YY/T 0287-2017 PDF in English
YY/T 0287-2017 (YY/T0287-2017, YYT 0287-2017, YYT0287-2017)
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Medical devices -- Quality management systems -- Requirements for regulatory purposes
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Medical devices. Quality management systems. Requirements for regulatory purposes
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Quality system—Medical devices—Particular requirements for the application of GB/T 19001—ISO 9001
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Standards related to (historical): YY/T 0287-2017
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YY/T 0287-2017: PDF in English (YYT 0287-2017) YY/T 0287-2017
Medical devices -- Quality management systems -- Requirements for regulatory purposes
ICS 11.040.01;03.120.10
C30
People's Republic of China Pharmaceutical Industry Standard
Replacing YY/T 0287-2003
Medical Device Quality Management System
Used for regulatory requirements
(ISO 13485.2016, IDT)
Published on.2017-01-19
2017-05-01 Implementation
The State Food and Drug Administration issued
Directory
Foreword V
Introduction VI
1 Range 1
2 Normative references 1
3 Terms and Definitions 1
4 Quality Management System 4
4.1 General Requirements 4
4.2 Document Requirements 5
4.2.1 General 5
4.2.2 Quality Manual 5
4.2.3 Medical Device Documentation 6
4.2.4 File Control 6
4.2.5 Record Control 6
5 Management responsibilities 6
5.1 Management Commitment 6
5.2 Focus on Customers 7
5.3 Quality Policy 7
5.4 Planning 7
5.4.1 Quality Objective 7
5.4.2 Quality Management System Planning 7
5.5 Responsibility, Authorization and Communication 7
5.5.1 Responsibilities and Permissions 7
5.5.2 Management Representative 7
5.5.3 Internal Communication 7
5.6 Management Review 8
5.6.1 General 8
5.6.2 Review Input 8
5.6.3 Review Output 8
6 Resource Management 8
6.1 Resource Availability 8
6.2 Human Resources 8
6.3 Infrastructure 9
6.4 Work Environment and Pollution Control 9
6.4.1 Working Environment 9
6.4.2 Pollution Control 9
7 Product realization 9
7.1 Planning for product realization 9
7.2 Processes Related to Customers 10
7.2.1 Determination of product requirements 10
7.2.2 Review of Product Requirements 10
7.2.3 Communication 10
7.3 Design and Development 10
7.3.1 General 10
7.3.2 Design and Development Planning 10
7.3.3 Design and Development Input 11
7.3.4 Design and Development Output 11
7.3.5 Design and Development Review 11
7.3.6 Design and Development Verification 11
7.3.7 Design and Development Confirmation 12
7.3.8 Design and Development Conversion 12
7.3.9 Designing and Developing Changed Controls 12
7.3.10 Design and Development Documentation 12
7.4 Procurement 12
7.4.1 Procurement Process 12
7.4.2 Purchase Information 13
7.4.3 Verification of Procured Products 13
7.5 Production and Service Delivery 13
7.5.1 Control of Production and Service Delivery 13
7.5.2 Cleaning of products 14
7.5.3 Installation Activity 14
7.5.4 Service Activity 14
7.5.5 Special Requirements for Sterile Medical Devices 14
7.5.6 Confirmation of Production and Service Delivery Process 14
7.5.7 Special requirements for confirmation of sterilization process and sterile barrier system 15
7.5.8 Identification 15
7.5.9 Traceability 15
7.5.10 Customer Property 15
7.5.11 Product Protection 15
7.6 Monitoring and Measuring Equipment Control 16
8 Measurement, Analysis and Improvement 16
8.1 General 16
8.2 Surveillance and Measurement 16
8.2.1 Feedback 16
8.2.2 Disposal 17
8.2.3 Reporting to Regulators 17
8.2.4 Internal Audit 17
8.2.5 Monitoring and Measurement of Processes 17
8.2.6 Surveillance and Measurement of Products 17
8.3 Nonconforming Product Control 18
8.3.1 General 18
8.3.2 Responsive Measures for Unqualified Products before Delivery 18
8.3.3 Responsive Measures for Unqualified Products after Delivery 18
8.3.4 Rework 18
8.4 Data Analysis 18
8.5 Improvement 19
8.5.1 General 19
8.5.2 Corrective Action 19
8.5.3 Preventive measures 19
Reference 30
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0287-2003 “Requirements for the Use of Medical Device Quality Management Systems for Regulations”, and YY/T 0287-
Compared with the main technical changes in.2003 are as follows.
--- Highlight the importance of regulatory requirements;
--- Expand the scope of application;
---Enhanced risk management requirements;
--- Increased requirements for communicating with regulators and reporting to regulatory agencies;
---Strengthen the requirements for post-market supervision and management;
--- Increased requirements for the formation of documents and records.
This standard uses the translation method equivalent to the adoption of the international standard ISO 13485.2016 "Medical Device Quality Management System for Regulations
Claim".
Please note that some of the contents of this document may involve patents. The issuing agency of this document does not assume responsibility for identifying these patents.
This standard is proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC221).
This standard was drafted by. Beijing National Medical Machinery Huaguang Certification Co., Ltd.
The main drafters of this standard. Milan Ying, Chang Jia, Zheng Yixi, Li Zhaohui, Li Xin, Wang Meiying, Chen Zhigang.
The previous versions of the standards replaced by this standard are.
---YY/T 0287-1996, YY/T 0287-2003.
introduction
0.1 General
This standard stipulates the requirements of the quality management system. Organizations involved in one or more stages of the life cycle of medical devices can follow this requirement.
Medical device design and development, production, storage and distribution, installation, service and eventual decommissioning and disposal, and related activities (eg, technical support
Design and development or supply. The requirements of this standard can also be used to provide products (such as raw materials, components, components, medical supplies) to such organizations.
Suppliers or other external parties of equipment, sterilization services, calibration services, distribution services, maintenance services. The supplier or external party can voluntarily choose the symbol
Meet the requirements of this standard or meet the requirements of this standard as required by the contract.
Some jurisdictions have regulatory requirements for the application of quality management systems to organizations serving various roles in the medical device supply chain. Therefore, this standard
Quasi-expected organization.
--- Identify one or more roles of the organization in accordance with applicable regulatory requirements;
--- Identify the regulatory requirements applicable to organizational activities based on these roles;
---Incorporate these applicable regulatory requirements into the organization's quality management system.
The definitions in the applicable regulatory requirements vary from country to country. The organization needs to comply with the law applicable to the jurisdiction of the medical device
The definition in the regulations interprets the definition of this standard.
This standard can also be used by internal and external parties (including certification bodies) to assess that the organization meets customer requirements and applies to quality management systems.
Regulatory requirements and the organization's own requirements. It is worth emphasizing that the requirements of the quality management system stipulated in this standard are
The addition of this requirement is necessary to meet customer requirements as well as applicable regulatory requirements in terms of safety and performance.
The adoption of a quality management system is a strategic decision of the organization. The design and implementation of an organization’s quality management system is subject to the following factors.
influences.
a) Impact of the organizational environment, environmental changes and organizational environment on the compliance of medical devices;
b) Organize changing needs;
c) the specific goals of the organization;
d) the products provided by the organization;
e) the process used by the organization;
f) the size and organization of the organization;
g) Regulatory requirements applicable to organizational activities.
The implementation of this standard does not mean that there is a need to unify the structure of different quality management systems, to harmonize documents, or to form a structure with the terms of this standard.
Consistent documents.
There are many types of medical devices. Some of the specific requirements specified in this standard apply only to the designated medical device category. This standard
Chapter 3 gives definitions of these categories.
0.2 clarify the concept
An explanation of the following terms or phrases in this standard.
--- When the phrase "appropriately" modifies a requirement, it is generally considered that the requirement is appropriate unless the organization can provide other reasonable reasons.
by. If a requirement is required for any of the following, the requirement is considered appropriate.
---Product meets requirements;
--- Meet applicable regulatory requirements;
--- Organize implementation of corrective measures;
---Organize management risk.
--- When the term "risk" is used, the application of this term within the scope of this standard relates to the safety or performance requirements or satisfaction of medical devices.
Applicable regulatory requirements.
---When a requirement requires "documentation," it also needs to be established, implemented, and maintained.
--- When the term "product" is used, it also means "service." The product is suitable for the customer's desired or required output or product implementation process
Any expected output formed.
--- When the term "regulatory requirements" is used, it covers any laws and regulations (such as laws, regulations, regulations) applicable to users of this standard
Or instruction) requirements. Application of the term "regulatory requirements" is limited to quality management system requirements and safety or performance of medical devices
Claim.
Use the following auxiliary verbs in this standard.
--- "Shall" indicate requirements;
--- "Yi" means proposal;
--- "Can" indicates permission;
--- "Can" means possible or able;
"Note" is a guide to understand or explain the requirements.
0.3 Process Method
This standard is based on the quality management process method. Any activity that receives input and converts it into output can be treated as a process. through
Often, the output of one process directly forms the input to the next process.
For an organization to operate effectively, it needs to identify and manage many interconnected processes. In order to achieve the desired result, a system of processes is
The applications within the organization, together with the identification and interaction of these processes, and the management of these processes, are called "process methods."
The use of this process approach in quality management systems emphasizes the importance of.
a) understand and meet requirements;
b) consider the process from the perspective of value added;
c) Obtain results of process performance and effectiveness;
d) Improve the process based on objective measurements.
0.4 Relationship with ISO 9001
This standard is an independent standard based on GB/T 19001-2008. For the convenience of users, Appendix B gives the standard and
GB/T 19001-2016 (instead of GB/T 19001-2008) correspondence.
ISO 13485.2016 aims to promote the harmonization of appropriate regulatory requirements for quality management systems worldwide.
Used for organizations that involve one or more stages of the medical device life cycle. This standard covers organizations involved in the life cycle of medical devices
Some of the specific requirements have eliminated those requirements in ISO 9001 that are not suitable for regulatory requirements. Due to these deletions, the quality management system
Organizations that meet this standard cannot claim to conform to the ISO 9001 standard unless their quality management system meets all requirements of ISO 9001.
0.5 Compatibility with other management systems
This standard does not include requirements for other management systems, such as specific requirements for environmental management, occupational health and safety management, or financial management.
begging. However, this standard enables the organization to coordinate or integrate its own quality management system with related management system requirements. Organization for
The establishment of a quality management system that meets the requirements of this standard may change one or more of its current management systems.
Medical Device Quality Management System
Used for regulatory requirements
1 Scope
This standard is for medical devices and related services that need to prove their ability to provide continuous compliance with customer requirements and applicable regulatory requirements.
The organization specifies the quality management system requirements. Such organizations can cover one or more stages of the medical device life cycle, including medical devices.
The design and development, production, storage and distribution, installation or service, and the design and development or provision of related activities (eg technical support). this
Standards can also be used to provide suppliers or external parties with products (including those related to quality management systems) to such organizations.
Unless otherwise specified, the requirements of this standard apply to organizations of all sizes and types. This standard applies to medical devices with the same requirements
This applies to the related services provided by the organization.
For the process required by this standard that is applicable to the organization but not implemented by the organization, the organization organizes monitoring and maintenance in the quality management system.
And it is responsible for controlling these processes.
If the applicable regulatory requirements permit the deletion of design and development controls, it can serve as a deduction from the quality management system.
by. If these regulations require other methods, these methods should be described in the quality management system. The organization has the responsibility to ensure that
The deletion of any design and development controls is explicitly stated in the declaration of this standard.
Any of the requirements in Chapter 6, 7 or 8 of this standard, if any of the medical devices involved in the activities or quality management system
When characteristics do not apply, organizations do not need to include such requirements in their quality management system. For any articles that have been determined not to be applicable, the group
Weave records its reason according to the requirements of 4.2.2.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article
Pieces. For undated references, the latest version (including all amendments) applies to this document.
GB/T 19000-2016 Quality Management System Foundation and Terminology (ISO 9000.2015, IDT)
3 Terms and Definitions
The definitions of GB/T 19000-2016 and the following terms and definitions apply to this document.
3.1
Advisory notice advisorynotice
A notice issued by the organization after the delivery of the medical device to provide additional information or suggest actions to be taken.
--- Use of medical devices;
---Changes in medical devices;
--- Medical device returned to the organization; or
--- The destruction of medical devices.
Note. The publication of advisory notices may require compliance with applicable regulatory requirements.
3.2
Authorized representative authorized delegate
In countries or jurisdictions, authorized by the manufacturer in writing and in accordance with the laws of the country or jurisdiction, on behalf of the manufacturer
The natural or legal person assigned to the task related to his or her duties.
[Source. GHTF/SG1/N055.2009, Definition 5.2]
3.3
Clinical evaluation
Assess and analyze clinical data related to medical devices to verify the clinical safety and performance of the device as intended by the manufacturer.
[Source. GHTF/SG5/N4.2010, Chapter 4]
3.4
Complaint
Medical devices that have been released from the organization’s control exist with presence, identity, quality, durability, reliability, availability, safety, or performance
There are inadequate written, electronic, or verbal communication of defects or services that claim to affect the performance of these medical devices.
Note. This definition of "complaint" is different from the definition defined by GB/T 19000-2016.
3.5
Distributor distributor
Natural or legal persons in the supply chain who represent themselves to sell medical devices to end users.
Note 1. Multiple dealers may be involved in the supply chain.
NOTE 2 Persons involved in such activities as storage and transport activities in the supply chain on behalf of manufacturers, importers or distributors are not distributors in this definition.
[Source. GHTF/SG1/N055, Definition 5.3]
3.6
Implantable medical devices implantablemedicaldevice
Medical devices that can only be removed by medical or surgical surgery are expected to.
--- Is inserted in whole or in part in the human body or in the natural cavity, or in place of the epidermis or the surface of the eye;
--- And stay at least 30 days.
Note. The definition of implantable medical devices includes active implantable medical devices.
3.7
Importer importer
The first nature in the supply chain that enables medical devices manufactured in other countries or jurisdictions to be sold in the countries or jurisdictions to be listed
Person or legal person.
[Source. GHTF/SG1/N055.2009, Definition 5.4]
3.8
Labeling
Labels, instruction manuals, and any other information related to the identification, technical description, intended use, and proper use of the medical device, but not
Including shipping documents.
[Source. GHTF/SG1/N70.2011, Chapter 4]
3.9
Life cycle
In the life of medical devices, from the initial concept to all stages of final decommissioning and disposal.
[Source. YY/T 0316-2016, Definition 2.7]
3.10
Manufacturer manufacturer
Natural or legal persons who, in their name, manufacture the medical equipment that is expected to be used and bear the medical device design and/or manufacturing responsibilities, regardless of
The design and/or manufacture of the therapeutic device is performed by the natural or legal person or performed by another natural person or natural persons or legal persons on their behalf.
Note 1. This “natural person or legal person” has the final law to ensure compliance with all applicable regulatory requirements in the country or jurisdiction where the medical device is expected to be available or sold.
Liability, unless the regulatory agency (RA) in the jurisdiction explicitly imposes that responsibility on another natural or legal person.
Note 2. Manufacturer's responsibilities are described in other GHTF guidance documents. These responsibilities include meeting pre-listing requirements and post-listing requirements, such as bad things
Report and corrective action notice.
Note 3. The "design and/or manufacture" referred to in the above definition may include the specification, production, manufacture, assembly, processing, packaging, repackaging, and labeling of medical devices.
Record, re-label, sterilize, install, or remanufacture; or combine multiple instruments (which may include other products) for medical purposes.
Note 4. If the assembly or modification does not change the intended use of the medical device, the medical device has been provided by another natural or legal person in accordance with the instructions for use.
A physical patient, any natural or legal person who assembles or modifies a medical device is not a manufacturer.
Note 5. Any natural or legal person who does not change the intended use of the medical device or improve the medical device in the name of the original manufacturer, so that the device is provided on its behalf
Use should be considered as a manufacturer of improved medical devices.
Note 6. Authorized representatives, distributors or importers who do not overwrite or change the existing mark and add their own address and contact information to or on the medical device.
Not considered as a manufacturer.
Note 7. Annexes that incorporate regulatory requirements for medical devices, natural or legal persons responsible for the design and/or manufacture of such attachments are considered to be manufacturers.
[Source. GHTF/SG1/N055.2009, Definition 5.1]
3.11
Medical device medicaldevice
Instruments, equipment, tools, machinery, appliances, implants, in vitro reagents, software, materials, or other similar or related items used in humans.
The intended use is determined by the manufacturer, whether used alone or in combination, to achieve one or more of the following specific medical purposes.
--- diagnosis, prevention, surveillance, treatment or relief of disease;
--- Diagnosis, monitoring, treatment, mitigation or compensation of injuries;
--- Examination, substitution, adjustment or support of physiological structures or physiological processes;
--- Support or maintenance of life;
--- Pregnancy control;
---Disinfection of medical devices;
--- Information is provided through in vitro examination of samples taken from the human body.
It acts on the human body or on the body surface. The main expected function is not through pharmacology, immunology or metabolism, but these methods
Can help achieve the desired functionality.
Note. Products that may be considered as medical devices in some countries or regions but are not considered as medical devices in other countries or regions include, but are not limited to.
--- Disinfectant;
---Aids for persons with disabilities;
--- Instruments containing animals and/or human tissues;
--- Instruments for in vitro fertilization or assisted reproductive technology.
[Source. GHTF/SG1/N071.2012, Definition 5.1]
3.12
Medical device family medicaldevicefamily
The same basic design and performance characteristics that are made by the same organization or for the same organization with regard to safety, intended use, and functionality
Group medical devices.
3.13
Performance evaluation performance evaluation
Assess and analyze data to establish or validate the ability of in vitro diagnostic medical devices to achieve their intended use.
3.14
Post-market surveillance post-marketsurveilance
The systematic process of collecting and analyzing experience gained from marketed medical devices.
3.15
Product
The result of the process.
Note 1. There are the following four generic product categories.
--- Services (such as transportation);
--- Software (such as computer programs, dictionaries);
--- Hardware (such as engine mechanical parts);
--- Process materials (such as lubricating oil).
Many products consist of components that belong to different product categories. Their attributes are services, software, hardware, or process-related materials, depending on the product's leading performance.
Minute. For example. The product "car" is made of hardware (such as tires), process material (such as. fuel, coolant), software (such as. engine control software, driver
Manual) and services (such as the sales staff's instructions).
Note 2. Services are generally intangible and are the result of the need to complete at least one activity at the supplier and customer interface. The provision of services can involve, for example.
--- Activities performed on customer-supplied tangible products (such as cars that need repair);
--- Activities completed on customer-supplied intangible products (such as the income statement needed to prepare tax returns);
--- Delivery of intangible products (such as providing information on knowledge transfer);
--- Create atmosphere for customers (such as hotels and restaurants).
Software consists of information, usually intangible products, and can exist in the form of methods, reports or procedures.
Hardware is usually a tangible product whose quantity has the characteristic of counting. Process material is usually a tangible product whose amount has continuous characteristics. Hardware and flow
Process materials are often referred to as goods.
Note 3. This definition of "product" is different from the definition defined in GB/T 19000-2016.
[Source. Rewrite GB/T 19000-20081], Definition 3.4.2]
1) Replaced by GB/T 19000-2016.
3.16
Purchasedproduct
Products provided by a party other than the organization's quality management system.
Note. The provision of products cannot necessarily infer business or financial arrangements.
3.17
Risk risk
The probability of injury occurring and the severity of the damage.
Note. This definition of "risk" is different from the definition defined by GB/T 19000-2016.
[Source. YY/T 0316-2016, definition 2.16]
3.18
Risk Management riskmanagement
Systematic application of management guidelines, procedures and practices for risk analysis, evaluation, control and monitoring.
[Source. YY/T 0316-2016, definition 2.22]
3.19
Sterile barrier system sterilebarriersystem
The minimum package that prevents the entry of microorganisms and enables the product to be used sterilely at the point of use.
[Source. GB/T 19633.1-2015, definition 3.22]
3.20
Sterile medical device stereomedicaldevice
Medical devices that are expected to meet sterility requirements.
Note 1. The sterility requirements for medical devices may be implemented in accordance with applicable regulatory requirements or standards.
4 Quality Management System
4.1 General requirements
4.1.1 The organization shall document and maintain the effectiveness of the quality management system in accordance with the requirements of this standard and applicable regulatory requirements.
The organization shall establish, implement, and maintain all requirements, procedures, activities, or documents that need to be documented in accordance with this standard or applicable regulations.
arrangement.
The organization should document one or more of its roles under the applicable regulatory requirements.
Note. The roles undertaken by the organization may include manufacturers, authorized representatives, importers, or distributors.
4.1.2 The organization shall.
a) consider the roles assumed by the organization to determine the processes required for the quality management system and the application of these processes throughout the organization;
b) apply risk-based methods to control the appropriate processes required for the quality management system;
c) Determine the sequence and interaction of these processes.
4.1.3 For each quality management system process, the organization shall.
a) Determine the required criteria and methods to ensure the effective operation and control of these processes;
b) Ensure that the necessary resources and information are available to support the operatio......
......
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.
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