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
Interestingly, how are we going to start our quality manual without knowing what standard this manual is for? The quality policy supposes to define it. The policy defines what standard or standards, a company wants to comply with. If you like this idea, your QMS will contain five levels as in the following list:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
ISO 9001 - Naming your documents
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."
It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documentation Standard Operating Procedures, known as SOPs. Unless one has a level called "Non-standard Operating Procedures," I really do not see a practical or economical reason for long titles like these. As long as the short name conveys the idea and leads us to the right place, let's use it. I will promote this optimization and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
Numbering your documents
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.
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 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!
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. - 15431
Quality Manual - level 1
Procedures - level 2
Instructions - level 3
Records - level 4
Interestingly, how are we going to start our quality manual without knowing what standard this manual is for? The quality policy supposes to define it. The policy defines what standard or standards, a company wants to comply with. If you like this idea, your QMS will contain five levels as in the following list:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
ISO 9001 - Naming your documents
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."
It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documentation Standard Operating Procedures, known as SOPs. Unless one has a level called "Non-standard Operating Procedures," I really do not see a practical or economical reason for long titles like these. As long as the short name conveys the idea and leads us to the right place, let's use it. I will promote this optimization and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
Numbering your documents
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.
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 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!
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. - 15431
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