Control of Mandatory Procedures and Supplementary Procedures

[Brian Hunt]

Hi - this may be a dumb question but I'm in a hurry

Am I right to say that for an ISO9001:2008 compliant QMS, there are six mandaory procdures that have to be documented and observed and twenty one mandatory records that, unless these out of the scope of the QMS, have to be completed to provice evidence that the QMS is operaing.


So for any additional procedures and activities that have to be performed to complete the records (e.g. management review) a procedure does not have to be within the controlled QMS but the associated records have to be consistenly and completely completed - which of course is easier with a procedure to follow?

 

[John Broomfield]

Re: Mandatory procedures and supplementary procedures - control of

Hi - this may be a dumb question but I'm in a hurry

Am I right to say that for an ISO9001:2008 compliant QMS, there are six mandaory procdures that have to be documented and observed and twenty one mandatory records that, unless these out of the scope of the QMS, have to be completed to provice evidence that the QMS is operaing.


So for any additional procedures and activities that have to be performed to complete the records (e.g. management review) a procedure does not have to be within the controlled QMS but the associated records have to be consistenly and completely completed - which of course is easier with a procedure to follow?

Brian,

ISO 9001:2008, clause 4.2.1d specifies the requirement.

Your management system's procedures (beyond the six specified by 4.2.1c) must be documented to the extent necessary for effective planning, operation and control of the processes.

The processes essential to your management system you determined per clause 4.1. If not, you could start by analyzing how the organization works as a system.

The sequence and interaction of the system's processes has to be documented as part of your quality manual. Best to focus the documented parts of the management system on the core process for converting the needs of customers into cash in the bank.

Remember also the very useful concept of the undocumented procedure as clarified by the definition of procedure in ISO 9000.

Your management system should not be in the business of generating records just to conform to a standard. Your management system should be about how you create more successful customers not keep auditors happy.

Best wishes,

John

 

[qusys]

Hi - this may be a dumb question but I'm in a hurry

Am I right to say that for an ISO9001:2008 compliant QMS, there are six mandaory procdures that have to be documented and observed and twenty one mandatory records that, unless these out of the scope of the QMS, have to be completed to provice evidence that the QMS is operaing.


So for any additional procedures and activities that have to be performed to complete the records (e.g. management review) a procedure does not have to be within the controlled QMS but the associated records have to be consistenly and completely completed - which of course is easier with a procedure to follow?

Hi Brian
my suggestion is to check clause 4.2.1 d) and e) of the ISO 9001.
It is ok that you must have at least the six mandatory documented procedures, but take into account that your QMS may require additional documentation that you realize that is necessary for the effectiveness of your QMS.
As to the records, a suggestion could be to make a "find research" in ISO standards and check the word "records". In this case if you cover all the requirements, you are ok, but also in this case you can have additional records that you esteem necessary and you can establish this in the documented records control procedure.
hope this helps

 

[JaneB]

Brian,

No, not quite.

You're thinking too narrowly.
Figure out what procedures, guidenlines/documentation you need to run your business effectively - that's what's meant in clause 4.2.1d.

Then, make sure you have procedures that cover the mandatory areas (not necessarily 6 individual procedures, but must cover the 6 areas). That's in clause 4.2.1c plus repeated in various other relevant sections.

Yes, you must have records wherever it says records shall be... (assuming you do the relevant activity of course!)
Then with this bit you've got it more or less right:

...for any additional procedures and activities that have to be performed to complete the records (e.g. management review) a procedure does not have to be within the controlled QMS but the associated records have to ...

exist.