7.5 - Production and Service Provision

[Jamie]

Hello everyone! I hope I'm doing this right. I've read through the forum for a few days before finally deciding to join. It appears to be a very very useful sight!

I do have a question in regards to 7.5. Do you have to have a procedure for this? I'm afraid I don't quite understand this clause. It seems to touch on so many other things like....Document Control, Control of monitoring and measuring equipment, Preservation of Product. I'm really at a loss on this one.

Any input would be greatly appreciated.

Thanks for having me!
Jamie

 

[E Wall]

Welcome Jamie

Glad you joined the Cove!

It would help if you provided a little background so we can provide the best 'level' of response for you. Does the company you work for currently hold an ISO 9001/2/3 1994 Certification? Are you new to the system or familiar with it? When you ask for a procedure...what level document reference are you aiming for?

7.5 does touch many areas. It addresses subjects that previously were scattered throughout the 1994 version (4.7, 4.8, 4.9, 4.10.5, 4.12, 4.15.2/3/4/5/6, and 4.19). Throughout the y2k version there are interactions between clauses (outputs of some are inputs for others) so it is beneficial to identify what those interactions are in order to best set up your system.

We have our next surveillance audit to the 1994 version in Jan '02. After that we are "Drawing a line in the sand" and moving forward with the transition so I am not as prepared as I'd like to be to provide documentation at this point (what I do have are goals and expectations).

Maybe some of the others can provide more specific guidance. You might also use the search tool (if you haven't already) to see if there has been other discussion on this clause.

 

[Greg Maggard]

Hello,
I have a couple of work instructions from some of the plants that I have worked in for examples. These are based from 4.7 and involve supplier and customer as well as internal I can e-mail them to you.

 

[Jamie]

Hi Eileen! Thanks for the response.

I work for a manufacturing company that has about 32 employees. We are not currently certified, however; we did have a system in place set up to the 1994 version of the standard. I was placed over our quality system back in June or July. It was my decision to start the new system from scratch for the 2000 version. The old system was way to overdocumented and covered the same process in 3 or 4 different procedures or work instructions.

In regards to 7.5, the standard doesn't state you "have" to have a procedure for this. I'm concerned because...I had my "quality manual draft" reviewed. In his notes by what I had documented for 7.5.1 and 7.5.2 he asked who does what and when unless there is a procedure for it.

7.5.1, I have documented in different ways
7.5.1 A) through Document Control
7.5.1 B) Document Control again and so on. I guess what I'm confused with is do I have to create another procedure to cover this same stuff? Do I need to reference all these procedures under 7.5.1 in my Quality Manual? The same problem with 7.5.2.

 

[Jamie]

Greg,

I'd appreciate that. It would be of great help.

Thanks.

 

[HFowler]

Jamie,

The ISO 9001:2000 Standard does not mention a requirement for a documented procedure for clause 7.5 or any of its subclauses. However, in order to make sure that relevant people in the organization understand these requirements, you might want to consider some form of documentation or at least training.

I've chosen to use a flowchart only for 7.5.3 Identification and Traceability for our organization here.

Best Regards,
Hank Fowler