Basic Documents

Documentation
Plain Language Procedure writing workshop

Midwest provides "boiler-plate" procedures for the required documents, including the manual. During training for small organizations we are able to start customizing these Word documents to reflect what the client does. Classes for larger organizations with PowerPoints do not allow this combination of activities.

ISO and its derivatives (like QS and TS) have been called a paper system. "Write what you do and do what your write" and you will pass. No matter that what you do is stupid, or doesn't work. Six Sigma and Baldrige followers especially deride ISO as inappropriate.
The new ISO 9001:2000 can be called the "show and tell" standard, because the writers specifically removed most of the requirements for paper procedures, and are more interested in what you do. "show me..." they could all be from Missouri, the "show me State."

And when you have shown, the auditor is likely to ask "well, so what?" Meaning what are you going to do about it, how are you goingto improve, where is that aspect of the business going. That's continuous improvement at work.

So within the ISO 9001:2000 you only need 6 documents:

Your Quality manual. This is the promise by your top executive that they will do what the standard says. So where the standard says "the organization shall..." your manual says "My Company does ..." With no procedure you will have to go further and say who in your company, and point to the "how."

4.2.3 Document Control. This procedure details how you control documents, usually with an index or list.
4.2.4 Records. This procedure says how you keep records, and typically contains a list of the records you plan to show your auditor.
8.2.2 Auditing. This details how you plan to run your internal audit system.
8.3 Nonconforming. This procedure says how you identify and record nonconformances, and how you prevent the use of stuff you have identified as nonconforming, your "red tag" system.
8.5 Corrective and preventive action. This could be 2 procedures, bit most people save a tree and do it in one. It details how you plan to operate these systems.

Any other procedures are up to you:

Sometimes it is easier to write something down than have everyone memorize it, such as an organization chart.
Other things are so complex, you have to write them down to remember, this is not frequent. These procedures often become training information.

Other things can be done in many different ways, and so your current agreement of how to do them is best kept in a procedure, like an internal contract.

Finally, sometimes you know you are barely meeting the requirements of the standard, if at all, so you want to put your best foot forward, and show the auditor that you really mean to do it that way. These are defensive procedures.

Midwest provides "boiler-plate" go-bys for your use or for you to ignore. They are minimal, about as short and sweet as you can get and still pass the audit. See 8.2.2 example below

Procedure 8.2.2 Auditing 10/01/03

(Name) manages this procedure for planning and implementing internal quality audits to verify whether quality activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

Planning consists of the following:

This procedure
Annual Audit Schedule
Checklist(s)
Audit announcement immediately prior to an audit activity.
Internal quality audits are scheduled on the basis of the status and importance of the activity to be audited and are carried out by personnel independent of those having direct responsibility for the activity being audited. Independent means not a person's element (if they are a champion), not their own work.

The results of the audits are recorded on the checklist and a formal written audit report (see 4.2.4 Record keeping) and brought to the attention of the personnel (especially management) having responsibility in the area audited. The management personnel responsible for the area shall take timely (as noted on the CAR form) corrective action on nonconformances found during the audit. Corrective action is per procedure 8.5.2 Corrective Action, for nonconformances discovered.

An audit has 4 records:

The announcement
The Checklist (completed completely)
The audit report
Copies of Corrective Action forms issued (typically not completed).
Follow-up audit activities will verify and record the implementation and effectiveness of the corrective action taken by looking at the area covered by a previous nonconformance. This is often documented on a copy of the original C/A form.

Revision: First issue.

Records are maintained in accordance with 4.2.4 Record Keeping

Approved By: __________________________ Date: _______________

End of Document

Writing procedures can be hard, and the written procedures can be incomprehensible. Midwest offers advice, but in larger organizations our "Plain Language Writing" workshop, using a text by T. Murawski can help.