Does this Process need an established Documented Procedure?

Z

zerodefectss

Hi! Every body!
We know there are only six necessary requirements for documented procedure in ISO 9001 :2008 standard. And the extent of the QMS documentation can differ from one organization to another due to: the size of the company;the complexity of process and product; the capability of personnel.

Many years ago,I learned ISO 9001:1994 standards,I know it has twenty documented procedures requirements, however,you know that there are the six documentation requirements in ISO 9001:2000, so it give us more creating space, it has a better flexibility.

Of cause,we can reduce documented procedure to a excllent organization(for manufacturing not service),even reduce until six documented procedure from twenty when ISO 9001:2000 release.

So, my quesion is that we can reduce documented procedure requirements to the manufacturing industry when ISO9001:2000 or 2008 released or not reduce.

I found one question that there are many peoples has much complaints to ISO 9001:94 documentation requirements.A colleague of mine cry byside a pile of system documents. This organization belong to manufacturing industry. Now I have a quesion, to this organization, its product and equipments and personnels keep the same,it can reduce documented procedure or not after ISO9001:2000 or 2008 release?

Again, one year ago, I found this quesion:the department have a process,related personnel know how to operate this process, and this process has related records, but this process have no a related documented procedure. How to do? Is it nonconformity or not? How to do is better?:)
 

somashekar

Leader
Admin
Re: Do this process need to establish a documented procedure?

It is up to the requirement of an organization to decide what documents are required by its QMS for effective performance.
Not bothering about the 6 or 20 documented procedure, almost all organizations have numerous documented procedures maintained and controlled. As personnel maturity and system maturity improves, organization can review to see if documented procedures can be reduced and just stronger procedures and understanding across the organization are developed., keeping in view the effective QMS operation and maintenance.
 

John Broomfield

Leader
Super Moderator
Re: Do this Process need an established Documented Procedure?

Hi! Every body!
We know there are only six necessary requirements for documented procedure in ISO 9001 :2008 standard. And the extent of the QMS documentation can differ from one organization to another due to: the size of the company;the complexity of process and product; the capability of personnel.

Many years ago,I learned ISO 9001:1994 standards,I know it has twenty documented procedures requirements, however,you know that there are the six documentation requirements in ISO 9001:2000, so it give us more creating space, it has a better flexibility.

Of cause,we can reduce documented procedure to a excllent organization(for manufacturing not service),even reduce until six documented procedure from twenty when ISO 9001:2000 release.

So, my quesion is that we can reduce documented procedure requirements to the manufacturing industry when ISO9001:2000 or 2008 released or not reduce.

I found one question that there are many peoples has much complaints to ISO 9001:94 documentation requirements.A colleague of mine cry byside a pile of system documents. This organization belong to manufacturing industry. Now I have a quesion, to this organization, its product and equipments and personnels keep the same,it can reduce documented procedure or not after ISO9001:2000 or 2008 release?

Again, one year ago, I found this quesion:the department have a process,related personnel know how to operate this process, and this process has related records, but this process have no a related documented procedure. How to do? Is it nonconformity or not? How to do is better?:)

zerodefectss,

Rid your system of unnecessary documentation.

If the process is effectively planned, operated and controlled then the procedure is working whether it is documented or not. If the undocumented procedure is effective then you have no nonconformity.

Some organizations use their management systems to capture and manage knowledge for newcomers to learn from. You may choose to put such documentation into a training manual.

Involve the supervisors and workers in deciding what documents add value and what documents to archive.

John
 

Sidney Vianna

Post Responsibly
Leader
Admin
Re: Do this Process need an established Documented Procedure?

Rid your system of unnecessary documentation.
Indeed. Lean documentation is the way to go.
Some organizations use their management systems to capture and manage knowledge for newcomers to learn from. You may choose to put such documentation into a training manual.
Well said again. Knowledge retention and management is facilitated by appropriate command media.
Involve the supervisors and workers in deciding what documents add value and what documents to archive.
Another good advice, but a word of caution: sometimes people will be against documenting their processes because of "job security" concerns. Some employees are weary of allowing for their "tribal knowledge" to be captured and transmitted for the fear of becoming replaceable.
 
D

dbzman

To document ort not to document, that is the question.

I have long thought that the system itself will tell you if you need a procedure or not. If the process is delivering without problems, (non-conformities, Corrective Actions, etc) and the employee are trained to the process, there is probably no need for a written procedure.

As you system grows and changes the need for procedures may change. The system is dynamic and so are your procedures.


:truce:
 

Stijloor

Leader
Super Moderator
To document ort not to document, that is the question.

I have long thought that the system itself will tell you if you need a procedure or not. If the process is delivering without problems, (non-conformities, Corrective Actions, etc) and the employee are trained to the process, there is probably no need for a written procedure.

As you system grows and changes the need for procedures may change. The system is dynamic and so are your procedures.


:truce:

How about preservation of knowledge? Knowledge, experience, lessons leaned; the most important assets an organization has..

Stijloor.
 

Pancho

wikineer
Super Moderator
Another often-forgotten reason for documenting even working processes is improvement.

Often it is only through small, cumulative tweaks to a process and its documentation that improvements become explicit, significant and internalized.
 
D

db

The answer is found in the standard. Read 4.2.1 d).

The question is: Does this process require documentation? That is, without something in writing, will there be unwanted variation leading to ineffective planning, operation or control of the process? Consider the notes ini 4.2.1 as well. When you combine the two, you can get a much better understanding whether a document is required.

Many times we ask if the standard requires something, when in reality, we should be asking if necessity requires it.
 

jkuil

Quite Involved in Discussions
Here are my thoughts
 

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