Policy Manual vs Procedure Manual?

L

Lmccrary

I am confused about the documentation requirements. The TS standard reads QMS documentation shall include a quality policy and policy objectives, a quality manual, required documented procedures, addition documents and records.
We are transitioning from QS to TS and I don't know for sure if we have to have a Policy Manual in addition to a procedure manual.
Does 'quality manual' mean policies or procedures?

I know it may seem like an easy question but I would imagine that we all have mental blocks occasionally. Mine has been going on for a couple of weeks now.

This sight has been extremely helpful and I appreciate the wealth of information provided by all the participants.

Thank you.
LMM
 
T

tomvehoski

I know there have been other threads about this subject and opinions vary. I normally use a policy manual that restates the standard and references the procedures for each TS requirement. If you don't have a realted procedure for something, expand on how you do it in the policy manual. I also have a cross reference for each point of TS to the procedure. It is not of much value for day to day operations, but it does prove that all TS requirements have been addressed. Auditors also like it since it helps to tie your documentation to the standard. I also use it to show a customer, in 20 pages, that there is a system in place without having to send all of the procedures if requested.

There is no "correct" format. You can state that your procedures manual is the policy manual, as long as it addresses each "shall". It would still be good to have a cross reference chart to the standard.

My typical format is:

Policy Manual = Standard Restated (about 20 pages)
Procedures = How we do each process (how to handle calibration)
Work Instruction = How to do sub-processes (how to calibrate a micrometer)
Records = Forms, databases, etc.

Quality System = Everything


Tom
 

Mike S.

Happy to be Alive
Trusted Information Resource
FWIW I think Tom stated very well how many folks, me included, handle this documentation issue. It is the basis for the old documentation pyramid with Level 1,2,3, and 4 documents. There are likely other ways, but this seems most popular and is easy enough for my simple mind to understand. Take a look at some of the Q manuals posted here for more concrete examples. If this doesn't answer your question, write back!
 
M

Michelle W.

I was under the impression that the policy documents could fall away. The only policy required is the policy statement itself. The standard specifies that the Quality Manual should contain the scope of the QMS, the documented procedures (or reference to them) and a description of the interaction between the processes of the QMS.

If one was to keep all the policy documents then surely the 20 would fall away (based on the old elements) and they would be replaced by just 5??
 
J

Jim Biz

External auditors opinion

Dont focus too much on "Just 5" policy documented procedures

The information ie "shalls" in the newest standard "Completley cover" the information in the older version.... PLUS Customer focus - employee involvement - workplace environment etc... Although only 5 documented procedures are "mandated" in the final wording......

I had this same conversation with an external auditor and in his opinion "In all likleyhood NO company will be able to "Adequatley" prove "effective" implementation with "Just 5 Procedures in place" Unless those procedures are legnthly enough to cover expected management tasks in all of the older 20 elements.
:thedeal:
 
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