主题：【分享】设备仪器的校准

（引用改写  作者：SGS高级培训讲师/主任审核员）

在ISO 9001质量体系推行过程中，对于“校准”的概念往往有很多疑惑和含糊的把握，甚至干脆采取逃避的方法，“见表就校”，归根到底还是没有清楚准确地理解ISO 9001：2000质量体系标准条文所致。总体概括起来有如下问题：
    哪些设备 / 仪器需要校准？
    企业内部校准对校准周期如何确定？需要什么资格？
    什么是校准，什么是检定？

    要回答第一个问题，首先请参照ISO9001：2000节选的条文：
7．6 监视和测量装置的控制  GB/T 19001：2000，质量管理体系-要求
Control of monitoring and measuring devices.  ISO9001:2000, Quality management systems Requirements
组织应确定需实施的监视和测量以及所需的监视和测量装置，为产品符合确定的要求（见7.2.1）提供证据。
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements(see7.2.1).
组织应建立过程，以确保监视测量活动可行并以与监视和测量的要求相一致的方式实施。
The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.
为确保结果有效，必要时，测量设备应：
Where necessary to ensure valid results, measuring equipment shall:
a)    对照能溯源到国际或国家基准的测量基准，按照规定的时间间隔或在使用前进行校准或检定。当不存在上述标准时，应记录校准或检定的依据；
be calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded;
b)    进行调整或必要时再调整；
be adjusted or re-adjusted as necessary;
c)    得到识别，以确定其校准状态；
be identified to enable the calibration status to be determined;
d)    防止可能使测量结果失效的调整；
be safeguarded from adjustments that would invalidate the measurement result;
e)    在搬运、维护和贮存期间防止损坏或生效；
be protected from damage and deterioration during handling, maintenance and storage.
此外，当发现设备不符合要求时，组织应对以往测量结果的有效性进行评价和记录。组织应对设备和任何受影响的产品采取适当措施。校准和验证结果的记录应予保持（见4.2.4）。
In addition, the organization shall assess and record the validity of the previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of calibration and verification shall be maintained (see 4.2.4).
当计算机软件用于规定要求的监视和测量时，应确认其满足预期用途的能力。确认应在初次使用进行，必要时再确认。
When used in the monitoring and measurement of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. NOTE See ISO 10012-1 and ISO 10012-2 for guidance.