Powered by Google-Search & Google-Books Chinese Standards Shop Database: 169760 (Oct 24, 2020)
HOME   Quotation   Tax   Examples Standard-List   Contact-Us   View-Cart
  

YY/T 0595-2020

Chinese Standard: 'YY/T 0595-2020'
Standard IDContents [version]USDSTEP2[PDF] delivered inStandard Title (Description)StatusRelated Standard
YY/T 0595-2020English2039 Add to Cart Days<=13 Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017 Valid YY/T 0595-2020
YY/T 0595-2020Chinese49 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House] Valid

   

BASIC DATA
Standard ID YY/T 0595-2020 (YY/T0595-2020)
Description (Translated English) Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017
Sector / Industry Medical Device & Pharmaceutical Industry Standard (Recommended)
Classification of Chinese Standard C30
Classification of International Standard 11.040.01; 03.120.10
Word Count Estimation 102,149
Date of Issue 2020-02-21
Date of Implementation 2020-04-01
Drafting Organization Beijing SINOMACH Huaguang Certification Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Wandong Medical Technology Co., Ltd., Shanghai Lianying Medical Technology Co., Ltd., Shanghai MicroPort Medical Devices (Group) Co., Ltd.
Administrative Organization National Medical Device Quality Management and General Requirements Standardization Technical Committee (SAC/TC 221)
Proposing organization State Drug Administration
Issuing agency(ies) National Medical Products Administration

YY/T 0595-2020
Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017
ICS 11.040.01; 03.120.10
C30
People's Republic of China Pharmaceutical Industry Standard
Replace YY/T 0595-2006
Medical device quality management system
YY/T 0287-2017 Application Guide
applicationofYY/T 0287-2017
Released on 2020-02-21
2020-04-01 Implementation
Issued by the State Drug Administration
Contents
Foreword Ⅴ
Introduction Ⅵ
1 Scope 1
2 Normative references 1
3 Terms and definitions 2
4 Quality management system 2
4.1 General requirements 2
4.2 Document requirements 6
4.2.1 General 6
4.2.2 Quality Manual 7
4.2.3 Medical Device Document 8
4.2.4 File Control 9
4.2.5 Record control 10
5 Management Responsibilities 12
5.1 Management Commitment 12
5.2 Focus on customers 13
5.3 Quality policy 14
5.4 Planning 14
5.4.1 Quality objectives 14
5.4.2 Quality management system planning 15
5.5 Responsibility, authority and communication 15
5.5.1 Responsibilities and authorities 15
5.5.2 Management representative 16
5.5.3 Internal communication 16
5.6 Management review 17
5.6.1 General 17
5.6.2 Review input 18
5.6.3 Review output 19
6 Resource Management 20
6.1 Resource provision 20
6.2 Human resources 20
6.3 Infrastructure 22
6.4 Work environment and pollution control 23
6.4.1 Working environment 23
6.4.2 Pollution control 25
7 Product realization 25
7.1 Planning of product realization 25
7.2 Customer-related processes 28
7.2.1 Determination of product requirements 28
7.2.2 Review of product requirements 28
7.2.3 Communication 29
7.3 Design and development 30
7.3.1 General 30
7.3.2 Design and development planning 32
7.3.3 Design and development inputs 33
7.3.4 Design and development output 35
7.3.5 Design and development review 36
7.3.6 Design and development verification 38
7.3.7 Design and development validation 39
7.3.8 Design and development conversion 40
7.3.9 Control of design and development changes 40
7.3.10 Design and development documentation 42
7.4 Procurement 43
7.4.1 Purchasing process 43
7.4.2 Purchasing information 46
7.4.3 Verification of purchased products 47
7.5 Production and service provision 48
7.5.1 Control of production and service provision 48
7.5.2 Cleaning of the product 50
7.5.3 Installation activities 51
7.5.4 Service activities 51
7.5.5 Special requirements for sterile medical devices 52
7.5.6 Validation of production and service provision processes 53
7.5.7 Special requirements for sterilization process and validation of sterile barrier systems 54
7.5.8 Logo 55
7.5.9 Traceability 56
7.5.10 Customer property 58
7.5.11 Product protection 58
7.6 Control of monitoring and measuring equipment 59
8 Measurement, analysis and improvement 61
8.1 General 61
8.2 Monitoring and measurement 64
8.2.1 Feedback 64
8.2.2 Complaint handling 65
8.2.3 Report to the regulator 67
8.2.4 Internal audit 67
8.2.5 Process monitoring and measurement 68
8.2.6 Product monitoring and measurement 69
8.3 Control of nonconforming product 70
8.3.1 General 70
8.3.2 Response measures for unqualified products found before delivery 71
8.3.3 Response measures for unqualified products found after delivery 72
8.3.4 Rework 73
8.4 Data analysis 73
8.5 Improvement 76
8.5.1 General 76
8.5.2 Corrective measures 78
8.5.3 Preventive measures 80
Appendix A (informative appendix) Example process of incorporating applicable regulatory requirements into the quality management system 82
Appendix B (informative appendix) YY/T 0287-2017 and "Medical Device Manufacturing Quality Management Specification" (issued on December 29,.2014)
And the corresponding example of the appendix 87
References 92
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY/T 0595-2006 "Medical Device Quality Management System YY/T 0287-2003 Application Guide", and
Compared with YY/T 0595-2006, the main technical changes are as follows.
--- Based on the text of YY/T 0287-2017, revised the guidelines of the articles in the text;
--- Added "Examples of the process of incorporating applicable regulatory requirements into the quality management system" (see Appendix A);
--- Added "YY/T 0287-2017 and" Medical Device Manufacturing Quality Management Specification "(promulgated on December 29,.2014) and appendix
Example of the corresponding relationship "(see Appendix B).
Please note that some content of this document may involve patents. The issuer of this document does not assume responsibility for identifying these patents.
This standard was proposed by the State 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 Equipment Huaguang Certification Co., Ltd., Shenzhen Mindray Biomedical Electronics Co., Ltd., Beijing Wandong
Medical Technology Co., Ltd., Shanghai Lianying Medical Technology Co., Ltd., and Shanghai MicroPort Medical Devices (Group) Co., Ltd.
The main drafters of this standard. Chang Jia, Milan Ying, Li Xin, Wang Meiying, Sun Ye, Wang Hongman, Xu Qiang, Wang Shumei, Li Yong.
The previous versions of the standard replaced by this standard are as follows.
--- YY/T 0595-2006.
introduction
This standard is dedicated to complying with the requirements of YY/T 0287-2017 and carrying out one or more stages related to the life cycle of medical devices
(Including the design and development of medical devices, production, storage and circulation, installation, service and final discontinuation and disposal, as well as the design and related activities
Developing or providing) organizations and suppliers or other external parties that provide products and services for them provide guidance to help their quality management system
Establishment, implementation and maintenance.
This standard provides application guidelines for chapters 4 to 8 of YY/T 0287-2017.
This standard provides examples that help organizations establish, implement and maintain a quality management system that meets the requirements of YY/T 0287-2017,
The description and optional items, these examples are not prescriptive, but only possible by the organization, not necessarily suitable for each organization.
This standard neither adds or changes the requirements of YY/T 0287-2017 nor stipulates any other requirements, and is intended to help stakeholders
Understand and apply YY/T 0287-2017, and clarify the various available methods and approaches that can meet the requirements of this standard.
The guidelines and other reference information provided by this standard can be used to comply with applicable regulatory requirements, but it is not
Compliance with standards and regulations.
The organization's quality management system should meet customer requirements, regulatory requirements applicable to the quality management system, and the organization's own requirements.
The organization provides a way to integrate applicable regulatory requirements into its quality management system. "Regulatory requirements" covers the application of YY/T
0287-2017 The user's requirements of any laws and regulations (such as laws, regulations, regulations or directives) are limited to the quality management system.
Summing up the safety or performance requirements of medical devices.
Different jurisdictions may have poor regulatory requirements for organizations applying various quality management systems in the medical device supply chain
Different, Appendix A provides an example of the process of incorporating applicable regulatory requirements into the quality management system, and Appendix B provides YY/T 0287-2017
Examples of correspondence with "Medical Device Manufacturing Quality Management Standards" (promulgated on December 29,.2014) and appendices.
The application of "risk" within the scope of this standard is related to the safety or performance requirements of medical devices or compliance with applicable regulatory requirements. all
Risks may exist in systems, processes or functions, and adopting a risk-based approach ensures that the organization is establishing, implementing, maintaining and improving quality management
In the process of managing the system, these risks are identified and considered.
The organization should apply a risk-based approach to all processes required by the quality management system. Organizations can apply a risk-based approach.
--- Determine the degree of control required for each process of the quality management system;
--- Identify and deal with risks that affect the conformity and effectiveness of the quality management system.
The organization can implement this by responding to processes such as complaint handling, post-market surveillance, non-conformity handling, corrective actions, and preventive measures
Now improved. These processes ensure that the organization obtains beneficial and cost-effective improvements. The quality management system itself does not necessarily bring about workflow
Process or product improvement, but it is a systematic way to achieve organizational goals that can guide the organization to improve overall performance and plan for the organization's continuous development
Provide a solid foundation.
The following auxiliary verbs are used in this standard.
--- "Should" is only used in the original YY/T 0287-2017, which means that it is required.
--- "Yi" means suggestion;
--- "May" means allow;
--- "Can" means possible or able.
"Note" is a guide to understand or explain the requirements.
Medical device quality management system
YY/T 0287-2017 Application Guide
1 Scope
1.1 General
This standard provides application guidelines for the requirements of the medical device quality management system in YY/T 0287-2017.
This standard applies to one or more stages related to the life cycle of medical devices (including the design and development, production and storage of medical devices
And circulation, installation, service and final discontinuation and disposal, as well as the design and development or provision of related activities) organizations of all sizes and types,
And suppliers or other external parties that provide products and services.
This standard does not apply to inspection by regulatory agencies or assessment by certification bodies.
1.2 Application
1.2.1 General
The relevant requirements in Chapters 6, 7, and 8 of YY/T 0287-2017 can be justified by one of the two ways of deletion or not applicable
Omit. For any reduction or inapplicability, the organization should describe and explain the reason in its quality manual.
1.2.2 Delete
The deletion of design and development shall comply with the requirements of regulations. If the applicable regulations allow the deletion of design and development, this can be used as an
The reasons for its deletion in the management system. The organization should provide a means to verify that the design of products and services is sufficiently safe and effective
This is explained in the department. When the organization declares compliance with YY/T 0287-2017, it should clarify any design and development in its quality management system.
Cut down.
Some regulations require organizations to place certain medical devices on the market without having to prove that they meet design and development control requirements
field. The organization should determine whether the design and development can be reduced based on the regulatory requirements applicable to different products and the countries or regions where they are to be marketed.
The regulations applicable in the country or region of listing require that certain types of medical devices (such as low-risk medical devices) or medical devices undergo certain
Compliance assessment procedures (such as type testing), then its design and development may not meet the requirements of 7.3 of YY/T 0287-2017. Even if the regulations allow
The organization may delete the requirements of 7.3 of the standard, and the organization still has the responsibility to meet the product realization requirements of the standards 7.1, 7.2, 7.4, 7.5 and 7.6.
In addition, outsourcing the design and development process cannot be used as a reason to delete 7.3 from the organization's quality management system.
1.2.3 Not applicable
The organization may evaluate the role based on its role and activities in different stages of the medical device life cycle and the types of medical device products.
Review all the requirements in Chapters 6, 7, and 8 of YY/T 0287-2017 and identify those activities that do not have to be completed by the organization or are not applicable to the group
The requirements of woven products can not be considered in the quality management system for the unsuitable requirements.
2 Normative references
The following documents are essential for the application of this document. For dated references, only the dated version applies to this article
Pieces. For the cited documents without date, the latest version (including all amendments) applies to this document.
Related standard:   YY/T 0771.1-2020  YY/T 0771.2-2020
Related PDF sample:   YY/T 0616.1-2016  YY/T 0313-2014
   
 
Privacy   ···   Product Quality   ···   About Us   ···   Refund Policy   ···   Fair Trading   ···   Quick Response
Field Test Asia Limited | Taxed in Singapore: 201302277C | Copyright 2012-2020