Procedure binding even if not required by the standard - Where's the requirement?

[W. de Jong]

As i far as i see it there are more roads that lead to Rome (as far as this is a correct translation) but you get the point. As always there are different views, the real answer lies somewhere in the middle.
But no need to get hostile guys! Relax

 

[Douglas E. Purdy]

Hello All:

I disagree with Randy. 4.2.1d and 4.2.3 only describe requirements for having documents and controlling them. These requirements do not say you have to follow them.

I started a thread about this a long time ago. I asked, where in ISO 9001 is there a requirement that procedures have to be followed?

I never learned the answer. I did receive many replys from "tell the employee to follow it or be fired" to response that indicated the question was without merit.

I started the thread becasue I thought it was interesting that ISO 9001 does not have an overt clasue that states something like all documented processes must be followed.

I think mirrorcrax has raised a worthy question.

I agree with Mirrorcrax. I think the 4.1 f) is as close as we will get to such a requirement.

Regards,

Dirk

I appreciate you giving credence to Mirrorcrax's question, but I am a bit confused. A standard requires that you have documents needed by the organization to ensure the effective planning, operation and control of its processes (4.2.1 d) and you are to conduct internal audits to determine whether the quality management system conforms to the planned arrangements ... (8.2.2 a), but you do not have to comply with the procedures because there is no "Shall" stating that you have to comply with the documents? Am I understanding your position correctly?

Thanks,
Doug

 

[Coury Ferguson]

As i far as i see it there are more roads that lead to Rome (as far as this is a correct translation) but you get the point. As always there are different views, the real answer lies somewhere in the middle.
But no need to get hostile guys! Relax

This is true. But as you can see, there are many positions on this subject, so lets look and the basic interpretations. Sidney from DnV (Well known Registrar), Randy from BsI (A RAB and/or IRCA accredited Auditor for another well known Registrar), and others that have over 15+ years experience in this field (that most likely have been around the bush and been run over by the train), over this discussion.

At anytime, when there are "Shalls" that require procedures or documents, they must be implemented and subject to audit. In addition, anytime a Company develops Procedures (regardless to the minimum of 6 required by ISO9001:2000) they become part of the Business System and therefore, they are required to be followed and are subject to audit. They also become a Legal and binding document.

 

[BadgerMan]

and you are to conduct internal audits to determine whether the quality management system conforms to the planned arrangements ... (8.2.2 a), but you do not have to comply with the procedures because there is no "Shall" stating that you have to comply with the documents? Am I understanding your position correctly?

Thanks,
Doug

8.2.2

a. conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b. is effectively implemented and maintained.

 

[Aaron Lupo]

Let's ask the question, why the he$$ would you take the time to develop and document a procedure/work instruction (or whatever yo wish to call it) if you don't have any intention of following. Do you have that much time on your hands?

 

[Douglas E. Purdy]

8.2.2

a. conforms to the planned arrangements (see 7.1), to the requirements of this International Standard and to the quality management system requirements established by the organization, and

b. is effectively implemented and maintained.

I appreciate your bold emphasis, but does having the document in the system make it a requirement, and who determines that it is effectively implemented and maintained? If you have to have a "Shall" in order to make a requirement that has to be complied with by a party or organization, then what is the purpose for the standard and who can enforce it?

Thanks,
Doug

 

[Jen Kirley]

Let's ask the question, why the he$$ would you take the time to develop and document a procedure/work instruction (or whatever yo wish to call it) if you don't have any intention of following. Do you have that much time on your hands?

This gets right to the heart of the matter, doesn't it?

We make procedures because we feel it's important to do things a certain way each time, and/or to provide guidance for learners, and/or to communicate our methods/controls.

If the procedure is impractical, too hard to use, or wrong, it should be revised. While in the approval process it should be reviewed by various people so as to get feedback on things the author didn't consider, and might edit.

If the procedure is outdated or not needed, obsolete the thing and get to what really matters: providing high value, high quality products and services for internal and external customers.

 

[BadgerMan]

does having the document in the system make it a requirement

Yes, IMO

who determines that it is effectively implemented and maintained

You do.........or a second or third party auditor

 

[Coury Ferguson]

We make procedures because we feel it's important to do things a certain way each time, and/or to provide guidance for learners, and/or to communicate our methods/controls

Jennifer,

I agree with you.

The original post was:

usually organizations have several procedures that exceed ól 9001's requirements with details related to their business, however, which clause do you think says that once a procedure is developed by the organizationit becomes binding even if not required by the standard, i think the closest is 4.1

Jennifer, do you really think that paragraph 4.1 (ISO9001:2000) is where the requirement is? In addition, do you think that even if procedures/work instructions, when written and implemented (even outside of the 6 required) are binding documents?

I think everyone has gotten a little here, even me.

 

[Randy]

To implement means to do...nuff said.

If you disagree get the paperwork (can be obtained from ANSI) and are such a hot shot, join TC176 and start changing what you don't like, or better yet start your own standards producing body and write your own.

However, if you truly believe that procedures that are part of your system documentation are just for eyewash purposes only and you don't have to do them then please don't cry, sling snot and try to appeal to an accreditation body the big fat and nasty NC's that you could potentialy earn from your head up the fanny attitude if you have a system voluntarily subjected to 3rd party audits and registration by accredited organizations.


This is as always my personal opinion