Measuring Equipment
Hello,
is the definition of the measuring equipment in ISO 9000 applicable for ISO 13485?
“Measuring equipment” is defined in ISO 9000 as “measuring instrument, software, measurement standard, reference material or auxiliary apparatus or combination thereof necessary to realize a measurement process”.
Could you elaborate on what type of equipment we must take in consideration during the implementation process?
Thanks.
Assign topic to the user
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
Yes, the definition regarding measuring equipment is the same in ISO 13485 and ISO 9001.
Measuring equipment can be scales, thermometers, pressure meters, equipment for measuring length, pH meters, and so on, so anything that you use in your production that is necessary to define some characteristic, or for the medical device or for the environment.
In case the production is outsourced, do we need to get the info from the manufacturer itself? Or this requirement is for "in-house" equipment?
If your production is outsourced, you need to have information on which measuring equipment is used for the production, quality control, and storage of your medical device and definitively you need to have proof that that equipment is regularly calibrated (you need to see the calibration certificates).
Usually, you will check this during the audit that you will conduct on your outsourced production.
Comment as guest or Sign in
Nov 11, 2022