1.1 A brief review of the ISO13485 standard
The ISO13485 standard has gone through two versions. In 1996, ISO published the ISO13485:1996 standard, "Quality Systems - Medical Devices - Specialized Requirements for the Application of ISO9001". In 1996, ISO published ISO13485:1996 "Quality System - Medical Devices - Requirements Specific to the Application of ISO9001", which is not a stand-alone standard but is to be used in conjunction with the ISO9001:1994 standard. In 2003, ISO/TC210 revised the 1996 version of the ISO13485 standard, and then published ISO13485:2003 "Requirements for the Use of Quality Management Systems for the Regulatory Use of Medical Devices", which is a stand-alone standard specific to the field of medical devices. The standard is an independent standard dedicated to the medical device field.
ISO13485 is a quality management system standard applied to the medical device field, which focuses on the safety and effectiveness of medical devices and emphasizes that the medical devices provided by the organization should meet customer requirements and regulatory requirements. Because the purpose of ISO13485 standard and the goal of medical device regulations are highly compatible, and the expectations of medical device industry and the public are completely consistent, ISO13485 standard has been highly valued and widely recognized by the global medical device industry, regulatory authorities and the society as soon as it was released. Many countries have transformed the ISO13485 standard into their own standards and implemented it in the medical device field. Our government attaches great importance to the ISO13485 standard, medical device regulatory authorities actively track the ISO13485 standard revision process, respectively in 1996 and 2003 after the release of the ISO13485 standard that is equivalent to the use of transformed into the industry standard YY/T0287-1996 and YY/T 0287-2003 standard, to ensure that China's industry standards and international standards to keep pace with the release of the international standard. international standards are synchronized. Medical device regulators also refer to and draw on the requirements of ISO13485 standard when formulating relevant medical device regulations. Driven by the government and the market, the concepts, principles and methods of ISO13485 have been rapidly spread and widely used in China's medical device industry, and have achieved great success.
1.2 Background of Revision of ISO13485 Standard
The birth of ISO13485 standard is closely related and accompanied by medical device regulations.The development of ISO13485 standard is inevitably also closely related and accompanied by medical device regulations. With the social change, economic development, the rise of a new round of scientific and technological industrial revolution, the speed of the global market integration process, the production mode of medical device industry, the marketing model is changing, resulting in the extension of the medical device industry chain and increasingly complex, the public on the safety and efficacy of medical devices has put forward new needs. Therefore, based on the major changes and adjustments of medical device regulations 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 start the revision of the ISO13485 standard in order to strengthen the compatibility of the new version of the standard and the medical device regulations, to satisfy the growing needs and expectations of users, and to realize the value of the ISO13485 standard. The ISO13485 standard value.
2. The main idea of revising the new version of the standard
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. Our SAC/TC/221 Technical Committee for Standardization of Quality Management and General Requirements for Medical Devices and CMD have been tracking and actively participating in the various stages of the draft revision of the new version of the standard, submitting revised comments and suggestions and voting. According to the requirements of ISO for making and revising standards, the process of making and revising ISO standards is divided into the preparation stage, the initiation stage, the draft stage, and the official standard release stage. In order to revise the 2003 version of ISO13485 standard, ISO/TC210 formulated the Design Specification for the Revision of ISO13485 (hereinafter referred to as the Design Specification). The Design Specification defines the main directions and requirements for revising the standard, and is used to guide the drafting and validation of the standard revision, and the main ideas for revising the standard are as follows:
2.1 Enhancement of the compatibility of the new version of the standard and the regulations
The name of the ISO13485 standard begins by stating that the standard is used for regulatory requirements. The important goal of the new version of the standard revision on the one hand to continue to maintain the ISO13485 standard in the field of medical devices in the application of the generality of the standard. On the other hand, it is important to further emphasize the close relationship between the standard and the regulation, and to enhance the compatibility between the requirements of the new version of the standard and the requirements of the regulation. This is to avoid unnecessary duplication of standard requirements and regulatory requirements, but also to avoid the contradiction between the two. In order to enhance the compatibility, the medical device regulations and regulatory requirements of relevant countries and regions have been brought together during the revision process of the standard, so that the quality management system requirements of the standard can be adapted to the differences in the regulatory requirements of different countries and regions, and help the medical device organizations to carry out the relevant regulatory requirements in the implementation of the standard.
2.2 The requirements of the new version of the standard should be clear and unambiguous
The intended users of the standard should be continuous, appropriate, and conducive to the implementation of the standard in medical device organizations; It should help the evaluation of relevant parties such as medical device regulatory bodies and certification bodies to be objective and consistent; It should be able to adapt to the development of new products, new technologies and quality management system technologies of medical devices; It should avoid requirements other than quality management system requirements, including those related to quality management system. Avoid requirements outside the quality management system, including regulatory requirements that are not suitable for use as quality management system requirements; Cover the full life cycle of medical device products and services, and be applicable to all sizes and types of medical device organizations, as well as suppliers and external parties in the medical device industry chain;2.3 The structure and model of the new version of the standard remain unchanged
The new version of the standard Continue to use the process-based quality management system model, the overall structure remains unchanged, is still eight chapters plus two appendices of the structure, but the new version of the standard provisions of the level of the original four levels to change to three levels, some provisions of the arrangement of the order of the appropriate adjustments to facilitate the implementation of the standard.
In the process of revising the new version of the standard, some members of ISO/TC210 raised the question of whether the new version of the standard is the same as the ISO9001:2015 standard, using the "ISO/IEC Guideline Part 1: Technical Working Procedures" of Appendix SL of the appendix 2 of the management system standard of the high-level structure. The overall structure of the 2003 version of ISO13485 remains unchanged for the following reasons:
(1) A major feature of ISO13485 is that it is closely related to the medical device regulations of various countries. At present, the medical device regulations of many countries are different degrees of reference or reference ISO13485 standard requirements, such as the European Union, Canada and Australia, etc. directly to the ISO13485 standard as a regulatory nature of the requirements of the implementation of regulatory, and even some members of the ISO13485 standard has become the world's medical device regulatory template. In order to facilitate the relative stability and authority of the implementation of medical device regulations, and to help strengthen the supervision of medical devices, ISO/TC210 has taken a cautious attitude and decided that the new version of the standard will still adopt the 2003 version of the overall structure of the ISO13485 standard to remain unchanged.
(2) ISO/TC210 hopes to summarize the experience of applying the advanced structure of management system of ISO9001:2015 standard, and then combine the actual situation of medical device industry on this basis, so as to better adopt the advanced structure of management system standard proposed by ISO, and to avoid unnecessary negative impacts due to the change of the overall structure of the standard, and to help the implementation of medical device regulations and the realization of ISO13485 standard in various countries. The ISO13485 standard is based on the actual situation of the medical device industry.
2.4 The new version of the standard writing language to be clear
The new version of the standard reference to use ISO9000:2005 "quality management system basics and terminology" standard terminology, is conducive to the consistency of understanding of the standard, to avoid multiple interpretations. The new version of the standard writing language efforts to maintain consistency with the ISO9001:2008 standard and ISO9000:2005 standard.
2.5 The new version of the standard needs to refer to, but not repeat, including the requirements of other related standards, such as: risk management, software, usability, sterilization, aseptic medical device packaging and other standards.
3. The main changes of the new standard
Compared with the 2003 version of the ISO13485 standard, the new standard has many changes from the content to the terminology, the main changes are as follows:
3.1 The new version of the standard is based on the main line of the regulation, and further highlights the importance of the regulatory requirements
The new standard impresses people is to further emphasize the status and role of the regulatory requirements in the standard. The new version of the standard is impressive to further emphasize the status and role of regulatory requirements in the standard, puts forward the medical device organization to integrate regulatory requirements into the quality management system of the three rules, that is, in accordance with applicable regulatory requirements to identify the role of the organization, based on the identification of these roles in the organization of the regulatory requirements applicable to the organization of the activities of the regulatory requirements of the organizational quality management system to integrate the applicable regulatory requirements to further clarify the relationship between the requirements of the quality management system and the regulatory requirements. The new version of the standard uses the term "regulatory requirements" in the number of standards from the 2003 version of 28 to 52, in the quality management system of many processes are required to comply with the requirements of this standard and regulatory requirements, clearly reflects the standard will be a comprehensive integration of regulatory requirements and quality management system requirements of the characteristics of the standard to strengthen the organization of medical devices, the main responsibility for quality and safety, and to help the regulatory requirements. Quality and safety of medical device organizations to strengthen the main responsibility for the implementation of 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 in the General Provisions of the standard is more clear about the scope of application of the standard, increased in the medical devices applicable to the whole life cycle of medical devices in all stages of the industrial chain of the medical device organization, but also increased in the supply side or other external parties and other requirements. This is conducive to the promotion and application of the new version of the standard at more levels and in a wider range, to better achieve the goal of the standard.
3.3 Enhanced Risk Management Requirements
When the new version of the standard proposes the use of the term 'risk', the application of the term within the scope of the standard is about the safety or performance requirements of the medical device or to meet the applicable regulatory requirements. Unlike the 2003 version of the standard, which only proposed risk management requirements in 7.1 Product realization process planning and 7.3.2 Design and development inputs, the new version of the standard mentions risk identification and management control in the purchasing process and external supplier control, software validation process, training planning, and feedback collection requirements, thus further expanding the scope of risk management application, which will be a new This will be a new challenge for medical device organizations. The new version of the standard strengthens the risk management requirements, not only for the implementation of risk management for the whole life cycle of medical device products and services, but also clarifies the requirements for the implementation of risk management for the processes of the quality management system, and proposes to "apply the risk-based methodology to control the appropriate processes required by the quality management system" (the new version of the standard 4.1.2b), which is a significant change from the 2003 version of the standard. There is a clear change from the 2003 version of the standard.
3.4 Increased requirements for purchasing and supplier control
The new version of the standard is more specific and clearer on the purchasing process and supplier control requirements. Clarified the four aspects in the supplier evaluation guidelines, namely, supplier performance, the ability of the supplier to provide products, the supplier to provide products on the quality of medical devices, and the risk of medical devices to adapt; clarified that the performance to meet the requirements of the procurement of products to be monitored, but also as a supplier re-evaluation of the content of the inputs; clarified that the failure to fulfill the requirements of the procurement of the supplier's disposal should be adapted to the risk of purchasing products and to comply with the regulatory requirements. It is clarified that the disposal of non-performing suppliers should be appropriate to the risks associated with the procured products and in accordance with regulatory requirements. Record-keeping requirements are also introduced for all of the above activities. The new version of the standard adds the requirement of "product specification" in the procurement information clause, and proposes to form a written agreement when applicable. In the procurement product validation process, it adds the requirement for the organization to take measures and validate the scope of activities when any changes in the procured products are found. This shows that the new version of the standard on procurement and supply-side control of the new requirements are more specific and detailed, with operability.
3.5 New Complaint Handling Provisions
The new version of the standard modifies the term "customer complaints" in the 2003 version of the standard to "complaints" and adds "8.2.2 Complaint Handling
The new version of the standard amends the term "customer complaints" to "complaints" and adds "8.2.2 Complaint Handling" to make it clear that the handling of complaints shall be documented in the applicable regulations and stipulates the requirements and responsibilities for the procedure documents, as well as the requirement to keep records of complaint handling. It can be seen in the new version of the standard, "complaint handling" has become an important part of the quality management system "monitoring and measurement" process, further emphasizing the importance of complaint handling.
3.6 Increased requirements for communication with and reporting to regulatory agencies
The new version of the standard 5.6.2 management review inputs include "reporting to regulatory agencies", 7.2.3 states that "the organization shall communicate with regulatory agencies in accordance with applicable regulatory requirements", and in 8.2.3 states that "the organization shall communicate with regulatory agencies in accordance with applicable regulatory requirements", and in 8.2.3 states that "the organization shall communicate with regulatory agencies in accordance with applicable regulatory requirements". 7.2.3 states that "The organization shall communicate with regulators in accordance with applicable regulatory requirements", and in 8.2.2d) states that "The need to report information to the appropriate regulator is identified". 8.2.3 of the standard is titled "Reporting to Regulators", and provides guidance on the content of the report as well as Standard 8.2.3 is titled "Reporting to Regulatory Authorities" and sets out requirements for the content of the report and the establishment of documentation of procedures and maintenance of records of the report. This requirement helps medical device organizations to deepen their understanding of the regulatory requirements through reporting and communication to the regulatory authorities, and to better implement the regulations; this change in the new version of the standard is conducive to the technical support of the standard for the supervision of medical devices, and is also conducive to the implementation of the regulations.
3.7 Strengthened requirements for post-marketing surveillance
The new version of the standard further clarifies the requirements for post-marketing surveillance, and adds the term "post-marketing surveillance" to the standard, stating that post-marketing surveillance refers to "the systematic process of collecting and analyzing the experience gained from the medical devices that have been marketed. ", the new version of the standard in 8.2.1 feedback, 8.2.2 complaint handling, 8.2.3 report to the regulatory body, 8.3.3 after the delivery of non-conformity found in the response measures, 8.4 data analysis and 8.5 improvement, all of which are post-market supervision of the new requirements.
3.8 Increased requirements for the formation of documents and records
The new version of the standard adds requirements for quality management system documents and records. Quality management system documents in the quality manual, procedure documents, process operation and control documents, as well as records of the requirements have not been reduced, unlike the ISO9001:2015 standard relatively weakened the requirements of the document. In the new version of the standard, the number of "forming documents" reaches 43, and the number of record keeping requirements reaches 50, which is more than the 2003 version of the standard. At the same time, new provisions related to documentation requirements, such as 4.2.3 Medical Device Documentation, 7.3.10 Design and Development Documentation requirements to increase the specific requirements of the document. Increase the document requirements not only reflect the binding role of the document, but also emphasize the organization to implement the quality management system requirements of the control capacity and effectiveness, give full play to the document communication intentions, unified action, to achieve the role of value-added.
3.9 Increase the requirements of the management system process
The new version of the standard has the following processes to increase the degree of specific requirements: 4.1.6 software validation, 5.6 management review, 6.3 infrastructure, 6.4.2 pollution control, 7.2 processes related to the customer, 7.3.2 design and development of planning, 7.3.3 inputs to the design and development, 7.3.9 Design and Development Change Control, 7.4.1 Procurement Process, 7.5.1 Control of Production and Service Delivery, 7.5.2 Product Cleaning, 7.5.4 Service Activities, 7.5.6 Confirmation of Manufacturing and Service Processes, 7.5.7 Specific Requirements for Confirmation of Sterilization Processes and Aseptic Barrier Systems, 7.5.11 Product Protection, 8.3.3 Response to Nonconformities Found after Delivery. Response measures.
The following provisions have been added to the new version of the standard: 4.2.3 Medical Device Documentation, 7.3.8 Design and Development Transition, 7.3.10 Design and Development Documentation, 8.2.2 Complaint Handling, and 8.2.3 Reporting to Regulatory Authorities.
The new clauses play an important role in standardizing the design and development process, enhancing the effectiveness of design and development, improving the technical requirements for medical devices as well as actively responding to feedback and handling complaints, and strengthening communication with regulatory agencies to implement the regulations.
3.10 Changes in terminology
The new version of the standard*** has 19 terms, compared with the 2003 version of the standard 8 terms have changed significantly. The new version of the standard retains the 2003 version of the standard "advice notice", "implantable medical devices", "marking", "medical devices The 2003 version of the standard retains the five terms of "advisory notice", "implantable medical device", "marking", "medical device", "sterile medical device", and the definition of "implantable medical device", "marking" terms have been refined. The term "customer complaint" in the 2003 edition has been revised to "complaint", and the definition has been further refined. The terms "active implantable medical device" and "active medical device" in the 2003 edition have been deleted. The new version of the standard adds 13 terms, including "authorized representative", "clinical evaluation", "distributor", "importer", "life cycle", "life cycle" and "life cycle". ", "life cycle", "manufacturer", "medical device family", "performance evaluation ", "post-market surveillance", "procured products", "risk", "risk management ", and "sterile barrier systems". The terminology added to the new version of the standard is conducive to deepening the consistent understanding and implementation of the standard, and also helps all parties to communicate with each other.
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