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
Actually, the documentation structure starts from the policy. The policy defines, among others, commitments with what standard a company intends to comply with. If you choose to use this approach, your quality management system will have five levels, similar to the structure below:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
ISO 9001 - 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 Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions.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 - document No's
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."
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 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!
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. - 15465
Quality Manual - level 1
Procedures - level 2
Instructions - level 3
Records - level 4
Actually, the documentation structure starts from the policy. The policy defines, among others, commitments with what standard a company intends to comply with. If you choose to use this approach, your quality management system will have five levels, similar to the structure below:
Quality Policy - level 1
Quality Manual - level 2
Procedures - level 3
Instructions - level 4
Records - level 5
ISO 9001 - 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 - document No's
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."
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 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!
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. - 15465
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