Clause 6.4: Equipment

What the clause asks for

Clause 6.4 covers every piece of equipment that can influence results: measuring instruments, software, measurement standards, reference materials, reference data, reagents, consumables and auxiliary apparatus. In summary the laboratory must:

• check that equipment conforms to specified requirements before it is placed or returned into service (6.4.4),
• calibrate equipment when measurement accuracy or uncertainty affects the validity of results, or when calibration is needed for metrological traceability (6.4.6),
• maintain a calibration programme that is reviewed and adjusted (6.4.7),
• label or otherwise identify calibration status or period of validity (6.4.8),
• take equipment out of service when it is overloaded, mishandled, gives questionable results or is outside specified requirements, and examine the effect on previous work (6.4.9),
• perform intermediate checks where needed to maintain confidence in performance (6.4.10),
• update correction factors when calibration produces them (6.4.11),
• protect against adjustments that would invalidate results (6.4.12).

Clause 6.4.13 lists the records to keep: a) identity, including software and firmware version; b) manufacturer name, type identification and serial number or other unique identification; c) evidence of verification that the equipment conforms to requirements; d) current location; e) calibration dates, results, adjustments, acceptance criteria and the due date or interval; f) reference material documentation; g) the maintenance plan and maintenance carried out; h) details of damage, malfunction, modification or repair.

What assessors sample

Assessors pick instruments from the bench and trace them to the register, then ask for the last certificate and how the result was checked against acceptance criteria. Typical findings: certificates filed but never reviewed, no acceptance criteria, due dates missed, intermediate checks done but not recorded, and retired items removed from the register.

Where this lives in AccreditBook

Record (6.4.13)	Field in AccreditBook
a, b Identity	Asset tag, name, manufacturer, model, serial number, notes for firmware
c Verification	Calibration event of kind “verification” with result
d Location	Location
e Calibration	Calibration events: date, provider, certificate number, result, as found, as left, uncertainty; acceptance criteria; interval and next due
f Reference materials	Reference standard tab: traceability chain, nominal value, uncertainty
g Maintenance	Maintenance interval and events of kind “maintenance”
h Damage and repair	Events of kind “repair”, status changes with reason

Next due is computed from the last calibration and the interval, or from the provider’s stated due date if you record one. Status changes (out of service, quarantined, retired) are logged with a reason, which supports 6.4.9.

See Equipment and Calibration events.