Hi, all !

I would like to know your interpretation of the term "SAFEGUARDED" in this clause. If examples are available, the better I will be able to understand the term.

Thanks.

Welcome to the forum,
An interesting first question:

Untill you mentioned it I never thought of this but I assume that it means that for example:
if there is an adjusting nut this is locked in place
If its positon is vital then it cnnot be moved,
Maybe even scales that have a spitit level in them which showes they have moved, is not safeguarded but is the next best thing

Any one else?

ISO definition of "safeguard" in their terminology document is: protect, secure, give safety to. So, safeguarded is "protected" or "secured". Hope that helps.

For calibrated equipment, the usual method of safeguarding is one or more adhesive seals, placed in a way that deters and detects any access attempts. Most calibration labs use them, and the legend on them usually indicates that the warrany or calibration is not valid if the seal is broken. The seals are often a type of plastic that self-destructs into tiny peices if someone tries to take it off.

I put a field in the record for the Test Equipment called Safeguarding and Protection.

It might say some of the examples given above like "films over adjusting screws" or it might just say "kept in cupboard".

Some items say "no special requirements"

You are showing the assessor that you have considered this issue.

Determining the definition of any word is really quite easy if you remember that clause 3, Terms and Definitions states that ISO 9000:2000 has normative status to define the meaning of the terms used in ISO 9001:2000. Also the TC-176 Secretariat has created document: ISO/TC 176/SC 2/N 526R "Guidance on the Terminology used in ISO 9001:2000 and ISO 9004:2000" on the ISO web site is also very informative.

When I teach the requirements of the International Standard to my auditors I use the order of preference approach to defining the meaning of the terms used in the standard.

The order of preference I teach is:

1. ISO 9000:2000
2. ISO 9001:2000
3. Concise Oxford Dictionary (or equivalent)

This is really the key to determining definitions of the terms used ISO 9001:2000. By using the above order of preference I have help my organization understand the standard and on occasion prevent an external auditors trying to justify a audit nonconformity by using personnel definition of a word used in the standard.

hope this helps

Thank you for all the replies. It definitely help me to understand more on this Clause 7.6 (d) and provide ideas on how to work with this clause.

Thank again.

Note : Would like to listen to more opinions/experiences on this issue.

For calibrated equipment, the usual method of safeguarding is one or more adhesive seals, placed in a way that deters and detects any access attempts. Most calibration labs use them, and the legend on them usually indicates that the warrany or calibration is not valid if the seal is broken. The seals are often a type of plastic that self-destructs into tiny peices if someone tries to take it off.

I agree, in the past we have used this procedure and if I remember correctly even glyptol. How did you safeguard software?
I remember a lot of problems with an automated ring out machine that was used to proof wire connections in medical and defense harnesses. the software was stored on cassett tapes and labeled for which part number it was for. When a harness needed tested we would hook up the appropriate connections and slip the cassett into the recorder. The entire harness could be "rung" out in a matter of seconds. However the auditors did voice concern over safeguarding. Method of storage, revision control and of course tampering. Storage and revision were handled quite readily but tampering remained an open issue.
The tapes were programmed by the same machine. We would hand ring a harness, check it twice and then instruct the machine to program a tape. As you can see it would be quite easy to make a new tape or tamper with the old one.
Our solution was to make what we called a master tape that was controlled by the QA manager (me) then I would performed unscheduled audits on the subject harnesses. Any ideas? Anyone?
:thanx: