产品质量保证英文模板word范文模板 12页文档格式.docx

1、DEMINERALIZED WHEY POWDER AS PER CONTRACT NO. CH/99/66.809 AND4760 bagsProtein （N x 6.38） Moisture Ash （550c） Ph （10% sol. 20c） Scorched particles （ADMI） NitrateStandard plate count Enterobacteriaceae Yeasts MoundsSulphite reducing clostridiaSpecification Min. Max. Max. 6.2 Disc A Max.Max. Max. Max.

2、 Max. Max.g5,000/g 10/g 50/g 50/g 10/g 12.0% 4.0% 1.0% -6.9 30mg/kAnalysis 13.5% 2.1% 0.5% 6.4 Disc A passes test3,000/g 5/g 5/g121,380.00 kgs gross 119,000.00 kgs netValo Edible Fats and Ingredients, Helsinki, Finland Shenzhen, ChinaWeight （kg）Date of Export: Apr. 20, 201XStaphylococcus aureus Salm

3、onellaShipping Marks:neg. in neg. inCH99/66.8091 g 50 gneg. in 1 g neg. in 50 g- Shenzhen CHINALapinla, Apr. 20, 201X Lapinla commune veterinarian篇二：3C认证工厂质量保证能力要求中英文版为保证批量生产的认证产品与已获型式试验合格的样品的一致性，工厂应满足本文件规定的产品质量保证能力要求。Factory shall meet the requirements for factorys quality assurance ability in this

4、 document, in order to ensure that all certified products are identical within accepted manufacturing tolerances to the sample or samples against which the type test was approved. 1 职责和资源/Responsibility, Authority and Resource1.1职责/Responsibility工厂应规定与质量活动有关的各类人员职责及相互关系，且工厂应在组织内指定一名质量负 责人，无论该成员在其他方面

5、的职责如何，应具有以下方面的职责和权限：Factory shall regulate the responsibilities and inter-relations of all the personnel involved in quality activities. And factory shall appoint a responsible person for quality from the organization who,irrespective of other responsibilities, shall have responsibility and authorit

6、y that include.a. 负责建立满足本文件要求的质量体系，并确保其实施和保持；Ensuring that quality system, which meets the requirements of this document, is established, implemented and maintained.b. 确保加贴强制性认证标志的产品符合认证标准的要求；Ensuring that the products with the certification label are produced in conformity with thestandards to whic

7、h they were certified.c. 建立文件化的程序，确保认证标志的妥善保管和使用；Establishing documented procedure to ensure that certification labels are kept and usedappropriately.d. 建立文件化的程序，确保不合格品和获证产品变更后未经认证机构确认，不加贴强制性认证标志。Establishing documented procedure to ensure that the certification label is not borne on anynon-conformi

8、ng product or changed product that was not notified by certification body.质量负责人应具有充分的能力胜任本职工作。The responsible person for quality shall be competent to perform the work.1.2资源/Resources工厂应配备必须的生产设备和检验设备以满足稳定生产符合强制性认证标准的产品要求；应配 备相应的人力资源，确保从事对产品质量有影响工作的人员具备必要的能力；建立并保持适宜 产品生产、检验、试验、储存等必备的环境。 Factory shal

9、l equip with necessary production facility and testing equipment in order to consistently manufacture the products in conformity with certification standards. In addition, factory shallprovide relevant human resources, to ensure that personnel performing work affecting productquality is competent, a

10、nd establish and maintain necessary environment suitable for manufacturing, test and inspection, storage etc.2. Documents and Records文件和记录2.1 Factory shall establish and maintain documented quality plan or relevant documents for certifiedproducts, and needed documents in order to ensure that related

11、 processes to product quality areoperated and controlled effectively. Quality plan shall define the objective of product design,realization process, test and related resource, as well as the requirements for changes （i.e. standard, workshop, critical components etc.） to certified products, use and m

12、anagement of labels.工厂应建立、保持文件化的认证产品的质量计划或类似文件，以及为确保产品质量的相关过程 有效运作和控制需要的文件。质量计划应包括产品设计目标、实现过程、检测及有关资源的规 定，以及产品获证后对获证产品的变更（标准、工艺、关键件等）、标志的使用管理等的规定。Design standard or specification, as one essential part of quality plan, shall not be lower than the requirements of national standard for the product.产品设

13、计标准或规范应是质量计划的一个内容,其要求应不低于有关该产品的国家标准要求。2.2 Factory shall establish and maintain documented procedure to control the documents required in this document, to ensure that工厂应建立并保持文件化的程序以对本文件要求的文件和资料进行有效的控制。这些控制应确保： a） documents are approved by authorized personnel prior to issue and re-approved after cha

14、nges.文件发布前和更改应由授权人批准，以确保其适宜性；b） changes and current revision status of documents are identified to prevent unintended use of obsoletedocuments.文件的更改和修订状态得到识别，防止作废文件的非预期使用；c） relevant versions of applicable documents are available at points of use.确保在使用处可获得相应文件的有效版本。2.3 Factory shall establish and ma

15、intain documented procedure to define the controls for the identification, storage, protection and disposition of records. Records shall remain legible, integral to provide evidence of product conformity to requirements.2.3 工厂应建立并保持质量记录的标识、储存、保管和处理的文件化程序，质量记录应清晰、完整以作为产品符合规定要求的证据。Records shall be ret

16、ained for an appropriate period.质量记录应有适当的的保存期限。3. Purchasing and Incoming Inspection3 采购和进货检验3.1 Control of Supplier3.1 供应商的控制Factory shall establish the procedure that defines the criteria for selection, evaluation and routine supervision of supplier, which provide critical components and material,

17、 to ensure the supplier has ability to provide the critical components and material in accordance with requirements. 工厂应制定对关键元器件和材料的供应商的选择、评定和日常管理的程序，以确保供应商具有保Records of the evaluations and routine supervision shall be maintained.工厂应保存对供应商的选择评价和日常管理记录。3.2 Inspection/Verification for Critical Compone

18、nts and Material3.2 关键元器件和材料的检验/验证Factory shall establish and maintain procedure of inspection or verification for purchased critical components and material, and procedure of periodic verification inspection, to ensure that critical components and material meet specified certification requirements.

19、 工厂应建立并保持对供应商提供的关键元器件和材料的检验或验证的程序及定期确认检验的程序，以确保关键元器件和材料满足认证所规定的要求。Inspection for purchased critical components and material may be carried out by factory or by supplier. Where inspection is performed at suppliers premise, factory shall state the intended inspection requirements to supplier.关键元器件和材料的

20、检验可由工厂进行，也可以由供应商完成。当由供应商检验时,工厂应对供应商提出明确的检验要求。工厂应保存关键件检验或验证记录、确认检验记录及供应商提供的合格证明及有关检验数据等。4. Monitoring and Measurement of Processes4 生产过程控制和过程检验4.1 Factory shall identify critical production processes and arrange operators with appropriate qualification at the processes. Where product quality can not

21、be guaranteed when no operating document, appropriate operating instructions shall be prepared to make production processes under control. 4.1 工厂应对关键生产工序进行识别，关键工序操作人员应具备相应的能力，如果该工序没有文件规定就不能保证产品质量时，则应制定相应的工艺作业指导书，使生产过程受控。4.2 Where environment condition is required, factory shall meet the requirements

22、.4.2 产品生产过程中如对环境条件有要求,工厂应保证工作环境满足规定的要求。4.3 Factory shall monitor and control appropriate process parameters and product characteristics, as applicable.4.3 可行时,工厂应对适宜的过程参数和产品特性进行监控。4.4 Factory shall establish and maintain maintenance procedure for manufacturing facility.4.4 工厂应建立并保持对生产设备进行维护保养的制度。4.5

23、 Production shall be inspected at appropriate stages of manufacture to ensure that components, sub-assemblies, wiring runs etc. are in accordance with the certification approved sample.4.5 工厂应在生产的适当阶段对产品进行检验，以确保产品及零部件与认证样品一致。5. Routine Tests and Verification Tests5 例行检验和确认检验Factory shall establish a

24、nd maintain documented routine tests and verification tests procedures to verify and demonstrate that products are in accordance with relevant requirements. The procedures shall include test items, contents, method, acceptance criteria etc. Test records shall be maintained. Routine tests and verific

25、ation tests shall meet the requirements specified in relevant product certification implementation rule. 工厂应制定并保持文件化的例行检验和确认检验程序，以验证产品满足规定的要求。检验程序中满足相应产品的认证实施规则的要求执行。Routine tests are line tests performed on 100% of production and are normally carried out at the final stage of manufacture. Normally

26、no further operations, except for labeling and packing, may be carried out after these tests.例行检验是在生产的最终阶段对生产线上的产品进行的100%检验，通常检验后，除包装和加贴标签外，不再进一步加工。Verification tests are tests in addition to the routine tests on samples taken randomly in order to verify and demonstrate that products consistently me

27、et standard requirements.确认检验是为验证产品持续符合标准要求进行的抽样检验。6. Inspection and Test Equipment6 检验试验仪器设备The equipment used for inspection and test must be regularly calibrated and checked for correct operation, and meet inspection and test capacity requirements.用于检验和试验的设备应定期校准和检查，并满足检验试验能力。检验和试验的仪器设备应有操作规程，检验人

28、员应能按操作规程要求，准确地使用仪器设备。6.1 Calibration and verification6.1 校准和检定Inspection and test equipment used for determining the conformity of the products being manufactured shall be calibrated or verified on a regular basis. All calibrations and verification undertaken on such equipment must be traceable to n

29、ational or international standards. Where no measurement standards exist, calibration method, acceptance criteria, calibration interval etc. shall be documented. Calibration and verification status of equipment shall be easily identified by user and management personnel. 用于确定所生产的产品符合规定要求的检验试验设备应按规定的周期进行校准或检定。校准或检定应溯源至国家或国际基准。对自行校准的，则应规定校准方法、验收准则和校准周期等。设备的校准状态应能被使用及管理人员方便识别。Calibration and verification records shall be kept.应保存设备的校准记录。6.2 Functional Check6.2 运行检查The equipment used for routine tests and verification tests shall undertake an functional check in addition to d