How do you decide what is a Process, a Procedure or Work Instruction?

[Pancho]

Just a quick Question regarding the review of procedures, do they need to be periodically reviewed and if so what is the specified period for ISO 9001:2008

Thanks

Section 4.2.3b of ISO 9001 requires a procedure that defines "the controls needed to review and update as necessary and re-approve documents". The standard doesn't require you to review periodically, but if you deem necessary to do so, then by all means put it in your procedure.

Remember that every time someone consults a procedure they are reviewing it, whether such review is recognized or not. You might want to take advantage of those hopefully numerous reviews to improve your documents by empowering users to modify them. If you do so, then you'd probably need a version tracking control too.

 

[fuzzy]

Just a quick Question regarding the review of procedures, do they need to be periodically reviewed and if so what is the specified period for ISO 9001:2008

Thanks

Listen to Pancho. He's got it down.

 

[AndyN]

Just a quick Question regarding the review of procedures, do they need to be periodically reviewed and if so what is the specified period for ISO 9001:2008

Thanks

If you have a copy of ISO 9001, you have the answers...

 

[ari septiyanto]

good morning all,

i need your help, it's related to difinition between Regulation, Procedure and Work Instruction. I need definition more deeply both of there.
before, i have done to define definition but according to document controller representative department, it's still not clear and dificult to understand to classify document that was they issued. they say, is it regultion, procedure or work instruction category?
I need help to clearly and deeply definition between Regulation, Procedure and Work Instruction.
Help me please,,,

 

[Pancho]

good morning all,

i need your help, it's related to difinition between Regulation, Procedure and Work Instruction. I need definition more deeply both of there.
before, i have done to define definition but according to document controller representative department, it's still not clear and dificult to understand to classify document that was they issued. they say, is it regultion, procedure or work instruction category?
I need help to clearly and deeply definition between Regulation, Procedure and Work Instruction.
Help me please,,,

If you are using ISO 9001, then, per its own section 3, your first source for definitions is ISO 9000. Of the three terms you need definition for, only "procedure" is explicit there (sec 3.4.5) "specified way to carry out an activity or a process". But work instruction is implicitly defined as another document similar to a procedure that "provide information about how to perform activities and processes consistently" (sec. 2.7.2e).

"Regulation" is not defined in ISO 9000, but it is used in its sec 2.2 with its dictionary meaning of "a rule or directive made and maintained by an authority", and obviously referring to external regulation. Of course, you could have internal regulation in your organization, and any rule or directive you issue could be called that.

So you can see that there are no walls between the definitions. For any one document, call it what feels good. If later you change your mind, change the document category. Trying to come up with strict categorization is just busywork.

 

[Jody1]

Generally I use the term Regulatory for any requirements that are essentially Lawful and determined by government not businesses.

Additionally there are government guidelines which are not regulatory in most cases.

In summary we have Procedures/work instructions etc within the organisation and legistive regulations that affect those from an external source.

Agree with above post for definitions and the ability to use regs internally if required, just not sure why you would want to.

Jody

 

[Cindy China]

As I understand that procedure is the same with process.Process is for the Managements to manage a department/a function...Work Instruction is for a single position/small function.However, there is no clear defination of these two document.And I also have a question: what's the purpose to separate these 2 document?Thank you.

 

[harry]

As I understand that procedure is the same with process. .......................

No, they are not. Please refer to ISO 9000 for clarification.

3.4.5
procedure
specified way to carry out an activity or a process (3.4.1)

3.4.1
process
set of interrelated or interacting activities which transforms inputs into outputs

Substituting 3.4.1 into 3.4.5,
procedure is a specified way to carry out an activity or a set of interrelated or interacting activities which transforms inputs into outputs

 

[ari septiyanto]

But work instruction is implicitly defined as another document similar to a procedure that "provide information about how to perform activities and processes consistently" (sec. 2.7.2e).

"Regulation" is not defined in ISO 9000, but it is used in its sec 2.2 with its dictionary meaning of "a rule or directive made and maintained by an authority", and obviously referring to external regulation. Of course, you could have internal regulation in your organization, and any rule or directive you issue could be called that.

Dear Mrr. Pancho,
thanks for your explanation, its very usefull to me.
if I can ask to you again, I don't understand for sec 2.7.2e and sec 2.2, where I can find it? where did that rule?
TQVM

 

[Pancho]

Dear Mrr. Pancho,
thanks for your explanation, its very usefull to me.
if I can ask to you again, I don't understand for sec 2.7.2e and sec 2.2, where I can find it? where did that rule?
TQVM

Those are section numbers from the ISO 9000 document.