ISO 13485:2016 Clause 8.2.6

[FuzzyD]

Hi Folks

In ISO 13485:2016 Clause 8.2.6

What does "As Appropriate" mean in the second paragraph in reference to "records shall identify the test equipment used to perform measurement activities".

Does this mean that the type of gage shall be indicated such as pitch mic. Gage Pin etc. or does this mean the specific gage Pitch mic gage ID 1244 as an example?
Thanks for your help!

FuzzyD
Quality Engineer always in training.

 

[blackholequasar]

Where I work, we indicate which calibrated instrument we used in specific. That way, if there is a calibration failure, we're able to go through our records and see what product was accepted or used by the failed asset and determine how to handle a potential recall. It's about traceability, to me. So putting the asset # and calibration due date is the minimum that I've applied where I work! And we haven't encountered any issues with this clause

 

[Tidge]

The typically bon mot regarding "as appropriate" is this: "If a clause is considered to be 'not appropriate' there will be documentation establishing the decision."

If you can't think of why something my not be appropriate, then consider it 'appropriate'.

 

[yodon]

Does this mean that the type of gage shall be indicated such as pitch mic. Gage Pin etc. or does this mean the specific gage Pitch mic gage ID 1244 as an example?

You'll want to capture the specific equipment used. If that equipment is found to be out of tolerance at some point, you need to be able to find what all was measured with that equipment for the impact assessment. Further, if you just say "gage pin" that may not provide the accuracy required.

 

[Tagin]

Just to note, 'as appropriate' is explained in 0.2 of 13485:2016:

— When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:

— product to meet requirements;​

— compliance with applicable regulatory requirements;​

— the organization to carry out corrective action;​

— the organization to manage risks.​

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