If a service-call is made, and measuring some input or output (electrical, radiation, gamma waves, etc) is required, should the service representative record the diagnostic equipment information, including serial numbers for tracing calibration?

Should his equipment (required to be in calibration) be documented on the repair report that is filed with customer service?

:biglaugh: :thanks: in advance.

If a service-call is made, and measuring some input or output (electrical, radiation, gamma waves, etc) is required, should the service representative record the diagnostic equipment information, including serial numbers for tracing calibration?

Should his equipment (required to be in calibration) be documented on the repair report that is filed with customer service?

:biglaugh: :thanks: in advance.

In my opinion, yes...

Yes!
Why would they not?
21CFR Part 820 sec 820.200 Servicing (d)(6) Service reports shall be documented and shall include Test and inspection data."

Since during the service call the technician must test, adjust and retest, I would definitely use calibrated equipment and record the ID for positive recall if needed.

Phil

If a service-call is made, and measuring some input or output (electrical, radiation, gamma waves, etc) is required, should the service representative record the diagnostic equipment information, including serial numbers for tracing calibration?

Should his equipment (required to be in calibration) be documented on the repair report that is filed with customer service?

:biglaugh: :thanks: in advance.

Yes to all questions.

If I am the customer for the service call, I ensure that the service technician signs my "Maintenance logbook", gives me service report with all sections filled in, complies with Good Documentation Practices, and provides attested calibration records of the instruments that he uses.

All these points are requirements of the industry that we work in :cool:

If a service-call is made, and measuring some input or output (electrical, radiation, gamma waves, etc) is required, should the service representative record the diagnostic equipment information, including serial numbers for tracing calibration?

Should his equipment (required to be in calibration) be documented on the repair report that is filed with customer service?

:biglaugh: :thanks: in advance.It's all in the standard.7.5.1 Control of production and service provision
7.5.1.1 General requirements
The organization shall plan and carry out production and service provision under controlled conditions. Controlled
conditions shall include, as applicable
a) the availability of information that describes the characteristics of the product,
b) the availability of documented procedures, documented requirements, work instructions, and reference
materials and reference measurement procedures as necessary,
c) the use of suitable equipment,
d) the availability and use of monitoring and measuring devices,
e) the implementation of monitoring and measurement,
f) the implementation of release, delivery, and post-delivery activities, and
g) the implementation of defined operations for labeling and packaging.

The organization shall establish and maintain a record (see 4.2.4) for each batch of medical devices that provides
traceability to the extent specified in 7.5.3 and identifies the amount manufactured and amount approved for
distribution. The batch record shall be verified and approved.

NOTE—A batch can be a single medical device7.5.1.2.3 Servicing activities

If servicing is a specified requirement, the organization shall establish documented procedures, work instructions, and reference materials and reference measurement procedures, as necessary, for performing servicing activities and verifying that they meet the specified requirements.
Records of servicing activities carried out by the organization shall be maintained (see 4.2.4).
NOTE—Servicing can include, for example, repair and maintenance