Definition of equipment for ISO 13485:2016


Quite Involved in Discussions
Hi folks, I am creating SOP's and have had some feedback regarding my description of "Equipment" on a purchase request form. Currently my definition is: " equipment used in the design control, production and incoming and test inspection processes. "

Anyone have any good ideas?



Starting to get Involved
We had a great internal discussion about this. Here's where we landed.

Equipment – machine or tool that performs a measuring or monitoring function and/or is used in manufacturing process to modify device. Equipment shall be limited to the items for which the performance of the equipment can impact the ability of the product to conform to requirements.

Examples to aid in clarifying the definition:

Equipment: Any device which requires calibration for its intended use is equipment. Additional examples: Laser Welder, Digital Volt Meter, soldering irons, T&Rh monitors, power supplies with readouts, torque drivers, UV curing equipment, electronic/pneumatic glue dispensing equipment, electronic balances. Note: Equipment may or not be calibrated depending on its use case.

Not Equipment: screwdrivers, electric screwdrivers without torque settings, jigs and assembly fixtures for non-critical alignments, non-calibrated weights, coffee mugs (just kidding, but critical for production!)
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