No Quality Manual, now what?

Andy to that we agree. Results and records provide evidence that supports organizational processes and those we have. I agree that procedures and manuals aren't evidence. For several years now we have focused on the processes and the outcomes of those processes. Measuring these to see how they affect product conformity and the QMS. I am happy to say we a process based QMS that works well for us.

 

Good discussion!

To summarize from these posts, it seems the "merits" people find in establishing and maintaining a Quality Manual is:

1. Provide "context" of organization (organizational overview?), and a "framework" for the QMS (an index & flowchart?)
2. Something to send to customers who request it
3. A training tool for new employees

Am I missing anything? ...if this is the breadth of actual value of the Quality Manual, then it's no wonder the requirement is removed.
(1) Can be summarized in a process flowchart
(2) This depends on the customer-organization arrangement, hardly something that needs to be enforced by the standard
(3) I suspect that its "usefulness" as a training tool is eclipsed by actual job-specific, procedure-specific training

For most organizations: business as usual. I'm sure there are examples of well-written Quality Manuals out there, but I've yet to be convinced of the additional value that would warrant encouraging companies to maintain such a document.

Until such a case can be made, I'm in the "good riddance" camp.

MM

 

The degree to which the relevance is determined is the first risk based thinking ~~~

 

Organizations itself may decide to have comprehensive QM of tens pages covering all chapters of the Standard. Like the case is with the present QM most of which are excessive in terms of 4.2.2 though they could be of 3 pages. I audited organizations with such brief QM in conformity with the Standard. which were well understood by employees.

 

I started with the SWOT Analysis using the sticky pad. Now I actually have information to build the Context of the Organization. We revisit this SWOT when we develop the Risk analysis of the QMS. The highest risk are the Threats and Weaknesses and we put Opportunities for improvement action plan. I do not know how it will go but it would be a very nice piece of story during the external audit because we will put our Top Management on the spot. He is OK with it. No more delegation-just hands on commitment to QMS.

 

Yes, from the SWOT we all identified the internal and external interested parties and determined who is relevant and not relevant. Form that we have developed the scope.