Control of Monitoring and Measurement Devices - ISO 13485 Clause 7.6 says ...

P

pangchiaboon

#1
Dear Sirs,

ISO 13485 Clause 7.6 says "The organization shall establishe documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements".

Can anybody please share what you understand from this clause. It would be good if you can give some example for better understanding.

Thank you.
 
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sagai

Quite Involved in Discussions
#2
Re: ISO 13485 Clause 7.6 says ...

Hi pangchiaboon,

there is a technical report for iso13485, the ISO/TR 14969:2004(E).
It helps the reader to minimaze the risk of misinterpretation of the original wording.
I think it is useful to have it, the corresponding part follows:

7.6.1 The requirements refer explicitly to monitoring and measuring devices, including test software. It is
helpful to approach the subject of control of monitoring and measuring devices from the perspective that
measuring is itself a process involving materials, equipment and procedures. The intent of the requirements is
to give the organization confidence in the monitoring and measuring devices that it uses to ensure that
product meets customer and regulatory requirements. <snip>
Regarding to your question, on a high level it means if you do not have such implemented procedure, you risk a major non conformity in case of the audit. In case you have it, you should ensure it meets the requirement in the standard, guidance is the TR. .

br
Sz.

NOTE: This was a large part of a copyrighted document - an ISO TR. Please do not copy and paste more than a "fair use" portion of any document in the future. Thank you.
 
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M

meimei

#4
Dear Sirs,

Lately I joined a small setup company, they are on the process of getting certified for ISO 13485 and recently went through a stage 1 audit. I facing some problems with the maintenance and calibration of laboratory equipment as follow:

1) Minor NC 6.3 Infrastructure: No evidence of monitoring of UV lamp life for the Fluorescence imager (UV).
My understanding that the lab staff are use the imager to view some result but that it was not the decision point of acceptance.

2) There are some equipment/instrument such as magnetic stirrer and vortex shaker that the lab staff use to stir or shaker the mixture. Do we need to have preventive maintenance and calibration for them since there is several of its in the lab and the lab staff are not concern on the rpm of the stirrer and violation of the shaker.

As the stage 2 audit is scheduled a month later, I won't want to make too much change to the existing QMS document.

Thanks in advance.
:thanx:
Warm regards
 
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