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YY/T 0287-2017 PDF English (YY/T 0287-2003: Older version)Search result: YY/T 0287-2017 (YY/T 0287-2003 Older version)
YY/T0287-2017 (YYT0287-2017): PDF in EnglishYY/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 t.......Source: https://www.ChineseStandard.net/PDF.aspx/YYT0287-2017 |