Hello...
I need some explanation about quality manual and documented manual (procedure). What we practice in our organisation now, we have our own quality manual, which describe all department procedures. But, we also have another file, which include all kind of forms and procedure that we use in our system.
My question is, if we have a complete procedure in Quality Manual, is it a must we need another procedure (flow chart) in the documented file (all the form and procedure) ? It look like 'double entry'.
Another question is, what would happen if, there is no procedure for Department A (as example) in Quality Manual, but it have in the documented file, which clearly expain about the procedures, person in-charge and form/record be used?
Hope to hear a respon from the member. Thank you :)

What standard are you working with?

Accreditation: ISO/IEC 17025, 17020, or 17024

Registration: ISO 9001, TS 16949, or similar

Hershal

Najwa --

When you say that there are documented procedures "separate" from the quality manual, that leads to a question.

Do the procedures and forms get the same (or similar) control as the quality manual? Are they reviewed and approved, and kept up to date?
Are people doing the process according to the documented procedures?
Have they been trained consistently?


If so, then it shouldn't matter a great deal. As long as you have "work instructions, if applicable (ISO 9001:2000, 7.5.1 (b), you are covered
whether these documents are in the quality manual or not.

If one of these conditions is not met, then you may have a concern -- at least, if you are trying to follow ISO 9001 or a similar standard.

On the other hand, if you have 2 different procedures for doing the same
thing, I would be concerned. Sooner or later the 2 procedures may
come in conflict. Then what?

Regards,
Brad

What standard are you working with?

Accreditation: ISO/IEC 17025, 17020, or 17024

Registration: ISO 9001, TS 16949, or similar

Hershal

we are working with ISO 9001:2000

Najwa --

When you say that there are documented procedures "separate" from the quality manual, that leads to a question.

Do the procedures and forms get the same (or similar) control as the quality manual? Are they reviewed and approved, and kept up to date?
Are people doing the process according to the documented procedures?
Have they been trained consistently?


If so, then it shouldn't matter a great deal. As long as you have "work instructions, if applicable (ISO 9001:2000, 7.5.1 (b), you are covered
whether these documents are in the quality manual or not.

If one of these conditions is not met, then you may have a concern -- at least, if you are trying to follow ISO 9001 or a similar standard.

On the other hand, if you have 2 different procedures for doing the same
thing, I would be concerned. Sooner or later the 2 procedures may
come in conflict. Then what?

Regards,
Brad

Yes, all the form and procedure are follow the Quality Manual, and be reviewed and verified, and up to date. The person who use the form will also be trained to fill in.

That mean, it's ok we have one complete procedure in Quality Manual and another one in the documented file. Yes, we have work instruction which we filing in the documented file.

So, it doesn't matter we have a procedure in documented file but not in the Quality Manual, or we have both. And it should not have any conflict between it. Is it right?...

My take is that if the complete (and adequate) process is documented within your Quality Manual, you have technically met the requirements of ISO 9001:2000.

Here is my concern....processes change...thus documentation changes. And frequently, too. By putting all of this detail within your Quality Manual, you run the risk of having to update your Quality Manual frequently and for many of us, that is a rather heavy task to do. I do not know if your organization is the same, Najwa.

Personally, I try to leave the details out of the Quality Manual. If someone wants to know how to do something, like an Internal Audit, she or he can go and find the separate document on it.

For what it's worth, our Quality Manual is at Revision 5....since 1998. Our WI on audits is at revision 10, since 1998.

My take is that if the complete (and adequate) process is documented within your Quality Manual, you have technically met the requirements of ISO 9001:2000.

Here is my concern....processes change...thus documentation changes. And frequently, too. By putting all of this detail within your Quality Manual, you run the risk of having to update your Quality Manual frequently and for many of us, that is a rather heavy task to do. I do not know if your organization is the same, Najwa.

Personally, I try to leave the details out of the Quality Manual. If someone wants to know how to do something, like an Internal Audit, she or he can go and find the separate document on it.

For what it's worth, our Quality Manual is at Revision 5....since 1998. Our WI on audits is at revision 10, since 1998.

Ok, i've got the idea. That means the WI must tally with Quality Manual. And it should be revised if any changes in WI.