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
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 Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions.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 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."
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.
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!
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.
To get around this issue, there is a simple solution - a "no designation" system. Part or document numbers in such systems are assigned sequential unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more. I worked with a company that did not use document No. at all. That documentation system used just document name followed by a revision number, like Process Validation Protocol AB. - 15432
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
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 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."
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.
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!
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.
To get around this issue, there is a simple solution - a "no designation" system. Part or document numbers in such systems are assigned sequential unique numbers. Areas of use, materials, suppliers, and other attributes are not reflected in part numbers. Moving in this direction, you can simplify your system even more. I worked with a company that did not use document No. at all. That documentation system used just document name followed by a revision number, like Process Validation Protocol AB. - 15432
About the Author:
Check our ISO 9001 documentation and order your Quality Management System tempales today!