7.1.5 监视和测量资源
7.1.5.2、测量溯源
当要求测量溯源时,或组织认为测量溯源是信任测量结果有效的前提时,测量设备应:
a. 对照能溯源到国际或国家标准的测量标准,按照规定的时间间隔或在使用前进行校准和(或)检定(验证),当不存在上述标准时,应保留作为校准或检定(验证)依据的形成文件的信息;
b. 予以识别,以确定其状态;
c. 予以保护,防止可能使校准状态和随后的测量结果失效的调整、损坏或劣化。
组织应建立、实施并保持一个过程以在要求校准和检定时召回监视和测量设备。
组织应保持一份监视和测量设备的登记册,并规定其校准/检定的过程,包括设备型号、唯一性标识、所在位置、校验周期、校验方法和接收准则。
注:监视和测量设备包括但不限于:试验硬件、试验软件、自动试验设备(ATE)和用于获取检验数据的绘图仪。也包括用于提供产品符合证据的个人拥有的和顾客提供的设备。
监视和测量设备的检定和校准应在合适的环境条件下实施(见7.1.4)。
当发现测量设备不符合预期用途时,组织应确定以往测量结果的有效性是否受到不利影响,必要时应采取适当的措施。
7.1.5.2、Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an essential part of providing confidence in the validity of measurement results, measuring equipment shall be:
a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information;
b. identified in order to determine their status;
c. safeguarded from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.
The organization shall establish, implement, and maintain a process for the recall of monitoring and measuring equipment requiring calibration or verification.
The organization shall maintain a register of the monitoring and measuring equipment. The register shall include the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria.
NOTE: Monitoring and measuring equipment can include, but are not limited to: test hardware, test software, automated test equipment (ATE), and plotters used to produce verification data. It also includes personally owned and customer supplied equipment used to provide evidence of product and service conformity.
Calibration or verification of monitoring and measuring equipment shall be carried out under suitable environmental conditions (see 7.1.4).
The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessary.