Attribute vs Variable Inspection Data ISO 13485 Requirement

[toffeeman]

Hi,

Is there a requirement in either ISO13485:2012 or ISO13485:2016 that variable data must be recorded during inspection (Incoming, Inprocess, Final QA)?

The reason I ask is that it came up in conversation with my colleagues that ISO13485 has this as a mandatory requirement but it is not mandatory for ISO9001.

I have reviewed the standard, and although it is best practice so as to monitor production processes (supplier & inhouse), it does not specifically state this as a requirement.

Any help on this would be greatly appreciated.

 

[Statistical Steven]

To the best of my knowledge the data type is not specified in ANY standard. You might not have variable data for an attribute characteristic such as absence or presence of a feature.

 

[Sam Lazzara]

Is there a requirement in either ISO13485:2012 or ISO13485:2016 that variable data must be recorded during inspection (Incoming, Inprocess, Final QA)?

Neither ISO 13485:2003 (EN ISO 13485:2012) or ISO 13485:2016 (EN ISO 13485:2016) specifically require variable (continuous) data values to be recorded. There are requirements to keep "records" of verification results, and in the 2016 standard, the extent of the records must be "proportionate to the risks" associated with the product. In the context of 13485:2016, the term "risk" relates to device safety/performance and applicable regulatory requirements.

One other key point - if there was an "applicable regulatory requirement" that says you must record variables data values, then you must do it. Pretty unlikely I think.

Having said all this, my personal policy is to record measured values whenever reasonable, practical, etc. It helps with data trending analysis and problem-solving later. And if I have nonconforming values, I would mandate the recording of measured values.