鉴别的设备－不动的或不适用的监控和测量设备明显标识和不被使用。所有不要求校准的监控和测量设备都明显标识。

                        Section 8 Measurement, analysis and improvement　第8部分
                        测量，分析和改进
                        8.1 General　总则
                        组织应策划并实施以下方面所需的监视、测量、分析和改进过程：
                        a) 证实产品的符合性；
                        b) 确保质量管理体系的符合性；
                        c) 持续改进质量管理体系的有效性。
                        这应包括对统计技术在内的适用方法及其应用程度的确定。
                        8.2 Monitoring and measurement　 监控和衡量
                        8.2.1 Customer satisfaction　 客户满意度
                        作为对质量管理体系业绩的一种测量，组织应监视顾客关于组织是否满足其要求的感受的相关信息，并确定获取和利用这种信息的方法。
                        8.2.1.C.1 Customer Satisfaction Data – The organization
                        shall establish and maintain a method to collect data
                        directly from customers concerning their satisfaction
                        with provided products. The
                        organization shall also collect customer data on how
                        well the organization meets commitments and its
                        responsiveness to customer feedback and needs. This data
                        shall be collected and analyzed. Trends of the data
                        shall be kept. [4]
                        8.2.1.C.1
                        客户满意度数据－组织应建立和维持一种收集直接来自客户关于他们对所提供产品的满意程度的数据的方法。组织也应从客户处收集组织满足承诺和对客户反馈和要求的反应的情况。这些数据应被汇集和分析。数据的趋势图应画出。

                        8.2.2 Internal audit   内审
                        组织应按策划的时间间隔进行内部审核，以确定质量管理体系是否：
                        a) 符合策划的安排（见7.1）、本标准的要求以及组织所确定的质量管理体系的要求；
                        b) 得到有效实施与保持。
                        考虑拟审核的过程和区域的状况和重要性以及以往审核的结果，组织应对审核方案进行策划。应规定审核的准则、范围、频次和方法。审核员的选择和审核的实施应确保审核过程的客观性和公正性。审核员不应审核自己的工作。
                        策划和实施审核以及报告结果和保持记录（见4.2.4）的职责和要求应在形成文件的程序中作出规定。
                        负责受审区域的管理者应确保及时采取措施，以消除向发现和不合格及其原因。跟踪活动应包括对所采取措施的验证和验证结果的报告（见8.5.2）。
                        8.2.3 Monitoring and measurement of processes   过程的监控和测量
                        组织应采用适宜的方法对质量管理体系过程进行监视，并在适用时进行测量。这些方法应证实过程实现所策划的结果的能力。当未能达到所策划的结果时，应采取适当的纠正和纠正措施，以确保产品的符合性。
                        8.2.3.C.1 Process Measurement – Process measurements
                        shall be developed, documented, and monitored at
                        appropriate points to ensure continued suitability and
                        promote increased effectiveness of processes. [9]
                        8.2.3.C.1
                        过程测量－应在适当点（工序）进行过程监视与测量（并保持记录），以确保（过程的）持续的适宜性和提升过程有效性。
                        8.2.4 Monitoring and measurement of product产品的监控和测量
                        组织应对产品的特性进行监视和测量，以验证产品要求已得到满足。这种监视和测量应依据所策划的安排（见7.1），在产品实现过程的适当阶段进行。
                        应保持符合接收准则的证据。记录应指明有权放行产品的人员（见4.2.4）。
                        除非得到有关授权人员的批准，适用时得到顾客的批准，否则在策划的安排（见7.1）已圆满完成之前，不能放行产品和交付服务。
                        8.2.4.HV.1 Inspection and Test Documentation – Each
                        inspection or testing activity shall have detailed
                        documentation. Details should include the following:
                        检验和试验文件－每次检验和试验活动将有详细的文件。具体如下：
                        a)     parameters to be checked with acceptable
                        tolerances, 　用可接受的公差检测的参数
                        b)     the use of statistical techniques, control
                        charts, etc., 　统计技术，控制图等的运用
                        c)     sampling plan, including frequency, sample size,
                        and acceptance criteria, 　抽样计划，包括频率，抽样尺寸和接受标准
                        d)     handling of nonconformances, 　不合格品的处理
                        e)     data to be recorded, 　要记录的数据
                        f)     defect classification scheme, 　缺陷分类方法
                        g)     method for designating an inspection item or lot,
                        and　指定一个或许多检验项的方法
                        h)     electrical, functional, and feature testing. [5]
                        　电气，功能性和特征试验
                        8.2.4.HV.2 Inspection and Test Records – Inspection and
                        test records shall include: 检验和试验记录－检验和试验记录包括：
                        a)     product identification, 　产品鉴定
                        b)     quantity of product inspected, 　检验产品的数量
                        c)     documented inspection procedure(s) followed,
                        　紧接的文件性的检验程序
                        d)     person performing the test and inspection,
                        　进行检验和试验的人
                        e)     date of inspection and/or test, and　检验和/或试验的日期
                        f)     number, type, and severity of defects found. [5]
                        　发现缺陷的数量，类型和严重性
                        8.2.4.H.1 Periodic Retesting – The organization shall
                        establish and maintain a documented
                        procedure(s) that ensures products are periodically
                        retested to assess the product's ability to continue to
                        meet design requirements. [5]
                        8.2.4.H.1
                        定期再试验－组织应建立和维持一个文件性的程序确保产品定期再检去评估产品持续满足设计需求的能力。〔5〕
                        8.2.4.H.2 Content of Testing – The initial test and
                        periodic retest shall be more extensive than the routine
                        quality tests. The initial test shall include those that
                        are contained in the customer’s and/or organization’s
                        product specifications and/or contracts. The results of
                        these tests shall be documented. [5]
                        8.2.4.H.2
                        试验内容－初始试验和定期再试验将比例行的质量试验更广泛。初始试验包括纳入客户和/或组织的产品规范书和/或合同。这些试验的结果将成文。
                        8.2.4.H.2-NOTE 1: Product specifications may include
                        environmental, vibration, flammability, and
                        operational stress type testing.
                        8.2.4.H.2－注1：产品说明书可包括环境性，振动，可燃性和操作压力型式试验。

                        第 9 楼：98.2.4.H.3 Frequency of Testing – The organization
                        shall establish and document the frequency for test and
                        periodic retest. When determining the test frequency,
                        the organization shall include the following:
                        试验频率－组织应该建立和编制试验及定期再试验的频率文件。确定试验频率时，组织可考虑如下：a)    
                        product complexity and service criticality,
                        　产品复杂性和服务的危险程度b) number of design, engineering and/or
                        manufacturing changes made to the product and whether
                        the change(s) affect form, fit, and/or function,
                        　产品设计，生产和/或制造变更的数量，且无论变更是否影响结构，合格性和/或功能。c) changes to
                        the manufacturing process,   制造过程的改变d) manufacturing
                        variations, (e.g., tooling wear),   制造误差（如：加工磨损）e)
                        material and/or component substitutions and failure
                        rates, and 材料和/或成分替代及不合格率，和f) the field performance
                        record of the product. [5] 产品的域性能记录〔5〕8.2.4.H.4 Testing
                        of Repair and Return Products – Repair and return
                        products shall be subjected to the appropriate
                        evaluation(s) and/or test(s) to ensure functionality to
                        product specification. [5]8.2.4.H.4
                        返修和返工产品的试验－返修和返工应接受适当的评估和/或试验以确保产品规格的功能。8.2.4.S.1 Test
                        Documentation – Software tests shall be conducted
                        according to a documentedprocedure(s) and the test plan.
                        Documentation of testing shall include:
                        试验文件－软件试验将按照文件性的程序和试验计划进行。试验文件包括：a) test results,  
                        试验结果b) analysis of test results,   试验结果的分析c) conformance
                        to expected results, and 与期望结果的一致性，和d) problem reporting
                        for nonconforming items. [11]   不合格项报告的问题8.3 Control of
                        nonconforming
                        product　不合格产品的控制组织应确保不符合产品要求的产品得到识别和控制，以防止其非预期的使用或交付。不合格品控制以及不合格品处置的有关职责和权限应在形成文件的程序中作出规定。组织应通过下列一种或几种途径，处置不合格品。a)
                        采取措施，消除发现的不合格；b) 经有关授权人员批准，适用时经顾客批准，让步使用、放行或接收不合格品；c)
                        采取措施，防止其原预期的使用或应用。应保持不合格的性质以及随后所采取的任何措施的记录，包括所批准的让步的记录（见4.2.4）。应对纠正后的产品再次进行验证，以证实符合要求。当在交付或开始使用后发现产品不合格时，组织应采取与不合格的影响或潜在影响的程度相适应的措施。8.4
                        Analysis of data  
                        数据分析组织应确定、收集和分析适当的数据，以证实质量管理体系的适宜性和有效性，并评价在何处可以持续改进质量管理体系的有效性。这应包括来自监视和测量的结果以及其他有关来源的数据。数据分析应提供有关以下方面的信息：a)
                        顾客满意（见8.2.1）；b) 与产品要求的符合性（见7.2.1）；c)
                        过程和产品的特性趋势，包括采取预防措施的机会；d) 供方。8.4.C.1 Trend Analysis of
                        Nonconforming Product – Trend analysis of discrepancies
                        found innonconforming product shall be performed on a
                        defined, regular basis and results utilized as input for
                        corrective and preventive action.8.4.C.1
                        不合格产品的趋势分析－在不合格产品中发现的差异的趋势分析应根据定义的、规则的根据及用于纠正和预防措施输入的结果执行。8.4.H.1
                        Field Performance Data – The quality management system
                        shall include the collection and analysis of field
                        performance data which can be used to help identify the
                        cause and frequency of equipment failure. In addition,
                        no trouble found (NTF) data shall also be maintained.
                        This information shall be provided to the appropriate
                        organizations to foster continual improvement.
                        [5]8.4.H.1
                        域性能数据－质量管理体系包括能用于帮助鉴别设备故障的起因和频率的域性能数据的收集和分析。另外，发现无错（NTF）的数据也要保留。这些信息用于适当的组织进行持续改善。8.4.V.1
                        Service Performance Data – The quality management system
                        shall include the collection and analysis of service
                        performance data, which can be used to identify the
                        cause and frequency of service failure. This information
                        shall be provided to the appropriate organizations to
                        foster continual improvement of the service. [5]8.4.V.1
                        服务性能数据－质量管理体系包括能用于帮助鉴别服务漏洞的起因和频率的服务性能数据的收集和分析。这些信息用于适当的组织进行服务的持续改善。〔5〕8.5
                        Improvement   改进8.5.1 Continual improvement  
                        持续改进组织应利用质量方针、质量目标、审核结果、数据分析、纠正和预防措施以及管理评审，持续改进质量管理体系的有效性。8.5.1.C.1
                        Quality Improvement Program – The organization shall
                        establish and maintain a documented Quality Improvement
                        Program to improve:8.5.1.C.1
                        质量改进计划－组织应该建立和维持一个资料性的质量改善计划去改善：a)     customer
                        satisfaction,   客户满意度b)     quality and reliability of
                        the product, and   产品质量和可靠度c)   other
                        processes/products/services used within the
                        organization. [5]   用于组织内部的其它的制程/产品/服务〔5〕8.5.1.C-NOTE 2:
                        Inputs to the continual improvement process may include
                        lessons learned from past experience, lessons learned
                        from previous projects, analysis of measurements and
                        post-project reviews, and comparisons with industry best
                        practices.8.5.1.C－注2：
                        持续改善过程的输入可包括从过去经验及以前的工程中所学得的教训，衡量和工程后检讨的分析，以及与最好的工业实践的对照。8.5.1.C.2
                        Employee Participation – The organization shall
                        implement methods for encouragingemployee participation
                        in the continual improvement process. [4]8.5.1.C.2
                        员工参与－组织将采取措施鼓励员工参与持续改善过程。〔4〕8.5.2 Corrective action  
                        纠正措施组织应采取措施，以消除不合格的原因，防止不合格的再发生。纠正措施应与所遇到的不合格的影响程度相适应。应编制形成文件的程序，以规定以下方面的要求：a)
                        评审不合格（包括顾客投诉）；b) 确定不合格的原因；c) 评价确保不合格不再发生的措施的需求；d)
                        确定和实施所需的措施；e) 记录所采取措施的结果（见4.2.4）；f)
                        评审所采取的纠正措施。8.5.2.C-NOTE 1: Undesirable deviations from
                        plans and objectives are considered
                        nonconformances.8.5.2.C－注1：不合需要的偏离计划和目标被认为是不合格的。8.5.2.C-NOTE
                        2: Review of corrective action is intended to ensure
                        that the action taken was
                        effective.8.5.2.C－注2：纠正措施的讨论倾向于确保所采取措施的有效性。Review
                        activities may include ensuring that root cause was
                        properly identified and addressed, appropriate
                        containment action was taken, and corrective actions
                        have not introduced additional
                        problems.讨论活动可包括确保根本原因被正确地确定，适当的对策被采取，并且纠正措施也没有引入附加的问题。8.5.2.C-NOTE
                        3: Consideration should be given to include training as
                        part of implementing corrective and preventive
                        actions.8.5.2.C－注3：应考虑将培训作为实施纠正和预防措施的部分。8.5.2.S.1
                        Problem Resolution – The organization shall establish
                        and maintain a documentedprocedure(s) to initiate
                        corrective action once a reported trouble is diagnosed
                        as a problem. Thedocumented procedure(s) should provide
                        guidelines for distinguishing among potential solutions
                        such as:8.5.2.S.1
                        问题决议－一旦一个被报告的故障被诊断为一个问题时，组织应建立和维持一个资料性的程序去促进纠正措施。资料性的程序文件应该提供区别如下潜在解决方案的准则。a)
                        patching,   修补程序b) immediate source code corrections,  
                        即时的源代码的纠正c) deferring solutions to a planned release,
                        and   延迟计划版本的解决方法d) providing documented “work-around”
                        operational procedure(s) and resolution within a
                        designated timeframe based on the severity of the issue.
                        [11] 依发行的严重性提供资料性的工作程序及在指定期限内的解决方案。〔11〕8.5.3 Preventive
                        action
                        预防措施组织应确定措施，以消除潜在不合格的原因，防止不合格的发生。预防措施应与潜在问题的影响程度相适应。应编制形成文件的程序，以规定以下方面的要求：a)
                        确定潜在不合格及其原因；b) 评价防止不合格发生的措施的需求；c) 确定并实施所需的措施；d)
                        记录所采取措施的结果（见4.2.4）；e) 评审所采取的预防措施