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
ISO 9001 - Naming your documents
Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their quality manual as "Quality Management System Quality Manual." This very descriptive title does define the document, but does not appear to be 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
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.
A company had some 130 employees. They had two part number formats: one for procedures, another for drawings. Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000022-003. Assemblers simplified the system and called it "twenty two."
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!
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. - 16747
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
Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their quality manual as "Quality Management System Quality Manual." This very descriptive title does define the document, but does not appear to be 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
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.
A company had some 130 employees. They had two part number formats: one for procedures, another for drawings. Procedures used XX-XXX number format. Drawings were numbered as XXXXXXX-XXX. One of the drawings had a number 000022-003. Assemblers simplified the system and called it "twenty two."
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!
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. - 16747
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