Hello, I was asked to add the measurement device (instrument type) in the form where quality folks enter the result for measuring the part dimension. In addition, I must provide the calibration identification of its device or using the serial number. Knowing that the gage(s) can breakdown and replacing the same gage type is needed, is that mean I have to revise the document each time I replace the same gage type because it has different serial number? I thank you in advance for providing the recommendation.
Hi Henry,
Please refer to ISO 13485:2016 Clause 7.6 Control of monitoring and measuring equipment which states " As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified or both......
b) be adjusted or re-adjusted in order to determine calibration status;
c)have identification in order to determine its calibration status;
d) be safeguard from adjustments....
e) be protected....
Records of the results of calibrtation and verification shall be maintained".
SO the answer is "YES" to add the instrument type, Calibration Identification and Serial Number .
Reg this question of yours :
"I have to revise the document each time I replace the same gage type because it has different serial number? "
In general the best and a pragmatic approach would be to have a Quality form (QF) or template for capturing the Inspection Test equipment details and this QF will serve as a record for each variant of the Instrument type, Model number along with its serial number. To make it clearer imagine the below as a form something like this should exist for each unique inspection test equipment model number, Serial number.
Inspection test equipment No.: ITE 123
Instrument Type: Multimeter Instrument Model No: ABC 1234
Serial Number: 45627 Calibration interval: 12 months
S.no Calibrated by Next calibration date Attach the report of calibration
1.
2.
3.