6.4 Equipment

6.4.1 Equipment Access and Requirements

The laboratory shall have access to equipment (including, but not limited to, measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables, or auxiliary apparatus) that is required for the correct performance of laboratory activities and that can influence the results.

Note:

A multitude of names exist for reference materials and certified reference materials, including reference standards, calibration standards, standard reference materials, and quality control materials. ISO 17034 contains additional information on reference material producers (RMPs). RMPs that meet the requirements of ISO 17034 are considered to be competent. Reference materials from RMPs meeting the requirements of ISO 17034 are provided with a product information sheet/certificate that specifies, amongst other characteristics, homogeneity and stability for specified properties and, for certified reference materials, specified properties with certified values, their associated measurement uncertainty, and metrological traceability.

Note:

ISO Guide 33 provides guidance on the selection and use of reference materials. ISO Guide 80 provides guidance to produce in-house quality control materials.

6.4.2 Use of Equipment Outside Permanent Control

When the laboratory uses equipment outside its permanent control, it shall ensure that the requirements for equipment of this document are met.

6.4.3 Equipment Handling and Maintenance

The laboratory shall have a procedure for handling, transport, storage, use, and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration.

6.4.4 Equipment Verification

The laboratory shall verify that equipment conforms to specified requirements before being placed or returned into service.

6.4.6 Calibration of Measuring Equipment

Measuring equipment shall be calibrated when:

  • The measurement accuracy or measurement uncertainty affects the validity of the reported results.
  • Calibration of the equipment is required to establish the metrological traceability of the reported results.
Note:

Types of equipment having an effect on the validity of the reported results can include:

  • Those used for the direct measurement of the measurand, e.g. use of a balance to perform a mass measurement.
  • Those used to make corrections to the measured value, e.g. temperature measurements.
  • Those used to obtain a measurement result calculated from multiple quantities.

6.4.7 Calibration Programme

The laboratory shall establish a calibration programme, which shall be reviewed and adjusted as necessary in order to maintain confidence in the status of calibration.

6.4.8 Equipment Identification

All equipment requiring calibration or which has a defined period of validity shall be labelled, coded, or otherwise identified to allow the user of the equipment to readily identify the status of calibration or period of validity.

6.4.9 Handling Defective Equipment

Equipment that has been subjected to overloading or mishandling, gives questionable results, or has been shown to be defective or outside specified requirements, shall be taken out of service. It shall be isolated to prevent its use or clearly labelled or marked as being out of service until it has been verified to perform correctly. The laboratory shall examine the effect of the defect or deviation from specified requirements and shall initiate the management of nonconforming work procedure (see 7.10).

6.4.10 Intermediate Checks

When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure.

6.4.11 Reference Values and Correction Factors

When calibration and reference material data include reference values or correction factors, the laboratory shall ensure the reference values and correction factors are updated and implemented, as appropriate, to meet specified requirements.

6.4.12 Prevention of Unintended Adjustments

The laboratory shall take practicable measures to prevent unintended adjustments of equipment from invalidating results.

6.4.13 Equipment Records

Records shall be retained for equipment which can influence laboratory activities. The records shall include the following, where applicable:

  • The identity of equipment, including software and firmware version.
  • The manufacturer's name, type identification, and serial number or other unique identification.
  • Evidence of verification that equipment conforms with specified requirements.
  • The current location.
  • Calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval.
  • Documentation of reference materials, results, acceptance criteria, relevant dates, and the period of validity.
  • The maintenance plan and maintenance carried out to date, where relevant to the performance of the equipment.
  • Details of any damage, malfunction, modification to, or repair of, the equipment.