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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

Document titles for your ISO 9001 QMS

Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their quality manual as “Quality Management System Quality Manual.” This very descriptive title does define the document, but does not appear to be efficient.

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 Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions.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 QMS document numbers

No standard prescribes to give a part or a document its number. It is an industry standard to give a document or a component its name, number and a revision level. Similar to part titles that we discussed above, document numbering conventions are often also may be optimized and simplified.

Once I worked with a company of less than 100 people, manufacturing fairly simple devices. Their documentation system consisted of a few numeration systems depending on the type of document. One of the procedures had a number 0000057-001, which they simply called “fifty seven.” A drawing was numbered 327-856-99-17.

Is it acceptable to have long and difficult-to-read and remember numbers? Yes, of course! Is it practical? I do not believe so! In the example above, the procedure number, without the tab, contained seven digits. This meant that the system was prepared to handle almost 10 million document or part numbers (PN). The company had approximately 250 documents and probably would never go beyond 300. If nothing else, just reading these numbers with five sequential zeros may give one a headache. Surprisingly, this is not the worst case I have experienced! The company that won my “The Worst Part Number” Grand Prize assigned 12 (!) digits to their part numbers in the alphanumeric format.

If you are designing and building a Trident-class submarine, a MIG-27 jet fighter or an international space station, you, most likely, will need millions of parts, so a long part number format would be needed and will make sense. Otherwise, save yourself the trouble of reading all those zeros and make your numbering system practical. One of my customers, who won my “The Best Part Number” Grand Prize, numbered their documents as 101, 102, 103, and so on. Short and sweet!

So far we explored opportunities for improvements in the area of document titles and numbers. Yet, there is another issue with part numbers. Many companies relate a document number to a document type. For example, 20-xxxx indicates a procedure, 30-xxxx indicates a drawing, POP-xxxx indicates a Production 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 extension 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 not being able to support new needs.

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.
About the Author:
If you are working on your ISO 9001 QMS, our documentation set can help your company. Visit Quality Works Website and order your Quality Management System system today! Quality Works provides management system consulting worldwide.
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Stefania - Staff di QualitiAmo

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