Procedures Required by ISO 9001:2008

[TXSUN]

Hi,

I found this info under a very old post about 9001:2000. Can someone please tell me if these are still valid for 2008?

Note: there are only six "required" procedures:

* Document Control (clause 5.5.6)?
* Control of Quality Records (clause 5.5.7)?
* Internal Audit (clause 8.2.2)?
* Control of Nonconformity (clause 8.3)?
* Corrective Action (clause 8.5.2)?
* Preventive Action (clause 8.5.3)?

If/as appropriate, procedures may also be "needed" for:

* Planning (5.4, 7.1, 8.1, 8.5.1)
* Communications (5.5.4)
* Management Review (5.6)
* Resource Management (6)
* Training (6.2.2)
* Customer Processes (7.2)
* Design and Development (7.3)
* Purchasing(7.4)
* Operations Control (7.5.1)
* Product ID/Traceability ( 7.5.2)
* Customer Property (7.5.3)
* Preservation of Product (7.5.4)
* Validation of Processes (7.5.5)
* Process Measurement/Monitoring (8.2.3)
* Product Measurement/Monitoring (8.2.4)
* Analysis/ Improvement (8.4, 8.5)

Thanks!
Deb

 

[Jim Wynne]

Re: ISO 9001:2008 Required Procedures

Welcome to the Cove.

There were no substantive changes in the 2008 version, so the documentation requirements are the same. In addition to the six you cite, 4.2.1 says that you must also have "... documents, including records, determined by the organization to be necessary to ensure the effective planning, operation and control of its processes."

 

[TXSUN]

Re: ISO 9001:2008 Required Procedures

THANK YOU!

One more area of clarification, please. I am learning to administrate our ISO program and find that we have no procedures except those that are in a PRM.

What is the difference between a PRM and a procedure? Since we are starting to write procedures, should I take them out of the PRM and instead reference the COPs and SOPs that we have on our server in the PRM?

Should these procedures be printed and put inside a notebook or is having them electronic enough?

This forum is INCREDIBLE!!!!

Thanks again!
Deb

 

[Jim Wynne]

Re: ISO 9001:2008 Required Procedures

THANK YOU!

One more area of clarification, please. I am learning to administrate our ISO program and find that we have no procedures except those that are in a PRM.

What is the difference between a PRM and a procedure? Since we are starting to write procedures, should I take them out of the PRM and instead reference the COPs and SOPs that we have on our server in the PRM?

What's a PRM?

Should these procedures be printed and put inside a notebook or is having them electronic enough?

So long as the requirements for document control are satisfied, the medium is a matter of choice.

 

[JJ777]

Re: ISO 9001:2008 Required Procedures

In addition to your ISO procedures that is needed list your processes and from your processes create procedures that will support your processes.

 

[TXSUN]

Re: ISO 9001:2008 Required Procedures

Thank you!

 

[AndyN]

Re: ISO 9001:2008 Required Procedures

In addition to your ISO procedures that is needed list your processes and from your processes create procedures that will support your processes.

Why do you think that it's necessary for a procedure for a process? Why, for example, can't a process be defined verbally? Or maybe a form used to check off and record the various steps through the process?

Just interested in the discussion as to why...

 

[JJ777]

Re: ISO 9001:2008 Required Procedures

To list the processes will meet the requirements of 4.2.2.c. this is how I interpret the standard. The procedures will just make it easier to understand the process.

 

[Jim Wynne]

Re: ISO 9001:2008 Required Procedures

To list the processes will meet the requirements of 4.2.2.c. this is how I interpret the standard. The procedures will just make it easier to understand the process.

Listing the processes doesn't explain their interactions.

 

[TXSUN]

Re: ISO 9001:2008 Required Procedures

Hi,

Thanks for the reply. We have a client who is buying an FDA device from us that prefers written procedures for certain processes. At first it seemed like a lot of work, but we are finding as we define them it makes training easier, etc.

We are using check-box forms also.

I appreciate you asking about this.