美国FDA 医疗器械体系法规QSR820中英文对照(五)

Subpart D--DocumentControls文件控制Sec. 820.40 Documentcontrols.文件控制Each manufacturer shallestablish and maintain pr

Subpart D--DocumentControls   文件控制

Sec. 820.40 Documentcontrols.文件控制

Each manufacturer shallestablish and maintain procedures to control all documents that are required bythis part. The procedures shall provide for the following:

    制造商应当建立和维护相应的规程用于控制本标准要求下的所有文件。规程应包括:

(a) Document approval and distribution. 文件的批准和下发

Each manufacturer shalldesignate an individual(s) to review for adequacy and approve prior to issuanceall documents established to meet the requirements of this part. The approval,including the date and signature of the individual(s) approving the document,shall be documented. Documents established to meet the requirements of thispart shall be available at all locations for which they are designated, used,or otherwise necessary, and all obsolete documents shall be promptly removedfrom all points of use or otherwise prevented from unintended use.

    制造商应当指定相应的人员对所有符合本标准要求的文件在其生效前进行充分审核,并批准。包括人员的签字和日期的批准应当予以记录。符合本标准要求的经批准过的文件应当在指定的,或其他必要的地点进行使用,所有已作废的文件应及时从防止其意外使用的所有使用点或以其它地点进行回收(removed)

(b) Document changes. 文件变更

Changes to documents shallbe reviewed and approved an individual(s) in the same function or organizationthat performed the original review and approval, unless specifically designatedotherwise. Approved changes shall be communicated to the appropriate personnelin a timely manner. Each manufacturer shall maintain records of changes todocuments. Change records shall include a description of the change,identification of the affected documents, the signature of the approvingindividual(s), the approval date, and when the change becomes effective.

    除非有特殊规定,否则应当由最初审核和批准该文件的部门或机构对变更后的文件进行重新审核和批准。经批准的变更应当及时地通知相应的人员。制造商应当保存文件变更的记录。文件变更的记录包括了变化部分的描述、受影响文件的标识、批准人员的签字、批准的日期、以及变更生效的时间。

Subpart E--PurchasingControls  采购控制

Sec. 820.50 Purchasingcontrols采购控制

 

Each manufacturer shallestablish and maintain procedures to ensure that all purchased or otherwisereceived product and services conform to specified requirements.

    制造商应当建立和维护相应的规程来保证所有的采购的和其他接收的产品和服务符合规定的要求。

(a) Evaluation of suppliers, contractors, and consultants.供应商的评估

Each manufacturer shallestablish and maintain the requirements, including quality requirements, thatmust be met by suppliers, contractors, and consultants. Each manufacturershall:

    制造商应当建立和维护相应的求要(包括必须被供应商所遵守的质量要求),制造商应当:

(1) Evaluate and selectpotential suppliers, contractors, and consultants on the basis of their abilityto meet specified requirements, including quality requirements. The evaluationshall be documented.

    基于符合指定要求(包括质量要求)的能力来评估和选择潜在的供应商。评估应当予以记录。

(2) Define the type andextent of control to be exercised over the product, services, suppliers,contractors, and consultants, based on the evaluation results.

    基于评估结果,明确覆盖供应商控制的类型和程度。

(3) Establish and maintainrecords of acceptable suppliers, contractors, and consultants.

    建立并维护合格供应商的记录。

(b) Purchasing data. 采购文件

Each manufacturer shallestablish and maintain data that clearly describe or reference the specifiedrequirements, including quality requirements, for purchased or otherwisereceived product and services. Purchasing documents shall include, wherepossible, an agreement that the suppliers, contractors, and consultants agreeto notify the manufacturer of changes in the product or service so thatmanufacturers may determine whether the changes may affect the quality of afinished device. Purchasing data shall be approved in accordance with 820.40.

    制造商应当建立和维护清楚描述或引用特定要求的资料。包括用于采购的、其他接收的产品和服务的质量要求。如果可能,采购文件应包括供应商同意向制造商告知其产品、服务变更的相关协议以便制造商可以确定变更是否会影响成品器械的质量。应依据820.40的相关要求批准采购资料。

Subpart F--Identificationand Traceability 标识和可追溯性

Sec. 820.60Identification.标识

 

Each manufacturer shallestablish and maintain procedures for identifying product during all stages ofreceipt, production, distribution, and installation to prevent mixups.

    制造商应当建立和维护标识程序,用以在接收、生产、销售和安装的所有阶段识别产品来避免混淆。

Sec. 820.65 Traceability.可追溯性

 

Each manufacturer of adevice that is intended for surgical implant into the body or to support orsustain life and whose failure to perform when properly used in accordance withinstructions for use provided in the labeling can be reasonably expected toresult in a significant injury to the usershallestablish and maintain procedures for identifying with a control number eachunit, lot, or batch of finished devices and where appropriate components. Theprocedures shall facilitate corrective action. Such identification shall bedocumented in the DHR.

    当依据标签上的外科植入体内的或用以维持生命体征的器械说明书使用器械时,由于操作不当(failureto perform)可能会导致使用者受到的重大的伤害,所以制造商应当建立和维护可追溯性规程,用成品器械或是相应组分的每个单元、批或批的控制号码作为标识。此程序有助于纠正措施。在器械历史记录用应当记录该标标识。

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