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
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
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.
It is common in regulated industries, such as medical device manufacturing and airspace to call 2nd-level documents Standard Operating Procedures or SOP. Do these companies have "Non-standard Operating Procedures", so long these titles differentiate them? Since a short name identifies a document, I really cannot justify long-named documents. I preach management system optimization and reduction of waste in all elements of management systems. I invite you too not to make things more difficult than they have to be to deliver the message.
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.
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.
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.
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
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.
It is common in regulated industries, such as medical device manufacturing and airspace to call 2nd-level documents Standard Operating Procedures or SOP. Do these companies have "Non-standard Operating Procedures", so long these titles differentiate them? Since a short name identifies a document, I really cannot justify long-named documents. I preach management system optimization and reduction of waste in all elements of management systems. I invite you too not to make things more difficult than they have to be to deliver the message.
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.
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.
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.
