Documentation Structure for ISO 9001 QMS
August 28th, 2008 by Mark Kaganov
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ISO 9001 documentation structure is outlined in the ISO 10013 Standard - Guidelines for Developing Quality Manuals. This standard recommends using a three-level structure. In practice, many companies use four-level documentation model that includes records. 4-level quality management system is shown below:
Quality Manual - level 1
Procedures - level 2
Instructions - level 3
Records - level 4
While auditing systems like the one above, I always asked clients about the position of their quality policy in this structure. If you start from a quality manual, how go you know what standard this manual should cover? The quality policy defines it and therefore it should be included into the structure:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
ISO 9001 - Naming your documents
Some companies use very “wordy” titles for their documents. One of companies I worked with named their Procurement procedure as “Standard Operating Procedure for Purchasing and Vendor Control.” While extremely descriptive, this title is not efficient.
It is common in regulated industries, such as medical device manufacturing and airspace to call 2nd-level documents Standard Operating Procedures or SOP. Do these companies have “Non-standard Operating Procedures”, so long these titles differentiate them? Since a short name identifies a document, I really cannot justify long-named documents. I preach management system optimization and reduction of waste in all elements of management systems. I invite you too not to make things more difficult than they have to be to deliver the message.
ISO 9001 QMS document numbers
It is not a specific requirement of the ISO 9001 or any other standard to uniquely identify a part or a document. It is perhaps a common-sense measure and a worldwide practice in any documentation system, to give a document or a component a number and a title, and to identify its revision level. As documentation titles, document numbering is an area for creativity and an opportunity for optimization.
One of my clients runs a small company of some 120 employees. Their documentation control procedure prescribed two numeration systems that dependent on the type of a document. QMS documents had numbers like XX-XXX, and production parts required part number format as XXXXXXX-XXX. One of the drawings had a number 000048-002. Folks on the floor called it “four-eight.”
Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer’s system above allowed seven digits and therefore could deal with ten million documents or part numbers. When I worked with this business, they used some 300 documents. If one plans to grow from 200 - 300 documents to a million, one has a long way to go! It is not only how many documents your QMS uses, reading these long strings with five sequential zeros gave everybody headache. Even though this example looks too complicated, “The Worst Part Number” Grand Prize won my other client. They used 14-digit alphanumeric part numbers!
I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or satellites, you, no doubt, will need millions of parts and therefore will need long part numbers. If not, make your life easy and stay away from all those zeros. The most practical system I worked with used a three-digit format for their part numbers. 202, 203, 204, and so on. Worked just fine!
There is another opportunity for improvement of many QMS - part number designation. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few QMS that used designation approaches showed that “no designation” systems are more practical. Several QMS that used designation I have worked with have failed. Not long ago, one of my clients mentioned that they ran out of range in their document numbering format. The QMS initially permitted for identifying suppliers through a two-digit identifier within the part number. While the company grew, the number of supplier increased beyond expectations and eventually the company needed more than 99 suppliers. This resulted in the document number format to being able to support new needs.
There are good news and bad news. The bed news is that designation systems can fail. The good news is that there is another way of dealing with document numbers: no designation at all! Using such systems, you give documents or parts sequential numbers. Going further, isn’t the part title the best identifier of the part? One company I know did not use part numbers at all - their procedures and instructions were simply identified by titles and a two-digit revision level.
