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Quality Austria Certification GmbH is accredited by the Federal Ministry for Digital and Economic Affairs (BMDW) and AAIG (IAQG) and is officially recognized in the OASIS database.■医疗器械：ISO 13485 认证

动机与优势

ISO 13485 是一项国际标准，为医疗器械制造商建立和验证有效的质量管理体系提供依据。该标准适用于所有处于供应链中的组织，或参与依据相关欧盟法规（医疗器械法规 MDR 和体外诊断医疗器械法规 IVDR）将产品投放市场的组织。

ISO 13485 是落实欧洲法规（如 MDR、IVDR）中系统要求的重要标准。不仅在欧洲，在全球范围内，从事医疗器械业务的经济运营者，依据该标准进行认证都具有重要意义。

该标准确立了对所有类型医疗器械的要求，包括服务和软件。医疗器械可涵盖无菌与非无菌、侵入性与非侵入性、非有源植入物与有源植入物等类别。

在欧洲法规规定的 MDR 和 IVDR 合规评审程序中（依据第10条），展示符合要求的质量管理体系是取得注册资格和投放市场（即获得 CE 标志）的前提条件。由于部分系统要求的法规并未规定具体执行细节，因此 ISO 13485 在实践中仍必须被采用。

ISO 13485 的若干要素与其他管理体系标准（尤其是 ISO 9001）一致。该标准特别强调法律合规，并在体系中引入依据 ISO 14971 的风险管理方法。

对组织而言，其优势不仅体现在注册方面，还包括提升组织自身绩效的透明度、按照既定流程运作，以及增强对法规变更的敏感性。同时，有效的风险管理措施有助于控制与医疗器械相关的潜在风险。

目标

· 确保质量、透明度、安全性与保障性

· 识别业务及产品风险

· 医疗器械注册的重要前提条件

目标群体

所有从事医疗器械研发、制造，并将其投放市场的组织，以及为其提供产品或服务的供应商和服务机构。

评估标准

ISO 13485 的应用特别适用于希望构建目标明确、逻辑清晰、集成度高的管理体系的组织。组织需在医疗器械的管理体系中，满足所有适用的法律法规要求，尤其是产品安全相关要求。

除了 ISO 9001 的评估标准外，还需要满足风险管理相关要求。此外，还需符合关于无菌医疗产品和可植入有源医疗产品的特殊要求。内部与外部审核将为体系的持续改进与合规性提供支持。

■Medical Devices: Certification acc. to ISO 13485

Motivation and benefits

ISO 13485 provides an international standard for enabling manufacturers of medical devices to substantiate an effective quality management system. This standard refers to all organizations that are operating within the supply chain or are involved in placing devices regulated by the relevant EU regulations for medical devices and in-vitro diagnostics on the market.

ISO 13485 is an important standard for the implementation of system requirements according to regulations in Europe (MDR, IVDR). Certification according to this standard is substantial for economic operators in the business of medical devices not only in Europe but also internationally.

The standard establishes requirements for all types of medical devices, which also include services and software. The medical devices range from sterile to non-sterile, invasive to non-invasive as well as non-active to active implants.

In the course of the conformity review procedures required in Europe for MDR and IVDR according to article 10, demonstration of a quality management system is an important prerequisite for obtaining registration and thus the right to sell medical devices in Europe or to place them on the market (CE marking). As the regulations of some system requirements don‘t include further details for the implementation, ISO 13485 still needs to be used in practice.

ISO 13485 has some features that are congruent with those of other management systems, especially ISO 9001. A focus is placed on complying with laws relevant to quality in the introduction of a risk management acc. to ISO 14971.

The advantages for organizations do not only include the registration aspects but also transparency of the organizations’ own performance, operations following defined processes and the fact that the organization is made aware of legal changes. Furthermore, effective actions for risk management can help to minimize and thus control risks in connection with the devices concerned.

Objectives

· assuring quality, transparency, safety and security

· identifying business and product risks

· important prerequisite for the registration of medical devices

· assuring quality, transparency, safety and security

· identifying business and product risks

· important prerequisite for the registration of medical devices

Target group

Any organization developing and manufacturing medical devices and placing them on the market as well as organizations that are suppliers or service providers to such organizations.

Any organization developing and manufacturing medical devices and placing them on the market as well as organizations that are suppliers or service providers to such organizations.

Criteria

Application of ISO 13485 is particularly conceived for organizations striving for a management system that is wellaimed, more conclusive and more integrated. In this respect, the organization needs to meet all the applicable and legal requirements in connection with product safety in the organization’s management systems for medical devices. In addition to the criteria for ISO 9001, requirements relating to risk management will have to be met. Moreover, special requirements placed on sterile medical products and medical products that can be implanted actively will have to be met. Internal and external audits are to provide relevant support.

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