This standard is drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0287-2003 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes in whole, and the following technical deviations have been made with respect to YY/T 0287-2003:
— the importance of regulatory requirements is highlighted;
— the scope of application is expanded;
— the requirements of risk management are strengthened;
— the requirements for communicating with and reporting to regulators are added;
— the requirements for post-listing supervision and management are added;
— the requirements for documentation and record-keeping are added.
This standard is identical with International Standard ISO 13485:2016 Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.
This standard was proposed by the China Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee 221 on Quality Management of and General Requirements for Medical Devices of Standardization Administration of China (SAC/TC 221).
The previous editions of this standard are as follows:
— YY/T 0287-1996, YY/T 0287-2003.
Introduction
0.1 General
This standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices, and design and development, or provision of associated activities (e.g. technical support). The requirements in this standard can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this standard or can be required by contract to conform.
Several jurisdictions have regulatory requirements for the application of quality management systems by organizations with a variety of roles in the supply chain for medical devices. Consequently, this standard expects that the organization:
— identifies its role(s) under applicable regulatory requirements;
— identifies the regulatory requirements that apply to its activities under these roles;
— incorporates these applicable regulatory requirements within its quality management system.
The definitions in applicable regulatory requirements differ from nation to nation and region to region. The organization needs to understand how the definitions in this standard will be interpreted in light of regulatory definitions in the jurisdictions in which the medical devices are made available.
This standard can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements applicable to the quality management system and the organization’s own requirements. It is emphasized that the quality management system requirements specified in this standard are complementary to the technical requirements for product that are necessary to meet customer and applicable regulatory requirements for safety and performance.
The adoption of a quality management system is a strategic decision of an organization. The design and implementation of an organization’s quality management system is influenced by the:
a) organizational environment, changes in that environment, and the influence that the organizational environment has on the conformity of the medical devices;
b) organization’s varying needs;
c) organization’s particular objectives;
d) product the organization provides;
e) processes the organization employs;
f) organization’s size and organizational structure;
g) regulatory requirements applicable to the organization’s activities.
It is not the intent of this standard to imply the need for uniformity in the structure of different quality management systems, uniformity of documentation or alignment of documentation to the clause structure of this standard.
There is a wide variety of medical devices and some of the particular requirements of this standard only apply to named groups of medical devices. These groups are defined in Clause 3.
0.2 Clarification of concepts
In this standard, the following terms or phrases are used in the context described below.
— When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:
— product to meet requirements;
— compliance with applicable regulatory requirements;
— the organization to carry out corrective action;
— the organization to manage risks.
— When the term “risk” is used, the application of the term within the scope of this standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.
— When a requirement is required to be “documented”, it is also required to be established, implemented and maintained.
— When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process.
— When the term “regulatory requirements” is used, it encompasses requirements contained in any law applicable to the user of this standard (e.g. statutes, regulations, ordinances or directives). The application of the term “regulatory requirements” is limited to requirements for the quality management system and the safety or performance of the medical device.
The following auxiliary verbs are used in this standard:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— "may" indicates permission;
— "can" indicates a possibility or a capability.
"Note" is for guidance in understanding or clarifying the associated requirement.
0.3 Process approach
This standard is based on a process approach to quality management. Any activity that receives input and converts it to output can be considered as a process. Often the output from one process directly forms the input to the next process.
For an organization to function effectively, it needs to identify and manage numerous linked processes. The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach.”
When used within a quality management system, such an approach emphasizes the importance of:
a) understanding and meeting requirements;
b) considering processes in terms of added value;
c) obtaining results of process performance and effectiveness;
d) improving processes based on objective measurement.
0.4 Relationship with ISO 9001
While this is a stand-alone standard, it is based on GB/T 19001-2008, which has been replaced by GB/T 19001-2016. For the convenience of users, Annex B shows the correspondence between this standard and GB/T 19001-2016.
ISO13485:2016 is intended to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations involved in one or more stages of the life-cycle of a medical device. This standard includes some particular requirements for organizations involved in the life-cycle of medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this standard cannot claim conformity to ISO 9001 unless their quality management system meets all the requirements of ISO 9001.
0.5 Compatibility with other management systems
This standard does not include requirements specific to other management systems, such as those particular to environmental management, occupational health and safety management, or financial management. However, this standard enables an organization to align or integrate its own quality management system with related management system requirements. It is possible for an organization to adapt its existing management system(s) in order to establish a quality management system that complies with the requirements of this standard.
Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes
1 Scope
This standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). This standard can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of this standard are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
The processes required by this standard that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.
If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to this standard reflect any exclusion of design and development controls.
If any requirement in Clauses 6, 7 or 8 of this standard is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 19000-2016 Quality Management Systems — Fundamentals and Vocabulary (ISO 9000: 2015, IDT)
3 Terms and Definitions
For the purposes of this document, the terms and definitions given in GB/T 19000-2016 and the following apply.
3.1
advisory notice
notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the:
— use of a medical device;
— modification of a medical device;
— return of the medical device to the organization that supplied it; or
— destruction of a medical device.
Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.
3.2
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under that country or jurisdiction’s legislation
[Source: GHTF/SG1/N055:2009, 5.2]
3.3
clinical evaluation
assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer
[Source: GHTF/SG5/N4:2010, Clause 4]
3.4
complaint
written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, usability, safety or performance of a medical device that has been released from the organization’s control or related to a service that affects the performance of such medical devices
Note: This definition of “complaint” differs from the definition given in GB/T 19000-2016.
3.5
distributor
natural or legal person in the supply chain who, on his own behalf, furthers the availability of a medical device to the end user
Note 1: More than one distributor may be involved in the supply chain.
Note 2: Persons in the supply chain involved in activities such as storage and transport on behalf of the manufacturer, importer or distributor, are not distributors under this definition.
[Source: GHTF/SG1/N055, 5.3]
3.6
implantable medical device
medical device which can only be removed by medical or surgical intervention and which is intended to:
— be totally or partially introduced into the human body or a natural orifice; or replace an epithelial surface or the surface of the eye;
— remain after the procedure for at least 30 days.
Note: This definition of implantable medical device includes active implantable medical device.
3.7
importer
natural or legal person in the supply chain who is the first in a supply chain to make a medical device, manufactured in another country or jurisdiction, available in the country or jurisdiction where it is to be marketed
[Source: GHTF/SG1/N055:2009, 5.4]
3.8
labelling
label, instructions for use, and any other information that is related to identification, technical description, intended purpose and proper use of the medical device, but excluding shipping documents
[Source: GHTF/SG1/N70:2011, Clause 4]
3.9
life-cycle
all phases in the life of a medical device, from the initial conception to final decommissioning and disposal
[Source: YY/T 0316-2016, 2.7]
3.10
manufacturer
natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s)
Note 1: This “natural or legal person” has ultimate legal responsibility for ensuring compliance with all applicable regulatory requirements for the medical devices in the countries or jurisdictions where it is intended to be made available or sold, unless this responsibility is specifically imposed on another person by the Regulatory Authority (RA) within that jurisdiction.
Note 2: The manufacturer’s responsibilities are described in other GHTF guidance documents. These responsibilities include meeting both pre-market requirements and post-market requirements, such as adverse event reporting and notification of corrective actions.
Note 3: “Design and/or manufacture”, as referred to in the above definition, may include specification development, production, fabrication, assembly, processing, packaging, repackaging, labelling, relabelling, sterilization, installation, or remanufacturing of a medical device; or putting a collection of devices, and possibly other products, together for a medical purpose.
Note 4: Any person who assembles or adapts a medical device that has already been supplied by another person for an individual patient, in accordance with the instructions for use, is not the manufacturer, provided the assembly or adaptation does not change the intended use of the medical device.
Note 5: Any person who changes the intended use of, or modifies, a medical device without acting on behalf of the original manufacturer and who makes it available for use under his own name, should be considered the manufacturer of the modified medical device.
Note 6: An authorized representative, distributor or importer who only adds its own address and contact details to the medical device or the packaging, without covering or changing the existing labelling, is not considered a manufacturer.
Note 7: To the extent that an accessory is subject to the regulatory requirements of a medical device, the person responsible for the design and/or manufacture of that accessory is considered to be a manufacturer.
[Source: GHTF/SG1/N055:2009, 5.1]
3.11
medical device
instrument, apparatus, implement, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purpose(s) of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease;
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury;
— investigation, replacement, modification, or support of the anatomy or of a physiological process;
— supporting or sustaining life;
— control of conception;
— disinfection of medical devices;
— providing information by means of in vitro examination of specimens derived from the human body;
and does not achieve its primary intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its intended function by such means
Note: Products which may be considered to be medical devices in some jurisdictions but not in others include:
— disinfection substances;
— aids for persons with disabilities;
— devices incorporating animal and/or human tissues;
— devices for in vitro fertilization or assisted reproduction technologies.
[Source: GHTF/SG1/N071:2012, 5.1]
3.12
medical device family
group of medical devices manufactured by or for the same organization and having the same basic design and performance characteristics related to safety, intended use and function
3.13
performance evaluation
assessment and analysis of data to establish or verify the ability of an in vitro diagnostic medical device to achieve its intended use
3.14
post-market surveillance
systematic process to collect and analyse experience gained from medical devices that have been placed on the market
3.15
product
result of a process
Note 1: There are four generic product categories, as follows:
— services (e.g. transport);
— software (e.g. computer program, dictionary);
— hardware (e.g. engine mechanical part);
— processed materials (e.g. lubricant).
Many products comprise elements belonging to different generic product categories. Whether the product is then called service, software, hardware or processed material depends on the dominant element. For example, the offered product “automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine control software, driver’s manual), and service (e.g. operating explanations given by the salesman).
Note 2: Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following:
— an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired);
— an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);
— the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission);
— the creation of ambience for the customer (e.g. in hotels and restaurants).
Software consists of information and is generally intangible and can be in the form of approaches, transactions or procedures.
Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally tangible and their amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.
Note 3: This definition of “product” differs from the definition given in GB/T 19000-2016.
[Source: GB/T 19000-2008 , 3.4.2, modified]
3.16
purchased product
product provided by a party outside the organization’s quality management system
Note: The provision of product does not necessarily infer a commercial or financial arrangement.
Foreword IV
Introduction V
1 Scope
2 Normative References
3 Terms and Definitions
4 Quality Management System
4.1 General requirements
4.2 Documentation requirements
4.2.1 General
4.2.2 Quality manual
4.2.3 Medical device documents
4.2.4 Control of documents
4.2.5 Control of records
5 Management Responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal communication
5.6 Management review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
6 Resource Management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control
7 Product Realization
7.1 Planning of product realization
7.2 Customer-related processes
7.2.1 Determination of requirements related to products
7.2.2 Review of requirements related to products
7.2.3 Communication
7.3 Design and development
7.3.1 General
7.3.2 Design and development planning
7.3.3 Design and development inputs
7.3.4 Design and development outputs
7.3.5 Design and development review
7.3.6 Design and development verification
7.3.7 Design and development validation
7.3.8 Design and development transfer
7.3.9 Control of design and development changes
7.3.10 Design and development files
7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
7.5 Production and service provision
7.5.1 Control of production and service provision
7.5.2 Cleanliness of product
7.5.3 Installation activities
7.5.4 Service activities
7.5.5 Particular requirements for sterile medical devices
7.5.6 Validation of processes for production and service provision
7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier system
7.5.8 Identification
7.5.9 Traceability
7.5.10 Customer property
7.5.11 Preservation of product
7.6 Control of monitoring and measuring equipment
8 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback
8.2.2 Complaint handling
8.2.3 Reporting to regulatory authorities
8.2.4 Internal audit
8.2.5 Monitoring and measurement of processes
8.2.6 Monitoring and measurement of product
8.3 Control of nonconforming product
8.3.1 General
8.3.2 Actions in response to nonconforming product detected before delivery
8.3.3 Actions in response to nonconforming product detected after delivery
8.3.4 Rework
8.4 Analysis of data
8.5 Improvement
8.5.1 General
8.5.2 Corrective action
8.5.3 Preventive action
Annex A (Informative) Comparison of content between YY/T 0287-2017 and YY/T 0287-
Annex B (Informative) Correspondence between YY/T 0287-2017 and GB/T 19001-
Bibliography
医疗器械 质量管理体系
用于法规的要求
1 范围
本标准为需要证实自身有能力提供持续满足顾客要求和适用的法规要求的医疗器械和相关服务的组织规定了质量管理体系要求。这类组织能涉及医疗器械生命周期的一个或多个阶段，包括医疗器械的设计和开发、生产、贮存和流通、安装或服务，以及相关活动(例如技术支持)的设计和开发或提供。本标准也能用于向这类组织提供产品(包括与质量管理体系相关的服务)的供方或外部方。
除非明确规定，本标准的要求适用于各种规模和类型的组织。本标准中应用于医疗器械的要求同样适用于组织提供的相关服务。
对于本标准所要求的适用于组织但不是由组织实施的过程，在质量管理体系中组织通过监视、维护和控制这些过程对其负有责任。
如果适用的法规要求允许对设计和开发控制进行删减，则能作为在质量管理体系中将其删减的理由。若这些法规要求能提供其他方法，这些方法要在质量管理体系中予以说明。组织有责任确保在符合本标准的声明中明确对设计和开发控制的任何删减。
本标准第6、7或8章中的任何要求，如果因组织开展的活动或质量管理体系所涉及的医疗器械的特点而不适用时，组织不需要在其质量管理体系中包含这样的要求。对于经确定不适用的任何条款，组织按照4.2.2的要求记录其理由。
2 规范性引用文件
下列文件对于本文件的应用是必不可少的。凡是注日期的引用文件，仅注日期的版本适用于本文件。凡是不注日期的引用文件，其最新版本(包括所有的修改单)适用于本文件。
GB／T 19000—2016质量管理体系 基础和术语(ISO 9000：2015，IDT)
3 术语和定义
GB／T 19000—2016界定的以及下列术语和定义适用于本文件。
3.1
忠告性通知 advisory notice
在医疗器械交付后由组织发布的旨在以下方面给出补充信息或建议要采取措施的通知：
——医疗器械的使用；
——医疗器械的改动；
——医疗器械返回组织；或
——医疗器械的销毁。
注：忠告性通知的发布可能要求符合适用的法规要求。
3.2
授权代表 authorized representative
在国家或管辖区内确定了的，接受制造商书面授权、按照该国家或管辖区的法律，代表制造商行使与其义务有关的指定任务的自然人或法人。
[来源：GHTF／SG1／N055：2009，定义5.2]
3.3
临床评价 clinical evaluation
评定和分析与医疗器械有关的临床数据以验证该器械按制造商的预期使用时的临床安全和性能。
[来源：GHTF／SG5／N4：2010，第4章]
3.4
投诉 complaint
宣称已从组织的控制中放行的医疗器械存在与标识、质量、耐用性、可靠性、可用性、安全或性能有关的缺陷或宣称影响这些医疗器械性能的服务存在不足的书面、电子或口头的沟通。
注：“投诉”的此定义不同于GB／T 19000—2016界定的定义。
3.5
经销商 distributor
供应链中代表其自身将医疗器械推销给最终用户的自然人或法人。
注1：供应链中可涉及多个经销商。
注2：供应链中代表制造商、进口商或经销商的涉及诸如贮存和运输活动的人员不是本定义中的经销商。
[来源：GHTF／SG1／N055，定义5.3]
3.6
植入性医疗器械 implantable medical device
只能通过医疗或外科手术去除的医疗器械，预期其：
——被全部或部分插入人体或自然腔道中，或替代上表皮或眼表面；
——并且存留至少30天。
注：植入性医疗器械的定义包含有源植入性医疗器械。
3.7
进口商 importer
在供应链中使其他国家或管辖区制造的医疗器械在所要上市的国家或管辖区可销售的第一个自然人或法人。
[来源：GHTF／SG1／N055：2009，定义5.4]
3.8
标记 labelling
与医疗器械的识别、技术说明、预期用途和正确使用有关的标签、使用说明书和任何其他信息，但不包括货运文件。
[来源：GHTF／SG1／N70：2011，第4章]
3.9
生命周期 life-cycle
在医疗器械生命中，从初始概念到最终停用和处置的所有阶段。
[来源：YY／T 0316—2016，定义2.7]
3.10
制造商 manufacturer
以其名义制造预期可用的医疗器械并负有医疗器械设计和／或制造责任的自然人或法人，无论此医疗器械的设计和／或制造是由该自然人或法人进行或由另外的一个或多个自然人或法人代表其进行。
注1：此“自然人或法人”对确保符合医疗器械预期可用或销售的国家或管辖区的所有适用的法规要求负有最终法律责任，除非该管辖区的监管机构(RA)明确将该责任强加于另一自然人或法人。
注2：在其他GHTF指南文件中说明了制造商的责任。这些责任包括满足上市前要求和上市后要求，比如不良事件报告和纠正措施通知。
注3：上述定义中所指的“设计和／或制造”可包括医疗器械的规范制定、生产、制造、组装、加工、包装、重新包装、标记、重新标记、灭菌、安装或再制造；或为了医疗目的而将多个器械(可能包括其他产品)组合在一起。
注4：假如组装或修改不改变医疗器械的预期用途，该医疗器械已经由另一自然人或法人按照使用说明书提供给个体患者，组装或修改医疗器械的任何自然人或法人不是制造商。
注5：不是以原制造商的名义更改医疗器械的预期用途或改进医疗器械的任何自然人或法人，使器械以其名义提供使用，宜认为是改进后的医疗器械的制造商。
注6：不覆盖或改变现有标记，只将自己的地址和联系方式加在医疗器械上或包装上的授权代表经销商或进口商，不被认为是制造商。
注7：纳入医疗器械法规要求的附件，负责设计和／或制造该附件的自然人或法人被认为是制造商。
[来源：GHTF／SG1／N055：2009，定义5.1]
3.11
医疗器械 medical device
用于人类的仪器、设备、工具机械、器具、植入物、体外试剂、软件、材料或其他类似或相关物品，其预期使用由制造商确定，不论单独使用或组合使用，以达到下列一个或多个特定的医疗目的：
——疾病的诊断、预防、监护、治疗或缓解；
——损伤的诊断、监护、治疗、缓解或补偿；
——生理结构或生理过程的查验、替代、调节或支持；
——生命的支持或维持；
——妊娠控制；
——医疗器械的消毒；
——通过对取自人体的样本进行体外检查的方式来提供信息。
其作用于人体体内或体表，主要预期功能不是通过药理学、免疫学或代谢的方式实现，但这些方式可有助于实现预期功能。
注：在一些国家或地区可认为是医疗器械但在另一些国家或地区不认为是医疗器械的产品包括但不限于：
——消毒物；
——残障人士的辅助器具；
——包含动物和／或人体组织的器械；
——用于体外受精或辅助生殖技术的器械。
—[来源：GHTF／SG1／N071：2012，定义5.1]
3.12
医疗器械族 medical device family
由同一组织或为同一组织制造的具有有关安全、预期用途和功能的相同的基本设计和性能特性的成组医疗器械。
3.13
性能评价 performance evaluation
评定和分析数据以确立或验证体外诊断医疗器械实现其预期用途的能力。
3.14
上市后监督 post-market surveillance
收集和分析从已经上市的医疗器械获得的经验的系统过程。
3.15
产品 product
过程的结果。
注1：有下列四种通用的产品类别：
——服务(如运输)；
——软件(如计算机程序、字典)；
——硬件(如发动机机械零件)；
——流程性材料(如润滑油)。
许多产品由分属于不同产品类别的成分构成，其属性是服务、软件、硬件或流程性材料取决于产品的主导成分。例如：产品“汽车”是由硬件(如轮胎)、流程性材料(如：燃料、冷却液)、软件(如：发动机控制软件、驾驶员手册)和服务(如销售人员所做的操作说明)所组成。
注2：服务通常是无形的，并且是在供方和顾客接触面上需要完成至少一项活动的结果。服务的提供可涉及，例如：
——在顾客提供的有形产品(如需要维修的汽车)上所完成的活动；
——在顾客提供的无形产品(如为准备纳税申报单所需的损益表)上所完成的活动；
——无形产品的交付(如知识传授方面的信息提供)；
——为顾客创造氛围(如在宾馆和饭店)。
软件由信息组成，通常是无形产品，并可以方法、报告或程序的形式存在。
硬件通常是有形产品，其量具有计数的特性。流程性材料通常是有形产品，其量具有连续的特性。硬件和流程性材料经常被称为货物。
注3：“产品”的此定义不同于GB／T 19000—2016界定的定义。
[来源：改写GB／T 19000—2008)，定义3.4.2]
3.16
采购产品 purchased product
由组织质量管理体系以外的一方提供的产品。
注：提供产品不一定能推断出商业或财务安排。
3.17
风险 risk
伤害发生的概率和该伤害严重度的组合。
注：“风险”的此定义不同于GB／T 19000—2016界定的定义。
[来源：YY／T 0316—2016，定义2.16]
3.18
风险管理 risk management
用于风险分析、评价、控制和监视工作的管理方针、程序及其实践的系统运用。
[来源：YY／T 0316—2016，定义2.22]
3.19
无菌屏障系统 sterile barrier system
防止微生物进入并能使产品在使用地点无菌取用的最小包装。
[来源：GB／T 19633.1—2015，定义3.22]
3.20
无菌医疗器械 sterile medical device
预期满足无菌要求的医疗器械。
注1：对医疗器械无菌的要求，可按照适用的法规要求或标准执行。
4 质量管理体系
4.1 总要求
4.1.1 组织应按照本标准的要求和适用的法规要求将质量管理体系形成文件并保持其有效性。
1) 被GB／T 19000—2016代替。
组织应按照本标准或适用的法规要求建立、实施和保持需要形成文件的所有要求、程序、活动或安排。
组织应将其在适用的法规要求下所承担的一个或多个角色形成文件。
注：组织所承担的角色可能包括制造商、授权代表、进口商或经销商。
4.1.2 组织应：
a) 考虑组织承担的角色来确定质量管理体系所篅的过程及这些过程在整个组织中的应用；
b) 应用基于风险的方法控制质量管理体系所需的适当过程；
c) 确定这些过程的顺序和相互作用。
4.1.3 对于每个质量管理体系过程，组织应：
a) 确定所需的准则和方法，以确保这些过程的有效运行和控制；
b) 确保可获得必要的资源和信息，以支持这些过程的运行和对这些过程的监视；
c) 实施必要的措施，以实现这些过程策划的结果并保持这些过程的有效性；
d) 监视、测量(适当时)和分析这些过程；
e) 建立和保持所需的记录以证实符合本标准并满足适用的法规要求(见4.2.5)。
4.1.4 组织应按照本标准要求和适用的法规要求管理这些质量管理体系过程。更改这些过程应：
a) 评价过程更改对质量管理体系的影响；
b) 评价过程更改对该质量管理体系中所生产的医疗器械的影响；
c) 按照本标准的要求和适用的法规要求进行控制。
4.1.5 若组织选择将影响产品符合要求的任何过程外包，组织应监视这类过程并确保对其进行控制。组织应保留外包过程符合本标准要求、顾客要求和适用的法规要求的责任。控制应与所涉及的风险和外部方满足7.4中要求的能力相适应。控制应包括书面质量协议。
4.1.6 组织应将用于质量管理体系的计算机软件应用的确认程序形成文件。在软件首次使用前应对软件应用进行确认，适当时，软件或其应用更改后也应对软件应用进行确认。
与软件确认和再确认有关的特定方法和活动应与软件使用有关的风险相适应。
应保留这些活动的记录(见4.2.5)。
4.2 文件要求
4.2.1 总则
质量管理体系文件(见4.2.4)应包括：
a) 形成文件的质量方针和质量目标；
b) 质量手册；
c) 本标准所要求的形成文件的程序和记录；
d) 组织确定的为确保其过程有效策划、运行和控制所需的文件，包括记录；
e) 适用的法规要求规定的其他文件。
4.2.2 质量手册
组织应编制质量手册，质量手册包括：
a) 质量管理体系的范围，包括任何删减或不适用的详细说明和理由；
b) 质量管理体系的形成文件的程序或对其引用；
c) 质量管理体系过程之间的相互作用的表述。
质量手册应概述质量管理体系的文件结构。
4.2.3 医疗器械文档
组织应为每个医疗器械类型或医疗器械族建立并保持一个或多个文档，文档包含或引用形成的文件以证明符合本标准要求和适用的法规要求。
文档的内容应包括但不限于：
a) 医疗器械的概述、预期用途／预期目的和标记，包括所有使用说明；
b) 产品规范；
c) 制造、包装、贮存、处置和流通的规范或程序；
d) 测量和监视程序；
e) 适当时，安装要求；
f) 适当时，服务程序。
4.2.4 文件控制
质量管理体系所要求的文件应予控制。记录是一种特殊类型的文件，应依据4.2.5的要求进行控制。
形成文件的程序应规定以下方面所需的控制：
a) 为使文件充分和适宜，文件发布前得到评审和批准；
b) 必要时对文件进行评审与更新，并再次批准；
c) 确保文件的现行修订状态和更改得到识别；
d) 确保在使用处可获得适用文件的有关版本；
e) 确保文件保持清晰、易于识别；
f) 确保组织所确定的策划和运行质量管理体系所需的外来文件得到识别，并控制其分发；
g) 防止文件的损坏或丢失；
h) 防止作废文件的非预期使用，对这些文件进行适当的标识。
组织应确保文件的更改得到原审批部门或指定的其他审批部门的评审和批准，被指定的审批部门应能获取用于做出决定的相关背景资料。
对于至少应保存一份的作废文件，组织应规定其保存期限。此期限应确保至少在组织所规定的医疗器械寿命期内，可得到这些医疗器械的制造和试验的文件，而且还应不少于记录(见4.2.5)或适用的法规要求所规定的保存期限。
4.2.5 记录控制
应保持记录以提供符合要求和质量管理体系有效运行的证据。
组织应建立程序并形成文件，以规定记录的标识、存储、安全和完整性检索、保留时间和处置所需的控制。
按照适用的法规要求，组织应对记录中包含的保密健康信息规定并实施保护方法。
记录应保持清晰、易于识别和检索。记录的更改应保持可识别。
组织应保存记录的期限至少为组织所规定的或适用的法规要求所规定的医疗器械的寿命期，而且还应从组织放行医疗器械起不少于两年。
5 管理职贵
5.1 管理承诺
最高管理者应通过以下活动，对其建立、实施质量管理体系并保持其有效性的承诺提供证据：
a) 向组织传达满足顾客要求以及适用的法规要求的重要性；
b) 制定质量方针；
c) 确保制定质量目标；
d) 进行管理评审；
e) 确保资源的可获得性。
5.2 以顾客为关注焦点
最高管理者应确保顾客要求和适用的法规要求得到确定和满足。
5.3 质量方针
最高管理者应确保质量方针：
a) 适应组织的宗旨；
b) 包括对满足要求和保持质量管理体系有效性的承诺；
c) 为制定和评审质量目标提供框架；
d) 在组织内得到沟通和理解；
e) 在持续适宜性方面得到评审。
5.4 策划
5.4.1 质量目标
最高管理者应确保在组织的相关职能和层次上建立质量目标，质量目标包括满足适用的法规要求和产品要求所需的内容。质量目标应是可测量的，并与质量方针保持一致。
5.4.2 质量理体系策划
最高管理者应确保：
a) 对质量管理体系进行策划，以满足4.1的要求以及质量目标；
b) 在策划和实施质量管理体系变更时保持其完整性。
5.5 职责、权限与沟通
5.5.1 职责和权限
最高管理者应确保职责和权限得到规定、形成文件并在组织内沟通。
最高管理者应将所有从事对质量有影响的管理、执行和验证工作的人员的相互关系形成文件，并应确保其完成这些任务所必要的独立性和权限。
5.5.2 管理者代表
最高管理者应在管理层中指定一名成员，无论该成员在其他方面的职责如何，应使其具有以下方面的职责和权限：
a) 确保将质量管理体系所需的过程形成文件；
b) 向最高管理者报告质量管理体系的有效性和任何改进的需求；
c) 确保在整个组织内提高满足适用的法规要求和质量管理体系要求的意识。
5.5.3 内部沟通
最高管理者应确保在组织内建立适当的沟通过程，并确保对质量管理体系的有效性进行沟通。
5.6 管理评审
5.6.1 总则
组织应将管理评审程序形成文件。最高管理者应按照形成文件的策划的时间间隔对组织的质量管理体系进行评审，以确保其持续的适宜性、充分性和有效性。评审应包括评价改进的机会和质量管理体系变更的篅求，包括质量方针和质量目标变更的需求。
应保留管理评审的记录(见4.2.5)。
5.6.2 评审输入
管理评审的输入应包括但不限于由以下方面产生的信息：
a) 反馈；
b) 投诉处置；
c) 给监管机构的报告；
d) 审核；
e) 过程的监视和测量；
f) 产品的监视和测量；
g) 纠正措施；
h) 预防措施；
i) 以往管理评审的跟踪措施；
j) 可能影响质量管理体系的变更；
k) 改进的建议；
l) 适用的新的或修订的法规要求。
5.6.3 评审输出
管理评审的输出应予记录(见4.2.5)并包括经评审的输入和与以下方面有关的任何决定和措施：
a) 保持质量管理体系及其过程适宜性、充分性和有效性所需的改进；
b) 与顾客要求有关的产品的改进；
c) 响应适用的新的或修订的法规要求所需的变更；
d) 资源需求。
6 资源管理
6.1 资源提供
组织应确定并提供所需的资源，以：
a) 实施质量管理体系并保持其有效性；
b) 满足适用的法规要求和顾客要求。
6.2 人力资源
基于适当的教育、培训、技能和经验，从事影响产品质量工作的人员应是胜任的。
组织应将确立能力、提供所需的培训和确保人员的意识等一个或多个过程形成文件。
组织应：
a) 确定从事影响产品质量工作的人员所需具备的能力；
b) 提供培训或采取其他措施以获得或保持所需的能力；
c) 评价所采取措施的有效性；
d) 确保组织的人员知晓所从事活动的关联性和重要性，以及如何为实现质量目标做出贡献；
e) 保留教育、培训、技能和经验的适当记录(见4.2.5)。
注：对于提供培训或采取其他措施的有效性的检查方法应与工作相关的风险相适应。
6.3 基础设施
为达到符合产品要求、防止产品混淆和确保产品有序处置，组织应将所需的基础设施的要求形成文件。适当时，基础设施包括：
a) 建筑物、工作场所和相关设施；
b) 过程设备(硬件和软件)；
c) 支持性服务(如运输、通讯或信息系统)。
若维护活动或缺少维护活动可能影响产品质量，组织应将此类维护活动的要求包括执行维护活动的时间间隔形成文件。适当时，要求应适用于生产设备、工作环境控制设备和监视测量设备。
应保留此类维护的记录(见4.2.5)。
6.4 工作环境和污染控制
6.4.1 工作环境
组织应将为达到符合产品要求所需工作环境的要求形成文件。
如果工作环境条件可能对产品质量有不良影响，组织应将工作环境要求以及监视和控制工作环境的程序形成文件。
组织应：
a) 将对特定人员的健康、清洁和着装要求形成文件，此类人员与产品或工作环境的接触可能影响医疗器械的安全或性能；
b) 确保需要在工作环境内的特殊环境条件下临时工作的所有人员是胜任的或在胜任人员监督下工作。
注：更多信息见ISO 14644和ISO 14698。
6.4.2 污染控制
适当时，为了防止对工作环境人员或产品的污染，组织对受污染或易受污染产品的控制应进行策划并将安排形成文件。
对于无菌医疗器械，组织应将控制微生物或微粒物污染的要求形成文件，在组装或包装过程中保持所要求的洁净度。
7 产品实现
7.1 产品实现的策划
组织应策划和开发产品实现所需的过程。产品实现的策划应与质量管理体系其他过程的要求相一致。
组织应在产品实现过程中，将风险管理的一个或多个过程形成文件。应保留风险管理活动的记录(见4.2.5)。
在策划产品实现的过程中，适当时，组织应确定以下方面的内容：
a) 产品的质量目标和要求；
b) 针对产品建立过程、文件(见4.2.4)和提供资源的需求，包括基础设施和工作环境；
c) 针对产品所要求的验证、确认、监视、测量、检验和试验、处置、贮存、流通和可追溯性活动以及产品接收准则；
d) 为实现过程及其产品满足要求提供证据所需的记录(见4.2.5)。
此策划的输出应以适合于组织运行方式的形式形成文件。
注：更多信息见ISO 14971。
7.2 与顾客有关的过程
7.2.1 产品要求的确定
组织应确定：
a) 顾客规定的要求，包括对交付及交付后活动的要求；
b) 顾客虽然没有明示，但规定的用途或已知的预期用途所必需的要求；
c) 与产品有关的适用的法规要求；
d) 确保医疗器械的特定性能和安全使用所需的任何用户培训；
e) 组织确定的任何附加要求。
7.2.2 产品要求的评审
组织应评审与产品有关的要求。评审应在组织向顾客做出提供产品的承诺(如提交投标书、接受合同或订单以及接受合同或订单的更改)前进行并应确保：
a) 产品要求已得到规定并形成文件；
b) 与以前表述不一致的合同或订单要求已得到解决；
c) 满足适用的法规要求；
d) 依照7.2.1识别的任何用户培训是可获得的或按计划是可获得的；
e) 组织有能力满足规定的要求。
应保留评审结果及评审所引起的措施的记录(见4.2.5)。
若顾客没有提供形成文件的要求，组织在接受顾客要求前应对顾客要求进行确认。
若产品要求发生更改，组织应确保相关文件得到修改，并确保相关人员知道已更改的要求。
7.2.3 沟通
组织应就以下方面与顾客的沟通进行策划并将安排形成文件：
a) 产品信息；
b) 处理问询、合同或订单，包括更改；
c) 顾客反馈，包括投诉；
d) 忠告性通知。
组织应按照适用的法规要求与监管机构沟通。
7.3 设计和开发
7.3.1 总则
组织应将设计和开发程序形成文件。
7.3.2 设计和开发策划
组织应对产品的设计和开发进行策划和控制。适当时，随着设计和开发的进展，应保持并更新设计和开发策划文件。
在设计和开发策划期间，组织应将以下方面形成文件：
a) 设计和开发的各个阶段；
b) 每个设计和开发阶段所需的一个或多个评审；
c) 适合于每个设计和开发阶段的验证确认和设计转换活动；
d) 设计和开发的职责和权限；
e) 确保设计和开发输出到设计和开发输入的可追溯的方法；
f) 所需的资源，包括必要的人员能力。
7.3.3 设计和开发输入
应确定与产品要求有关的输入，并保留记录(见4.2.5)，这些输入应包括：
a) 根据预期用途所确定的功能、性能、可用性和安全要求；
b) 适用的法规要求和标准；
c) 适用的风险管理的一个或多个输出；
d) 适当时，来源于以前类似设计的信息；
e) 产品和过程的设计和开发所必需的其他要求。
应对这些输入进行评审，以确保输入是充分和适宜的，并经批准。
这些要求应完整、清楚，能够被验证或确认，并且不能互相矛盾。
注：更多信息见IEC 62366-1。
7.3.4 设计和开发输出
设计和开发输出应：
a) 满足设计和开发输入的要求；
b) 给出采购生产和服务提供的适当信息；
c) 包括或引用产品接收准则；
d) 规定产品特征，该特性对于产品的安全和正确使用是必需的。
设计和开发输出的方式应适合于对照设计和开发输入进行验证，设计和开发输出应在发布前得到批准。
应保留设计和开发输出的记录(见4.2.5)。
7.3.5 设计和开发评审
应依据所策划并形成文件的安排，在适宜的阶段对设计和开发进行系统评审，以：
a) 评价设计和开发的结果满足要求的能力；
b) 识别并提议必要的措施。
评审的参加者应包括与所评审的设计和开发阶段有关的职能的代表以及其他专业人员。
应保留评审结果和任何必要措施的记录，包括所评审的设计、涉及的参加者和评审日期(见4.2.5)。
7.3.6 设计和开发验证
为确保设计和开发输出满足设计和开发输入的要求，应依据所策划并形成文件的安排对设计和开发进行验证。
组织应将验证计划形成文件，验证计划包括方法、接收准则，适当时包括包含样本量原理的统计技术。
如果预期用途要求医疗器械连接至或通过接口连接至其他的一个或多个医疗器械，验证应包括证实当这样连接或通过接口连接时设计输出满足设计输入的要求。
应保留验证结果和结论及必要措施的记录(见4.2.4和4.2.5)。
7.3.7 设计和开发确认
为确保产品能够满足规定的应用要求或预期用途要求，应依据策划并形成文件的安排对设计和开发进行确认。
组织应将确认计划形成文件，确认计划包括方法、接收准则，适当时包括包含样本量原理的统计技术。
设计确认应选择有代表性产品进行。有代表性产品包括最初的生产单元批次或其等同品。应记录用于确认的产品选择的理由说明(见4.2.5)。
作为设计和开发确认的一部分，组织应按照适用的法规要求进行医疗器械临床评价或性能评价。用于临床评价或性能评价的医疗器械不视为放行给顾客使用。
如果预期用途要求医疗器械连接至或通过接口连接至其他的一个或多个医疗器械，确认应包括证实当这样连接或通过接口连接时已满足规定的应用要求或预期用途。
确认应在向顾客放行产品使用前完成。
应保留确认结果和结论及必要措施的记录(见4.2.4和4.2.5)。
7.3.8 设计和开发转换
组织应将设计和开发输出向制造转换的程序形成文件。这些程序应确保设计和开发输出在成为最终生产规范前经验证适合于制造并确保生产能力能满足产品要求。
应记录转换的结果和结论(见4.2.5)。
7.3.9 设计和开发更改的控制
组织应将控制设计和开发更改的程序形成文件。组织应确定更改对于医疗器械功能、性能、可用性、安全、适用的法规要求及其预期用途等的重要程度。
应识别设计和开发的更改。更改在实施前应经：
a) 评审；
b) 验证；
c) 适当时，确认；
d) 批准。
设计和开发更改的评审应包括评价更改对在制的或已交付的组成部件和产品的影响，以及对风险管理的输入或输出和产品实现过程的影响。
应保留更改及其评审和任何必要的措施的记录(见4.2.5)。
7.3.10 设计和开发文档
组织应为每个医疗器械类型或医疗器械族保留设计和开发文档。该文档应包含或引用形成的记录以证明符合设计和开发要求，该文档还应包含设计和开发更改的记录。
