Identifying Quality Documents and Records from Non-Quality

[sheryljuco]

please help us to identify quality documents from non-quality. personally i get confuse when employees are asking me about this. i could definitely tell which is a quality or non-quality document/record but when i'm ask how i did it, my thoughts get tangled. i hoope you could help us draw the line between the two. thanks a lot. GOD BLESS YOU ALL...INDEED!

 

[Claes Gefvenberg]

Re: how to identify quality documents and records from non-quality

please help us to identify quality documents from non-quality.

Hello sheryljuco, and welcome to the Cove

Quality documents... Ok, assuming we're talking about clause 4.2.4 in ISO9001:2000:

Apart from the other clauses referring to 4.2.4, you need to ask yourself if it would hurt you (or rather your QMS) not to have the documents...

Can you prove that you fulfil the requirements of the standard, and that your QMS works the way it should without the document in question?

/Claes

 

[sheryljuco]

Re: how to identify quality documents and records from non-quality

Apart from the other clauses referring to 4.2.4, you need to ask yourself if it would hurt you (or rather your QMS) not to have the documents...

Can you prove that you fulfil the requirements of the standard, and that your QMS works the way it should without the document in question?

Thanks for your warm welcome, do you have any definition that would differentiate the two (quality and non-quality documents)????

 

[Claes Gefvenberg]

Re: how to identify quality documents and records from non-quality

do you have any definition that would differentiate the two (quality and non-quality documents)????

Not really. I use the above questions.

/Claes

 

[David Hartman]

Re: how to identify quality documents and records from non-quality

Welcome to the Cove sheryljuco!

I have two thoughts in response to your query:

1. Why differentiate? Why not handle/control ALL of your documents, instead of setting up two differing processes for controlling documentation?​

2. If you are going to differentiate, you will have to review each document, then decide if it is written to support any portion of your QMS (this will have to be your call, without reviewing the documentation ourselves we are not going to be able to help in this decision).

Start by defining which of your upper level documentation supports the QMS, then define which lower level documents (work instructions, assembly processes, forms, etc.) support those applicable upper level documents.​

 

[Mike S.]

Re: how to identify quality documents and records from non-quality

Thanks for your warm welcome, do you have any definition that would differentiate the two (quality and non-quality documents)????

Claes' questions are excellent ones to help determine if it is a Q record or "other" record.

Also, ISO 9000-2000 section 3.7.6 has a definition that might help by itself, or might help you build your own definition.

 

[RoxaneB]

I would also ask myself the following:

1. Does this document impact my organization's ability to meet our Customers' requirements? If yes, it is a Quality document.
2. Does this document impact my organization's ability to meet the requirements of ISO 9001:2000? If yes, it is a Quality document.
3. Is this document a requirement of ISO 9001:2000? If yes, it is a Quality document.
4. Does this document relate to (or is it linked to) any document(s) that answered 'yes' to any Questions 1-3? If yes, it is a Quality document.
5. Is this document a required record of ISO 9001:2000? If yes, it is a Quality record.
6. Is this document generated as an output from following a Quality document? If yes, it is a Quality record.

And welcome!

 

[sheryljuco]

Re: how to identify quality documents and records from non-quality

Claes' questions are excellent ones to help determine if it is a Q record or "other" record.

Also, ISO 9000-2000 section 3.7.6 has a definition that might help by itself, or might help you build your own definition.

Do you mind discussing what does this specific section says, about quality and non quality documents? in our iso9k2k standard there is no. 3 clause but no specific 3.7.6. it would be of big help for me.

thank you to all of you who finds time to reply to my posts.

 

[Mike S.]

Re: how to identify quality documents and records from non-quality

Do you mind discussing what does this specific section says, about quality and non quality documents? in our iso9k2k standard there is no. 3 clause but no specific 3.7.6. it would be of big help for me.

thank you to all of you who finds time to reply to my posts.

In 9000-2000 Fundamentals and Vocaulary document (not 9001-2000) you find this:

3.7.6
record
document (3.7.2) stating results achieved or providing evidence of activities performed
NOTE 1 Records can be used, for example, to document traceability (3.5.4) and to provide evidence of verification (3.8.4),
preventive action (3.6.4) and corrective action (3.6.5).
NOTE 2 Generally records need not be under revision control.


By the way -- welcome to the Cove.