This standard is identical to ISO/TR 14969:2004 "Medical Devices — Quality Management Systems — Guidance on the Application of ISO 13485:2003". ISO 13485:2003 already translated into YY/T 0287-2003 "Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes".
The word "should" used in this standard just for directing or assigning role, which is different from the word "shall" used in YY/T 0287-2003 (idt ISO 13485:2003).
This standard can be used together with YY/T 0287 "Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes".
Appendix A and Appendix B of this standard are informative.
Throughout this standard, when the text of YY/T 0287-2003 is directly quoted, it appears enclosed in boxes prefaced by: “YY/T 0287-2003, Medical Devices — Quality Management Systems — Requirements for Regulatory Purposes”.
Pattern style words in this standard, Introduction 0.3 are inclined letters in the original text.
This standard was proposed by Department of Medical Device Supervision of State Food and Drug Administration.
This standard is under the jurisdiction of National Technical Committee 221 on Quality Management and General Requirements for Medical Device of Standardization Administration of China (SAC/TC 221).
Drafting organizations of this Standard: National Technical Committee 221 on Quality Management and General Requirements for Medical Device of Standardization Administration of China and Beijing Hua Guang Certification of Medical Devices Co., Ltd.
Chief drafting staffs of this standard: Zhang Mingzhu, Chen Zhigang, Zheng Yihan, Wu Junhua, Qin Shuhua and Li Huimin.
Introduction
0.1 General
0.1.1 This standard provides guidance to assist in the development, implementation and maintenance of quality management systems that aim to meet the requirements of YY/T 0287 for organizations that design and develop, produce, install and service medical devices, or that design, develop and provide related services. It provides guidance related to quality management systems for a wide variety of medical devices and related services. Such medical devices include active, non-active, implantable and non-implantable medical devices and in vitro diagnostic medical devices.
YY/T 0287 specifies the quality management system requirements for medical devices for regulatory purposes (see Appendix A). YY/T 0287 accommodates the previous YY/T 0288 by permissible exclusion as specified in YY/T 0287-2003, 1.2.
When judging the applicability of the guidance in this standard, one should consider the nature of the medical device(s) to which it will apply, the risk associated with the use of these medical devices, and the applicable regulatory requirements.
As used in this standard, the term “regulatory requirement” includes any part of a law, ordinance, decree or national and/or regional regulation applicable to quality management systems for medical devices and related services.
This standard provides some approaches that an organization can use to implement and maintain a quality management system which conforms with YY/T 0287. Alternative approaches can be used if they also satisfy the requirements of YY/T 0287.
0.1.2 The guidance given in this standard is applicable to the design, development, production, installation and servicing of medical devices of all kinds. It describes concepts and methods that can be considered by organizations which are establishing and maintaining quality management systems.
An organization can voluntarily incorporate guidance from this standard, wholly or in part, into its quality management system.
0.1.3 Guidance contained in this standard can be useful as background information for those representing quality management system assessors, Conformity Assessment Bodies and regulatory enforcement bodies.
The guidance contained in this standard is not to be used for identifying specific deficiencies of quality management systems, unless such guidance is voluntarily incorporated by the organization into the documentation describing and supporting the organization’s quality management system, or unless such guidance is specifically made part of the regulatory requirements relevant to the organization’s operation.
0.2 Process approach
YY/T 0287 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, with the objective of meeting customer and regulatory requirements, and providing medical devices that meet customer and regulatory requirements.
For an organization to function effectively, it has to identify and manage numerous linked activities. An activity using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach.”
An advantage of the process approach is the ongoing control which it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.
If used within a quality management system, such an approach emphasizes the importance of:
— understanding and meeting requirements;
— considering processes in terms of added value;
— obtaining results of process performance and effectiveness; and
— improving processes based on objective measurement.
The model of a process-based quality management system shown in Figure 1 illustrates the process linkages presented in YY/T 0287-2003, Clauses 4 to 8. This illustration shows that customers and regulatory authorities play a significant role in defining requirements as inputs. Monitoring of customer feedback requires the evaluation of information relating to whether the organization has met the customer requirements. The model shown in Figure 1 covers all the requirements of YY/T 0287, but does not show processes at a detailed level.
In addition, the methodology known as “Plan-Do-Check-Act” (PDCA) can be applied to all processes. PDCA can be briefly described as follows:
P — Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization’s policies.
D — Do: implement the processes.
C — Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results.
A — Act: take actions to improve process performance.
Figure 1 Model of a Process-based Quality Management System
0.3 Relationship with other standards, guidance documents and regulatory requirements
The relationship between YY/T 0287, this standard and the general standards for quality management systems (GB/T 19001 and GB/T 19004) is summarized as follows.
a) This standard provides guidance on the application of YY/T 0287.
b) YY/T 0287 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical devices industries. It follows the format, structure and process approach of GB/T 19001. It differs from GB/T 19001 in that it specifies additional requirements but does not include the explicit requirements for continual improvement and customer satisfaction.
c) GB/T 19001 is an national standard for quality management systems in general.
d) GB/T 19004 gives guidance on a wider range of objectives of quality management systems than does this standard, particularly for the continual improvement of an organization’s overall performance and efficiency, as well as its effectiveness. GB/T 19004 is suitable as a guide for organizations whose top management wishes to move beyond the requirements of YY/T 0287, in pursuit of continual performance improvement and customer satisfaction. However, it is not intended for certification or for contractual purposes.
YY/T 0287 includes those generic quality management system requirements contained in GB/T 19001 that are relevant to a regulated organization that designs and develops, produces, installs and/or services medical devices, or which designs and develops and provides related services. This standard, however, does not set out to provide specific guidance with respect to these generic quality management system requirements which are common to both YY/T 0287 and GB/T 19001. Guidance on GB/T 19001 can be found, for example, in the ISO brochure, GB/T 19001 for Small Businesses – What to do, and in GB/T 1000 Introduction and Package module.
Guidance provided in this standard has taken into consideration requirements and guidance contained in documents from the following organizations:
— Global Harmonization Task Force (GHTF);
— International Organization for Standardization (ISO);
— European Committees for Standardization (CEN and CENELEC);
— national regulatory bodies.
Many of these documents are listed in the Bibliography.
0.4 Compatibility with other management systems
Conformance to YY/T 0287 quality management system requirements does not automatically constitute conformity with national or regional regulatory requirements. It is the organization’s responsibility to identify and establish compliance with relevant regulatory requirements.
Foreword III
Introduction IV
0.1 General IV
0.2 Process approach IV
0.3 Relationship with other standards, guidance documents and regulatory requirements VI
0.4 Compatibility with other management systems VII
1 Scope
1.1 General
1.2 Application
2 Normative References
3 Terms and Definitions
4 Quality Management System
4.1 General requirements
4.2 Documentation requirements
5 Management responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, authority and communication
5.6 Management review
6 Resource Management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment
7 Product Realization
7.1 Planning of product realization
7.2 Customer-related processes
7.3 Design and development
7.4 Purchasing
7.5 Production and service provision
7.6 Control of monitoring and measuring devices
8 Measurement, Analysis and Improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Appendix A (Informative) Terms Used in Certain Regulatory Administrations to Describe Documents Referenced in This Standard
Appendix B (Informative) Analysis of Significant Changes from YY/T 0287-1996 to YY/T 0287-
Bibliography
