YY/T 0287-2017 English PDF (YYT0287-2017)

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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 fa...