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生产现场的ISO9001:2008体系认证审核内容及方法和要求 发布时间: 2012-01-03 16:18 点击:

生产现场的ISO9001:2008体系认证审核内容及方法和要求
The production site of ISO9001: 2008 system certification audit contents and methods and requirements
生产现场对制造业而言,即生产车间,对服务业而言主要指服务现场地包括加工部分,如宾馆饭店的后国、维修业的修理现场等。质量管理体系(QMS)认证最终落实到产品质量上,生产现场是产生产品质量的关键场所,也是执行落实组织方针、目标,落实体系各项要求的主要部门,所以对生产现场的审核尤为重要。
Production in the manufacturing sector, namely the production workshop, for the service industry mainly refers to the service site includes the processing part, such as a hotel after the country, repair repair site. Quality management system ( QMS ) certification and ultimately to the implementation of the quality of products, production site is the product quality of the key places, also be implementation policy of the organization, target, fulfil system requirements of the primary sector, so the production site audit is very important.
生产现场应审核哪些条款
Production site shall audit which clause
生产现场以审核7.5为主,尤其是7.5.1、7.5.2,这些条款的实施只能在生产现场完成,8.1.4中的过程(工序)检验一般也在生产现场进行。同时,生产现场是执行落实各条款的主要部门,如车间的文件、记录是否得到控制(4.2),计量器具(卡尺、秤、仪表等)是否满足7.6要求,生产环境(环境温度。湿度、空气中灰尘颗粒数等)是否满足工艺要求(6.4),原材料、外协件的质量是否适宜(7.4),对不合格品如何标识、评审、处置(8.3),如何运用统计技术(8.4),纠正措施、预防措施等自我完善机制的执行(8.5)。另外,组织方针、目标的理解、贯彻落实也体现在每个工人身上(5.3、5.4),生产资源、人力资源能否满足生产需要(6.2、6.3)等。这些要求虽然在管理层和主管科室均进行了审核,但单凭主管人员的回答或记录,不能说明对这些要素的执行程度,只有通过对生产现场验证、与工人的交谈才能作出结论。
Production site to review 7.5, especially 7.5.1, 7.5.2, these terms only in the production site to carry out, in the process ( 8.1.4 process ) inspection in general is the production site. At the same time, production site is implemented the provisions of the major departments, such as the workshop of the file, record is under control (4.2 ), measuring instruments ( caliper, scales, instrumentation ) whether or not to meet the 7.6 requirements, the production environment ( ambient temperature. Humidity, air dust particle number) whether meet the requirements of process ( 6.4), raw materials, parts quality suitability ( 7.4), the unqualified products how to identify, review, ( 8.3) disposed of, how to apply statistical techniques ( 8.4), corrective, preventive measures, a self-improvement mechanism implementation ( 8.5). In addition, the policy of the organization, the goal of understanding, carry out fulfil also reflected in each worker ( 5.3, 5.4), production resources, human resource can meet the need of production ( 6.2, 6.3). Although these requirements in management and administrative departments are examined, but only by competent personnel to answer or record, not to the elements of the executive level, only by the production site validation, and workers talk to make a conclusion.
审核的方法及要求
Audit method and requirements
对同一条款的审核,车间与管理科室是不同的。对管理科室主要查对该要求如何管理和控制,而对车间的审核则侧重于执行。对车间办公室的审核,审核员仅了解车间在体系中的职能分配、工艺流程、合同完成情况,原材料的质量、设备、资源状况,对生产过程的监视、控制,以及设备的维护、保养、纠正、预防措施即可,而应把大部分时间用在对生产班组生产过程的审核上。
On the same terms review, workshop and management departments are different. On the management departments mainly check the requirements of how to manage and control, and the workshop on the audit focuses on the implementation of. On the workshop office audit, the auditor only understand workshop in system function allocation, process flow, the completion of the contract, the quality of raw material, equipment, resources, process monitoring, control, and equipment maintenance, maintenance, corrective, preventive measures can be, and should spend most of their time in the production the group's production process audit.
对生产/服务过程的审核,必须按工艺流程(工序)或识别的服务过程—一审核。当工序较多时,可适当抽样,但关键工序、特殊工序必须审核,一般工序可适当抽样,确保过程真实受控。
On the production and service process audit, must according to the process ( process) or identification service process - a review. When more procedures, appropriate sampling, but the key process, special procedures must review, general procedure can be proper sampling, ensure real process controlled.
对工序的审核,应使用“过程方法”,即—一审核该过程(工序)涉及的要求。以硬件产品生产企业为例,审核某一道工序的检查内容如下:
The process audit, should use the" process approach", namely, a review of the process ( process) to request. Hardware products manufacturing enterprises as an example, a process audit inspection as follows:
检查该工序使用的图纸、工艺文件,评价文件的充分性、适宜性、可操作性,并检查文件受控情况(7.5.1a),b)4.2.1、4.2.3);
Check the working procedure drawings, technical documents, documents for evaluation of adequacy, suitability, maneuverability, and check the file control ( 7.5.1a ), B 4.2.1, 4.2.3 ) );
对照工艺,检查现场的环境温度、湿度等(6.4,有要求时);
The control process, check the scene of the environment temperature, humidity etc. ( 6.4, request );
对照工艺,观察工人实际操作情况,评价是否按工艺操作;
The control process, observation of the actual operating conditions of workers, to evaluate whether by operation;
对照工艺、图纸检查设备的精度、吨位是否适宜(7.5.1C);
The control process, drawing check equipment precision, the suitability ( 7.5.1C ) tonnage;
观察监视和测量装置的显示数值是否在规定公差范围内(7.5.1d)、e),并查前一段时期监控记录;
Observation of monitoring and measuring devices, display value whether in terms of the tolerance range ( 7.5.1d ), e ), and check the former period of monitoring and recording;
观察该工序产品(半成品)的产品标识、检验试验状态标识(7.5.3);
The observation of the process products ( semi-finished products ) product identification, inspection and test status ( 7.5.3 );
观察该工序产品(半成品)的产品防护,搬运方法及对前面已.加工部位的防护(7.5.5);
The observation of the process products ( semi-finished products ) products protection, conveying method and on the front. The machining parts protection ( 7.5.5 );
观察测量仪器(卡尺、千分尺、台秤、天平、温度表、压力表等)是否在有效期内,能否满足被测对象的精度要求(7.6);
Observation of measuring instruments ( caliper, micrometer, scales, scales, thermometers, pressure gauges and other ) is the period of validity, can meet the precision requirement of the object to be measured ( 7.6);
询问操作工人对公司方针目标的理解与执行,以及参加培训的情况,体系运行过程中问题的沟通情况;
Ask workers to operate the company policy goal of understanding and execution, and to participate in the training, system operation problems of the process of communication;
实际动手测量该工序加工的产品符合情况。
Practical measurement in the process of product compliance.
如果该工序为特殊工序,除以上审核外,还应审核人员资格。能力及设备能力(GP值),对工艺方法进行鉴定等。
If the process for special process, in addition to the above review, should also examine the qualification of personnel. Ability and capacity ( GP ), the method of identification.