Interpretation of the Standard

I. Overview

1. Brief Review of ISO13485 Standard

The ISO13485 standard has gone through two versions. In 1996, ISO released ISO13485:1996 "Quality System"; Medical devices‐ The ISO 9001 Application Specific Requirements "standard is not a * standard, but a standard to be used in conjunction with the ISO 9001:1994 standard. After ISO/TC210 revised the 1996 version of ISO 13485 in 2003, ISO 13485:2003 "Quality Management Systems for Medical Devices - Requirements for Regulatory Purposes" was released, which is a specialized standard for the field of medical devices. At present, ISO/TC210 has officially released and implemented the third edition of ISO13485 standard on March 1, 2016. The State Food and Drug Administration promptly translated this standard into YY/T0287-2017 idt ISO13485:2016 "Requirements for Medical Device Quality Management System for Regulatory Use" and released it for implementation.

The ISO13485 standard is a quality management system standard applied in the field of medical devices, which highlights the safety and effectiveness of medical devices and emphasizes that the medical devices provided by organizations must meet customer and regulatory requirements. Due to the high alignment between the purpose of the ISO13485 standard and the objectives of medical device regulations, which are completely consistent with the expectations of the medical device industry and the public, the ISO13485 standard has received high attention and widespread recognition from the global medical device industry, regulatory authorities, and society since its release. Many countries have converted the ISO13485 standard into their own national standards and implemented it in the field of medical devices. The Chinese government attaches great importance to the ISO13485 standard. The medical device regulatory authorities actively track the revision process of the ISO13485 standard, which was equivalent to the industry standard YY/T 0287-199 * YY/T 0287-2003 after its release in 1996 and 2003, to ensure that the release of industry standards in China is synchronized with international standards. The medical device regulatory authorities have also referenced and borrowed the requirements of ISO13485 standard when formulating relevant medical device regulations. Under the promotion of the government and the market, the concept, principles, and methods of ISO13485 standard have been rapidly disseminated and widely applied in China's medical device industry, and have achieved great success. With the implementation of the new version of YY/T0287-2017/ISO13485 "Requirements for the Use of Medical Device Quality Management Systems in Regulations" by the State Food and Drug Administration in 2017, it will have a significant and far-reaching impact on the medical device industry.

2. Background of revising ISO13485 standard

The birth of ISO13485 standard is closely related to and accompanied by medical device regulations; The development of the ISO13485 standard is inevitably closely linked and accompanied by medical device regulations. With social changes, economic development, the rise of a new round of technological industrial revolution, and the acceleration of global market integration, the production and marketing models of the medical device industry are changing, leading to the extension and increasing complexity of the medical device industry chain. The public has put forward new demands for the safety and effectiveness of medical devices. Therefore, based on the significant changes and adjustments in medical device regulations in various countries around the world, the practice of quality management technology development, the needs of the medical device industry development, and the feedback from the ISO13485 standard user survey, ISO has decided to initiate the revision of the ISO13485 standard to strengthen the compatibility between the new version of the standard and medical device regulations, meet the growing needs and expectations of users, and realize the value of the ISO13485 standard.  

3. Main ideas for revising the new standard

The new version of the standard is revised by the International Organization for Standardization's ISO/TC 210 Technical Committee on Quality Management and General Requirements for Medical Devices. The SAC/TC221 Medical Device Quality Management and General Requirements Standardization Technical Committee in China has been tracking and actively participating in the various stages of the revision of the new standard draft, submitting revision opinions and suggestions, and voting on them. According to the requirements of ISO standard revision, the process of revising ISO standards is divided into preparation stage, initiation stage, draft stage, and formal standard release stage. To revise the 2003 version of the ISO13485 standard, ISO/TC210 developed the "Design Specification for the Revision of ISO13485" (hereinafter referred to as the "Design Specification"). The "Design Specification" determines the main direction and requirements for revising standards, which are used to guide the drafting and verification of standard revisions. The main ideas for revising standards are as follows:

(1) Enhance the compatibility of new standards and regulations

The name of ISO13485 standard clearly states "requirements for regulations" at the beginning, indicating the close relationship between standards and regulations. The important goals of the revised version of the standard are to maintain the universality of the ISO13485 standard in the field of medical devices, and to further emphasize the close relationship between standards and regulations, and to enhance the compatibility between the requirements of the new standard and regulations. This is to avoid unnecessary duplication between standard requirements and regulatory requirements, as well as to avoid their mutual contradictions. In order to enhance compatibility, relevant national and regional medical device regulations and regulatory requirements were gathered during the standard revision process, so that the quality management system requirements of the standard can adapt to the differences in regulatory requirements of different countries and regions, which helps medical device organizations to implement relevant regulatory requirements when implementing the standard.

(2) The requirements of the new version of the standard should be clear and explicit

The requirements of the new version of the standard should be continuous and appropriate for the expected users of the standard, and should be conducive to the implementation of medical device organizations; It should contribute to the objective and consistent evaluation of relevant parties such as medical device regulatory agencies and certification agencies; Should be able to adapt to the development of new medical device products, new technologies, and quality management system technologies; Requirements outside the quality management system, including regulatory requirements that are not suitable as requirements for the quality management system, should be avoided; It should cover the entire lifecycle of medical device products and services, applicable to all sizes and types of medical device organizations, and can also be used by suppliers and external parties in the medical device industry chain.

(3) The requirements of the new standard should cover the entire lifecycle of medical device products and services, applicable to all sizes and types of medical device organizations, as well as suppliers and external parties in the medical device industry chain.

(4) The structure and pattern of the new standard remain unchanged

The new version of the standard continues to adopt a process based quality management system model, with the overall structure remaining unchanged, still consisting of eight chapters and two appendices. However, the hierarchical structure of the new standard's clauses has been changed from the original four levels to three levels, and the arrangement order of some clauses has been appropriately adjusted to facilitate the implementation of the standard.

During the revision process of the new standard, some members of ISO/TC210 raised the question of whether the new standard, like ISO 9001:2015, adopts the high-level structure of the management system standard provided in Appendix 2 of Annex SL of ISO/IEC Guidelines Part 1: Technical Work Procedures. After discussion, ISO/TC210 has decided that the new version of the standard will still adopt the 2003 version of ISO13485, with the overall structure remaining unchanged, for the following reasons:

1) One of the main features of the ISO13485 standard is its close connection with medical device regulations in various countries. At present, many countries' medical device regulations refer to or draw on the requirements of the ISO13485 standard to varying degrees. For example, the European Union, Canada, and Australia directly regulate the ISO13485 standard as a regulatory requirement, and some members even believe that the ISO13485 standard has become a global template for medical device regulation. In order to facilitate the relative stability and authority of the implementation of medical device regulations, and to strengthen the supervision of medical devices, ISO/TC210 adopts a cautious attitude and has decided to continue using the 2003 version of ISO13485 as the overall structure of the new standard.

2) ISO/TC210 aims to summarize the experience of applying the advanced structure of the management system in accordance with ISO 9001:2015 standards, and based on this, combine it with the actual situation of the medical device industry, in order to better adopt the advanced structure of the management system standards proposed by ISO, avoid unnecessary negative impacts caused by changes in the overall structure of the standards, and contribute to the implementation of medical device regulations in various countries and the achievement of the goals of ISO 13485 standards.

(5) The new standard writing language should be clear

The new version of the standard refers to the terminology of the ISO9000 "Quality Management System Fundamentals and Terminology" standard, which is beneficial for consistency in understanding the standard and avoiding multiple interpretations. The writing language of the new standard strives to be consistent with ISO9001 and ISO9000 standards.

(6) The new version of the standard should refer to but not repeat the requirements of other relevant standards, such as risk management, software, usability, sterilization, sterile medical device packaging, etc.