ISO 13485:2016 Compliant QMS [Role of an eQMS]

ISO 13485:2016 质量管理体系标准

The ISO 13485:2016 is an international regulatory standard that specifies the requirements for Quality Management Systems (QMS) in the medical device industry.

ISO 13485:2016 是一项国际监管标准，规定了医疗器械行业质量管理体系（QMS）的要求。

A QMS that meets the ISO 13485:2016 requirements demonstrates a commitment to quality and customer satisfaction, which is essential to any medical device manufacturer.

符合 ISO 13485:2016 要求的 QMS 表明对质量和客户满意度的承诺，这对任何医疗器械制造商都是至关重要的。

This article will discuss the purpose of the ISO 13485:2016 standard, its main requirements, and eQMS software’s role in supporting compliance with the ISO 13485:2016.

本文将讨论 ISO 13485:2016 标准的目的、主要要求以及 eQMS 软件在支持符合 ISO 13485:2016 方面的作用。

SimplerQMS helped several medical device companies transition from paper-based and hybrid systems to eQMS and easily manage all quality management processes in one system. We are ISO 13485:2016 certified, and our software supports compliance with QMS requirements outlined in ISO 13485:2016, US FDA 21 CFR Part 820 (QSR), and EU MDR.

SimplerQMS 帮助了几家医疗器械公司从纸质和混合系统过渡到 eQMS，并在一个系统中轻松管理所有质量管理流程。我们是 ISO 13485:2016 认证的，我们的软件支持符合 ISO 13485:2016、美国 FDA 21 CFR 第 820 部分（QSR）和欧盟 MDR 中规定的 QMS 要求。

Request a personalized demo if you want to learn more about how SimplerQMS can support compliance with ISO 13485.

如果您想了解更多关于 SimplerQMS 如何支持符合 ISO 13485 的信息，请请求个性化演示。

What Is the ISO 13485:2016 Quality Management System Standard? 什么是 ISO 13485:2016 质量管理体系标准?

The ISO 13485:2016 is an international regulatory standard that specifies medical device manufacturers’ Quality Management System (QMS) requirements. It can be used by an organization involved in one or more stages of the life cycle of a medical device.

ISO 13485:2016 是一项国际监管标准，规定了医疗器械制造商的质量管理体系（QMS）要求。它可以被参与医疗器械生命周期的一个或多个阶段的组织使用。

Any company involved in the design, development, manufacturing, storage, delivery, installation, or technical support of medical devices must be able to prove that its products and related services consistently meet customer and regulatory requirements.

任何参与医疗器械的设计、开发、制造、储存、交付、安装或技术支持的公司必须能够证明其产品和相关服务始终符合客户和监管要求。

Medical device manufacturers that comply with the ISO 13485:2016 requirements have processes in place to ensure device quality and safety to their customers.

符合 ISO 13485:2016 要求的医疗器械制造商已经建立了确保设备质量和安全的流程。

The processes required by the ISO 13485:2016 standard concern quality management for medical devices, much like the FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR).

ISO 13485:2016 标准要求的流程涉及医疗器械的质量管理，类似于 FDA 21 CFR Part 820，也被称为质量体系规定（QSR）。

The FDA QSR specifies the current good manufacturing practice requirements for finished devices in the US market for human use.

FDA QSR 规定了美国市场上用于人类使用的成品设备的当前良好制造规范要求。

Both the ISO 13485:2016 and FDA 21 CFR Part 820 requirements are entirely comparable. And in February 2022, the FDA issued a proposed rule to harmonize the 21 CFR Part 820 with the ISO 13485:2016.

ISO 13485:2016 和 FDA 21 CFR 第 820 部分的要求完全可比。2022 年 2 月，FDA 发布了一项拟议规则，以使 21 CFR 第 820 部分与 ISO 13485:2016 协调一致。

The goal is to align the US regulation more closely with the international consensus standard of QMS for medical devices used by many other regulatory authorities worldwide in the years to come.

目标是在未来几年内使美国的监管更加接近国际共识标准，即许多其他全球监管机构使用的医疗器械质量管理体系。

The ISO 13485:2016 is also related to the EU Medical Device Regulation (MDR) regarding the QMS requirements for medical device manufacturers.

ISO 13485:2016 还与欧盟医疗器械法规（MDR）有关，涉及医疗器械制造商的质量管理体系要求。

However, the MDR is more comprehensive than the ISO 13485:2016 and specifies other requirements for medical devices.

然而，MDR 比 ISO 13485:2016 更全面，并规定了医疗器械的其他要求。

Manufacturers of medical devices in the European market usually adhere to the ISO 13485:2016 standard. ISO 13485:2016 certified manufacturers can speed up the MDR certification process regarding the QMS requirements.

欧洲市场上的医疗器械制造商通常遵守 ISO 13485:2016 标准。获得 ISO 13485:2016 认证的制造商可以加快 MDR 认证过程，满足质量管理体系的要求。

To become ISO 13485:2016 certified, obtain FDA clearance, and MDR certification, medical device manufacturers must have a QMS that complies with the relevant regulations and standards requirements.

要获得 ISO 13485:2016 认证、FDA 许可和 MDR 认证，医疗器械制造商必须拥有符合相关法规和标准要求的质量管理体系（QMS）。

It is possible to comply with the QMS requirements in these regulations and standards using paper-based or hybrid QMS systems, but it can be challenging. Various issues can arise, including losing documents, physical storage issues, auditing problems, etc.

可以使用基于纸质或混合的 QMS 系统来满足这些法规和标准的 QMS 要求，但可能会面临一些挑战。可能会出现各种问题，包括文件丢失、物理存储问题、审计问题等。

While with electronic quality management systems (eQMS), medical device manufacturers can count on workflow automation, electronic signatures, data security, and cloud-based storage. It is also possible to ensure responsibility by assigning specific people to specific tasks.

而使用电子质量管理系统（eQMS），医疗器械制造商可以依靠工作流自动化、电子签名、数据安全和基于云的存储。还可以通过指派特定人员负责特定任务来确保责任。

That is why companies are increasingly turning to eQMS software solutions. Electronic QMS solutions allow medical device companies to effectively manage their QMS documentation and simplify the process of achieving compliance with the ISO 13485:2016.

这就是为什么公司越来越倾向于使用 eQMS 软件解决方案。电子 QMS 解决方案使医疗器械公司能够有效管理其 QMS 文件，并简化达到 ISO 13485:2016 合规性的过程。

Such software offers a convenient way to manage the required records and documents, including procedures and protocols. It also streamlines various processes, such as managing customer complaints, changes, non-conformances, and CAPAs.

这种软件提供了一种方便的方式来管理所需的记录和文件，包括程序和协议。它还简化了各种流程，如管理客户投诉、变更、不符合和 CAPA。

SimplerQMS is an eQMS software solution that offers a cloud-based platform to help medical device companies manage their documentation and processes in compliance with the ISO 13485:2016.

SimplerQMS 是一种 eQMS 软件解决方案，提供基于云的平台，帮助医疗器械公司按照 ISO 13485:2016 合规性管理其文件和流程。

What Is the Purpose of ISO 13485:2016 QMS Standard? ISO 13485:2016 质量管理体系标准的目的是什么？

The purpose of ISO 13485:2016 is to set forth the QMS requirements for medical device organizations to ensure their devices and services consistently meet customer and regulatory requirements.

ISO 13485:2016 的目的是为医疗器械组织制定质量管理体系要求，以确保其设备和服务始终符合客户和监管要求。

Having ISO 13485:2016 compliance facilitates medical device manufacturers to align their QMS more closely with relevant requirements in FDA 21 CFR Part 820 and MDR.

符合 ISO 13485:2016 的要求有助于医疗器械制造商更加密切地与 FDA 21 CFR Part 820 和 MDR 的相关要求保持一致。

Previously, in the European Economic Area, the Medical Devices Directive (MDD) set all the necessary steps to ensure that medical devices were placed on the market legally and safely. Being a directive, it was voluntary and individual countries could create their regulations.

在欧洲经济区，以前的医疗器械指令（MDD）规定了确保医疗器械合法安全上市的所有必要步骤。作为一项指令，它是自愿性的，各个国家可以制定自己的法规。

The MDD was replaced by the Medical Device Regulation (MDR) in May 2021.

2021 年 5 月，医疗器械指令（MDD）被医疗器械法规（MDR）所取代。

The MDR is a regulation and, therefore, mandatory for the medical devices industry in the EU. It ensures that medical devices produced in or supplied to the EU must be safe for the end user and of high and uniform quality. MDR covers the whole device’s life cycle processes and specifies the QMS requirements for medical devices.

MDR 是一项法规，因此对欧盟的医疗器械行业来说是强制性的。它确保在欧盟生产或供应的医疗器械必须对最终用户安全，并具有高质量和统一质量。 MDR 涵盖了整个器械的生命周期过程，并为医疗器械规定了质量管理体系（QMS）要求。

Since the ISO 13485:2016 is a QMS standard for the medical device industry, compliance with it reflects the QMS requirements stated in the MDR and FDA 21 CFR Part 820.

由于 ISO 13485:2016 是医疗器械行业的质量管理体系标准，符合该标准反映了 MDR 和 FDA 21 CFR 第 820 部分中规定的 QMS 要求。

What Are the Requirements of ISO 13485:2016 Standard? ISO 13485:2016 标准的要求是什么？

ISO 13485:2016 standard has several sections to cover all the requirements for QMS. It brings a greater emphasis on risk management and risk-based decision-making than in previous editions.

ISO 13485:2016 标准有几个部分，涵盖了质量管理体系的所有要求。与以前的版本相比，它更加强调风险管理和基于风险的决策。

Note

Below, we will briefly discuss some of the sections presented in the ISO 13485:2016 standard. The information here is just a part of the standard and has educational purposes only. Please always refer to ISO 13485:2016 standard for official information.

下面，我们将简要讨论ISO 13485:2016标准中提出的一些部分。这里的信息只是标准的一部分，仅供教育目的。请始终参考ISO 13485:2016标准获取官方信息。

Sections 1 to 3 are related to the scope, normative references, and terms and definitions. This article will not focus on these sections. If you want to learn more, please refer to the complete ISO 13485:2016 standard.

第 1 至 3 节与范围、规范性引用和术语和定义有关。本文不会重点讨论这些部分。如果您想了解更多，请参考完整的 ISO 13485:2016 标准。

Quality Management System (Section 4) 质量管理体系（第 4 节）

Medical device organizations must document QMS-related procedures and ensure they comply with the ISO 13485:2016 requirements.

医疗器械组织必须记录与 QMS 相关的程序，并确保其符合 ISO 13485:2016 的要求。

This means manufacturers need to implement and maintain processes regarding quality manuals, medical device files, control of documents, control of records, and any other procedure regarding the manufacturing of medical devices.

这意味着制造商需要实施和维护与质量手册、医疗器械文件、文件控制、记录控制以及与医疗器械制造相关的任何其他程序有关的流程。

Documentation is a core element of QMS. Having well-documented procedures ensures that processes are consistently performed, and that personnel is aware of the processes for each task.

文档编制是 QMS 的核心要素。有良好的文档编制程序可以确保流程得到一致执行，并使人员了解每个任务的流程。

Document changes also need to be controlled. The change control ensures the distribution and record of responsibility, records the workflow of the change and provides audit traceability.

文档变更也需要受到控制。变更控制确保分发和责任记录，记录变更的工作流程，并提供审计可追溯性。

SimplerQMS provides a complete eQMS solution for the medical device industry, having all QMS modules in place, including the core modules such as document control, change management, training, audit management, risk management, CAPA, non-conformance, supplier management, and so on.

SimplerQMS 为医疗器械行业提供完整的电子质量管理系统（eQMS）解决方案，包括核心模块如文件控制、变更管理、培训、审计管理、风险管理、CAPA、不符合项、供应商管理等。

Moreover, any computer software used as an eQMS should always be fully validated. After any update, a full validation must be performed, and all validation documentation must be readily available at any time.

此外，任何作为 eQMS 使用的计算机软件都应始终进行全面验证。在任何更新后，必须进行全面验证，并且所有验证文件必须随时可用。

The SimplerQMS system is validated according to GAMP5. We perform monthly re-validation of the system, freeing our customers from spending time on software validation activities. The system fully complies with the ISO 13485:2016, 21 CFR Part 11 and 820, and the EU Annex 11 requirements regarding validation and electronic signatures.

SimplerQMS 系统根据 GAMP5 进行验证。我们每月对系统进行重新验证，使我们的客户免于花费时间进行软件验证活动。该系统完全符合 ISO 13485:2016、21 CFR Part 11 和 820 以及欧盟附件 11 关于验证和电子签名的要求。

Management Responsibility (Section 5) 管理责任（第 5 节）

Medical device companies’ top management must ensure that responsibilities and authorities are defined, documented, and communicated within the organization.

医疗器械公司的高层管理人员必须确保责任和权限在组织内得到定义、记录和传达。

The top management is responsible for monitoring the efficiency and effectiveness of the QMS.

高层管理人员负责监督质量管理体系的效率和有效性。

Resource Management (Section 6) 资源管理（第 6 节）

Medical device manufacturers must provide the necessary resources to implement QMS, maintain effectiveness, and meet applicable regulatory and customer requirements. These resources can be in the form of infrastructure and personnel ongoing training and competencies management.

医疗器械制造商必须提供必要的资源来实施质量管理体系，保持有效性，并满足适用的法规和客户要求。这些资源可以是基础设施和人员持续培训和能力管理。

Infrastructure includes buildings, workspace, equipment, transport, and communication systems. All maintenance activities are required to be documented.

基础设施包括建筑物、工作空间、设备、交通和通信系统。所有维护活动都需要有文件记录。

Regarding the equipment, it is important to have QMS software that supports equipment management. SimplerQMS offers a solution that allows medical device organizations to create a list of all equipment, monitor the current state of equipment, schedule calibrations, send automatic notifications for maintenance tasks due dates, and more.

关于设备，拥有支持设备管理的 QMS 软件非常重要。SimplerQMS 提供了一种解决方案，允许医疗设备组织创建设备清单，监控设备的当前状态，安排校准，发送维护任务到期的自动通知等。

One important part of personnel resources management is providing training. Employees need to receive training in a wide range of documents to ensure that their competencies match company requirements and that the knowledge of their impact on the quality and safety of the products is known.

人员资源管理的一个重要部分是提供培训。员工需要接受各种文件的培训，以确保他们的能力与公司要求相匹配，并且了解他们对产品质量和安全的影响的知识。

You can achieve efficient, well-recorded, and compliant training processes with SimplerQMS Training Management Software.

您可以通过 SimplerQMS 培训管理软件实现高效、良好记录和合规的培训流程。

Various features are available, including creating training plans, routing training plans for review or updating, measuring training effectiveness with customizable quizzes, monitoring training with status reports, and automatically setting periodic tasks so training will be repeated after one year, for example, and much more.

提供多种功能，包括创建培训计划，将培训计划路由进行审查或更新，使用可定制的测验评估培训效果，通过状态报告监控培训情况，并自动设置定期任务，以便在一年后重复培训等等。

Product Realization (Section 7) 产品实现（第 7 节）

As part of product realization, efficient quality procedures are established for the design, development, manufacture, packaging, labeling, and transportation of every medical device manufactured by your company.

作为产品实现的一部分，为您公司制造的每个医疗设备的设计、开发、制造、包装、标签和运输建立了高效的质量程序。

When using an eQMS, such as SimplerQMS, the final product release document can easily be reviewed, approved, and linked to all the people and processes related to medical device manufacturing.

在使用 eQMS（如 SimplerQMS）时，最终产品发布文件可以轻松地进行审查、批准，并与与医疗设备制造相关的所有人员和流程进行关联。

Design and Development (Section 7.3) 设计和开发（第 7.3 节）

The design and development of a medical device must be planned and controlled to ensure performance, usability, and safety requirements according to the intended use.

医疗设备的设计和开发必须经过计划和控制，以确保根据预期用途满足性能、可用性和安全要求。

A high volume of documents is generated during this phase of a medical device lifecycle, and all input, output, and changes need to be recorded.

在医疗设备生命周期的这个阶段会产生大量文件，所有的输入、输出和变更都需要记录。

SimplerQMS Design Control Software facilitates the development of your medical devices by managing design and development plans, design review, verification, validation, and design transfer.

SimplerQMS 设计控制软件通过管理设计和开发计划、设计审查、验证、确认和设计转移来促进医疗设备的开发。

The system allows the creation of customizable views, snapshots of document collections, and more. You can also relate design control documentation to relevant documents and regulatory chapters.

该系统允许创建可定制的视图、文档集合的快照等。您还可以将设计控制文档与相关文档和法规章节相关联。

Recommended Reading: Design Controls for Medical Devices

推荐阅读：医疗设备的设计控制。

Purchasing (Section 7.4) 采购（第 7.4 节）

This subsection of the ISO 13485:2016 specifies that manufacturers must select and evaluate suppliers.

ISO 13485:2016 的这个子节规定制造商必须选择和评估供应商。

For instance, manufacturers need to have a plan for monitoring, re-evaluating, and auditing suppliers. During these audits, eventual audit findings must be assessed and documented.

例如，制造商需要制定监控、重新评估和审计供应商的计划。在这些审计中，必须评估和记录可能的审计结果。

Medical device organizations can manage and monitor suppliers more effectively with eQMS software that also supports supplier management processes.

医疗器械组织可以通过支持供应商管理流程的 eQMS 软件更有效地管理和监控供应商。

SimplerQMS Supplier Quality Management Software allows you to create and maintain Approved Supplier List, schedule supplier audits, set up automatic reminders for tasks’ due dates and certificate expiration dates, etc.

SimplerQMS 供应商质量管理软件允许您创建和维护批准供应商列表，安排供应商审计，设置任务截止日期和证书到期日期的自动提醒等。

Recommended Reading: Medical Device Supplier Management Process (8 Steps)

推荐阅读：医疗器械供应商管理流程（8 个步骤）

Control of Monitoring and Measuring Equipment (Section 7.6) 监控和测量设备的控制（第 7.6 节）

Medical device organizations must monitor and control equipment related to devices providing evidence of device conformity with the ISO 13485:2016 standard.

医疗器械组织必须监控和控制与设备相关的设备，以提供符合 ISO 13485:2016 标准的设备证据。

Among other things, companies need to implement and record periodic equipment tasks, such as calibrations and adjustments, according to the applicable guidelines.

除其他事项外，公司需要根据适用的指南实施和记录定期设备任务，例如校准和调整。

SimplerQMS supports equipment management processes, including calibration and maintenance activities.

SimplerQMS 支持设备管理流程，包括校准和维护活动。

For instance, the system sends notifications to specific personnel to inform them about a calibration or maintenance task before due dates. It automatically creates a complete equipment calibration and maintenance log readily available for audits.

例如，该系统会在截止日期之前向特定人员发送通知，告知他们校准或维护任务。它会自动创建完整的设备校准和维护日志，以备审计之用。

Measurement, Analysis, and Improvement (Section 8) 测量、分析和改进（第 8 节）

This section of the ISO 13485:2016 emphasizes the monitoring, measuring, analyzing, and improving processes needed to demonstrate product conformity and ensure the effectiveness of the QMS.

ISO 13485:2016 的这一部分强调了监控、测量、分析和改进过程，以证明产品符合性并确保质量管理体系的有效性。

To comply with post-market surveillance requirements, medical device manufacturers must gather and monitor information if their device has met customer requirements, using appropriate methods, including statistical techniques, feedback, and customer complaints.

为了符合售后监测要求，医疗器械制造商必须收集和监控信息，以确定其设备是否满足客户要求，使用适当的方法，包括统计技术、反馈和客户投诉。

Complaint handling is one of several important processes since it is through complaints that customers give feedback on non-conformance and adverse events of medical devices.

投诉处理是几个重要过程之一，因为正是通过投诉，客户对医疗器械的不符合和不良事件提供反馈。

In SimplerQMS software, companies can create complaint documents using templates based on requirements. These complaints can be initiated from several different sources. SimplerQMS has pre-configured workflows that can guide you in handling complaints.

在 SimplerQMS 软件中，公司可以根据要求使用模板创建投诉文件。这些投诉可以来自多个不同的来源。SimplerQMS 具有预配置的工作流程，可以指导您处理投诉。

One way of handling a complaint can be escalating it to a CAPA. For example, during an external audit, any audit findings must be escalated to a CAPA.

处理投诉的一种方式是将其升级为 CAPA。例如，在外部审计期间，任何审计发现都必须升级为 CAPA。

SimplerQMS CAPA Management Software allows medical device companies to initiate the CAPA process directly from audit findings with just a few clicks and link all documents together.

SimplerQMS CAPA 管理软件允许医疗器械公司仅需点击几下即可从审计发现中直接启动 CAPA 流程，并将所有文件链接在一起。

Furthermore, companies can easily use SimplerQMS Audit Management Software to schedule, conduct, document, and report on internal, regulatory, and supplier audits. This helps manage and track audit-related activities, assign tasks and responsibilities, and ensure the timely completion of assignments.

此外，公司可以轻松使用 SimplerQMS 审计管理软件安排、进行、记录和报告内部、监管和供应商审计。这有助于管理和跟踪与审计相关的活动，分配任务和责任，并确保任务及时完成。

What Does It Mean To Be ISO 13485:2016 Certified? 什么是 ISO 13485:2016 认证的意义？

To be ISO 13485:2016 certified means that an organization has a QMS that complies with the requirements of the ISO 13485:2016 standard and is certified by an external certification body.

ISO 13485:2016 认证意味着一个组织拥有符合 ISO 13485:2016 标准要求的质量管理体系，并由外部认证机构进行认证。

Medical device companies can choose the scope of their certification. This means a manufacturer can have a QMS ISO 13485:2016 certificated only in specific standard sections.

医疗器械公司可以选择其认证的范围。这意味着制造商可以在特定标准部分中获得 ISO 13485:2016 质量管理体系认证。

For example, a medical device manufacturer can still achieve ISO 13485:2016 certification despite not having Design and Development processes. The certificate will list the excluded sections that are not relevant to the manufacturer’s QMS.

例如，即使没有设计和开发流程，医疗器械制造商仍然可以获得 ISO 13485:2016 认证。证书将列出与制造商质量管理体系无关的被排除的部分。

Having ISO 13485:2016 certification allows companies to:

拥有 ISO 13485:2016 认证使公司能够：

• Demonstrate compliance with regulatory requirements 证明符合监管要求
• Ensure the establishment of QMS processes to manufacture safe and effective medical devices 确保建立 QMS 流程以制造安全有效的医疗器械
• Demonstrate validated processes to manage risk effectively 证明有效管理风险的验证过程
• Gain a competitive advantage in the market 在市场上获得竞争优势

How To Be ISO 13485:2016 Certified? 如何获得 ISO 13485:2016 认证？

Due to the complex certification process, this article will only provide a brief overview of how to become ISO 13485:2016 certified.

由于认证过程复杂，本文仅提供如何获得 ISO 13485:2016 认证的简要概述。

The first step is to choose a certification body. They audit medical device organizations and issue certificates proving that the QMS complies with the ISO 13485:2016 requirements.

第一步是选择认证机构。他们审核医疗器械组织并发放证书，证明 QMS 符合 ISO 13485:2016 的要求。

Note that ISO is not involved in certification and does not issue certificates. So, it is important to check if the certification body uses relevant ISO’s Committee on Conformity Assessment (CASCO) standards and is nationally accredited to provide independent confirmation of competence.

请注意，ISO 不参与认证工作，也不发放证书。因此，重要的是要检查认证机构是否使用相关的 ISO 合规评定委员会（CASCO）标准，并且具有国家认可，以提供独立的能力确认。

You can contact your national accreditation body or visit the International Accreditation Forum (IAF) CertSearch to find an accredited certification body.

您可以联系您的国家认可机构或访问国际认可论坛（IAF）CertSearch，以找到认可的认证机构。

In the second step, the certification body evaluates medical device companies’ documents regarding the ISO 13485:2016 scope under which they wish to be certified in a Stage 1 audit.

在第二步中，认证机构将评估医疗器械公司关于他们希望在 ISO 13485:2016 范围内获得认证的文件，在第一阶段审核中。

If the certification body finds that the documents are compliant, it will conduct an on-site audit, also known as a Stage 2 audit.

如果认证机构发现文件符合要求，它将进行现场审核，也称为第二阶段审核。

Finally, the certification body will issue a certificate if the organization QMS complies with the ISO 13485:2016 requirements in the audited scopes.

最后，如果组织的质量管理体系符合 ISO 13485:2016 的要求，认证机构将发放证书，证明审核范围内的合规性。

Benefits of Being ISO 13485:2016 Certified 成为 ISO 13485:2016 认证的好处

Here are some of the main benefits medical device organizations have from being ISO 13485:2016 certified.

以下是医疗器械组织从 ISO 13485:2016 认证中获得的主要好处。

Comply With Regulatory Requirements 遵守法规要求

If certified, you can prove compliance with a set of requirements of an international regulatory standard that reflects the QMS requirements of EU MDR and US FDA 21 CFR Part 820.

如果获得认证，您可以证明符合国际监管标准的一系列要求，这反映了欧盟 MDR 和美国 FDA 21 CFR 第 820 部分的质量管理体系要求。

Attract New Customers 吸引新客户

It improves the confidence of potential customers of your product when they acknowledge compliance and certification to the ISO 13485:2016 standard.

当潜在客户了解到您的产品符合 ISO 13485:2016 标准并获得认证时，他们对您的产品的信心会提高。

Become a Top Manufacturing Supplier 成为顶级制造供应商

It is easier to be approved as a medical device manufacturing supplier since you can demonstrate validated quality processes.

由于您可以展示经过验证的质量流程，因此更容易获得批准作为医

Assess and Manage Risks Efficiently 高效评估和管理风险

The quality and safety of your medical devices are ensured through ISO 13485:2016 compliant processes being consistently followed by personnel. This way, non-conformances or risks can be detected and assessed more easily.

通过人员始终遵循 ISO 13485:2016 合规流程，确保医疗设备的质量和安全性。这样，可以更容易地检测和评估不符合要求或风险。

Improve Processes and Efficiency 改进流程和效率

By streamlining quality processes, you will reduce non-conformances and avoid rework, resulting in greater efficiency, cost savings, and ensuring continuous improvement.

通过简化质量流程，您将减少不符合要求和避免返工，从而提高效率、节省成本，并确保持续改进。

Implement Evidence-Based Decision-Making 实施基于证据的决策

You are constantly provided with relevant and useful information from processes that help you make decisions in line with your goals.

您不断从流程中获得相关和有用的信息，帮助您根据目标做出决策。

The ISO 13485:2016 is a regulatory standard in the medical device industry. As mentioned above, it can speed up the MDR certification process regarding QMS requirements and might be aligned with FDA 21 CFR Part 820 in the future, adding even more benefits to achieving ISO 13485:2016 compliance and certification.

ISO 13485:2016 是医疗器械行业的监管标准。如上所述，它可以加快有关质量管理体系要求的 MDR 认证过程，并可能在将来与 FDA 21 CFR Part 820 保持一致，为实现 ISO 13485:2016 合规性和认证带来更多好处。

The Role of an eQMS in Supporting Compliance With the ISO 13485:2016 QMS Standard 电子质量管理系统（eQMS）在支持符合 ISO 13485:2016 QMS 标准方面的作用

Requirements for a QMS in the medical device industry are specified in the ISO 13485:2016. Companies can achieve compliance using paper-based, hybrid, or electronic QMS.

医疗器械行业的质量管理体系（QMS）要求在 ISO 13485:2016 中有明确规定。公司可以使用纸质、混合或电子 QMS 来实现符合要求。

Small companies with sufficient resources can implement successful paper-based and hybrid QMS.

资源充足的小公司可以实施成功的纸质和混合 QMS。

However, using a paper-based or hybrid QMS can present some challenges. Gathering all responsible personnel signatures can be time-consuming, and storing all the files requires a lot of physical space.

然而，使用纸质或混合 QMS 可能会面临一些挑战。收集所有负责人的签名可能耗时，而存储所有文件需要大量的物理空间。

Implementing a digital solution to QMS is an important decision for a medical device company. With eQMS, you can easily streamline processes to save time and costs while improving efficiency.

实施数字化解决方案对医疗设备公司来说是一个重要的决策。通过 eQMS，您可以轻松优化流程，节省时间和成本，同时提高效率。

SimplerQMS provides a complete eQMS software solution with all life science QMS modules. From document control and change control management to supplier management, audit management, and more.

SimplerQMS 提供了一个完整的 eQMS 软件解决方案，包括所有生命科学 QMS 模块。从文件控制和变更控制管理到供应商管理、审计管理等等。

SimplerQMS is a comprehensive eQMS platform that supports medical device companies achieving compliance with the ISO 13485:2016 while increasing efficiency and reducing costs.

SimplerQMS 是一个全面支持医疗设备公司实现 ISO 13485:2016 合规性的 eQMS 平台，同时提高效率并降低成本。

If you are interested in identifying the value of an eQMS for your organization and presenting it to the decision-makers and stakeholders, download an eQMS business case template.

如果您有兴趣确定 eQMS 对您的组织的价值，并向决策者和利益相关者展示，请下载 eQMS 商业案例模板。

Frequently Asked Questions About ISO 13485:2016 关于 ISO 13485:2016 的常见问题

What Is the Current Version of ISO 13485? ISO 13485 的当前版本是什么？

The current version of the ISO 13485 standard is the ISO 13485:2016, published in March 2016. It is the third edition of the ISO 13485 that cancels and replaces previous versions.

ISO 13485 的当前版本是 ISO 13485:2016，于 2016 年 3 月发布。这是 ISO 13485 的第三版，取消并替代了以前的版本。

It also summarizes the changes incorporated into the latest version compared with the previous one in Annex A.

它还在附录 A 中总结了与上一版相比最新版本中所包含的变化。

Where is ISO 13485:2016 Compliance Required? ISO 13485:2016 的合规要求在哪里？

Compliance with the ISO 13485:2016 is required by medical device companies involved in the manufacturing of medical devices and related services.

参与医疗器械制造和相关服务的医疗器械公司需要符合 ISO 13485:2016 的合规要求。

Additionally, QMS that complies with the ISO 13485:2016 can be presumed to conform with QMS requirements in EU MDR and can be aligned with FDA 21 CFR Part 820 in the future.

此外，符合 ISO 13485:2016 的质量管理体系可以被认为符合欧盟 MDR 的质量管理体系要求，并且未来可以与 FDA 21 CFR 第 820 部分对齐。

Does the FDA Accept Compliance with ISO 13485:2016 QMS Requirements? FDA 是否接受符合 ISO 13485:2016 质量管理体系要求？

The FDA does accept compliance with the ISO 13485:2016 via the Medical Device Single Audit Program (MDSAP) regarding QMS requirements.

FDA 确实接受符合 ISO 13485:2016 质量管理体系要求，通过医疗器械单一审计计划（MDSAP）。

MDSAP allows a single regulatory audit of a medical device manufacturer to be valid across all program members: Australia, Brazil, Canada, Japan, and the United States.

MDSAP 允许对医疗器械制造商进行一次监管审计，该审计在所有计划成员国家有效，包括澳大利亚、巴西、加拿大、日本和美国。

Additionally, in February 2022, the FDA issued a proposed rule to align the QMS regulation, 21 CFR Part 820, with the ISO 13485:2016 standard. However, due to COVID-19, the decision was delayed and will be analyzed soon.

此外，2022 年 2 月，FDA 发布了一项拟议规则，将质量管理体系法规 21 CFR Part 820 与 ISO 13485:2016 标准对齐。然而，由于 COVID-19 的影响，决定被推迟，将很快进行分析。

Who Enforces ISO 13485:2016 QMS Requirements? 谁执行 ISO 13485:2016 质量管理体系要求？

The ISO 13485:2016 was created and issued by the International Organization for Standardization (ISO). ISO is an independent, non-governmental international organization with a membership of standards bodies from 167 countries.

ISO 13485:2016 是由国际标准化组织（ISO）创建和发布的。ISO 是一个独立的、非政府的国际组织，拥有来自 167 个国家的标准机构的成员。

ISO does not provide certification or conformity assessment. Medical device organizations need to contact an external certification body to be certified.

ISO 不提供认证或符合性评估。医疗器械组织需要联系外部认证机构进行认证。

Authorized third-party certification bodies enforce the ISO 13485:2016 QMS requirements through audits. The certification is valid for three years.

授权的第三方认证机构通过审核来执行 ISO 13485:2016 质量管理体系要求。认证有效期为三年。

Once your organization has received the ISO 13485:2016 certification, you will be regularly audited to ensure your compliance, usually once a year. Recertification audits are required as the 3-year validity expires.

一旦您的组织获得 ISO 13485:2016 认证，您将定期接受审核以确保您的合规性，通常每年一次。当 3 年有效期到期时，需要进行再认证审核。

What Is the Difference Between ISO 13485:2016 And EN ISO 13485:2016? ISO 13485:2016 和 EN ISO 13485:2016 之间有什么区别？

Both the ISO 13485:2016 and the EN ISO 13485:2016 are the same word-by-word standard. However, the European EN version has the Z annexes to compare sections where compliance with the international ISO 13485:2016 fails to address EU requirements adequately.

ISO 13485:2016 和 EN ISO 13485:2016 是完全相同的逐字逐句标准。然而，欧洲 EN 版本附有 Z 附件，用于比较国际 ISO 13485:2016 未能充分满足欧盟要求的部分。

What Is the Difference Between ISO 9001:2015 And ISO 13485:2016? ISO 9001:2015 和 ISO 13485:2016 之间有什么区别？

The main difference between ISO 9001:2015 and ISO 13485:2016 QMS requirements is that the first is the internationally accepted standard for organizations in any type of industry.

ISO 9001:2015 和 ISO 13485:2016 质量管理体系要求的主要区别在于前者是国际公认的适用于任何行业的标准。

On the other hand, the ISO 13485:2016 specifically addresses QMS requirements for medical device organizations and is a regulatory standard.

另一方面，ISO 13485:2016 专门针对医疗器械组织的质量管理体系要求，并且是一项监管标准。

Final Thoughts 总结

Medical device organizations must have a robust QMS to comply with Life Science regulations and standards, ensuring safe and effective devices are placed on the market.

医疗器械组织必须拥有强大的质量管理体系（QMS），以符合生命科学法规和标准，确保安全有效的设备上市。

The ISO 13485:2016 is a regulatory standard for medical device QMS. Manufacturers that comply with this standard demonstrate the ability to provide devices and related services that consistently meet customer and applicable regulatory requirements.

ISO 13485:2016 是医疗器械质量管理体系的法规标准。符合该标准的制造商表明他们有能力提供符合客户和适用法规要求的设备和相关服务。

Using paper-based and hybrid QMS presents challenges, such as human errors, lost documents, time-consuming audits, the need for physical storage, and so on.

使用纸质和混合质量管理体系存在挑战，如人为错误、丢失文件、耗时的审计、需要实体存储等。

An alternative to these is eQMS. A digital solution helps medical device manufacturers to secure and store data in a cloud-based system, and streamline quality processes.

这些的替代方案是电子质量管理体系（eQMS）。数字化解决方案帮助医疗器械制造商在基于云的系统中安全存储数据，并简化质量流程。

SimplerQMS Software provides a robust eQMS that complies with the ISO 13485:2016. We offer a complete solution with all core QMS modules, including document control, change management, training, audit management, risk management, CAPA, non-conformance, supplier management, and more.

SimplerQMS 软件提供符合 ISO 13485:2016 的强大 eQMS。我们提供完整的解决方案，包括文档控制、变更管理、培训、审计管理、风险管理、CAPA、不符合项、供应商管理等所有核心 QMS 模块。

Request a demo of the SimplerQMS solution and talk with our experts about streamlining your quality management processes and making ISO 13485:2016 compliance easier.

请求 SimplerQMS 解决方案的演示，并与我们的专家讨论如何简化您的质量管理流程，使 ISO 13485:2016 的合规更加容易。

References 参考文档

• ISO 13485:2016 Compliant QMS [Role of an eQMS]