A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 9001 QMS. This model in the standard proposes use of a three-level arrangement. Most companies I worked with utilize four-level structures instead to include records, A typical four-level documentation structure consists of:

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

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.

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 Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions.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

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.

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.

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!

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!

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.