ISO9001:2000 Quality Work Instructions & Forms - Seeking Templates and Examples

V

vattony

#1
Where can I find examples of ISO9001:2000 work instructions and quality forms. I have the section procedures.
Is there somewhere on the web where you can purchase the work instruction and forms templates?

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E

emgall

#4
Hi Russ,

I'm struggling with the same problems - and would appreciate a copy of your template.

thanks in advance

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Ed Gall
 
V

vattony

#5
Russ,

Yes, I would appreciate a copy of your work instructions template.

Thanks,
vattony
Originally posted by Russ:
vattony-

I have a Word template for work instructions, if that will help?
 
A

Allison

#6
ISO9001:2000 Work Instruction & Forms

Well, I need to find ISO9001:2000 Work Instruction. Do you know where I can find it? In the internet, it seems no such software for you.

Also, do you know which brand of software is good in internet as I need to establish quality system to my company based on ISO9001:2000. The idea case is buying one software that it can have quality manual, procedures and work instruction.
 

Wes Bucey

Quite Involved in Discussions
#7
Allison said:
Well, I need to find ISO9001:2000 Work Instruction. Do you know where I can find it? In the internet, it seems no such software for you.

Also, do you know which brand of software is good in internet as I need to establish quality system to my company based on ISO9001:2000. The idea case is buying one software that it can have quality manual, procedures and work instruction.
vattony, emgall, Russ, Catherine Lim, Allison:
I fear you are starting on the wrong track by characterizing work instructions and "quality forms" as ISO9001:2000.

One of the primary misinterpretations of the Standard is that there is a "uniform style of documentation."

This is absolutely not true.

Elsewhere in the Cove (use the search feature), we have discussed the concept repeatedly that an organization may have Quality Manuals ranging from "one page" to hundreds of pages and still be within ISO9001:2000 Standards. It is an exactly similar situation for Work instructions and record forms (what you probably mean by "Quality form")

The primary requirement is that the document, if you use one, be useful to your organization. Hence, You could have one work instruction as simple as:
"cover all shipping labels with clear plastic tape to protect them from smearing."

You might have a work instruction as complicated as a 100 page operating manual for a computer-controlled machining center, published by the manufacturer and adopted by your organization as a "work instruction."

Similarly, you could have a "Quality Form" (record) as simple as one line:
"production for Machine 3 was 1,000 pieces, 0 rejects, on July 29, 2004."

Am I making myself clear in that I believe you are erring by trying to be too formulaic in adapting your Quality Management System to ISO9001:2000?
 
J

J Oliphant

#8
its how you treat them

absolutely agree with wes.. but I wish to add an important qualifier, its not what the records or forms look like- its how you treat them. The standard makes it clear that procedures and records are to be controlled.

controlled meaning that
  • the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
  • revisions are tracked. documents must be identified in such a way that you can prove that any given document is the lastest revision
  • the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
  • that documenation is kept in identified, protected places for at least a specified retention time

many organizations will include some formatting to show revision #, identification, and location (be it book # or whatever). The system then tracks how you control your documenation could create formatting, or other storage requirements.

Surely a great way to handle documenation is to set up an all electronic system to store work instructions. This will not create so exactly a 'standard' work instruction, but it may specify that the work instruction is written within a word processor application and has a page or other formatting to indicate revison #, identification, approval, etc.

more complex software allows you to store records on the computer and provides software to create a unique, traceability electronic signature. We make FDA grade product BUT are pretty low tech, so we may never go there... :(

PS. I have restrained myself from quoting the standard.. since the standard is copyrighted-- it would be bad to quote it, correct??
 

Wes Bucey

Quite Involved in Discussions
#9
J Oliphant said:
absolutely agree with wes.. but I wish to add an important qualifier, its not what the records or forms look like- its how you treat them. The standard makes it clear that procedures and records are to be controlled.

controlled meaning that
  • the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
  • revisions are tracked. documents must be identified in such a way that you can prove that any given document is the lastest revision
  • the documenation is approved and that only the latest approved documenation (be it procedures or forms) are used
  • that documenation is kept in identified, protected places for at least a specified retention time
many organizations will include some formatting to show revision #, identification, and location (be it book # or whatever). The system then tracks how you control your documenation could create formatting, or other storage requirements.

Surely a great way to handle documenation is to set up an all electronic system to store work instructions. This will not create so exactly a 'standard' work instruction, but it may specify that the work instruction is written within a word processor application and has a page or other formatting to indicate revison #, identification, approval, etc.

more complex software allows you to store records on the computer and provides software to create a unique, traceability electronic signature. We make FDA grade product BUT are pretty low tech, so we may never go there...
sad.gif


PS. I have restrained myself from quoting the standard.. since the standard is copyrighted-- it would be bad to quote it, correct??
Most of what you cite in your post falls under a subset of Document Management called Configuration Management. Do a search for the term here in the Cove or Google the internet for more on the term.

In general, Document Management includes lots of things besides just "control" - there are lots of misinterpretations on what "control" means as well.

Computer handling of document management
I agree this can be most efficient for many companies. Others are so small and shuffle so few papers, they find it more efficient to deal with paper, saving the costs of hardware, software, training. So, not everyone is best served by Electronic Document Management (Everyone should note there is a difference between "file sharing" and "document management" - also do a search on these terms.)

Copying copyrighted materials.
under the doctrine of "Fair Use" anyone may copy and reproduce excerpts of copyrighted material for review or educational purposes - reproducing the ENTIRE document is forbidden. Here in the Cove, most excerpts we copy and display in posts fall under the fair use doctrine.

Folks who have the Standard (ISO9001:2000) can look at Section 4.2 Documentation Requirements. particularly look at Note 2 under 4.2.1 which says
ISO9001:2000 said:
Note 2 The extent of the quality management system documentation can differ from one organization to another due to
a) the size of the organization and type of activities
b) the complexity of processes and their interactions, and
c) the competence of the personnel.
Note 3 The documentation can be in any form or type of medium.
Further, 4.2.4 Control of records, is very short and explicit:
ISO9001:2000 said:
Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system. Records shall remain legible, readily identifiable and retrievable. A documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records.
4.2.3 Control of documents discusses control of documents by saying the organization defines what controls may be needed, not the Standard.

It might be appropriate to discuss two main types of documents briefly.
  1. Plans (of a product, process, or activity (blueprints, Procedures, Work Instructions, etc.)
  2. Records (proof an activity was performed (shipping documents, inspection sheets, time sheets, etc.)
Correspondence may fall in either category (proposal to do something = plan, a complaint about a product = record)

So now,vattony, emgall, Russ, Catherine Lim, Allison, does this make the task easier or harder for you? Most importantly - do you each have a copy of the Standard for reference?
 
Last edited:
A

Allison

#10
Iso9001:2000

Wes Bucey said:
vattony, emgall, Russ, Catherine Lim, Allison:
I fear you are starting on the wrong track by characterizing work instructions and "quality forms" as ISO9001:2000.

One of the primary misinterpretations of the Standard is that there is a "uniform style of documentation."

This is absolutely not true.

Elsewhere in the Cove (use the search feature), we have discussed the concept repeatedly that an organization may have Quality Manuals ranging from "one page" to hundreds of pages and still be within ISO9001:2000 Standards. It is an exactly similar situation for Work instructions and record forms (what you probably mean by "Quality form")

The primary requirement is that the document, if you use one, be useful to your organization. Hence, You could have one work instruction as simple as:
"cover all shipping labels with clear plastic tape to protect them from smearing."

You might have a work instruction as complicated as a 100 page operating manual for a computer-controlled machining center, published by the manufacturer and adopted by your organization as a "work instruction."

Similarly, you could have a "Quality Form" (record) as simple as one line:
"production for Machine 3 was 1,000 pieces, 0 rejects, on July 29, 2004."

Am I making myself clear in that I believe you are erring by trying to be too formulaic in adapting your Quality Management System to ISO9001:2000?

I understand your meaning. I need to establish quality system in my company. I am searching in internet to find templates of quality manual, procedure and work instruction based on ISO9001:2000 to help to set up the system faster. Especially of work instruction, I need some example or template to help me to tailor-make one for my customer services company.
 
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