EN ISO-IEC 80079-34_2011 - 2015-4.16(中英).docx

Assessment checklistwith reference to:DIRECTIVE 94/9/EC ANNEX IV/VII&IECEx SCHEME DOCUMENTATION REVIEW AND ASSESSMENT OF IMPLEMENTATION(For surveillance audits, major document changes only may be reviewed)Applicable standards:NEK EN ISO/IEC 80079-34, July 2011(ISO/IEC 80079-34:2011, modified)Explosive atmospheres Part 34: Application of quality systems for equipment manufactureISO/IEC 80079-34 Ed. 1.0 Explosive atmospheres Part 34: Application of quality systems for equipment manufactureIn the check list Ex certificate means EC Type Examination Certificate and/or ExTR (CoC).Possible audit verdicts: P = Pass, F = Fail, N = Not applicable. Placed in the column “Verdict”. Clause条款Requirements要求Document review/Comments文件评审/评论Verdict判定4QUALITY MANAGEMENT SYSTEM REQUIREMENTS质量管理体系要求4.1General requirementswith the following addition:总要求，增加下列内容：EN ISO 9001:2008 applies.The quality system shall ensure that the product conforms to the type described in the Ex-certificate and the technical documentation.质量体系应该保证产品符合欧共体型式检验证书中描述的类型。1.按照ISO 9001:2008建立了质量体系 是否2.质量体系经认证机构认证注册 是否证书号:3.在总的质量文件中引用了ISO/IEC80079-34:2011.ed.1.0 是否4.在专门的质量文件中规定了相应于ISO/IEC80079-34:2011.ed.1.0的要求 是否文件名称/编号：5认证产品生产是否有关键的分包项目：是否1） 分包项目和分包方：对分包产品的质量控制方式：4.2Documentation requirements 文件要求4.2.1General 总则EN ISO 9001:2008 applies.4.2.2Quality manual 质量手册EN ISO 9001:2008applies.4.2.3Control of documents with the following addition: 文件控制增加下列要求EN ISO 9001:2008applies.a)Equipment documents / technical documentation and manufacturers documents shall be controlled.设备文件/技术文件化资料和制造商文件应予以控制。检查区域： 负责人：1.文件控制程序名称/编号：2.检查包括受控文件清单、文件审批、变更、文件修订状态识别、文件保管和发放等：3.检查对于外来文件（防爆标准等）的收集和控制： documents for equipment: technical documentation as stated in annex III of the directive 94/9/EC.(Scheduled drawings etc.)设备文件*：94/9/EC指令的附件中规定的技术文件，（目录图纸 等）。* 设备文件、目录图纸可理解为审查后图纸和文件。 manufacturers documents, for example instructions as stated in 1.0.6 in annex II of the directive 94/9/EC, associated drawings, technical sheets, sales literature etc.制造商文件：如94/9/EC指令附件II中的1.0.6条中规定的说明书，关联图纸，技术图表,销售用说明书和印刷品等等。4.对于技术类文件，在文件化的程序或规定中规定了下列内容： 是否文件名称/编号b)documented procedures shall ensure that information contained within manufacturers documents is compatible with technical documentation. The manufacturer shall not initially approve or subsequently amend related drawings unless they are in compliance with the schedule drawings;文件化的程序应保证制造商文件中包含的信息与设备文件一致。除批准或更改的关联图纸与目录图纸一致外，制造商不应该对批准后（首次批准或补充修改）关联图纸进行修改;防爆有关的图样的更改需经指定的检测机构同意；(见5.5.1 b) （7.3.7）c)the quality system shall ensure that no factor (type, characteristic, position etc.) defined within the Ex certificate and technical documentation (e.g. schedule drawings) is modified;质量体系应保证Ex证书和技术文件（如；（审批后）目录图纸）中规定的要素（类型、特征，位置等）不被修改。是否有程序保证审批后的图纸与生产过程及其它环节中使用或引用了审批图纸的一致性？d)there shall be a documented system that refers all related drawings to the relevant schedule drawings;应有文件化的体系使所有有关图纸与有关防爆批准图纸；e)where there are common schedule drawings associated with more than one Ex certificate, there shall be a documented system to ensure simultaneous supplementary action in the event of an amendment to such drawings;对与多个EC型式检验证书有关联的共用的目录图纸，应有文件化程序保证在对这类图纸更改时，同步补充。NOTE 1 Some manufacturers use common components with common drawing numbers on more than one product. Some of these products may have different persons responsible for them. Therefore, if one product with a common component and drawing number is revised to meet a need and the necessary supplementary certificate obtained, there needs to be a system for ensuring that any other certificates that call up such components are also subject to supplementary certification. This is in order to avoid those products not being in compliance with their technical documentation. The system should identify the component drawing version, and this version shouldnt be modified by anybody other than the person(s) responsible for the equipment.注：一些制造商在一个以上的产品上使用图纸编号完成相同的共用部件。这样的一些产品可能有不同的人负责。因此，若使用共有部件的一个产品和图纸，按需要进行修改，获得了必要的证书补充件。需要有一体系，确保其它使用该共用部件的产品也必须取得证书的补充件。这是为了避免采用同一部件的产品与其技术文件要求不符。体系应能够识别修改后的图纸版本，而且这一版本应不被作原部件负责人之外的任何人修改。是否有程序保证共用图纸更改时的一致性？f)where a manufacturer also has drawings for products not intended for use in potentially explosive atmospheres, the manufacturer shall have a system that enables both the related drawings and schedule drawings to be clearly identified.若制造商同时也生产非危险场所用产品，应有体系能够清楚标识相有关图样和与防爆有关的图样。NOTE 2The following examples indicate some methods to achieving this: use of visual marker use of a unique series of drawing numbers, e.g. all drawings concerning certified product have an Ex prefix to the drawing number.注2 下面是实现这一要求的方法： 使用直观的标记； 使用独特的系列图纸编号,例如：所有防爆电气产品有关的图纸在图纸编号前加前缀Ex。如果同时生产其他产品，防爆有关图样与其他图样区别（例如通过编号或加盖“Ex”标记）：g)the manufacturer shall document who is responsible for the quality system of each Ex certificate.制造厂应编制文件，在文件中指明对每个EC型式检验证书和质量体系报告负责的指定的检验机构。NOTE 3 In some Certification Schemes, the body responsible for the quality system associated with each Ex certificate may be different from the body that issued the Ex certificate and therefore needs to be clearly identified.注3 在一些认证方案中，负责质量体系的机构，与每个Ex证书颁发的机构可能不是同一家机构，因此，需要清楚地识别出。在文件中指明负责EC型式检验证书和体系报告负责的检验机构，(见5.5.1)h)where equipment documents or manufacturers documents are passed to a third party, they shall be provided in a way that is not misleading.对设备文件或者制造厂文件要转给第三方时，应保证其不被误送。如果防爆图样提供给第三方（生产厂、分包方等），应以不会误导方式提供。i)the manufacturer shall have a documented process to annually check the validity of all Ex related certificates, standards, regulations and other external specifications.制造商应编制文件化的程序，对所有与防爆认证相关的证书，标准，法规和其它外部技术规范性的文件的有效性进行核查。查标准查新及有效性核查（包括涉及到的产品的最近标准，体系标准等4.2.4Control of quality records 质量记录控制with the following addition:做到下列要求：EN ISO 9001:2008 applies.The manufacturer shall retain adequate quality records to demonstrate conformity of the product and satisfy national regulation and legislation.制造商应保持足够的质量记录，以证明产品的符合性，并满足国家的法律法规要求。NOTE In the absence of specific national regulations and legislation, it is suggested that a minimum of 10 years period shall be applied.注：如果国家的法律法规没有特别的规定，建议这些记录至少保存10年。检查区域： 负责人：1.质量记录控制程序名称/编号：2.检查包括质量记录清单、记录保管期限、保存办法、检索、填写要求等：3.检查应保存的记录是否含盖了标准中规定的项目： 是否Those arising from regulatory requirements. 法规要求。 technical documentation for the certified type and copy of the Ex certificate.型式批准的技术文件和检验的副本。 the documentation concerning the quality system. 与质量体系有关的文件 updates to the quality system 更新的质量体系文件 notification provided by the Notified Body including reports指定检验机构提供的通知，包括试验报告 test reports, where applicable, resulting from tests conducted during unexpected visits.如果适用，在不能预料的调查期间所做试验的试验报告Examples of other documents requiring control and retention are:NOTE In the absence of specific National regulation and legislation it is suggested a minimum of 10 years period will be applied. customer order. 顾客订单 contract review 合同评审 training records 培训记录 inspection and test data (pr. batch) 检查和试验数据（每批） calibration data 校准数据 sub-contractor evaluation 分包合同评估 delivery data (customer, delivery date and quantity, including serial numbers where available). 交货资料信息(顾客,交货日期和数量,包括序列号（如果有）5MANAGEMENT RESPONSIBILITY管理职责5.1Management commitment管理承诺EN ISO 9001:2008 applies.5.2Customer focus以顾客为关注焦点EN ISO 9001:2008applies.5.3Quality policy质量方针EN ISO 9001:2008applies.5.4Planning策划EN ISO 9001:2008applies.5.4.1Quality objectives质量目标EN ISO 9001:2008applies.5.4.2Quality management system planning质量管理体系策划with the following addition:按如下要求：EN ISO 9001:2008applies.All the elements, requirements and provisions adopted by the manufacturer in order to ensure compliance of the product with its Ex certificate and technical documentation shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit consistent interpretation of quality programmes, plans, manuals and records.质量体系应该保证产品与欧共体型式检验证书中所描述的产品一致。制造厂采纳的所有要素，要求和措施都应以书面形式的方针、程序和作业指导书形式，按系统和排序方式编制成文件。质量体系文件应保证质量计划、策划、手册和记录等协调一致。5.5Responsibility, authority and communication 职责、权限和沟通5.5.1Responsibility and authority职责、权限with the following addition:按如下要求：EN ISO 9001:2008applies.Responsibilities and authority for the following shall be defined:应规定下面的职责和权限：质量负责人（领导层）：管理者代表姓名、职务：防爆产品认证协调人员姓名/职责：a)the effective co-ordination of activities with respect to equipment intended for use in potentially explosive atmospheres;对与防爆产品有关的活动的有效相互协调和管理。b)the liaison with the issuer of the Ex certificate (when not issued by the manufacturer) with respect to any proposed change to the design defined in the Ex certificate and technical documentation.（当不是制造商颁发的），在Ex证书和技术文件中规定的设计提出的任何更改, 需要与负责颁发Ex证书的检验机构进行联络;c)the liaison with the body responsible for the verification of the quality system with respect to intended updating of the quality system;对质量体系提出的任何更改, 需要与负责颁发ATEXQAN证书的指定的检验机构进行联络;NOTE 1 It is not practicable for the manufacturer to inform the notified body each time the quality system is updated. It isonly practicable to inform them of “substantial” updating of the quality system relevant to the type of protection.Similarly, it is not practicable to specify in general terms what types of updating are or are not “substantial”. It is thereforerecommended that the manufacturer should inform the body responsible for the verification of the quality system on any update of the quality system having consequences on the product compliance.注1：每次更改质量体系生产商都通知负责验证质量体系的机构，这样做不太现实。唯一可行的是，把质量体系中与防爆型式有关的“实质性”改动通知他们。同样，用通用术语规定什么样的改动是“实质性”改动，什么类型的改动是“实质性改动”或者非“实质性改动”，也不太现实。因此建议生产商宜将任何对产品符合性产生影响的质量体系的改动都通知负责验证质量体系的机构。d)the authorization of initial approval and changes to related drawings, where appropriate;若适用，首次批准和更改相关图纸的权限；e)the authorising of concessions (see 8.3j);让步处理权限（参见8.3条）;f)the customers information of any applicable specific conditions of use and any schedules of limitations;将任何安全使用的特殊条件以及任何限制程序通知顾客。NOTE 2Certificate numbers with a suffix X contain special conditions for safe use. Component certificates numbers (with a suffix U) maycontain schedules of limitations.注2: 合格证编号带有后缀“X”时包含有特殊使用条件。编号带有后缀“U”的部件合格证可能含有限制条件。NOTE 3 For each Ex Certificate it is recommended that an authorised person(s) is (are) appointed who shouldhave responsibility and authority for the above activities so providing an unambiguous focal point within the organization.注3：对于每一个防爆合格证，建议指定一位授权人员，授权进行上述活动的职责和权限，以便在生产商内部提供明确的关注点。g)the reviewing of Ex certificate and technical documentation and identifying any changes that effect product compliance with the certificate.审查防爆证书，技术文件，并识别任何影响产品与证书符合的更改。5.5.2Management representative管理者代表EN ISO 9001:2008applies.5.5.3Internal communication内部沟通EN ISO 9001:2008 applies.5.6Management review管理评审5.6.1General 总则with the following addition:按如下要求：EN ISO 9001:2008 applies. a)the maximum intervals between reviews should normally be 12 months and shall not exceed 14 months;正常情况下，评审的最长时间间隔应为12个月，不能超过14个月；b)top management shall chair the review;最高管理者应主持评审；c)the person(s) responsible for the activities as detailed in 5.5.1 shall participate in the review;如在5.5.1中规定的负责评审活动的人员应参加评审；5.6.2Review input评审输入with the following addition:按如下要求：EN ISO 9001:2008 applies.The review shall include the overall effectiveness of the quality management system with respect to product intended for use in explosive atmospheres.评审应包括对有关防爆产品的质量管理体系有效性的全面评审。NOTE Results of audits should include both internal audits and those conducted by other parties (e.g. a body responsible for the verification of the quality system, if one is involved).注：审核结果宜包括内部评审和其它方（例如验证质量体系的机构，如果有的话）进行的评审。5.6.3Review output评审输出EN ISO 9001:2008 applies.8.2.2Internal audit内审with the following addition:按下列要求：EN ISO 9001:2008 applies. 内部质量审核程序名称/编号： 按照策划的时间进行内审（时间间隔一般不超过14个月）：是否 最近的一次内审的时间：1）查阅内审记录： 2）内审应关注质量体系的有效性和认证产品的一致性： 是否1. 对审核发现的问题，是否采取纠正和预防措施并记录： 是否The audit programme shall address the effectiveness of the elements of the quality system as described in this standard to ensure that the products are in conformity with the Ex certificate. The maximum period between audits should normally be 12 months and shall not exceed 14 months.审查程序应按照本标准中所述的质量体系的要素的有效性逐条审查，以保证产品符合EC型检验证书的要求。内部审查的最长间隙时间应为12个月，不能超过14个月；NOTE 1 One method of demonstrating effectiveness is the use of vertical auditing whereby a product awaiting despatch is used to prove the system. The auditor examines all aspects of the system associated with the production of that product from a certification viewpoint. This should include appropriate documentation (drawings, inspection checklists, test records, material certificates etc.), product identification, handling, storage, training of staff and any other elements of the system which can affect the compliance of the product to the certification parameters.注1：表明有效性的方法之一是垂直审核，用待发货产品验证体系。审核员从认证的角度检查体系与产品生产有关的各个方面。宜包括有关文件（图纸、核查表、试验记录、原料合格证等）、产品标识、处置、存放、人员培训，以及体系中影响产品与认证参数符合性的其它要素。NOTE 2 For those manufacturers that employ checklists to assist in their internal audit programmes then the inclusion of the requirements of this European standard into the appropriate checklists and the retention of internal audit records is another alternative method of addressing this requirement.注2：对于在内部审核方案中采用核查的生产商，把本标准的要求加入核查表并保留内审记录，也是符合该项要求的方法。NOTE 3 Manufacturers may employ either method or some other equivalent method.注3：生产商也可采用其它等效的方法。 6RESOURCE MANAGEMENT资源管理6.1Provision of resources资源提供EN ISO 9001:2008applies.6.2Human resources人力资源6.2.1General总则EN ISO 9001:2008 applies.6.2.2Competence, awareness and training能力、意识和培训with the following addition: 按下列要求：EN ISO 9001:2008applies.The manufacturer shall ensure that all persons having an impact on Ex compliance receive appropriate training.制造商应确保所有影响产品防爆性能符合性的人员接受相适应的培训。EXAMPLE People having impact may include those concerned with manufacturing, inspecting, testing, sales, marketing, supply management, calibration and control services and other services例如：对产品防爆性能有影响的人员可包括制造过程，检验，试验，销售，市场，供应管理，计量和控制服务及其它服务6.3Infrastructure基础设施EN ISO 9001:2008 applies.6.4Work environment工作环境EN ISO 9001:2008 applies.7PRODUCT REALIZATION 产品实现7.1Planning of product realization产品实现的策划NOTE Examples are given in annexes A and B注：在附件A和B中给出示例EN ISO 9001:2008 applies.Permissible exclusion with the agreement of ExCB/NB7.2Customer-related processes 与顾客有关的过程7.2.1Determination of requirements related to the product与产品有关的要求的确定EN ISO 9001:2008 applies.7.2.2Review of requirements related to the product与产品有关的要求的评审with the following addition:按下列要求：EN ISO 9001:2008 applies.The review shall ensure that any stated customer requirement is compatible with the Ex certificate e.g. equipment group, temperature class, type of protection, EPL and ambient temperature range.评审应保证顾客的任何指定的需求都与EC型式检验证书内容相一致，例如：环境温度。NOTE：In some situations, such as internet sales, a formal review is impractical for each order. In such the information made available to the customer and the order acknowledgement should include as a minimum the Ex marking.注：在某些情况，如网络销售，对每笔订单进行正式的合同评审是不现实的。在这种情况下，可以给客户提供的信息和订单信息中应至少包括Ex 标志的基本信息。7.2.3Customer communication顾客沟通EN ISO 9001:2008 applies.Permissible exclusion with the agreement of ExCB/NB7.3Design and development（产品的）设计和开发7.3.1Design and development planning设计和开发的策划Not within the scope of this standard7.3.2Design and development inputs设计和开发的输入Not within the scope of this standard7.3.3Design and development outputs设计和开发的输出Not within the scope of this standard7.3.4Design and development review设计和开发的审核Not within the scope of this standard7.3.5Design and development verification设计和开发的验证Not within the scope of this standard7.3.6Design and development validation设计和开发的有效性Not within the scope of this standard7.3.7Control of design and development changes 设计和开发的变更with the following addition:EN ISO 9001:2008 applies.The person identified in 5.5.1 a) shall approve any changes that could compromise Ex compliance. 在5.5.1 a)中规定的人员应对可能涉及到的防爆符合性的变更进行批准。7.4Purchasing采购7.4.1Purchasing process采购过程with the following addition:按下列要求：EN ISO 9001:2008 applies.Permissible exclusion with the agreement of ExCB/NBa)while manufacture, test and final inspection may be sub-contracted, the responsibility for ensuring conformance with the Ex Certificate shall not be sub-contracted.当制造、试验和成品检验可以分包时，保证符合EC型式检验证书的责任不能分包。检查区域： 负责人：1.是否制订了关键材料和元器件的供应商选择、评定和管理文件 是否文件名称/编号：2.对于认证产品的关键和/或主要的零、部件，是否有分包性质的供应商 是否对于此类分包商，是否制订了专门的评定和管理规定（专门的文件或包含在其他文件中）是否文件名称/编号：1. 合格分供方名录编号/批准日期： 关键供应商的评定频次：评定规定执行情况：4.认证产品关键材料、零件和元器件供应商名录（位置不够可另附页）：（供应商选择的办法和日常管理内容包括评价的方法、内容和