Your ISO 9001 Quality Management System documentation
ISO 10013, Guidelines for Developing Quality Manuals, gives an example of a documentation structure for ISO 9001 quality management systems. While this document suggests using a three-level structure, most companies implement four-level documentation structures to include records, as required by element 4.2.4 Control of quality records, of the ISO 9001:2000 Standard. A typical four-level documentation structure includes:
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
Document titles for your ISO 9001 QMS
As you may have noticed, the titles of the documents in the structure above are quite short. Various companies use different conventions for their document titles. For example, one of my customers titled their quality manual as “Quality Management System Quality Manual.”
This tendency to use long titles and document identifiers like “Standard Operating Procedure” most likely comes from regulated industries. Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions. If a short name sufficiently describes a document, let’s use it. I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be.
ISO 9001 - document No’s
In addition to tiles, document numbering systems very often can be optimized too. No standard requires assigning a document its number. This practice is an industry standard. Similar to part titles that we discussed above, document numbering practices often may be simplified too. Look at the example below:
A company had some 130 employees. They had two part number formats: one for procedures, another for drawings. Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000022-003. Assemblers simplified the system and called it “twenty two.”
One can certainly use these long-long numbers, but is it practical? So far I did not meet a single company that could justify such an approach. When I audited this client, the organization had less than 250 documents. There were no indications that the company will significantly grow. Therefore, to use document number format allowing hundreds of thousands of numbers could hardly be justified. The most unreadable part numbers I had to deal with was at a mid size company with 13-digit alphanumeric part number format! Try to write those in your audit report!
If you are developing or optimizing your ISO 9001 quality management system, consider a simple rule: “The shorter - the better”. If you are constructing a hydro electric plant or building an aircraft carrier, you will need millions of parts. To number this kind of inventory, one will definitely need long numbers. If not, think optimization. Once I audited a company that numbered their documents 303. 304, 305, etc. They deserve applauds!
Another debatable issue with the part-numbering format is part number designation. Some systems associate a part number with a particular part type. For example, 10xxx indicates a procedure, 20xxx indicates a drawing, PLxxx indicates a policy-level document, and so on. My experience with a number of medical device manufacturers has convinced me in the benefits of a “no designation” system. Three systems that used designation I have worked with have failed. Just recently, one of my customers reported that they ran out of range in their part-numbering format. The system allowed for assigning materials through a two-digit designator within the part number. When the system was designed a few years ago, needing more than 99 materials was not considered possible. Unfortunately, things changed, and just a few years later, the company needed more than 99 materials causing the existing part number format to fail.
An alternative approach to part numbering is a “no designation” system, where parts are given sequential unique numbers within a specified format, regardless of their type, material, application or other attributes. After all, isn’t the part title the best designator? Seriously, through my entire professional career, I worked only with one company that did not use even document numbers. Their documents were simply identified by titles and a two-digit revision level, like The Prefect Manual 01.
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