ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》通用要求-深圳市九域企业管理顾问有限公司
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ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》通用要求

Date2023-03-16 10:15:16  Views878次

中国合格评定国家认可委员会(英文缩写:CNAS)等同采用ISO/IEC 17025:2017《检测和校准实验室能力的通用要求》 作为对检测和校准实验室能力进行认可的基本认可准则。为支持特定领域的认可活动, CNAS还根据不同领域的专业特点,制定一系列的特定领域应用说明,对本准则的要求进行必要的补充说明和解释,但并不增加或减少本准则的要求。

申请CNAS认可的实验室应同时满足本准则以及相应领域的应用说明。
本准则内容及条款号与国际标准 ISO/IEC 17025:2017内容及条款号完全一致。CNAS鼓励申请认可的机构购买和使用正版国际和国家标准。

4 通用要求General requirements

4.1 公正性Impartiality
4.1.1 实验室应公正地实施实验室活动,并从组织结构和管理上保证公正性。
Laboratory activities shall be undertaken impartially and structured and managed so as to safeguard impartiality.
4.1.2 实验室管理层应作出公正性承诺。
The laboratory management shall be committed to impartiality.
4.1.3 实验室应对实验室活动的公正性负责,不允许商业、财务或其他方面的压力损害公正性。
The laboratory shall be responsible for the impartiality of its laboratory activities and shall not allow commercial, financial or other pressures to compromise impartiality.
4.1.4 实验室应持续识别影响公正性的风险。这些风险应包括实验室活动、实验室的各种关系,或者实验室人员的关系而引发的风险。然而,这些关系并非一定会对实验室的公正性产生风险。
The laboratory shall identify risks to its impartiality on an on-going basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. However, such relationships do not necessarily present a laboratory with a risk to impartiality.
注:危及实验室公正性的关系可能基于所有权、控制权、管理、人员、共享资源、财务、合同、市场营销(包括品牌推广)、支付销售佣金或其他引荐新客户的佣金。
NOTE  A relationship that threatens the impartiality of the laboratory can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing (including branding), and payment of a sales commission or other inducement for the referral of new customers, etc.
4.1.5 如果识别出公正性风险,实验室应能够证明如何消除或最大程度降低这种风险。
If a risk to impartiality is identified, the laboratory shall be able to demonstrate how it eliminates or minimizes such risk.
4.2 保密性Confidentiality
4.2.1 实验室应通过作出具有法律效力的承诺,对在实验室活动中获得或产生的所有信息承担管理责任。实验室应将其准备公开的信息事先通知客户。除了客户公开的信息,或当实验室与客户有约定时(例如为回应投诉的目的),其他所有信息都被视为专有信息,应予以保密。
The laboratory shall be responsible, through legally enforceable commitments, for the management of all information obtained or created during the performance of laboratory activities. The laboratory shall inform the customer in advance, of the information it intends to place in the public domain. Except for information that the customer makes publicly available, or when agreed between the laboratory and the customer (e.g. for the purpose of responding to complaints), all other information is considered proprietary information and shall be regarded as confidential.
实验室应有遵守军工产品、国防科技工业保密的有关规定。
4.2.2 实验室依据法律要求或合同授权透露保密信息时,应将所提供的信息通知到相关客户或个人,除非法律禁止。
When the laboratory is required by law or authorized by contractual arrangements to release confidential information, the customer or individual concerned shall, unless prohibited by law, be notified of the information provided.
4.2.3 实验室对于从客户以外的渠道(如投诉人、监管机构)所获取的有关客户的信息,应在客户和实验室间保密。除非信息的提供方同意,实验室应为信息提供方(来源)保密,且不应告知客户。
Information about the customer obtained from sources other than the customer (e.g. complainant, regulators) shall be confidential between the customer and the laboratory. The provider (source) of this information shall be confidential to the laboratory and shall not be shared with the customer, unless agreed by the source.
4.2.4 人员,包括委员会委员、签约人员、外部机构人员或代表实验室的个人,应对在实施实验室活动过程中获得或产生的所有信息保密,法律要求除外。
Personnel, including any committee members, contractors, personnel of external bodies, or individuals acting on the laboratory’s behalf, shall keep confidential all information obtained or created during the performance of laboratory activities, except as required by law.
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