封面图
正文内容
（一）采购控制与进货检验
（1） Procurement Control and Incoming Inspection
企业应当建立并实施采购控制程序。供应商的管理应当参照《医疗器械生产企业供应商审核指南》（国家食品药品监督管理总局通告2015年第1号）有关要求，以确保采购物品符合规定的要求，且不低于法律法规的相关规定和强制性标准的相关要求。
Enterprises should establish and implement procurement control procedures. The management of suppliers should refer to the relevant requirements of the "Guidelines for Supplier Audit of Medical Device Manufacturing Enterprises" (Notice No. 1 of the State Food and Drug Administration in 2015) to ensure that the purchased items meet the specified requirements and are not lower than the relevant provisions of laws and regulations and mandatory standards.
企业应当根据采购物品对产品质量的影响程度，确定对采购物品，特别是对成品质量影响较大的主要原材料、零部件、组件等实施常规控制的验证/确认/监视/测量/检验/试验程序与要求，确保其符合规定要求。接收和拒收及其相关处置措施都应予以记录。
Enterprises should determine the verification/confirmation/monitoring/measurement/inspection/testing procedures and requirements for routine control of purchased items, especially the main raw materials, components, and components that have a significant impact on the quality of finished products, based on their impact on product quality, to ensure that they comply with specified requirements. The acceptance, rejection, and related disposal measures should be recorded.
企业应当建立并实施进货检验规程。进货检验规程至少应当明确采购物品的名称、规格型号、验证/确认/监视/测量/检验/试验项目与方法、适用的仪器设备和器具、抽样程序、抽验方案、接收准则、引用标准/引用测量程序和相关记录等内容。抽样方案应当具有统计学依据，应当对统计推断的置信度进行分析，确保抽检的样品具有代表性。
Enterprises should establish and implement purchase inspection procedures. The incoming inspection procedures should at least clarify the name, specifications and models, verification/confirmation/monitoring/measurement/inspection/testing items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, reference standards/reference measurement procedures, and relevant records of the purchased items. The sampling plan should have statistical basis, and the confidence level of statistical inference should be analyzed to ensure that the sampled samples are representative.
（二）过程控制与过程检验
（2） Process Control and Inspection
企业应当根据生产过程对成品质量的影响程度，确定对中间品、生产过程实施常规控制的验证/确认/监视/测量/检验/试验程序与要求，确保生产过程受控、生产过程中规定的要求得到满足。接收和拒收及其相关处置措施都应予以记录。
Enterprises should determine the verification/confirmation/monitoring/measurement/inspection/testing procedures and requirements for routine control of intermediate products and production processes based on the degree of impact of the production process on the quality of finished products, to ensure that the production process is controlled and the requirements specified in the production process are met. The acceptance, rejection, and related disposal measures should be recorded.
企业应当建立并实施过程检验规程。过程检验规程至少应当明确中间品的名称、规格型号、验证/确认/监视/测量/检验/试验项目与方法、适用的仪器设备和器具、抽样程序、抽样方案、接收准则、引用标准/引用测量程序和相关记录等内容。抽样方案应当具有统计学依据，应当对统计推断的置信度进行分析，确保抽检的样品具有代表性。
Enterprises should establish and implement process inspection procedures. The process inspection procedures should at least clarify the name, specifications and models, verification/confirmation/monitoring/measurement/inspection/test items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, reference standards/reference measurement procedures, and relevant records of intermediate products. The sampling plan should have statistical basis, and the confidence level of statistical inference should be analyzed to ensure that the sampled samples are representative.
企业应当对关键工序进行验证，对特殊过程进行确认。验证/确认记录至少应当包括验证/确认方案、验证/确认项目与方法、操作人员、结果评价、再验证/再确认等内容。生产过程中采用的计算机软件对产品质量有影响的，也应当进行确认。
Enterprises should verify key processes and confirm special processes. The verification/confirmation record should at least include the verification/confirmation plan, verification/confirmation items and methods, operators, result evaluation, re verification/re confirmation, and other contents. If the computer software used in the production process has an impact on product quality, it should also be confirmed.
企业应当根据关键工序和特殊过程的验证/确认或再验证/再确认结果，对关键工序、特殊过程实施必要的过程检验、过程参数的监视和测量。过程参数的监视和测量相关要求既可以包含在过程的作业指导文件中，也可以包含在过程的检验规程中。
Enterprises should implement necessary process inspections, monitoring and measurement of process parameters for key processes and special processes based on the verification/confirmation or re verification/re confirmation results. The requirements for monitoring and measuring process parameters can be included in both the operation guidance documents of the process and the inspection procedures of the process.
（三）成品检验与成品放行
（3） Finished product inspection and release
企业应当根据强制性标准以及经注册或者备案的产品技术要求、产品交付要求、企业内部控制标准等制定成品检验规程。成品检验规程应当确定成品需要实施常规控制的验证/确认/监视/测量/检验/试验程序与要求，确保每批成品都符合接收准则。接收和拒收及其相关处置措施都应予以记录。
Enterprises should develop finished product inspection procedures in accordance with mandatory standards, registered or registered product technical requirements, product delivery requirements, and internal control standards. The finished product inspection procedures should determine the verification/confirmation/monitoring/measurement/inspection/testing procedures and requirements for routine control of finished products, ensuring that each batch of finished products meets the acceptance criteria. The acceptance, rejection, and related disposal measures should be recorded.
成品的检验规程至少应当明确成品的名称、规格型号、验证/确认/监视/测量/检验/试验项目和方法、适用的仪器设备和器具、抽样程序、抽样方案、接收准则、引用标准/引用测量程序和相关记录等内容。抽样方案应当具有统计学依据，应当对统计推断的置信度进行分析，确保抽检的样品具有代表性。
The inspection procedures for finished products should at least clarify the name, specifications and models, verification/confirmation/monitoring/measurement/inspection/test items and methods, applicable instruments and equipment, sampling procedures, sampling plans, acceptance criteria, reference standards/reference measurement procedures, and relevant records of the finished products. The sampling plan should have statistical basis, and the confidence level of statistical inference should be analyzed to ensure that the sampled samples are representative.
成品检验规程的内容原则上应当覆盖已注册或者备案的产品技术要求中需要常规控制的检验项目和检验方法。不能覆盖的，应当在成品检验规程中予以说明。必要时，应当给出经过确认的替代解决方案。
The content of the finished product inspection regulations should, in principle, cover the inspection items and methods that require routine control in the technical requirements of registered or registered products. If it cannot be covered, it should be explained in the finished product inspection procedures. If necessary, confirmed alternative solutions should be provided.
企业应当建立并实施成品放行程序，明确成品放行条件、放行批准要求。成品放行前至少应当符合以下条件：完成所有规定的工艺流程；规定的批生产记录完整齐全；所有规定的进货、过程、成品检验、验证等质量控制记录完整齐全，结果符合规定要求，检验/试验/验证/确认人员及其审核、授权批准人员均已按规定签发记录；产品实现全过程，特别是采购、生产等过程中的不合格、返工、返修、降级使用、紧急放行等特殊情况已经按规定处理完毕；产品说明书、标签及其版本符合规定要求；经授权的放行人员已按规定签发产品放行单，批准成品放行。
Enterprises should establish and implement finished product release procedures, clarify the conditions and approval requirements for finished product release. Before the release of finished products, at least the following conditions should be met: complete all specified process flows; The specified batch production records are complete and complete; All specified quality control records for procurement, process, finished product inspection, verification, etc. are complete and complete, and the results meet the specified requirements. Inspection/testing/verification/confirmation personnel and their reviewers and authorized approvers have issued records in accordance with the regulations; The entire process of product realization, especially special situations such as non conformities, rework, repair, degraded use, emergency release, etc. in the procurement, production, etc. have been handled according to regulations; The product manual, label, and version meet the specified requirements; The authorized release personnel have issued a product release form according to regulations and approved the release of finished products.
（四）其他有关要求
（4） Other relevant requirements
若供应商生产及质量管理能力波动、企业生产及质量管理能力波动可能对采购物品、中间品、成品质量造成明显影响的，用于监视上述波动的验证/确认/监视/测量/检验/试验项目原则上应当分别纳入进货检验、过程检验与成品检验的常规控制项目中。
If fluctuations in the production and quality management capabilities of suppliers, as well as fluctuations in the production and quality management capabilities of enterprises, may have a significant impact on the quality of purchased goods, intermediate products, and finished products, the verification/confirmation/monitoring/measurement/inspection/testing items used to monitor the aforementioned fluctuations should be included in the routine control items of incoming inspection, process inspection, and finished product inspection, respectively.
需要常规控制的进货检验、过程检验和成品检验项目原则上不得进行委托检验。对于检验/试验等条件和设备要求较高，确需委托检验的项目，可委托具有资质的检验机构进行检验。
In principle, entrusted inspections are not allowed for incoming inspection, process inspection, and finished product inspection items that require routine control. For projects with high requirements for inspection/testing conditions and equipment that require entrusted inspection, qualified inspection agencies can be entrusted for inspection.
企业确定采购物品、中间品、成品质量控制性能指标和检验方法时，应当优先采用国家标准、行业标准，特别是强制性国家标准、行业标准的相关内容; 其次应当考虑采用国际标准相关内容。如果国家标准、行业标准、国际标准不适用，企业可以采用行业通行做法或自行建立企业内部控制标准。必要时，企业应当对自行建立的内部控制标准采用的检验方法开展验证和确认。
When determining the quality control performance indicators and inspection methods for purchased goods, intermediate products, and finished products, enterprises should prioritize the use of national and industry standards, especially the relevant content of mandatory national and industry standards; Secondly, consideration should be given to adopting relevant international standards. If national, industry, or international standards are not applicable, enterprises can adopt industry practices or establish their own internal control standards. When necessary, enterprises should verify and confirm the inspection methods used in their own established internal control standards.
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