Medical network - on February 6, 2017, on January 19, the state administration of drug safety release YY/T 0287-2017 "medical device quality management system for regulatory requirements" standard, the standard implementation since May 1, 2017.
In 2011, in response to the medical device industry and the regulation of new challenges, the international organization for standardization (ISO) launched the iso13485:2003 2003 "medical device quality management system Used for regulatory requirements, revision of the work, and were published on March 1, 2016 iso13485:2003 2016 "medical device quality management system Used for regulatory requirements ", which is the third version of the standard hl-tech corporation.
Considering hl-tech corporation standard to the important role of quality management of medical equipment, closely follow the departments of administration of drug safety standard management revision process, combining the reality of China's medical equipment industry and regulatory, again will iso13485:2003 2016 standard into idt YY/T0287-2017 iso13485:2003 2016 "medical device quality management system Used for regulatory requirements "promulgated standards.
The new standard compared with 2003 edition hl-tech corporation standard, there are 11 main changes:
1, the new standards and regulations as the main line, further highlights the importance of regulatory requirements
Impressive new standard is further emphasizes the position and role of the regulations in the standard, put forward the medical equipment organization regulations can be incorporated into the quality management system of the three rules, namely, in accordance with the applicable regulatory requirements to identify the roles of organization, according to these regulations for character recognition is suitable for the organization activities, in the organization quality management system into the applicable regulatory requirements, further clarify the relationship between the quality management system requirements and regulations.
Use the term "regulations" in the new standard number increased from 2003 edition standard 28 to 52, stipulate in the process of quality management system to meet the requirements of this standard and regulatory requirements, distinct reflected the standard regulations and quality management system requirements to fusion of characteristics, to strengthen the quality and safety of medical equipment organization's main body responsibility, to help implement the regulations.
2, the new standards more clear scope
Standard compared to the 2003 version, the new standard in general more clear about the standard of the applicable scope, increase the applicable to each stage of whole life cycle of medical device industry chain, the organization of medical equipment, also increased the applicable to the supplier or other external parties and other requirements. This is helpful to the new standard in more and more widespread promotion and application of better achieve the standard.
3, strengthen the risk management requirements
In the new standard "0.2 illustrate concepts", put forward "when using the term" risk ", the term in the standard within the scope of the application is about the safety of medical equipment performance requirements or meet the requirements of the applicable laws and regulations ".
With only 2003 edition standard in the product realization process planning, 7.3.2 7.1 design and development input request of risk management, the new standards in the purchasing process and external supplier control, software validation process, training plan, feedback information collection requirements mentioned in both risk identification and management of control, thus further expands the application range of risk management, it will be the medical equipment organization faces new challenges.
The new standard to strengthen the risk management requirements, not only for medical equipment in whole life cycle of products and services of the implementation of risk management, and made clear to the quality management system implementation process of risk management requirements, proposed "the application of the method based on risk control of appropriate processes needed for the quality management system" (the new standard 4.1.2 b). This is and 2003 edition standard has obvious change.
4, the increase of purchasing and supplier control requirements
The new standard of purchasing process and more specific requirements for the supplier's control.
Made clear in the supplier evaluation criteria in four aspects, namely the supplier performance, the products supplied by the supplier, the supplier provide products impact on the quality of medical apparatus and instruments, and medical equipment adapted risk; Made clear to meet the product requirements of performance monitoring, even at the same time as the supplier to evaluate the content of the input; Has been clear about the disposal of the supplier fails to fulfill its purchase requirements should be suitable to the risks related to purchasing products and shall conform to the regulations.
For the above activities are put forward at the same time maintain a record of requirements. The new standards in terms of purchasing information to increase the "product specification" requirements, and put forward the applicable to form a written agreement. In purchasing the product validation process, increased the organization when found any changes in the purchasing products to take measures and the requirements of the scope of validation activities.
This shows the new standard of purchasing and supplier control new request more specific and detailed, operable.
Clause 5, the new complaints handling
The new standards will be 2003 version of the standard term "customer complaints" changed to "complain"; And increase the clause "8.2.2 complaints handling", required by applicable laws and regulations of the clear form program file complaints should be dealt with, and the program file specifies the requirements and responsibilities, and to keep complaints handling records.
Visible in the new standard, "complaint handling" as the quality management system of "monitoring and measurement" an important part of the process, further emphasized the importance of complaint handling.
6, increase the communication with regulators, and reported to the regulatory requirements
5.6.2 management review input the new standard contains "report to regulators" content, 7.2.3 stipulated in "the organization shall, in accordance with the applicable regulations and regulatory agencies communication", in 8.2.2 d) specified in the "to determine the information reported to the appropriate regulatory agencies need", standard 8.2.3 is entitled "report to regulators," prescribed the report content and establish procedures and maintain records. The proposition of this help medical equipment organization by report to regulators and communication deepen understanding regulations, better to implement the laws and regulations; The new standard that change can play standard for medical device regulatory role in technical support, but also to the implementation of laws and regulations.
7, to strengthen the post-marketing surveillance requirements
The new standard to further clarify the post-marketing surveillance requirement and increase the term "post-marketing surveillance", this paper post-marketing surveillance refers to the collection and analysis from the listed medical devices to gain experience of system process, the new standard in the 8.2.1 feedback, 8.2.2 complaints handling, 8.2.3 report to regulators, 8.3.3 are included nonconforming product is found after delivery of response measures are 8.4, 8.4, data analysis and improvement of public supervision and regulation after the new requirements.
8, increased formation of files and records
The new standards to increase the quality management system documents and records. Quality management system documents of the quality manual, program files, process operation to control documents and records was reduced, different from the ISO9001:2015 standard relative weakening the demand of file. "Form file" in the new standard to 43, keep records requirements up to 50, 2003 version of the standard. At the same time new terms required by the relevant documents, such as holdings of medical equipment document, 7.3.10 design and development of the document requires increased file specific requirements. For not only reflect increased documents the constraints of the role, but emphasizes the organization the ability to control and effect of implement quality management system requirements. Give full play to the document communication intention, unified action, the action of added value.
9, increasing the management system about the process
In the new standard has the following process increased by different degree of specific requirements: 4.1.6 software verification, management review, 5.6 6.3 6.3 infrastructure, 6.4.2 pollution control, process related to the customer, the design and development of 7.3.2 planning, 7.3.3 design and development input, 7.3.9 design and development of change control, 7.4.1 procurement process, 7.5.1 control of production and service provision, 7.5.2 products clean, 7.5.4 service activities, 7.5.6 confirmation, 7.5.7 sterilization process of production and service, and confirm the special requirements of sterile barrier system, 7.5.11 product protection, 8.3.3 are included find nonconforming response after delivery.
The new standards to increase the following terms: holdings medical equipment document, 7.3.8 design and development of conversion, the design and development documentation 7.3.10, 8.2.2 complaints handling, 8.2.3 report to regulators.
New provisions to the specification design and development process, to improve the effectiveness of the design and development, improve the medical equipment technical requirements, and actively respond to feedback and handling complaints, and strengthen the communication with regulators, has important effect to the implementation of the laws and regulations.
10, the change of the term
The new standard term a total of 19, compared with 2003 standard large changes have taken place in eight terms. The new standard retained the 2003 edition of "advice notice", "medical planted instruments", "tag", "medical devices", five terms, such as "sterile medical devices" and the "medical planted instruments", the definition of term "tags" has carried on the elaboration. Amend the 2003 version of the term "customer complain" to "complain", and further elaborated the definition. Deleted the 2003 version of the standard of "active implantable medical devices" and the term "active medical devices". Added 13 terms, the new standard has "authorized representative", "clinical evaluation", "dealer", "importer", "life cycle" and "manufacturer", "medical devices" and "performance evaluation", "post-marketing surveillance", "purchasing products", "risk", "risk management", "sterile barrier system. The new standards to increase the term is conducive to deepening the consistent understanding and implementing the standard, can also help the parties mutual communication.
11, the change of the appendix
The new standards revised the 2003 edition of the standard two appendices:
Appendix A (informative appendices), YY/T0287-2003 / ISO 13485:2003 and the content of the new standard. The appendix can help organizations to understand the new medical devices standards and standards of translation work.
Appendix B (informative appendices), the new standards and ISO9001:2015 standard of the content. Because the new standard is a GB/T19001-2008 / ISO9001:2008 standard on the basis of independent standard, for the convenience of the user in the field of medical apparatus and instruments, the new standards formulated the appendix B, will be the new standard and the ISO9001:2015 standard content were compared.
Attachment: YY/T 0287-0287 "medical device quality management system for regulatory requirements for medical devices industry standard number, name and scope of application
YY/T 0287-0287 "medical devices quality management system for regulatory requirements,
This standard stimulates the need to prove their ability to provide continuing to meet customer requirements and the applicable regulatory requirements of medical equipment and related services of the organization's quality management system requirements. This standard applies to involve medical equipment life cycle of the industrial chain of organizations, namely the design of medical equipment development and production enterprises, trading enterprises, logistics companies, scientific research institutions, maintenance services company, installation company, and to provide medical equipment organization product supplier or other external parties (such as raw materials, components, parts, medical equipment, sterilization, calibration services, distribution services, maintenance services and other organizations). This standard instead of YY/T 0287-0287 "medical devices quality management system for regulatory requirements. |
