The birth of the ISO13485 standard is closely related to and accompanied by medical device regulations; the development of the ISO13485 standard is bound to be closely integrated with and accompanied by medical device regulations. With social changes, economic development, the rise of a new round of technological and industrial revolution, and the acceleration of the global market integration process, the production methods and marketing models of the medical device industry are changing, resulting in the extension and complexity of the medical device industry chain. The safety and effectiveness of the device raises new demands. Therefore, according to the major changes and adjustments of medical device regulations in various countries in the world, the practice of quality management technology development, the needs of medical device industry development, and the feedback from the ISO13485 standard user survey, ISO decided to start the revision of the ISO13485 standard to strengthen the new version of the standard and Compliance with medical device regulations to meet the growing needs and expectations of users and realize the value of the ISO13485 standard.

2. The main idea of the new version of the standard revision

The new version of the standard is revised by the International Organization for Standardization ISO/TC 210 Technical Committee on Quality Management and General Requirements for Medical Devices. my country's SAC/TC/221 Medical Device Quality Management and General Requirements Standardization Technical Committee and CMD have been tracking and actively participating in the drafts of the new version of the standard revision at various stages, submitting revised opinions and suggestions and voting. According to the requirements of ISO standard formulation and revision, the process of formulation and revision of ISO standards is divided into preparation stage, start-up stage, draft stage, and formal standard release stage. In order to revise the 2003 edition of the ISO13485 standard, ISO/TC210 has formulated the "ISO13485 Revised Design Specification" (hereinafter referred to as the "Design Specification"). The "Design Specification" determines the main direction and requirements of the revised standard, which is used to guide the drafting and verification of the revised standard. The main ideas of the revised standard are as follows:

2.1 Improve the compatibility of new standards and regulations

The name of the ISO 13485 standard begins by stating "Requirements for Regulations", illustrating the close relationship between standards and regulations. On the one hand, the important goal of the revision of the new version of the standard is to continue to maintain the generality of the application of the ISO13485 standard in the field of medical devices. On the other hand, it is necessary to further emphasize the close relationship between standards and regulations, and to improve the compatibility of new standards and regulations. This is not only to avoid unnecessary duplication of standard requirements and regulatory requirements, but also to avoid contradictions between the two. In order to improve compatibility, the medical device regulations and regulatory requirements of relevant countries and regions are brought together during the standard revision process, so that the standard quality management system requirements can adapt to the differences in regulatory requirements of different countries and regions, which will help medical device organizations in the Implement relevant regulatory requirements when implementing standards.

2.2 The requirements of the new version of the standard should be clear and unambiguous

(1) It should be continuous and appropriate for the intended users of the standard, and it should be beneficial to the implementation of the medical device organization;

(2) It should contribute to the objective and consistent evaluation of relevant parties such as medical device regulatory agencies and certification bodies;

(3) It should be able to adapt to the development of new medical device products, new technologies and quality management system technologies;

(4) Requirements outside the quality management system should be avoided, including regulatory requirements that are not suitable as quality management system requirements;

(5) It should cover the whole life cycle of medical device products and services, applicable to medical device organizations of all sizes and types, and can also be used for suppliers and external parties in the medical device industry chain;

2.3 The structure and schema of the new version of the standard remain unchanged

The new version of the standard continues to adopt the process-based quality management system model, and the overall structure remains unchanged, still the structure of eight chapters and two appendices, but the new version of the standard clause level has changed from the original four levels to three levels, some clauses. The order of arrangement has been adjusted appropriately to facilitate the implementation of the standard.

During the revision process of the new version of the standard, some members of ISO/TC210 asked whether the new version of the standard, like the ISO9001:2015 standard, adopts the management given in Appendix 2 of Annex SL of the "ISO/IEC Guidelines Part 1: Technical Working Procedures" High-level structure of system standards. After discussion in ISO/TC210, it was decided that the new version of the standard still adopts the 2003 version of the ISO13485 standard and the overall structure remains unchanged for the following reasons:

(1) One of the main features of the ISO13485 standard is that it is closely related to the medical device regulations of various countries. At present, the medical device regulations of many countries refer to or learn from the requirements of the ISO13485 standard to varying degrees. For example, the European Union, Canada and Australia directly implement the ISO13485 standard as a regulatory requirement. Some members even think that the ISO13485 standard has become a standard. Worldwide medical device regulatory template. In order to facilitate the relative stability and authority of the implementation of medical device regulations and help strengthen the supervision of medical devices, ISO/TC210 adopts a more cautious attitude and decides that the new version of the standard still adopts the 2003 version of the ISO13485 standard and the overall structure remains unchanged.

(2) ISO/TC210 hopes that by summarizing the experience of ISO9001:2015 standard application management system advanced structure practice, on this basis, combined with the actual situation of the medical device industry, in order to better adopt the advanced structure of the management system standard proposed by ISO, avoid Unnecessary negative effects caused by changes in the overall structure of the standard are helpful for the implementation of medical device regulations in various countries and the realization of the goals of the ISO13485 standard.

2.4 The new version of the standard writing language should be clear

The new version of the standard refers to the terminology of the ISO9000:2015 "Quality Management System Fundamentals and Terminology" standard, which is conducive to the consistency of understanding of the standard and avoids multiple interpretations. The new version of the standard is written in an effort to align with the ISO9001:2008 and ISO9000:2015 standards.

2.5 The new version of the standard should refer to but not repeat the requirements of other related standards, such as: requirements for risk management, software, usability, sterilization, sterile medical device packaging, etc.

3. Major changes in the new version of the standard

Compared with the 2003 version of the ISO13485 standard, the new version of the standard has many changes in terms of content and terms. The main changes are as follows: 3.1 The new version of the standard focuses on regulations, further highlighting the importance of regulatory requirements

The new version of the standard is impressive because it further emphasizes the status and role of regulatory requirements in the standard, and proposes three rules for medical device organizations to integrate regulatory requirements into the quality management system, that is, to identify the role of the organization in accordance with applicable regulatory requirements, and based on these The roles identify the regulatory requirements applicable to the organization's activities and integrate these applicable regulatory requirements into the organization's quality management system, further clarifying the relationship between the quality management system requirements and regulatory requirements. The number of the term "regulatory requirements" used in the new version of the standard has increased from 28 in the 2003 version of the standard to 52. In many processes of the quality management system, it is stipulated that the requirements of this standard and regulatory requirements must be met, which clearly reflects the standard's combination of regulatory requirements and regulatory requirements. The quality management system requires the characteristics of comprehensive integration, which strengthens the main responsibility of the medical device organization for quality and safety, and contributes to the implementation of the regulatory requirements.

3.2 The new version of the standard is more clear about the scope of application

Compared with the 2003 version of the standard, the new version of the standard more clearly defines the scope of application of the standard in the general provisions, increases the medical device organization applicable to all stages of the medical device life cycle industry chain, and also increases the scope of application for suppliers or other external parties, etc. Require. This is conducive to the promotion and application of the new version of the standard at more levels and in a wider range, and better achieve the standard goals.

3.3 Strengthening Risk Management Requirements

In the new version of the standard "0.2 Clarifying the concept", it is proposed that "when the term 'risk' is used, the application of the term within the scope of the standard is related to the safety or performance requirements of medical devices or to meet applicable regulatory requirements". Different from the 2003 version of the standard, which only requires 7.1 product realization process planning and 7.3.2 design and development input to put forward risk management requirements, the new version of the standard has all the requirements in the procurement process and external supplier control, software confirmation process, training planning, and feedback information collection. It refers to the identification and management of risks, which further expands the scope of application of risk management, which will be a new challenge for medical device organizations. New version mark. The standard strengthens the risk management requirements, not only implements risk management for the whole life cycle of medical device products and services, but also clarifies the requirements for the implementation of risk management in the process of the quality management system, and proposes "the application of risk-based methods to control the quality management system. appropriate process" (new edition 4.1.2b). This is a significant change from the 2003 version of the standard.

3.4 Increase the requirements for purchasing and supplier control

The new version of the standard has more specific and clear control requirements for the procurement process and suppliers. It clarified the four aspects in the supplier evaluation criteria, namely supplier performance, supplier ability to provide products, impact of supplier's products on the quality of medical devices, and compatibility with medical device risks; clarified the performance to meet the requirements of purchased products Monitoring is carried out and is also used as an input for supplier re-evaluation; it is clarified that the disposition of suppliers who fail to fulfill purchasing requirements should be appropriate to the risks associated with the purchased product and comply with regulatory requirements. At the same time, the above activities are all required to keep records. The new version of the standard adds the requirement of "product specification" to the purchase information clause, and proposes to form a written agreement when applicable. During the purchased product verification process, there is an increased requirement for the organization to take action and verify the scope of activities when any changes to the purchased product are identified. It can be seen that the new version of the standard has more specific and detailed requirements for procurement and supplier control, and is operational.

3.5 Added Complaint Handling Clause

The new version of the standard modifies the term "customer complaint" in the 2003 version of the standard to "complaint", and adds the "8.2.2 Complaint Handling" clause, making it clear that the complaint handling required by the applicable regulations should be formed into a procedural document, and the procedure document stipulates requirements and Responsibilities and requirements to keep records of complaints handling. It can be seen that in the new version of the standard, "complaint handling" has become an important part of the "monitoring and measurement" process of the quality management system, further emphasizing the importance of complaint handling.

3.6 Added requirements for communicating with and reporting to regulators

The new edition of Standard 5.6.2 Management review input provisions includes "reporting to the regulatory authority", 7.2.3 stipulates that "the organization shall communicate with the regulatory authority in accordance with applicable regulatory requirements", and in 8.2. The need for agencies to report information", Standard 8.2.3, titled "Reporting to Regulatory Bodies", specifies requirements for the content of reports and for establishing procedural documents and maintaining records of reports. The introduction of this requirement will help medical device organizations to deepen their understanding of regulatory requirements and better implement regulations through reporting and communicating with regulatory agencies; this change in the new version of the standard is not only conducive to the technical support of the standard for medical device supervision, but also Conducive to the implementation of laws and regulations.

3.7 Strengthened post-market surveillance requirements

The new version of the standard further clarifies the requirements for post-market surveillance. The standard adds the term "post-market surveillance" to clarify that post-market surveillance refers to "the systematic process of collecting and analyzing experience gained from medical devices that have been marketed". The new version of the standard is in 8.2.1 Feedback, 8.2.2 Complaint handling, 8.2.3 Reporting to regulatory agencies, 8.3.3 Response measures for non-conforming products found after delivery, 8.4 Data analysis and 8.5 Improvements all set new requirements for post-market surveillance.

3.8 Added requirements for documentation and records

The new version of the standard adds requirements for quality management system documentation and records. The requirements for quality manuals, procedure documents, process operation control documents and records in the quality management system documents have not been reduced, which is different from the ISO9001:2015 standard, which has relatively weakened the requirements of the documents. The new version of the standard has 43 "documented" and 50 record-keeping requirements, an increase over the 2003 version. At the same time, new clauses related to document requirements are added, such as 4.2.3 Medical Device Documentation, and 7.3.10 Requirements for Design and Development Documents, adding specific document requirements. The addition of document requirements not only reflects the binding role of documents, but also emphasizes the control ability and effect of the organization's implementation of the requirements of the quality management system, and gives full play to the document's communication intention, unified action, and value-added role.

3.9 Requirements for adding management system related processes

In the new version of the standard, the following processes have increased specific requirements to varying degrees: 4.1.6 software validation, 5.6 management review, 6.3 infrastructure, 6.4.2 pollution control, 7.2 customer-related processes, 7.3.2 design and development planning, 7.3.3 Design and development input, 7.3.9 Design and development change control, 7.4.1 Procurement process, 7.5.1 Control of production and service provision, 7.5.2 Cleaning of product, 7.5.4 Service activities, 7.5.6 Validation of production and service processes, 7.5.7 Specific requirements for sterilization process and sterile barrier system validation, 7.5.11 Product protection, 8.3.3 Response measures for nonconforming products after delivery.

The new version of the standard adds the following clauses: 4.2.3 Medical Device Documentation, 7.3.8 Design and Development Conversion, 7.3.10 Design and Development Documentation, 8.2.2 Complaint Handling, 8.2.3 Reporting to Regulatory Authorities The new clauses have an impact on normative design and development process, improve the effectiveness of design and development, improve technical requirements for medical devices, actively respond to feedback and handle complaints, and strengthen communication with regulatory agencies, which play an important role in implementing regulations.

3.10 Changes in terminology

The new version of the standard has a total of 19 terms, which has undergone major changes compared with the 8 terms of the 2003 version of the standard. The new version of the standard retains the 5 terms of "advisory notice", "implantable medical device", "marking", "medical device" and "sterile medical device" of the 2003 version of the standard, and has a strict understanding of the terms of "implantable medical device". The definitions of the terms "Medical Device" and "Marking" have been refined. Modified the 2003 version of the term "customer complaint" to "complaint" and further refined the definition. The terms "active implantable medical device" and "active medical device" from the 2003 edition of the standard have been removed. The new version of the standard adds 13 terms, including "authorized representative", "clinical evaluation", "distributor", "importer", "life cycle", "manufacturer", "medical device family", "performance evaluation", "Post-Market Surveillance", "Purchased Product", "Risk", "Risk Management", "Sterile Barrier System". The terms added in the new version of the standard are conducive to deepening the consistent understanding and implementation of the standard, and also help all parties communicate with each other.

3.11 Changes to the appendix

The new version of the standard revises two appendices of the 2003 version of the standard:

Appendix A (informative appendix), YY/T0287-2003/ISO 13485:2003 and the new version of the standard content comparison. This appendix helps medical device organizations understand the new version of the standard and the transition of the standard.

Appendix B (informative), content comparison between the new standard and the ISO9001:2015 standard. Because the new version of the standard is an independent standard based on the GB/T19001:2008/ISO 9001:2008 standard, for the convenience of users in the medical device field, the new version of the standard has formulated Appendix B to compare the content of the new version of the standard with the ISO9001:2015 standard. .

4. Actively implement the new version of the standard, strengthen the construction of the quality management system, and push the medical device quality management to a new stage

Nearly two decades have passed since the ISO13485 standard, and we are approaching the third decade of the ISO13485 standard.

The first decade of the ISO13485 standard was the decade of exploration and initiation. Under the strong promotion of the Chinese government, the ISO13485:1996 standard was equivalently adopted and converted into the YY/T0287-1996 standard. The medical device organization has gone through a stage from recognizing the standard to knowing each other, from hazy to awakening. At first, the medical device organization mechanically established documents at all levels in accordance with the requirements of the standard, and also formed documents for the things to be done, and then did things according to the requirements of the documents, built the foundation of enterprise quality management, and established a documented quality management system. Afterwards, through the implementation of the system operation, I gradually realized the path and method of standardizing quality management, and produced good results in practice. Especially at the beginning of this century, the quality management principles and process methods issued by ISO are the new highlights of quality management, which have promoted the leap of quality management thinking of medical device organizations and the sublimation of quality management practice.

The second decade of the YY/T0287/ISO13485 standard has been a decade of great changes. Under the promotion of the government and the market, especially under the guidance of medical device regulations, the appearance of my country's medical device industry has undergone great changes. The advanced management concepts of the YY/T0287/ISO13485 standard and the requirements and methods of the standard have combined with the actual situation of the medical device industry to generate great power, and the quality management level of my country's medical device industry has made significant progress. A group of medical device organizations that implement the YY/T0287/ISO13485 standard have continuously summed up experience, pursued excellence, and achieved success, becoming leaders and demonstrators in the medical device industry. At present, nearly a quarter of medical device organizations in my country have implemented the YY/T0287/ISO13485 standard certification of third-party certification bodies. These organizations, together with third-party certification agencies, actively study and implement the YY/T0287/ISO13485 standard, combine their own actual conditions, and implement the medical device regulations based on the YY/T0287/ISO13485 standard, establish a standardized quality management system, and continuously improve the management level. Ensuring the safety and effectiveness of medical devices has become the main force in the development of the medical device industry. The second decade of the YY/T0287/ISO13485 standard is a decade to promote the transformation of medical device quality management in my country. The past ten years is a decade in which the appearance of the medical device industry has undergone significant changes, which has made great contributions to the rapid development of my country's medical device industry.

On the occasion of preparing for the third decade of the ISO13485 standard, medical device organizations should release the new version of the standard as an opportunity to actively respond to the challenges of global industrial restructuring, profound changes in market demand, changes in customer quality concepts, and more intense competition in medical device quality. . Medical device organizations should actively implement the new version of the standard from a new starting point, strengthen the construction of the quality management system, and push the medical device quality management to a new stage.

4.1 Strengthen the construction of quality management system, continue to ensure the safety and effectiveness of medical devices, and continuously improve product quality

Quality determines the market, and the implementation of YY/T0287/ISO13485 standard is a powerful means and effective way to standardize the quality management system, ensure the safety and effectiveness of medical devices and improve product quality. Therefore, as the new version of the standard continues to clearly state that "the adoption of a quality management system is a strategic decision of the organization", it fully demonstrates the importance of the quality management system to the realization of the organization's strategy. The successful practice of the medical device industry in implementing the YY/T0287/ISO13485 standard in the past two decades has also strongly proved that the organization's adoption of the quality management system is a correct strategic decision. Therefore, actively implementing the new version of the standard, applying contemporary advanced quality management principles, concepts and methods, and strengthening the construction of the quality management system are of great significance for achieving the strategic goals of medical device organizations and promoting the sustainable development of medical device organizations.

(1) To strengthen the construction of quality management system, we must adhere to people-oriented. People are the most valuable resource and determine the success or failure of the quality management system. Among the eight quality management principles of the standard, "customer focus", "leadership role", "full participation", and "mutually beneficial relationship with suppliers" all focus on people's needs and play their role. The medical device organization is the main body of the quality and safety of medical devices. The managers of the medical device organization bear the primary responsibility for the quality and safety of medical devices, and the employees also bear their own quality and safety responsibilities in each process of the quality management system. Therefore, medical device organizations, from managers to employees, must enhance quality awareness, dare to take on and resolutely implement quality and safety responsibilities. In today's information Internet era, the concept of customer needs is undergoing profound changes. Medical device organizations can only closely integrate with customers, and customers must participate in the design and development, production, manufacturing, service, and use of the quality management system. , jointly determine customer needs, improve customer experience, and promote customer satisfaction. Therefore, medical device organizations should work with customers and related parties to build a quality management system. In short, the construction of quality management system must be people-oriented and give full play to the role of people in order to continuously ensure and continuously improve the quality of medical devices and achieve the goals of the quality management system.

(2) To strengthen the construction of the quality management system, it is necessary to deeply understand the requirements of the quality management system stipulated by the standard with a systematic thought. The standard gives the best way and method to realize the requirements of the quality management system, that is, the process method and the PDCA model. Understand the interrelated and interacting elements of the quality management system, and achieve the desired output of the quality management system.

(3) To strengthen the construction of the quality management system, it is necessary to fully understand the importance of relevant process standards and product standards and the necessity of their application in order to achieve the goals of the quality management system. To this end, medical device organizations should not only have appropriate resource guarantees, but also have the support of a series of technical standards and related technical specifications. A quality management system encompasses many processes such as risk management, procurement, sterilization, sterile barrier systems, clean environment, software, usability, etc. These processes have already specified specific requirements in corresponding international standards, national standards, industry standards or normative documents. Medical device organizations need to apply these applicable process standards or normative documents to guide and regulate the operation of the corresponding process to ensure the effectiveness of the process. The new version of the standard continues to point out that the quality management system requirements are supplementary to product technical requirements, so the YY/T0287/ISO13485 standard requires medical device organizations to input applicable medical device product standards into the quality management system. Generally applicable product standards are contained in customer requirements, regulatory requirements or interested party requirements. Medical device organizations should implement the specific requirements of safety, performance, acceptance criteria, conformity assessment methods, instructions for use, etc. in these applicable product standards throughout the operation of the quality management system to ensure that the output of the quality management system can meet or exceed. Applicable product standard requirements. Therefore, in the construction of the quality management system, medical device organizations must attach great importance to the role of applicable process standards, product standards and normative documents, understand and apply these applicable standards well, and continuously realize the effectiveness of the quality management system.

(4) To strengthen the construction of the quality management system, it is necessary to highlight the risk management of medical devices. The risk management of medical device organizations is an integral part of the quality management system. Standardizing risk management is of great significance for the organization to strengthen the construction of the quality management system. The new version of the standard emphasizes that the quality management system should cover the entire life cycle of medical devices, and requires risk analysis, evaluation and management at all stages, processes and different levels of medical device products in the entire life cycle of medical devices. In a sense, risk management is essentially a decision-making process. Risk decision-making should be based on data. It is based on the historical and realistic professional and technical data of each process of medical device products and quality management systems. Risk analysis and evaluation and management. Medical device organizations should use the YY/T 0316/ISO 14971 medical device risk management standard as a guide to learn and master the principles, requirements, steps and methods of risk management, and carry out in-depth risk management in combination with product standards. Therefore, in strengthening the construction of the quality management system, it is necessary to further combine the actual situation of the medical device industry, play the role of risk management, reflect the value of risk management, and achieve the goal of ensuring the safety and effectiveness of medical devices.

(5) To strengthen the construction of quality management system, we must insist on improvement and innovation. To improve the quality management system is to optimize resources, optimize processes, improve innovative products and services, make the quality management system adapt to changes in the internal and external environment of the organization, and ensure and improve the quality of products and services output by the quality management system. Medical device organizations should combine their own actual conditions, seize opportunities for improvement, clarify the direction of quality management system improvement, formulate improvement plans and measures, and promote the implementation of quality management system improvements and achieve results. By improving the quality management system, it is not only necessary to improve the effectiveness of the quality management system, but also to improve the efficiency of the quality management system, build the brand of the organization, and create the future of the organization.

4.2 Strengthen the construction of quality management system, implement the standard idea of taking regulatory requirements as the main line, and promote the implementation of medical device regulations and the coordination of global medical device regulations

In the full text of the new version of the standard, regulatory terms frequently appear, and regulatory requirements are emphasized everywhere, which fully reflects the professional characteristics of the standard used in the field of medical devices. Strengthening the combination of standards and regulations is the main idea of the new version of the standard. The new version of the standard strengthens the regulatory requirements for medical devices from the following aspects:

First of all, in the new version of the standard 0.1 general provisions, three rules for the combination of standards and regulatory requirements are proposed. The first is to identify the role of the organization in the medical device industry chain; the second is to identify the applicable regulatory requirements according to the organization's role; the third is to integrate the applicable regulatory requirements into the organization's quality management system. The three rules clarify the relationship between regulatory requirements and the organization and its quality management system, and determine that regulatory requirements are an important part of the quality management system and need to be integrated into the organization's quality management system, changing the quality management system requirements and quality management systems that existed in many organizations in the past. The tendency of regulatory requirements to separate from each other is not conducive to the formation of synergy, which seriously affects the implementation of regulatory requirements and the effective operation of the quality management system.

Secondly, the new version of the standard further clarifies that the integration of regulatory requirements into the whole process of medical devices means that regulatory requirements must be combined with the corresponding processes of the quality management system, and various activities are organically integrated into a whole. In the new version of the standard 4.1.1, 4.1.4, 4.1.5 and other clauses, the organization has added regulatory requirements to the management and control of each process of medical devices and the outsourcing process in establishing, implementing, and maintaining the document requirements of the quality management system. , to further ensure that the whole process and activities of the organization's quality management system must not only meet the standard requirements, but also meet the regulatory requirements, which are highly consistent with the national requirements for the whole-process supervision of medical devices.

Third, due to differences in national conditions, industrialization levels, and cultures, the definitions of terms or process requirements in medical device regulations vary from country to country. The new version of the standard reflects the idea of using the definitions and requirements of terms stipulated in the national regulations, and the requirements of this standard can be interpreted with the requirements and definitions of the national regulations. On the one hand, this reflects the awe of legal and regulatory documents, which is conducive to the implementation of regulations. On the other hand, the enforcement of regulatory requirements is also conducive to the implementation of the requirements of the new version of the standard. Finally, the new version of the standard adds requirements for medical device organizations to report and communicate with medical device regulators. This requirement added in the new version of the standard is very necessary. On the one hand, it helps the organization to correctly understand and implement the regulatory requirements under the guidance of the regulatory agency, avoid detours, save resources and improve efficiency; on the other hand, it helps the organization to After the problem, the problem can be solved in time to minimize the risk.

4.3 Strengthen the construction of quality management system, further clarify the relationship between customer requirements and regulatory requirements, and promote the sustainable development of the organization

The YY/T0287/ISO13485 standard stipulates that the quality management system must meet two requirements, namely customer requirements and regulatory requirements. The standard specifies two requirements as the input of the quality management system. After the operation of the quality management system, the output meets the expected results of the two requirements and realizes the value-added. The two requirements are interrelated, interacting, and indispensable. They are unified in the quality management system, which is the value of the organization's implementation of the YY/T0287/ISO13485 standard.

Medical device regulations are mandatory requirements. Medical device products that do not meet regulatory requirements are not allowed to be marketed, and organizations that do not meet statutory requirements are prohibited from producing medical devices, so as to ensure the basic right of the public to maintain life, safety and health. At the same time, fair punishment for illegal acts will be implemented to promote the implementation of legal requirements. As a market entity, medical device organizations must operate in accordance with the law, ensure that the organization's quality management system meets the requirements of regulations, effectively implement the responsibility of the main body of medical device quality and safety, adhere to the bottom line of regulatory requirements, and ensure the safety and effectiveness of medical devices. Customers' requirements are diverse, personalized, and constantly changing. In addition to the safe and effective quality requirements of medical devices, customers are also concerned about the quality of products such as cost performance, advanced product performance, applicability, reliability, and maintainability. Characteristics level, service quality level, marketing model, etc. Only by constantly identifying and excavating customer requirements and expectations can medical device organizations meet customer requirements and occupy the market. It can be seen that the construction of an organization's quality management system must meet both regulatory requirements and customer requirements. Regulatory requirements and customer requirements are both related and different, and have both commonalities and differences. Regulatory requirements are the bottom line of an organization's survival and development, and customer requirements are the basic conditions for an organization's survival and development. The two requirements are indispensable, and the two requirements have different connotations, which cannot be confused or replaced. Therefore, the two requirements are unified in the quality management system to form an organic whole. The two requirements of the quality management system are like two wings of a bird. Without one wing, a bird cannot fly. Only when both wings are full and both wings are strong can they spread their wings and fly higher and farther. We must deeply understand the two requirements repeatedly emphasized by the YY/T0287/ISO13485 standard, and continuously strengthen the construction of the quality management system to achieve the goal of the quality management system.

5 Conclusion    

In the third decade of implementing the YY/T0287/ISO13485 standard, we must fully recognize the important role and far-reaching significance of the YY/T0287/ISO13485 standard for the healthy and rapid development of the medical device industry. The YY/T0287/ISO13485 standard is an important part of my country's medical device standard system, the core standard of the medical device quality management and general requirements sub-standard system, the basis of medical device process standards, and the quality assurance of medical device product standards. A quality management system standard applicable to all organizations throughout the medical device life cycle. Since the vast majority of medical device organizations in my country establish quality management systems in accordance with the framework of the YY/T0287/ISO13485 standard, the release of the new version of the standard will inevitably have a significant impact on the quality management system of medical device organizations. Profound changes in the internal and external environment, the maturity level of the quality management system, and the experience and lessons of operation, according to the requirements of the new version of the standard and the newly adjusted regulatory requirements to revise and improve the quality management system documents, strengthen the main responsibility of the organization's quality and safety and the quality responsibility of the post, Apply process method and PDCA model to strengthen process control and management, carry out product and process risk management, increase traceability and feedback response speed in the life cycle of medical devices, and improve the adequacy, effectiveness and efficiency of quality management system. suitability. In the third decade of implementing the YY/T0287/ISO13485 standard, the quality management of medical device organizations needs to change from normative management to lean management, and move towards excellent performance management; the implementation of standards must change from mechanical clauses that meet standard requirements to scientific systems. The transformation of the way to meet the requirements of the standard, and the move from the appearance standard to the god-like standard; the transformation of the medical device organization's own quality management to the quality management of the medical device industry chain, and the move towards the management of the whole life cycle of medical devices. The implementation of the new version of the standard does not start from the terms and concepts of the standard, but from the input of the quality management system of the organization, the control and management of the process operation, and the actual output of the quality management, and apply the management concepts and requirements of the standard to systematically solve the quality management of the organization. System practical problems, create value, and promote customer and related party satisfaction. The operation of the quality management system is dynamic, so it is necessary to continuously improve the quality management system, establish a vigorous quality management system, enhance the core competitiveness of the organization, build the organization brand, and realize the strategy and goals of the medical device organization.