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YY/T 0595-2020 PDF English


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YY/T 0595-2020English1175 Add to Cart 0-9 seconds. Auto-delivery. Medical devices--Quality management systems--Guidance on the application of YY/T 0287-2017 Valid
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YY/T 0595-2020: PDF in English (YYT 0595-2020)

YY/T 0595-2020 YY PHARMACEUTICAL INDUSTRY STANDARD OF THE PEOPLE’S REPUBLIC OF CHINA ICS 11.040.01; 03.120.10 C 30 Replacing YY/T 0595-2006 Medical devices- Quality management systems- Guidance on the application of YY/T 0287-2017 ISSUED ON: FEBRUARY 21, 2020 IMPLEMENTED ON: APRIL 01, 2020 Issued by: National Medical Products Administration Table of Contents Foreword ... 4  Introduction ... 5  1 Scope ... 7  2 Normative references ... 8  3 Terms and definitions ... 8  4 Quality management system ... 9  4.1 General requirements... 9  4.2 Document requirements ... 17  5 Management responsibilities ... 28  5.1 Management commitment ... 28  5.2 Focus on customers ... 30  5.3 Quality policy ... 31  5.4 Planning ... 32  5.5 Responsibility, authority and communication ... 34  5.6 Management review ... 37  6 Resource management ... 42  6.1 Provision of resources ... 42  6.2 Human resources ... 43  6.3 Infrastructure ... 46  6.4 Working environment and pollution control ... 48  7 Product realization ... 53  7.1 Planning of product realization ... 53  7.2 Customer-related processes ... 57  7.3 Design and development... 61  7.4 Procurement ... 86  7.5 Production and service provision ... 96  7.6 Control of monitoring and measuring equipment ... 119  8 Measurement, analysis and improvement ... 122  8.1 General ... 122  8.2 Monitoring and measurement ... 127  8.3 Control of nonconforming product ... 139  8.4 Data analysis ... 145  8.5 Improvement ... 150  Appendix A (Informative) Examples of the process of integrating applicable regulatory requirements into the quality management system ... 160  Appendix B (Informative) Example of corresponding relationship between YY/T 0287-2017 and "Medical device manufacturing quality management specification" (released on December 29, 2014) and Appendix ... 167  References ... 173  development control requirements. The organization should determine whether the design and development can be deleted according to different products and the applicable regulatory requirements of the country or region to be marketed. For example, if the applicable regulations of the country or region to be marketed provide for medical device categories (such as low-risk medical devices) or the medical device has passed a specific conformity assessment procedure (such as type test), the design and development may not meet the requirements of 7.3 of YY/T 0287-2017. Even if the regulations allow the organization to delete the requirements of clause 7.3 of this standard, the organization is still responsible for meeting the product realization requirements of 7.1, 7.2, 7.4, 7.5, 7.6 of this standard. In addition, outsourcing the design and development process cannot be used as a reason to delete clause 7.3 from the organization's quality management system. 1.2.3 Inapplicability The organization can review all the requirements in Chapters 6, 7, 8 of YY/T 0287-2017 according to its own roles and activities at different stages of the medical device’s life cycle and the types of medical device products; identify those activities do not need to be completed by the organization or requirements that are not applicable to the organization’s products. Those inapplicable requirements may not be considered in the quality management system. 2 Normative references The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) are applicable to this standard. GB/T 19000-2016 Quality management systems - Fundamentals and vocabulary (ISO 9000:2015, IDT) YY/T 0287-2017 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016, IDT) 3 Terms and definitions The terms and definitions defined in GB/T 19000-2016 and YY/T 0287-2017 are applicable to this document. information system resources, etc.; - Guide the necessary changes to the quality management system; - Respond to feedback; - Initiate corrective and preventive measures; - Accept and respond to independent external assessments; - Use appropriate evaluation methods, such as internal audits and management reviews. The organization should identify one or more roles of itself in the medical device’s life cycle or supply chain in accordance with the applicable regulatory requirements in different jurisdictions; document them. Organizations play different roles in different jurisdictions, and the applicable regulatory requirements are also different. Organizations can assume the following different roles under applicable regulatory requirements: - Manufacturer; - Suppliers of raw materials, parts or components; - Contract manufacturer; - Packaging, sterilization or logistics service provider; - Metrology and calibration service agencies; - Importer; - Dealer; - Authorized representative. 4.1.2 The organization's quality management system is composed of interrelated processes. The organization's establishment of a quality management system should identify and determine the required processes and their application in the entire organization based on one or more roles it assumes. The determination and application of these processes are related to the organization's activities, operation methods, management requirements, applicable regulatory requirements. The quality management system requires the application of a risk-based approach to the appropriate processes of the organization. The organization can apply a risk-based approach to determine the degree of control required for each process of the quality management system. Identify and deal with risks that affect the compliance and effectiveness of the quality management system. The following clauses of YY/T 0287-2017 do not clearly state the relevant risks, but risk-based methods have been applied: - Time interval for management review (see YY/T 0287-2017, 5.6); - Control of production and service provision (see YY/T 0287-2017, 7.5.1); - The nature of the handling of nonconforming products and the necessary corrections (see YY/T 0287-2017, 8.3); - Determination of measures to prevent the occurrence and recurrence of nonconformities (see YY/T 0287-2017, 8.5.2, 8.5.3). Organizations can take a variety of measures to deal with risks; the requirements of YY/T 0287-2017 have covered these measures, such as: - Specify responsibilities and authorities; - Identify training needs, implement training and assign competent personnel; - Implement the design and development of products and processes; - Prepare specific method documents and work instructions; - Confirm the implementation process; - Calibrate or verify the monitoring and measuring equipment; - Implement inspection or other monitoring and measurement of products and processes; - Implement corrective measures and ensure that they are extended to other relevant departments of the organization. 4.1.3 After determining the various processes required by the quality management system and the related risks of each process, the organization may focus on each process. Each process has some basic elements that need to be addressed, which can be addressed by considering the following questions: - How does the organization know whether a process is effective? - What needs to be done to ensure that the process runs effectively? - Which controls are necessary for process monitoring? - How does the organization know whether the process control is effective? - What human resources and material resources are needed to operate and b) Quality manual (see YY/T 0287-2017, 4.2.2); c) All requirements, procedures, activities or arrangements and records that need to be documented as specified in YY/T 0287-2017; d) The documents required by the organization to ensure that the processes related to the quality management system are effectively planned, operated and controlled, including records, such as the quality plan formed by the quality planning of a specific project, product, process or contract; work instructions, operating procedures, etc. prepared for carrying out a certain activity or process. Quality records refer to documents that provide objective evidence of quality activities completed or quality results achieved; e) Other documents required by applicable regulatory requirements. Regulatory requirements may specify processes that must be described in documented procedures or use specific types of document carriers, such as clinical evaluation activities (see YY/T 0287-2017, 7.3.7) or review of experience in post-production activities (see YY/T 0287-2017, 8.2.1) which are used as a part of the medical device documentation (see YY/T 0287-2017, 4.2.3). Documents that meet applicable regulatory requirements, documents required by YY/T 0287-2017, documents (including records) determined by the organization to effectively control its activities, these three constitute quality management system documents and meet document control and record control (see YY/T 0287-2017, 4.2.4, 4.2.5) requirements. 4.2.1.3 The procedures or work instructions can be made into charts or audiovisual materials. 4.2.1.4 The documented procedures (including work instructions and flow charts) should be concise, clear and easy to understand; it should state the methods to be used and the criteria to be met. These procedures mainly identify activities and describe the following: - What to do and who will do it; - When, where and how to do it; - What materials, equipment and documents are used; - How to monitor and measure an activity; - What records are required to be kept. 4.2.1.5 In terms of the effectiveness of the quality management system, the documents should be evaluated against the following criteria, such as: Medical device documentation is a road map that shows how the product completes related activities in accordance with the requirements of the quality management system. The medical device documents should be controlled in the same way as other documents, kept updated and archived. Medical device documentation may include complete files, copies of approved files, or maintain an index of relevant files and records. 4.2.3.2 Regulators in different jurisdictions usually require specific parts of the medical device documentation as part of the market license. The content of medical device documents required by regulatory agencies in different jurisdictions is different. Medical device documentation may include but is not limited to the following: - General description of the medical device, including device classification and planned changes as appropriate; - Product specifications, including drawings, composition, formulas, parts specifications and medical device software specifications; - Production process procedures, including equipment specifications, production methods, all special processing and infrastructure requirements; - Quality assurance procedures and specifications, including acceptance criteria and measuring equipment used; - Packaging specifications, including methods and processes; - Description of Intended use/purpose; - Design output that meets the applicable regulatory requirements for medical devices; - Risk management records, including the results of risk analysis, risk control measures, resulting residual risks and risk/benefit analysis; - Mark, including any instructions for use; - Installation specifications; - Product maintenance procedures or instructions; - The unique identification of the applied device; - Records of various languages available in the country or region where the medical device is intended to be marketed; - Clinical evaluation data; - Information on the materials and components that make up the medical data analysis. For these system records, YY/T 0287-2017 requires the organization to determine the appropriate retention period. When determining the retention period, the organization should consider the nature of the medical device, the risks associated with its use, the records involved and the applicable regulatory requirements. 4.2.5.5 Handwritten records should use non-erasable media. The person authorized to fill in or check the record shall have clear handwriting and keep the signature or seal and date. Where appropriate, good recording practices should include: - Enter data and observation results in time; - Do not make records in advance or late; - Do not use other people's signatures or seals; - All items should be completed or checked when using the form to record; - When transmitting data, it should be faithful to the original data and be transcribed and verified by others; - Check the completeness and correctness of all entries; - Prepare page numbers to ensure completeness. 4.2.5.6 If an error is found in the record, the correction method should ensure that the original input data cannot be lost and the correction content has a signature and date. When appropriate, the reason for the correction should be recorded. If an electronic record system is used instead of paper records, the electronic record system should include as far as possible a time-stamped, unmodifiable, system-formed inspection and tracking log, so that record changes can be traced back. The log may include the identity of authorized users, creation, deletion, modification/correction, date and time, links, and embedded notes. 4.2.5.7 The organization may make additional provisions for the entry of key data in electronic records, such as: - The second authorized person with login name, identity, date and time who can verify data entry through the keyboard; - As part of the verification system function, a second inspection can be performed on the electronic record system that directly obtains the data. The application of the above system can ensure the integrity of electronic records and prevent unauthorized entry. The subject of electronic records is complex and constantly evolving. Applicable regulatory requirements and management as an integral part of the quality management system must also meet the applicable system requirements. Top management should implement the following activities: - By formulating a quality policy, clarify its commitment to implement and maintain a quality management system that meets the requirements of YY/T 0287-2017 and applicable laws and regulations; - Establish measurable quality objectives to ensure that the operation of the quality management system complies with YY/T 0287-2017 and the quality policy; - Improve the quality management system and communicate the value of the organization's quality management system through the quality policy and quality objectives; ensure the normal operation of the quality management system (during management review); support the quality management system training for employees; support quality personnel; allocate resources for the quality management system; - Through regular review of the elements of the quality management system, review the suitability, adequacy and effectiveness of the quality management system; identify the problems of the quality management system; solve these problems through decision-making, measures and the provision of necessary resources (carried out during management review). Top management’s considerations should include, but are not limited to: - Ensure that the sequence and interaction of the various processes are designed to effectively achieve the planning results; - Ensure that the inputs, activities and outputs of each process are clearly defined and controlled; - Monitor inputs and outputs to verify that the processes are related to each other and operate effectively; - Identify hazards (sources) and manage risks; - Conduct data analysis to promote necessary process improvement; - Determine the person in charge of each process and assign corresponding responsibilities and authorities; - Manage each process to achieve process goals; - Ensure that a written agreement has been signed with the supplier (see YY/T 0287-2017, 7.4). out in stages according to needs and planning requirements, usually including continuing education or further education training. For full-time, part-time or contract personnel that affect the quality of products, the organization usually provides appropriate training according to the work assigned by the personnel to ensure the competence of the personnel. The training should cover: ●The nature of the work and the responsibilities of the employees; ●The organization's quality management system documents, including quality policy, quality objectives and related program documents, work instruction documents, etc.; ●Technical knowledge and job skills related to products. d) Evaluate the effectiveness of training or other measures taken to ensure personnel capabilities. If training is provided or other measures are taken for a job, the organization should use the following methods to evaluate effectiveness based on the risks related to the job: ● Investigate the trainees to assess whether they have the required knowledge and information; ●Test or ask trainees to assess their ability to apply objective criteria; ●Evaluate the work performance of trainees; ●Review the trainer’s assessment of the effectiveness of the training. Note: The organization shall consider the risk of insufficient completion of tasks or processes before determining the level of effectiveness of training and declaring competence by demonstrating that personnel have the ability to complete tasks or processes. e) Strengthen quality awareness education. For example, by refining the quality objectives of each level, so that personnel know the relevance of the work they are engaged in and the importance of the quality management system. f) Keep records of personnel capabilities. The personnel competency records should include the records of the measures taken (such as transfer, recruitment), or records of the personnel received training, the results of the measures taken, which constitute evidence that the personnel are competent. Records show that the measures or training courses have been successfully completed and the personnel have acquired the required capabilities. The method of evaluating ability should be adapted to the risk of the job. The effectiveness of any further measures, education b) Process equipment (such as production equipment, various control equipment containing computer software, test equipment, various tools, auxiliary tools, etc.), that is, equipment directly used in the product realization process; c) Supporting services (such as outlets that provide maintenance activities after product delivery, warehousing logistics, communication services, IT and network technology applications, etc.). If an information management system is applied, the organization should consider whether the business processes covered by the quality management system are coordinated with the information management system that provides supporting services. 6.3.4 The organization should plan appropriate infrastructure and ensure that it meets the needs of production capacity; meanwhile it is easy to clean, maintain or take other required measures. The layout of the site should have sufficient space for the orderly disposal of products; at the same time prevent material or product confusion, such as incoming materials, different batches of product in progressing, scrap materials, reworked products, any other unqualified materials, medical device final products, production equipment, inspection tools, documents and drawings, etc. Organizations should plan and document the process of product transfer. The organization should specify the appropriate storage and disposal conditions required for product protection (see YY/T 0287- 2017, 7.5.11), including available space, specific environmental conditions and transportation methods. 6.3.5 The infrastructure should be designed, constructed, correctly installed and positioned so that it can be properly operated, maintained, debugged and cleaned. For infrastructure: - In order to meet product requirements, the organization shall implement full life cycle management of infrastructure, including the process of purchase, installation, use, maintenance, overhaul and scrapping. The organization should consider ways to respond to risks, such as preventing possible problems (e.g., preventive maintenance of critical equipment) or planning future needs; - When applicable, the organization should ensure that the restricted ranges or allowable tolerances of production, measurement, installation, service and test equipment are documented and are available for inspection by the operator at any time; - The organization should document and make it easy to obtain the maintenance, cleaning and inspection procedures for all equipment used for production, measurement, testing, repair and work environment control. The time interval of debugging and maintenance required should be - People in the working environment; - Storage conditions and conditions of circulation links. For the work environment, the organization should consider the following factors: - Appropriate parameters, indicators and control requirements related to the workplace; - Appropriate visitor waiting areas and facilities; - Maintenance of proper sanitary equipment (such as toilets) and maintenance of personnel hygiene; - Non-production activities that need to be isolated (such as catering preparation); - Use appropriate methods/mechanisms to reduce the risks caused by potential hazards (sources) (such as electrostatic discharge of electronic components, disposal of animal-derived materials, other contamination of products or spillage of volatile chemicals). These requirements apply to activities that directly affect the conformity of products and services. 6.4.1.2 Environmental control in product realization 6.4.1.2.1 The need and degree of work environment control depends on the type of products produced and external environmental factors. Work environment control refers to the guidance, management, coordination and monitoring of activities and variable factors that affect environmental conditions, so that the state of the work environment can be controlled. The organization should define qualitative and quantitative constraints on the characteristics of the defined work environment, in order to describe the degree of control over the environment. The types of facilities, equipment, resources and documents required to determine, monitor and maintain the working environment will be affected by the degree of environmental control. If the output of the environmental control system cannot be verified (see YY/T 0287-2017, 7.5.6), the organization should verify the environmental control system and conduct regular monitoring to verify that the environmental system is operating normally. The organization should document these systems and their inspections. 6.4.1.2.2 According to YY/T 0287-2017, 7.5.2, there are situations where the working environment may affect product quality. Examples of situations where the working environment may affect product quality involve the following medical devices: requirement of the work environment, to determine whether the lack of corresponding control will increase the risk in product use, that is, the need and degree of environmental control can be traced through the records of product risk management activities. If environmental conditions are critical in the product manufacturing process, the organization should establish requirements for the working environment in which the product is located. When applicable, ensure the traceability of the environment in which the product is located. 6.4.1.3 Personnel 6.4.1.3.1 For any personnel who may come into contact with the product or the working environment (including those who enter the work area temporarily or for a short time), if their clothing, cleanliness, health conditions have an adverse effect on the product, the organization should clarify the requirements for the dressing, cleanliness, health of these specific personnel and document them. Examples of people who may enter the work environment are as follows: - Production staff and their supervisors and managers; - Material manager; - Manufacturing engineer; - Design and development engineer; - Quality inspection personnel, quality assurance personnel, quality engineering personnel; - Any material or service (including cleaning service) supplier; - Personnel responsible for the maintenance of production equipment; - Customer; - Auditor; - Visitors. 6.4.1.3.2 The organization should pay attention to the health status of personnel meeting the specified requirements. If the health of the personnel may have an adverse effect on the product, they need to be restored to their health before they can operate or enter a controlled working environment. For medical devices that are essential for sterile provision, sterilization before use, or microbiological cleaning, the health of the personnel during the production process is particularly important. 6.4.1.3.3 The organization shall provide professional training and (or) supervision for personnel working under special environmental conditions (such that the medical devices produced in its quality management system are safe and operate as expected. As part of the quality management system, product realization activities have a direct impact on the safety and performance of medical devices. These plans should be consistent with the requirements of other processes in the quality management system, which may include: - Specify the input required for each process; - Determine the expected results of each process; - Determine the sequence of each process and document it, including the time limit necessary to achieve the expected results; - Allocation of appropriate human resources and clear assignment of responsibilities; - Determine the necessary monitoring and measurement of each process parameter. The organization prepares planning documents to clearly understand the process and requirements in order to achieve success in product realization activities. The planned output should also clarify who is responsible for establishing requirements for quality objectives, processes, documents (including records) and resources in product realization. 7.1.1.4 The determination of the life span of a medical device is part of the product realization plan. By determining the life span of the medical device, the identified residual risk can be partially controlled. When the medical device is used for an extended period of time, this residual risk may increase to an unacceptable level. The life span of medical devices should be determined based on regulations, standards, technical, commercial or other considerations. The organization may document the basis for determining the life of medical devices. To help determine the life span of medical devices, the following factors should be considered and the reasons for determining the life span recorded: - Storage period of medical devices; - Replacement of degradable components and consumable parts or the expiry date of medical devices; - Normal use, maintenance and maintenance of medical devices; - The number of uses or the period of use of the device based on the life test of the medical device; - The expected material degradation; ......
 
Source: Above contents are excerpted from the PDF -- translated/reviewed by: www.chinesestandard.net / Wayne Zheng et al.