control del proceso de esterilización.,MantenerCada lote de esterilizaciónSe deben registrar los parámetros del proceso de esterilización., y el registro de esterilización debe ser…TrazableAl productoCada lote de producción. | |||
| 7.5.6Validación del proceso de producción y prestación de servicios. | 7.5.1 | 13485 La confirmación del proceso se ha perfeccionado aún más.Requerir. | |
| Las organizaciones deben identificar los resultados de sus procesos de producción y prestación de servicios. No se pueden seguir o no. Monitoreo o medición continuos para verificar el proceso., porque | La producción debe ser un proceso especialconductaconfirmar, y guardarRegistrar,incluirConfirmar el plan, metodos, operadores, evaluación de resultados, y reconfirmación.contenido. | ||
| Por lo tanto, el defecto ocurre durante el uso del producto o después de la prestación del servicio. | 7.5.2 | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Sólo se hará evidente más tarde.. | Utilizado en el proceso de producción Software informático para productos La calidad se ve afectada Sí, se debe realizarVerificar o confirmar. | ||
| confirmarDebería poder demostrar la capacidad de estos procesos para lograr consistentemente los resultados planificados.. | |||
| La organización debe incluir el documento del procedimiento de confirmación del proceso.,Bolsa incluida: | |||
| a)para la revisión del proceso y las estipulaciones de aprobación de permitir pero; | |||
| b)Equipos de Identificación y Cualificaciones del Personal; | |||
| c)Utilice un método específico,programa y criterios de aceptación; | |||
| d)When appropriate, Determinar técnicas y principios estadísticos utilizados en el muestreo.; | |||
| e)Requisitos de registro(See4.2.5); | |||
| F)Confirmar nuevamenteIncluyendo reconfirmaciónPautas; | |||
| gramo)Proceso de cambio de aprobación. | |||
| Las organizaciones deben asignar fondos para la producción y la prestación de servicios. Software informático de confirm Esto crea un procedimiento documentado. La verificación del software debe realizarse dentro de Confirm antes del primer uso.,apropiado en este momento, hereSoftware changesorAfter applicationWith softItemconfirmandConfirm againofSpecific methodsandActivityanswerRelated to the application of this softwareriskConsistent, includingImpact on product compliance capability. | |||
| The necessity of confirmationmeasureand confirmedresultandin conclusion | |||
| ofRecordIt should be maintained(See4.2.4 and4.2.5). | |||
| 7.5.7 Process validation of sterilization and aseptic barrier systemsSpecial requirements | 《Guía GMP para la inspección in situ de dispositivos médicos estériles, pero”: | 1)13485Specific sterilization methods were mentioned.The process of aseptic barrier systemFor specific requirements, please refer to the relevant documentation.ISO11607-1 andISO 11607-2; | |
| The organization shouldsterilizationandsterile barrier systemofprocessconfirmThe program forms a file(Ver 4.2.4). | 7.20.1 | 2)Other related to sterile medical devicesFor specific requirements, please refer to the document.GMP noneGuidance on on-site inspection of medical devicesin principle”. | |
| Where appropriate, the sterilization process and aseptic barrier system should be implemented.Before implementationas well asBefore subsequent product or process changesgo throughconfirm. | Sterilization of sterile medical devices should be established.The process is verified and documented.. | ||
| confirmresultandin conclusionAnd the measures taken as confirmed | Check the sterilization process confirmation procedure documents to see if they conform to…Meets the requirements. | ||
| Necessary measuresRecords should be kept.(See4.2.4 and | *7.20.2 | ||
| 4.2.5). | The sterilization process should be carried out in accordance with relevant standards.Before the first implementationconductconfirmWhen necessaryConfirm again,andMaintain a record of the sterilization process confirmation. | ||
| Nota: Further information can be found at [link/reference].ISO 11607-1 andISO 11607-2. | existFirst timeBefore sterilizing the product, is the sterilization process monitored?confirm.existProducts, equipo de esterilización, process parameterswaitWhen changes occurShould the sterilization process be carried out?Confirm again. | ||
| Validation of sterilization or aseptic processing proceduresComplies with relevant standards,likeGB18278~GB18280Sterilization Validation and Routine of Medical and Healthcare ProductsRegulation and control requirementsWhether the record or report has been reviewed and approved. | |||
| If aseptic processing technology is used to ensure the sterility of the product, then… | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Whether or not in accordance with relevant standards, such asYY/T0567″medicalAseptic processing of therapeutic productsPerformedProcess simulation testTest. | |||
| Has the sterilization process been maintained?Record. | |||
| Sterilization confirmation was used to determine the quality of the initial packaging and the product.Initial contaminant bacteriaandacceptable levels of particulate pollution. | |||
| 7.5.8 logo | 7.7.1 | 13485Se enfatizó que si se aplican las regulaciones aplicables. Los requisitos estipulan que las organizaciones deben asignar equipos médicos. Documentación sistemática para la identificación única de dispositivos mecánicos.;Y sólo en el GMPIdispositivos médicos implantablesEl “Directrices para la inspección in situ” menciona la unicidad.Logotipo. | |
| La organización debe identificar el producto de la documentación del programa.,yUtilizado durante todo el proceso de realización del productoMétodos apropiadosIdentificar el producto. | Se deben establecer programas de control de identificación de los productos.,usoMétodos apropiadosLos productos deben etiquetarse con fines de identificación para evitar el mal uso y la confusión.. | ||
| En la implementación del productoTodo el procesoEn China, la organización debería, de acuerdo aMonitoreo y mediciónRequisitosIdentificar el estado del productoEn todo el productoProducción, almacenamiento, e instalación y servicio durante el proceso,MantenerProductosIndicador de estadoPara garantizar que solo aquellos que pasanLas inspecciones y pruebas necesarias o las concesiones autorizadas están bienSolo los productos pueden serEnviar, usar o instalarSi hayRequisitos regulatorios aplicablesLas regulaciones estipulan que las organizaciones deben responder.Sistema para asignar identificadores únicos a dispositivos médicosFormación de texto | *7.8.1 | ||
| Artículo. | Los productos deben etiquetarse durante el proceso de producción. Estado de inspección,Prevenir el flujo de productos intermedios de calidad inferior a la secuencia de procesos posteriores.. | ||
| Las organizaciones deben establecer procedimientos documentados para garantizarRegreso a la organizaciónTodos los dispositivos médicos pueden serIdentificaciónY pueden ser conDistinguir productos calificados. | Verificar si existen regulaciones sobre el método de marcar el estado de inspección., e inspeccionar las marcas de estado de inspección en el proceso de producción en el sitio para ver si cumplen con las regulaciones. | ||
| *7.9.1 | |||
| Se debe establecer el productoTrazabilidadProcedimientos, regulaciones para la producciónAlcance y alcance de la trazabilidad del productologotipoY registros necesarios. | |||
| 《Guía de inspección in situ GMP para dispositivos médicos implantablesen principio”: | |||
| *7.22.1 | |||
| Se debe establecer y documentar un procedimiento de trazabilidad., especificando el alcance y extensión de la trazabilidad de los dispositivos médicos implantables. Identificador único y los registros requeridos. | |||
| Consultar los documentos del procedimiento de trazabilidad para ver si especifican el alcance., medida, identificación única, y registros requeridos para la trazabilidad de dispositivos médicos implantables. | |||
| 7.5.9Trazabilidad | *7.9.1 | none | |
| 7.5.9.1Principios generales | Se debe establecer el productoProcedimientos de trazabilidadReglamento de producciónSaborÁmbito, medida, identificación, and necessary records of traceability. | ||
| The organization shouldTraceability proceduresThese procedures should be documented and specified to conform toApplicable regulatory requirementsofCan Scope of traceability, proceduresand placeRecords maintained, | |||
| (See4.2.5). | |||
| 7.5.9.2Specific requirements for implantable medical devices | 《Guía de inspección in situ GMP para dispositivos médicos implantablesen principio”: | none | |
| The records required for traceability should include, but are not limited to, those that may be necessary.guideMedical devices that fail to meet their safety and reliability requirementsCan be requiredofComponents, materials and working environmentenvironmental conditionsThe record. | 7.22.1 | ||
| The organization should requireResale serviceSuppliers or distributors maintainMedical device distribution recordsso thatTracingWhen inspect | When specifying traceability requirements for records, it should includeIncluding the possibility of finalThe product does not meet its specifications.The required raw materials, production equipment, and operatorsPersonnel and production environmentRecords, etc.. | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| This record can be obtained when needed. | Check the product’s labeling, production records, and inspection records to see if the raw materials, production equipment, operadores, and production environment used in the product’s production can be traced.content. | ||
| Freight Packaging RecipientofnameandaddressRecordsIt should be maintained(See4.2.5). | 9.6.1 | ||
| It should be required thatAgents or distributorssaveMedical device distribution recordsso thatTracing. | |||
| 9.6.2 | |||
| Should be preservedFreight Packaging RecipientofnameandaddressThe record. | |||
| 7.5.10 Customer property | none | The inspection principles do not emphasize customers in a separate chapter.Property requirements. | |
| whenCustomer propertyUnder the organization’s control or use, the organization shall identify, verificar, protect, and maintain the resources available to it.Used or constitutes part of the productCustomer property. | |||
| ifCustomer materialsoccurLost, damaged, or found to be unsuitableAt that time, shouldReport to CustomersAnd keep records. | |||
| (See4.2.5). | |||
| 7.5.11 Product Protection | 7.11.1 | The inspection principles have been further refined to include protective equipment.Physical requirements. | |
| existProcessing, almacenamiento, treatment and saleIn this process, organizations document protective procedures to ensure that products meet requirements.ProtectionApplicable to medical devicesComponentsDuring processing, almacenamiento, handling, and distribution, when the product is exposed to…Expected situation and harmAt that time, the organization should pass through | Se deben establecer productosProtecciónEl procedimiento especifica los requisitos de protección para los productos y sus componentes., incluyendoProtección contra la contaminación, protección electrostática, protección contra el polvo, protección contra la corrosión, protección del transporte, etc.Requisitos. La protección debe incluir…Etiquetado, transporte,Embalaje, almacenamiento y protecciónesperar. | ||
| Proteja su producto de las siguientes manerasEvite alteraciones, contaminación, o | Inspección in situ para verificar si los procedimientos de protección del producto cumplen con los requisitos de las especificaciones.; Inspección in situ y verificaciones aleatorias de los registros relevantes para confirmar que la protección del producto cumple con los requisitos.. | ||
| daño: | |||
| a)Diseño y construcciónEmbalaje adecuado e instrumento de capacidad de carga.; | |||
| b)Si el embalaje por sí solo no puede proporcionar protección, entonces se deben tomar las medidas necesarias. Las condiciones especiales requieren documentación.. | |||
| If there are special requirements, then it should be…controlandremember | |||
| record(See4.2.5). | |||
| 7.6Surveillanceand measurement equipmentEquipment control | The organization should determineMonitoring and measurementAnd the necessary monitoring and measurementDeviceTo ensure that the product meets the specified requirementsProvide evidence. | *3.3.1 | 1)The inspection principles have further refined the requirements for the content of the usage records of inspection instruments and equipment; |
| The organization shouldProgram documentationTo ensure surveillance andMeasurement activities are feasible and require monitoring and measurement.begConsistentImplemented in this manner. | It should be equipped withProduct inspection requirements are compatibleofInspectionTesting instrumentsandequipmentThe main testing instruments and equipment shouldWhen haveClear operating procedures. | 2)Los principios de inspección enfatizan los instrumentos de mediciónRequisitos; | |
| Para garantizar la validez de los resultados., el equipo de medición debe, cuando sea necesario, incluir: | Verificar si la empresa posee el equipo de prueba relevante comparándolo con los requisitos y métodos de inspección del producto.. Verificar si se han establecido procedimientos operativos para el equipo de prueba principal.. | 3)13485Se enfatizó que la comparación puede rastrear la fuente. A la medición estándar internacional y/o nacional Estándar de cantidad. | |
| a)La comparación puede remontarse aEstándares internacionales y/o nacionalesEstándares de medición,de acuerdo aIntervalo de tiempo especificadoOAntes de usarconductaCalibración o verificación. | 3.4.1 | ||
| Si los estándares anteriores no están disponibles, La calibración o inspección debe registrarse.. | Testing instruments and equipment should be established.Usage RecordsThe record should includeUse, calibration, and maintenanceandrepairwaitCondition. | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| The basis for determination(See4.2.5); | 3.5.1 | ||
| b)conductAdjustmentor if necessaryreadjust; suchAdjustments or further adjustments should be madeRecord(See4.2.5); | Appropriate equipment should be providedMeasuring instrumentsMeasuring instrumentsMeasuring range and accuracyshouldMeets usage requirementsMeasuring instruments shall be marked with their…Calibration validity periodSave the corresponding recordrecord. | ||
| c)getlogo,byDetermine its calibration statusstate; | Check the calibration records of the measuring instruments to determine if they are being used within their validity period. | ||
| d)To prevent measurement results from becoming invalidofAdjustment; | 8.1.1 | ||
| e)existTransportation and maintenanceandStorageperiodPrevent damageor failure. | It should be establishedQuality control proceduresRegulations for productsInspection departments, personnel, operations, etc.Require. | ||
| The organization should perform calibration or verification in accordance with the documented procedures. | Check the quality control procedures to see if they specify the responsibilities of the product inspection department, personnel qualifications, and inspection operating procedures. | ||
| In addition, whenThe equipment was found to be non-compliant.At that time, the organization | 8.1.2 | ||
| Addressing previous measurement resultsValidityconductevaluateandRecord. | It should be stipulatedTesting instrumentsandequipmentofUse, CalibrationRequirements, and procedures for product release. | ||
| The organization should take appropriate measures regarding the equipment and any affected products.measure. | Check the quality control procedures to see if they specify the use and calibration of testing instruments and equipment. | ||
| Records of calibration and verification results should be maintained.(See | 8.2.1 | ||
| 4.2.5). | shouldregularTest instruments and equipmentcalibrationorInspectionand givelogo. | ||
| Organizational response toMonitoring and measurement requirementsofcomputersoftwareThe application confirmation process is documented. This type of…The software should be available for initial use.Confirm before use.,appropriateAt that time, in this type of softwareAfter changes or during applicationConfirm | Check whether the testing instruments and equipment have been calibrated or verified as required and whether they have been labeled.8.2.2 | ||
| recognize. | It should be stipulated that testing instruments and equipment are subject to…Transportation, maintenance | ||
| The specific methods and activities related to software verification and re-verification should be aligned with the risks associated with software use.This includes the impact on the product’s ability to conform to specifications.Internal risks. | During protection and storageProtection requirements,Preventing inspection resultsIf inaccurate. | ||
| Results and confirmed conclusions, and measures taken as a result of confirmation.Records of necessary measures should be kept.(See4.2.4and4.2.5). | 8.2.3 | ||
| Nota: Further information can be found at [link/reference].ISO 10012. | whenThe testing instruments and equipment were found to be non-compliant.At that time, previous test results should be reviewed.evaluate, and saveVerification records. | ||
| Revise los registros de uso y mantenimiento del equipo para ver si se evaluaron los resultados de las pruebas anteriores y se mantuvieron registros relevantes cuando los instrumentos y equipos de prueba no cumplieron con los requisitos.. | |||
| 8.2.4 | |||
| Para usopruebadeSoftware de computadoraSe debe realizarConfirmarreconocer. | |||
| 8 PruebaCuantificación, análisis y mejora | La organización debe planificar e implementar los siguientes aspectos según sea necesarioMonitoreo, medición, analizar y mejorar procesos: | *11.2.1 | Los principios de inspección se han perfeccionado aún más para mejorar el sistema de seguimiento. Requisitos específicos. |
| 8.1 | a)Confirmar la conformidad del producto; | Los dispositivos médicos deben establecerse de acuerdo con las regulaciones pertinentes. Sistema de monitoreo de eventos adversos Realizar eventos adversos Monitoreo y reevaluación Trabajo, mantener registro relevante. | |
| Principios generales | b)Confirmar el Sistema de Gestión de Calidad de Cumplimiento; | Ver los eventos adversos establecidos por la empresa. Sistema de monitoreo, | |
| c)Mantener el sistema de gestión de calidadValidez. | ¿Está estipulado??Personal de gestión de eventos adversos sospechosos | ||
| Esto debería incluir [the following]Técnicas estadísticas que incluyen métodos apropiados | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| yNivel de aplicaciónLa determinación. | Responsabilidades, principios de presentación de informes, procedimientos de presentación de informes, y plazos de presentación de informes,Formular un plan para el lanzamiento e implementación de dispositivos médicosReevaluaciónEl proceso Orden y expedientes, etc., y símbolosRequisitos de cumplimientoRevisar los registros relevantes para confirmar si ha ocurrido algún evento adverso, e implementar los procedimientos requeridos en consecuencia. | ||
| 11.3.1 | |||
| Debe establecersePrograma de análisis de datosRecopilación y análisisRelacionado con la calidad del producto., eventos adversos, comentarios de los clientes, and the operation of the quality management system.Data verificationProduct safetyandValidityAnd keep relevant records. | |||
| Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded. | |||
| 8.2 | 8.2.1 feedback | 9.5.1 | Sin diferencias significativas |
| Monitoring and measurementquantity | As a measure of the performance of the quality management system, the organization should address the relevant organizational…Have the customer’s needs been met? begInformation should be collected and monitored.Methods of acquiring and utilizing this informationCreate a document. | It should be establishedCustomer feedback handling procedureTo process customer feedback informationTracking analysis. | |
| The organization shouldFeedback systemThe program forms a file. ThisSuch a feedback process should include collecting feedback from…Productionand post-production activity dataAccording to the regulations. | Check whether the program documentation specifies the implementation of the above activities and whether customer feedback information is tracked and analyzed. | ||
| The information collected during the feedback process should be able to provideMonitoring and maintaining product requirementsand providing product realization or improvement processesRisk Management PotentialInput. | 11.3.1 | ||
| ifApplicable regulations requireThe organization received fromProductionPost-activity specific experienceThe review of this experience should constitute | A data analysis procedure should be established to collect and analyze data related to product quality, eventos adversos, yComentarios de los clientesDatos relacionados con el funcionamiento del sistema de gestión de calidad, verificaciónSeguridad y eficacia del productoY mantener registros relevantes. | ||
| Se convierte en parte del proceso de retroalimentación.. | Revisar los registros de implementación del análisis de datos para ver si se llevó a cabo de acuerdo con los procedimientos prescritos., si se aplicaron técnicas estadísticas, y si se conservaron registros de los resultados del análisis de datos. | ||
| 8.2.2 Manejo de quejas | 11.1.1 | 13485 Refinar aún más los procedimientos de manejo de quejas. Requisitos y responsabilidades específicos.. | |
| La organización debe basar sus decisiones en las leyes y regulaciones aplicables. Requiere un manejo oportuno. El procedimiento de queja está documentado.. | Se deben designar departamentos pertinentes para que sean responsables de recibir, investigando, evaluando, and processing the information.Customer complaintsand maintain relevantRecordReview relevant documents regarding responsibilities and authority to determine if the above activities are stipulated. | ||
| These programs should include at least the followingRequirements and Responsibilities: | 11.4.1 | ||
| a)Receive and record information; | It should be establishedCorrective action proceduresTo determine the cause of the problem, effective measures should be taken to prevent the problem from recurring. | ||
| b)Evaluation information to determine whether feedback constitutes a voteLawsuit; | |||
| c)Investigate complaints; | |||
| d)SureReport the information to the appropriate regulatory authorities.demand; | |||
| e)Processing andComplaints about related products; | |||
| F)Determined to carry outThe need for correction or corrective action.ifThe complaint was not investigated.The reasons for such actions should be documented. Any corrections arising from the complaint handling process… | |||
| Or corrective measures should be documented. | |||
| If the investigation confirmsComplaints are activities outside the organization | |||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| ToThe relevant information should be inOrganizations and relevant external partiesInterchange. | |||
| Complaint handling recordShould be maintained(See | |||
| 4.2.5). | |||
| 8.2.3 Report to regulatory agencies | *11.5.1 | Sin diferencias significativas | |
| Complaints that comply with the prescribed adverse event reporting guidelines are required by applicable regulations.Issue notices or advisory noticesThe organization shouldNotify appropriate supervisionDocumented procedures of the organization. | For medical devices that pose safety hazards, they should be handled in accordance with relevant regulations.Regulations require measures such as recalls.Measures, and in accordance with regulations, toReport from relevant departments. | ||
| Reporting regulatory agency recordsShould be maintained | 11.6.1 | ||
| (See4.2.5). | Products should be establishedInformation notification procedurePromptly deliverTasteChanges, UseWaiting for supplementary information notificationUser unit, related enterprise or consumer. | ||
| 8.2.4 Internal audit | 11.7.1 | 13485The selection of auditors and the implementation of audits should be clearly defined to ensure the audit process is effective.Objectivity and impartiality; auditors should not auditCheck your own work. | |
| The organization should follow the plan.Time intervalconductInternal auditTo determine whether the quality management system is: | An internal audit procedure for the quality management system should be established, stipulating…The audit criteria, scope, frequency, participants, metodos, record requirements, and assessment of the effectiveness of corrective and preventive actions.This includes ensuring that the quality management system complies with…This specificationRequirements. | ||
| a)conform toPlanning and documented arrangements,This standardRequirements and the organization’s establishedQuality Management SystemRequirements andApplicable laws and regulationsRequire; | Check whether the internal audit process includes the above.Content. Review internal audit documents.Personnel conducting internal auditsyesnoAfter training,Internal audit recordsDoes it meet the requirements?Request: Have any measures been taken regarding the issues identified in the internal audit?correctPositive measures,whetherefficient. | ||
| b)getImplementación y mantenimiento efectivos. | |||
| La organización debe documentar los procedimientos para describirlos. Planificación, revisión de implementación, y reportar los resultados de la revisiónDeberes yRequerimientos. | |||
| El programa de auditoría debe planificarse teniendo en cuenta el estado y la importancia de las áreas y procesos a auditar., así como los resultados de auditorías anteriores. Los procedimientos de auditoría deben definirse y documentarse. Directrices Alcance, Intervalo y método(See4.2.5)AuditorLa selección e implementación de auditorías debe garantizar que el proceso de auditoría sea…Objetividad e imparcialidad. Los auditores no deben auditarse a sí mismos. | |||
| mi trabajo. | |||
| Registros de la auditoría y sus resultados., incluyendoIdentificación del procesoyÁrea auditadayen conclusiónSe debe realizar un registroMantener.(See4.2.5). | |||
| ResponsibleManagers of the audited areaAny necessary actions should be taken in a timely manner.Correction and corrective actionsTo eliminateThe identified nonconformities and their causes. Follow-up activities should…Including the measures takenVerification and verification resultsReport. | |||
| Nota: Further information can be found at [link/reference].ISO 19011. | |||
| 8.2.5 Process monitoring and measurement | 8.3.2 | 13485Emphasizing that when the planned goals are not achievedAs a result, corrective measures should be taken where appropriate.Corrective measures. | |
| Organizations should adopt appropriate methods toQuality Management SystemSystem processconductSurveillanceWhen appropriate, quality managementSystem processMeasurementThese methods should be verified.Pass | Incoming inspection that requires routine controlProcess inspectionIn principle, finished product inspection items should not be outsourced for inspection. For inspections with high requirements for conditions and equipment, it is advisable to… | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Cheng’s ability to achieve the planned results.whenThe planned results were not achieved.When appropriate, measures should be taken.Correction and corrective actions. | For items requiring commissioned testing, a qualified institution can be commissioned to conduct the testing to prove that the product meets mandatory standards and the registered or filed product technical requirements.beg. | ||
| 8.4.2 | |||
| Inspection records should include incoming inspection,Process inspectionInspection records, inspection reports or certificates for finished products.Books, etc.. | |||
| 8.2.6 Product monitoring and measurement | *8.3.1 | 1)The inspection principles clarify that product technical requirements should be formulated in accordance with mandatory standards and registered or filed product technical requirements to develop product inspection procedures; | |
| Organizations should monitor and measure the characteristics of products to verify them.Product requirements have been met.Such monitoring and measurement should be based on the planned, documented arrangements and procedures during the product realization process.suitable | According toMandatory standardsand those that are registered or filedProduct Technical RequirementsDevelop product inspection procedures and issue corresponding certificates.Inspection report or certificate.checkCheck whether the product inspection procedures cover mandatory standards.In addition to verifying the performance indicators of the registered or filed product technical requirements; confirming whether the inspection records can prove that the product meets the requirements; and checking whether the corresponding inspection reports or certificates have been issued in accordance with the inspection procedures and inspection results.. | 2)The inspection principles have further refined the inspection requirements for the products; | |
| At this stageconduct. | 8.3.2 | ||
| Should maintain complianceAcceptance CriteriaEvidence.Identification of personnel authorized to release productsIt should be recorded.(See | Requires routine controlIncoming inspection, process inspectionandFinished product inspectionProject in principleOutsourcing inspections is not allowed.TestFor testing conditions and equipment with high requirements,Para artículos que requieren subcontratación de pruebas, a qualified testing agency can be commissioned.The agency conducts inspections to prove that the product complies with mandatory standards.Standards and technical requirements for registered or filed products. | 3)Although13485not yetThis section emphasizes that each batch (unit) of products should have a batch inspection record. Record and meet traceability requirements.But in the previous section “7.5.1 Production and | |
| 4.2.5)Where appropriate, records should identify the activities used to conduct the measurement.Test equipment. | *8.4.1 | la frase “control sobre la prestación de servicios” se menciona. | |
| Sólo cuando se hayan completado con éxito los arreglos planificados y documentados Sólo cuando se hayan completado Lanzamiento de productos y servicios de entrega. Para dispositivos médicos implantables La organización debe mantener registros de las pruebas y de la identidad del personal de pruebas.. | Cada lote (unidades)Todos los productos deben tener un registro de inspección de lotes y satisfacer el requisito de seguimiento. | 4)Los requisitos pertinentes para los dispositivos médicos implantables deben consultarse. | |
| 8.4.2 | 《GMP Dispositivos médicos implantablesDirectrices de inspección in situ. | ||
| Los registros de inspección deben incluir la entrada…inspección de mercancías, inspección de procesos e inspección de productos terminadosTestRecords, informes o certificados de inspecciónLibros, etc.. | |||
| 《Principios rectores de inspección in situ de dispositivos médicos implantables GMP: | |||
| *1.5.2 | |||
| Debe contar con la correspondiente agencia de inspección de calidad o inspectores de tiempo completo.. | |||
| Check the organizational chart, departmental responsibilities, and personnel appointment documents to confirm whether they meet the requirements. | |||
| 8.3 | 8.3.1 Principios generales | 10.1.1 | Sin diferencias significativas |
| Non-conforming productscontrol | The organization should ensureProducts that do not meet product requirementshave toarriveIdentificationandcontrolTo prevent itUnexpectedUse | It should be establishedNon-conforming product control proceduresThe regulations are not in complianceQuality controlResponsibilities and authority of departments and personnel. | |
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Or delivery. The organization shall stipulate.Non-conforming product controland regulationsNon-conforming product identification, documentation, isolation,evaluateandDisposal of substandard productsRelevant duties and authorities The program forms a file. | *10.2.1 | ||
| Unsatisfactory evaluationIt should include decisionsThe need to conduct an investigationand notification regarding thisAny external party responsible for non-compliance. | Non-conforming products should be inspected.Identification, recording, isolation,ReviewBased on the review results, appropriate measures should be taken against non-conforming products.Disposal measures. | ||
| Should be maintainedNon-conforming natureAnd subsequentlyTake anyWhat measuresRecords, includingEvaluation, any surveyandRecord of the reasons for the decision(See4.2.5). | On-site inspections were conducted to verify whether the labeling and isolation of non-conforming products complied with the procedural documents, and random checks were performed on the non-conforming product handling records to ensure that the review was conducted in accordance with the document requirements. | ||
| 8.3.2Response measures for non-conforming products before delivery | *8.5.1 | 13485 More detailed pre-delivery non-conformitiesProduct response measures. | |
| Shi | Se deben especificar los productosProcedimiento de liberación,conditionandRelease batchStandard requirements. | ||
| The organization should follow the followingOne or moreThe method of handling is notqualified products: | Verifique el procedimiento de lanzamiento del producto para ver si el proceso de lanzamiento está claramente definido.. | ||
| a)takeMeasures to eliminate identified nonconformities; | Conditions and release approval requirements. The regulations should specify the conditions for releasing products.Personnel and their duties and authorityand should maintainapproveThe record. | ||
| b)Take measuresTo prevent its original intended use or shoulduse; | 8.5.2 | ||
| c)Authorization to use concessions,ReleaseorAccepting unqualifiedTaste. | The released products should be accompanied byCertificate of Conformity. | ||
| The organization should ensure that non-conforming products are only produced after they have been supplied.combinereason,ApprovedandTo meet applicable regulationsbegIt can only be implemented under certain circumstances.Concession Acceptance. | |||
| Concession Acceptance and Authorization of ConcessionsPersonnel identification records | |||
| It should be maintained(See4.2.5). | |||
| none | *9.1.1 | 1)13485Not separatelyCheng Zhang emphasized the requirements of sales, onlyIn the7.2.3 The communication chapter mentionsSome terms; | |
| Products should be establishedSales recordsand satisfyTraceableRequire. | 2)Direct within ChinaSelling self-produced products or choosing medical device distributors must also comply with the requirements of the “Administrative Measures for the Operation of Medical Devices” and the “Good Manufacturing Practice for Medical Devices”. | ||
| 9.1.2 | |||
| Sales records should include at least:Medical device nameName, specifications, model, cantidad, production batch number, and availability. | |||
| Expiry date, sales date, name and address of the purchasing unit,Contact information, etc.contenido. | |||
| 9.2.1 | |||
| Direct sales of self-produced productsOr chooseMedical device distribution companiesIt should comply withMedical device related regulations and standards. | |||
| 9.2.2 | |||
| Medical device distributors were found to haveillegal and irregular Business activitiesAt that time, it should be reported toReport from the local food and drug administration department. | |||
| 8.3.3Response measures for non-conforming products after delivery | 10.3.1 | 13485 The definition of advisory notices has been clarified. | |
| Shi | In productsAfter saleDiscover ProductsUnqualifiedAt that time, it should be done promptly. | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| whenAfter delivery or commencement of useWhen nonconforming products are discovered, the organization should take measures appropriate to the impact or potential impact of the nonconformity.Take measuresThe records should beTo maintain(See4.2.5). | Tomar medidas en el momentoMedidas correspondientes,me gustarecordar, Destrucción Medidas como la inspección in situ de los productos. Cuando se encuentran defectos después de la venta. | ||
| La organización debe Cumplir con los requisitos reglamentarios aplicables Publicado de Consejos El programa forma un archivo Estos procesos El procedimiento debe ser fácilmente implementable. Esto difiere de emitir avisos de aviso.. | deMedidas de eliminación,ya seaRetiro y Destrucciónesperar. | ||
| Registro de medidas cerradas. Debe mantenerse.(See4.2.5). | |||
| 8.3.4 Rehacer | 10.4.1 | Los principios de inspección establecen claramente que los elementos que no se pueden reelaborar deben…Cuando se establezcan los sistemas de manipulación pertinentes. | |
| Teniendo en cuenta los posibles efectos adversos del retrabajo en el producto, considere,La organización debe basarse enProcedimientos documentadosImplementaciónRetrabajoEstos (rehacer) Los procedimientos deben pasar por los mismos que el programa original de revisión y aprobación.. | Defective products canReworkYes, enterprises should preparereturnWork control documentsRework control documentation should include…doIndustry guidelines, re-inspection and re-verification, etc.contenido. | ||
| After rework, the product should undergo…verifyEnsure itsComplies with applicable acceptance criteria and regulatory requirements.. | Check the rework control documents to see if any rework is permitted.Regulations on non-conforming productsRandomly check rework activity records to confirm whether they comply with the requirements of the rework control documents. | ||
| Rework should be maintainedRecord(See4.2.5). | 10.4.2 | ||
| No reworkYes, it should be establishedRelated handling system | |||
| Spend. | |||
| 8.4 | Organizations should identify, collect, and analyze appropriate data.According to, to confirmThe suitability and effectiveness of the quality management systemefficacyThe program should be documented.statisticsTechnology and its application scopeanddegreeIncludingAppropriate methodsThe determination. | 11.3.1 | 13485 The data analysis has been further refined.Specific input content. |
| Data Analysis | Data analysis should include…The monitoring measurement generateddataandData from other relevant sourcesAt least including | A data analysis program should be established to collect and analyze data.Related to product quality, eventos adversos, comentarios de los clientes, and the operation of the quality management system.The data is used to verify product safety and effectiveness, and relevant records are maintained. | |
| The following inputs are required: | Review the implementation records of the data analysis to see if it was conducted according to the prescribed procedures and if the required technologies were applied.Statistical TechniquesThe data analysis results were also recorded. | ||
| a)feedback; | |||
| b)andProduct compliance; | |||
| c)Processes and productsCharacteristics and Trendsincluding takingPreventive measuresOpportunity; | |||
| d)Supplier; | |||
| e)Review; | |||
| F)When appropriate,Service Report. | |||
| If data analysis showsInadequate quality management systemshould,Inadequate or ineffectiveThe organization should follow80.5 ofThis analysis should be used as input for improvement. | |||
| Records of data analysis results should be kept.(See4.2.5). | |||
| 8.5 | 8.5.1 Principios generales | *1.3.2 | No significant differences.13485 The knowledge was slightly refined.Don’t implement any necessary changes. |
| improve | Organizations should utilizeQuality policy, quality objectives, audit | The management representative shall be responsible for establishing, implementing, and maintaining [the system/system]. | |
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| Results, post-market surveillance, data analysis, corrective andPreventive measures and management reviewComeIdentificationandImplementationAny necessaryChangeTo ensure and maintain quality controlTheoretical systemSustained suitability and adequacyandValidityas well asSafety and performance of medical devices. | Quality management system, reporting on the operation of the quality management system andImprovement requirementsThis will raise employees’ awareness of meeting regulations, rules, and customer requirements. | Use the method. | |
| Check whether the above responsibilities are clearly defined. Review the management representative’s report on quality management.System operation ConditionandimproveRelated records. | |||
| *11.8.1 | |||
| Management reviews should be conducted regularly to evaluate and audit the quality management system to ensure its effectiveness.Sustained suitability and adequacyandValidity. | |||
| Review management review documents and records, including the management review plan, management review report, y…Related improvement measuresDoes the management review report include a review of the law? | |||
| Evaluation of compliance. Whether a management review was conducted within the stipulated timeframe, whether improvement measures were proposed and specific responsibilities and requirements were implemented, and whether the plan was followed.Shi. | |||
| 8.5.2 Corrective measures | 11.4.1 | No significant differences.13485 Slightly refinedRequirements for corrective actions. | |
| The organization should takemeasureTo eliminate the non-conforming original | It should be establishedCorrective action procedures,SureThe cause of the problem,takeEffective measures,preventRelatedThe problem occurred again.. | ||
| Por lo tanto, to prevent the recurrence of nonconformities, any necessary corrective actions should be taken promptly. The corrective actions should be commensurate with the severity of the impact of the nonconformity. | 11.7.1 | ||
| Organizations shouldDocumented procedures, in order to stipulate | An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, metodos, and record requirements.correctpreventionEvaluation of the effectiveness of measures, etc.Content to ensure that the quality management system complies with the requirements of this specification. | ||
| The following requirements: | Check if the internal audit procedures include the above. Review the internal audit documents and identify the personnel who conducted the internal audit. | ||
| a)Unsatisfactory review(includeCustomer complaints); | Whether training was conducted, whether internal audit records meet requirements, and whether issues identified during internal audits were addressed.Corrective measures were taken.,Is it effective?. | ||
| b)SureReasons for non-compliance; | |||
| c)Evaluation ensures failureMeasures to prevent it from happening againofneed; | |||
| d)Plan and take the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files; | |||
| e)verificarMedidas correctivasIncumplimiento de los requisitos reglamentarios aplicablesoEfectos adversos en la seguridad y el rendimiento de los dispositivos médicos; | |||
| F)Revisar las medidas tomadas, medidas correctivas de validez. Cualquier investigación y tomar medidas de registro deben mantenerse. | |||
| (See4.2.5). | |||
| 8.5.3 Medidas preventivas | 11.4.2 | No hay diferencias significativas.13485 Ligeramente refinadoRequisitos para medidas preventivas. | |
| La organización debe identificar medidas para eliminar las razones del posible incumplimiento. Para evitar que ocurran no conformidades., Las medidas preventivas deben ser apropiadas a la gravedad del problema potencial.. | Se deben establecer procedimientos de medidas preventivas.,SeguroProblemas potencialesRazones,takeEffective measures,Para evitar que ocurran problemas. | ||
| La organización debería establecer procedimientos documentados para describir los siguientes:mendigar: | 11.7.1 | ||
| a) SeguroPosibles no conformidades y sus causas.; | An internal audit procedure for the quality management system should be established, specifying the audit criteria, scope, frequency, participants, metodos, record requirements, and corrective actions.Preventive measures include | ||
| ISO 13485:2016 | New versionGMP/Inspection principles | A Brief Analysis of Differences | |
| b)evaluatePreventing non-conformitiesmeasuresneed; | Evaluation of effectiveness, etc.Content to ensure that the quality management system complies with the requirements of this specification. | ||
| c)planAnd the necessary measuresCreate document,Implementation measuresWhen appropriate, includingUpdate files; | Check whether the internal audit procedures include the above-mentioned content. Review internal audit documents to verify whether the personnel conducting the internal audit have received training and whether the internal audit records meet the requirements. | ||
| d)verifyPreventive measuresIt does not adversely affect the ability to meet applicable regulatory requirements or the safety and performance of the medical device.; | Request: Regarding the issues identified in the internal audit,Corrective measures were taken | ||
| e)When appropriate,ReviewThe preventive measures takenValidity. | Positive measures,Is it effective?. | ||
| anyinvestigationand the measures takenmeasureofRecordShould be protected | |||
| hold(See4.2.5). | |||
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