THG Formulations

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:

Manual – level 1

Procedures – level 2

Instructions – level 3

QMS Records – level 4

While auditing systems like the one above, I always asked clients about the position of their quality policy in this structure. If you start from a quality manual, how would you know what standard this manual should cover? The quality policy defines it and therefore it should be included into the structure:

Policy – level 1

Manual – level 2

ISO 13485 Procedures – level 3

Instructions – level 4

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.

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 XXXXXX-XXX. One of the drawings had a number 000076-003. Folks on the floor called it “seventy six.”

One can certainly use these long-long numbers, but is it practical? So far I did not meet a single company that could justify such an approach. When I audited this client, the organization had less than 200 documents. There were no indications that the company will significantly grow. Therefore, to use document number format allowing hundreds of thousands of numbers could hardly be justified. The most unreadable part numbers I had to deal with was at a mid size medical device manufacturer with–digit alpha-numeric part number format! Try to write those in your audit report!

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!

Another debatable issue with the part-numbering is part number designation. Some management systems associate a part number with a particular part type. For example, 20-xxx indicates a procedure, 30-xxx indicates a drawing, P-xxx 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 of my clients’ systems that used designation failed. Just recently, one of my customers reported that they ran out of range in their part-numbering format. The documentation 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, company’s needs changed over time, and just a few years later, the quality management system needed more than 99 materials causing the existing part number format to fail.

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 Management consulting services.