7.1.5 Monitoring and Measuring Resources

7.1.5.1 General

The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements.

The organization shall ensure that the resources provided:

a. are suitable for the specific type of monitoring and measurement activities being undertaken;

b. are maintained to ensure their continuing fitness for their purpose.

The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources.

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.