ISO 13485 documentation structure is outlined in the Guidelines for Developing Quality Manuals (ISO 10013 Standard). 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:
Manual – level 1
Procedures – level 2
Works Instructions – level 3
Quality 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 business wants to comply with. If you like this idea, your ISO 13485 QMS will contain five levels as in the following list:
Policy – level 1
Quality Manual – level 2
Operating Procedures – level 3
Instructions – level 4
Quality Records – level 5
Document titles for your ISO 13485 QMS
Companies use various approaches to titling their manuals, procedures, instructions, etc. For example, one of my customers titled their documentation management procedure as “Documentation Management – Document Control Operating Procedure.” This very descriptive title does define the document, but does not appear to be efficient.
Regulated industries, including medical device manufacturers, are known for calling 2nd-level documents Standard Operating Procedures or SOPs. Do these companies have “Non-standard Operating Procedures”, so these long titles differentiate them? Since a short name identifies a document, I really cannot justify long names for 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 13485 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 simplified.
A company had some 75 employees. They had two part number formats: one for procedures, another for drawings. Procedures used AA-NNN number format. Drawings were numbered as NNNN-NNN. One of the drawings had a number 00011-003. Assemblers simplified the system and called it “Eleven.”
Do these long numbers identify documents? Yes, they do! Are they economical? No, they are not! My customer’s system allowed six digits and therefore could deal with one 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 four 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 designing or constructing a top-end X-ray machine, a jet fighter or a satellite, you will need millions of parts and procedures, so a long part number format would be needed and will make business sense. Otherwise, save yourself the trouble of writing all those zeros and make your numbering system practical. One of my customers, who won my “The Best Part Number” Grand Prize, numbered their ISO 13485 quality management system documents as 401, 402, 403, and so on. Short and sweet!
There is another opportunity for improvement of many ISO 13485 QMS – part number designation. Many companies relate a document type to the document number. For example, WI-xxxx indicates an instruction, DR-xxxx indicates a drawing, SOP-xxxx indicates a standard operating procedure, etc. My practice with a few ISO 13485 QMS’s 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 identifier 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 to not being able to support new needs.
There are good news and bad news. The bed news is that designation systems can fail. The good news is that there is another way of dealing with document numbers: no designation at all! Using such systems, you give documents or parts just sequential numbers. Going further, isn’t the part title the best identifier of the part? One company I know did not use part numbers at all – their procedures and instructions were simply identified by titles and their revision levels.
Tags: 13485, business, international standards, iso 13485, iso 13485 2003, iso certification, quality assurance, quality management, Small Business