ISO 9001-94, 4.16.

How far does one go to protect records from "loss". If records are stored in an unlocked shed, should that be sufficient or should the shed be locked. The standard does not say to protect the records from "theft".

Any opinions? Thanks.

Originally posted by Michael36:
ISO 9001-94, 4.16.

How far does one go to protect records from "loss". If records are stored in an unlocked shed, should that be sufficient or should the shed be locked. The standard does not say to protect the records from "theft". Any opinions? Thanks.

I think the standard is looking for a "good faith" effort to protect the records and the difference between "loss" and "theft" is one of semantics.

When you say shed I hope you are not talking about something like a chicken shack! Where they are stored is up to you as long as they are readily retrieveable in a "facility" that provides a suitible environment to prevent damage or deterioration and to prevent loss. (paraphrased from QS)

It comes down to common sense.

If records are stored on a network, I would cover this requirement with a process on backing up the hard drives that included storing the backup medium in a controlled environment and also off-site.

If records are stored in an outside shed, I would make sure that there were no holes in the roof to let in rain and yes I would put a lock on the door.

ASD...