Documentation Structure for ISO 13485 QMS

Documentation Structure for ISO 13485 QMS

A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 13485 QMS. The model in the standard proposes use of a 3-level arrangement. Most companies I worked with utilize four-level structures to include records, A typical 4-level documentation structure consists of:

QMS Manual – level 1

ISO 13485 Procedures – level 2

Works Instructions – level 3

Records – level 4

Actually, the documentation structure for a medical device manufacturer starts from the policy. The policy, among others, defines the standard or standards 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:

QMS Policy – level 1

Quality Manual – level 2

ISO 13485 Procedures – level 3

Instructions – level 4

QMS Records – level 5

Document titles for your ISO 13485 QMS

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.

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.

Numbering your ISO 13485 documents

It is not a specific requirement of the ISO 13485 or any other standard to uniquely identify a part or a document. It is 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 long documentation titles that we discussed earlier, document numbering formats very often are also an opportunity for optimization.

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!

I hope it is clear that only when extensive part numbers are justified, we do not have other options. If you build helicopters or space probes, 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. 502, 503, 204, and so on. Worked just fine!

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.

To get around this issue, there is a simple solution – a “no designation” system. Document numbers in such systems are simply assigned 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’s at all. That documentation system used just document names followed by their revision numbers, like Process Validation Protocol AB.

If you are working on your ISO 13485 quality management system, and want to avoid common mistakes, check out our ISO 13485 Quality Assurance consulting services.