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YY/T 0287-2017: Medical devices -- Quality management systems -- Requirements for regulatory purposes
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 stand...