基于CMA认证的水环境监测实验室质量管理体系建立与优化研究外文翻译资料

ISO17025标准第七章译文

7

Process requirements

7

过程要求

7.1

Review of requests, tenders and contracts

7.1

要求、标书和合同的评审

7.1.1

The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:

1. the requirements are adequately defined, documented and understood;
2. the laboratory has the capability and resources to meet requirements;
3. where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customerrsquo;s approval;

NOTE 1 It is recognized that externally provided laboratory activities can occur when:

• the laboratory has the resources and competence to perform the activities, however, for unforeseen reasons is unable to undertake these in part or full;
• the laboratory does not have the resources or competence to perform the activities.

d) the appropriate methods or procedures are selected and are capable of meeting the customersrsquo; requirements.

NOTE 2 For internal or routine customers, reviews of requests, tenders and contracts can be performed in a simplified way.

7.1.1

实验室应有评审要求、标书和合同的程序。该程序应确保：

1. 明确规定要求，形成文件， 并被理解；
2. 实验室有能力和资源满足这些要求；
3. 当使用外部提供者时，应满足 6.6 的要求，实验室应告知客户由外部提供者实施的实验室活动，并获得客户同意；

注 1：在下列情况下可能使用外部提供的实验室活动：

——实验室有开展活动的资源和能力，然而由于不可预见的原因不能承担部分或全部活动；

——实验室没有开展活动的资源和能力。

1. 选择适当的方法或程序，并能满足客户的要求。

注 2：对内部或例行客户，要求、标书和合同的评审可简化进行。

7.1.2

The laboratory shall inform the customer when the method requested by the customer is considered to

7.1.2

当客户要求的方法不合适或是过时的，实验室应通知客户。

be inappropriate or out of date.

7.1.3

When the customer requests a statement of conformity to a specification or standard for the test or calibration (e.g. pass/fail,

in-tolerance/out-of-tolerance) the specification or standard, and the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule

selected shall be communicated to, and agreed with, the customer.

7.1.3

当客户要求针对检测或校准做出与规范或标准符合性的声明

（如通过/未通过，在允许限内/ 超出允许限）时，应明确规定判定规则。选择的判定规则应与客户沟通并得到同意，除非规范或标准本身已包含判定规则。

NOTE For further guidance on statements of conformity, see ISO/IEC Guide 98-4.

注：符合性声明的进一步指南见

ISO/IEC 98-4。

7.1.4

Any differences between the request or tender and the contract shall be resolved before laboratory activities commence. Each contract shall be acceptable both to the laboratory and the customer. Deviations requested by the customer

shall not impact the integrity of the laboratory or the validity of the results.

7.1.4

要求或标书与合同之间的任何差异，应在实验室活动开展前解决。每项合同应被实验室和客户双方接受。客户要求的偏离不应影响实验室的诚信或结果的有效性。

7.1.5

The customer shall be informed of any deviation

from the contract.

7.1.5

与合同的任何偏离应通知客户。

7.1.6

If a contract is amended after work has commenced, the contract review shall be repeated

and any amendments shall be communicated to all affected personnel.

7.1.6

如果工作开始后修改合同，应重复进行合同评审，并将修改内容通知所有受影响的人员。

7.1.7

The laboratory shall cooperate with customers or their representatives in clarifying the customerrsquo;s request and in monitoring the laboratoryrsquo;s

performance in relation to the work performed.

7.1.7

在澄清客户要求和允许客户监视其相关工作表现方面，实验室应与客户或其代表合作。

NOTE Such cooperation can include:

1. providing reasonable access to relevant areas of the laboratory to witness customer-specific laboratory activities;
2. preparation, packaging, and dispatch of items needed by the customer for verification purposes.

注：这种合作可包括：

1. 允许适当进入实验室相关区域，以观察与该客户相关的实验室活动。
2. 客户出于验证目的所需的物

品的准备、包装和发送。

7.1.8

Records of reviews, including any significant changes, shall be retained. Records shall also be retained of pertinent discussions with a customer relating to the customerrsquo;s requirements or the

results of the laboratory activities.

7.1.8

应保存评审记录，包括任何重大的变化。针对客户要求或实验室活动结果与客户的讨论也应作为记录予以保存。

7.2

Selection, verification and validation of methods

7.2

方法的选择、验证和确认

7.2.1

Selection and verification of methods

7.2.1

方法的选择和验证

7.2.1.1

The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for

analysis of data.

7.2.1.1

实验室应使用适当的方法和程 序开展实验室活动和（适当时） 评定测量不确定度，以及使用统计技术进行数据分析。

NOTE “Method” as used in this document can be considered synonymous with the term “measurement procedure” as defined in ISO/IEC Guide 99.

注：本标准所用“方法”可视为是

ISO/IEC 指南 99 定义的“测量程序”的同义词。

7.2.1.2

All methods, procedures and supporting documentation, such as instructions, standards, manuals and referenc