Dear Friend

In ISO 9001

" Documents required by the quality management
system shall be controlled "


is this mean that all documents must be controled under the control of documents


i have work instruction and it is not documented it is ok , or it must to documented it

thanks

You have 2 questions:
1. Yes, you have to control documents which affect the quality of the produst(s).
2. If you have a work instruction that is 'not documented' (I *assume* you mean people are trained on how to do something but there is no documented procedure), then the training must be documented.

the work instruction is already made

but it is not documented

and is located beside the machines

Dear Friend

In ISO 9001

" Documents required by the quality management
system shall be controlled "


is this mean that all documents must be controled under the control of documents


i have work instruction and it is not documented it is ok , or it must to documented it

thanks

All documents and records which form part of the QMS should be controled.Even the relevent standards you refer to should be controled.They should be latest issue.Not only you should control records and documents.It is also mandatory for you document a procedure for control of documents and records.
Work instructions are documents.You should control them also.
V.J.Brahmaiah

A very direct answer.

Yes, you need to control those work instructions.

and is located beside the machines

it should be controled :cool:

Dear Friend

In ISO 9001

" Documents required by the quality management
system shall be controlled "


is this mean that all documents must be controled under the control of documents


i have work instruction and it is not documented it is ok , or it must to documented it

thanks

To finish with your problem:

1. Not all documents in the company should be controled. The standard asks you clearly to control "documents required by the QMS". There might be documents in your company not related to the QMS. Try to find them, and see if those are influencing the quality of your product. If not, no problem.
Try to make a list just for your information. It will help. DO NOT APPEND IT TO THE SYSTEM, IT IS JUST FOR YOUR INFO. Than make a list with all documents that should be controled

2. Is a work instruction influencing the quality of the product? YES.

3. Is it documented (written on some support, check the definition of DOCUMENT in ISO 9000)?
If NOT - it is just good practice.
If YES - you should control it.

In your situation - "It is behind the machine" - that means it exists physically, it is "information on a support" - YOU MUST CONTROL IT according to your QMS procedure for document control.

the work instruction is already made

but it is not documented The question I have is your definition of 'Documented'. I think that may be part of the issue in the discussion. But, the other folks who responded are correct.

the work instruction is already made

but it is not documented

What do you mean? If it is 'made' it is 'documented' isn't it? Do you mean it's not yet controlled? Has it been:-

Approved and the revision identified per your own procedure?

the work instruction is already made

but it is not documented

Work instruction shall be under control. You need to make it as control document and control as per clause 4. Also, training must be given to concern member.