The monitoring and measuring resources clause of ISO9001:2015 is specifically concerned with monitoring product and service for conformity to requirements. the term "resources" is used rather than "equipment". This is quite deliberate and is in recognition that monitoring and measuring resources may include people. IE: Personnel and the environment they are operating in. (For example, the visual aesthetic assessment of vehicle interior trim components before acceptance may include equipment such as colour recognition systems, light boxes and reference standards but also a trained & assessed (verified) specialist.)

Under ISO 9001:2015, organisation are required to first determine and then 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 specified requirements.

IE: Resources are suitable for the specific type of monitoring and measurement activities required and are monitored / maintained to ensure their continuing fitness for their purpose. (Instruments must be accurate, reliable and precise enough. Gauge "Repeatability and Reproducibility Studies" often referred to as gauge R & R, can be used to great effect for this purpose and hence, required by some customers.)

Documented information must also be retained as evidence of fitness for purpose of the monitoring and measurement resources. (IE not just the monitoring or measuring equipment - this could include training / assessment records for appropriate personnel for example.)

Measurement traceability

If measurement traceability (IE: to national or international measurement standards) is determined to be a requirement, or is considered by the organisation to be essential to providing confidence in the validity of measurement results (as is usually the case,) then the measuring equipment must be calibrated or verified, or both, at specified intervals, or prior to use and be traceable to the specified measurement standards.

Should no such standards exist (for most standard equipment they do,) the basis used for calibration / verification must be retained as documented information.

Comment:

"Verification" is confirming that the equipment is meeting or acceptable to relevant standards. IE: No correction or adjustment is carried out. (When checking a tape measure to a master rule for example.) When "calibrating" to a known standard, the equipment may be adjusted as part of the calibration process to bring it to within acceptable limits. (When checking a mechanical engineering micrometer to a master set of slip blocks for example.)

Note that the organisation is also required to 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 take appropriate action as necessary.

IE: If the equipment fails to meet verification criteria (EG: tape graduations worn off) or adjustment outside of permissible tolerances is required to bring back into calibration (EG: excessive adjustment required on the micrometer.) This might involve quarantining and re-checking of stocks or even recall if product has been shipped to the customer.

Identification of calibration status of equipment is still required as is the need to safeguard it from adjustments, damage or deterioration that would invalidate the calibration status and subsequent measurement results.

Audit Check:

Auditors are being advised to confirm that documented information (records) are being retained by organisations to demonstrate that all monitoring and measuring resources are fit for purpose (IE: not just the equipment.)

The Quality Planning process should determine the product and process characteristics which need to be monitored and measured in addition to Customer and regulatory requirements as appropriate.

Identification of calibration status within 9001:2015 does not specifically require that "Calibration next due" labels are on every piece of equipment, as for example, If each is marked with a unique serial number it may be cross-referenced to a master calibration log and certificate. However, calibration status is often a problem for organisations to maintain and is an easy (and hence frequent) area for auditors to review during process audits.

Visible and clear stickers, stating calibration due dates on all relevant equipment (or its cross referenced box if the environment is not conducive to stickers on the actual instruments, such as in an oily machine shop for example) or colour coded tags and appropriate signage indicating the current calibration colour, are just two ways in which organisations can make it easy for themselves to keep on top of this part of the management system and also avoid audit non conformities.