Iso Professional
Posted on Wednesday, March 9th, 2011 at 6:29 pm |
| No items matching your keywords were found. |
Iso Professional
Documentation Structure for ISO 13485 QMS by Mark Kaganov..
ISO 10013, Guidelines for Developing Quality Manuals, gives an example of a documentation structure for ISO 13485 quality management systems. While this document suggests using a three-level structure, most organizations implement four-level documentation structures to include quality records, as required by element 4.2.4 Control of quality records of the ISO 13485 Standard. A typical four-level documentation structure includes:
Quality Manual - level 1
Operating 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 business wants to comply with. If you like this idea, your ISO 13485 QMS will contain five levels as in the following list:
QMS Policy - level 1
QMS Manual - level 2
Operating Procedures - level 3
Work Instructions - level 4
QMS Records - level 5
Document titles for your ISO 13485 QMS
As you may have noticed, the titles of the documents in the structure above are quite short. Various medical device manufacturers use different conventions for their document titles. For example, one of my customers titled their quality manual as "Quality Management System Quality Manual."
It is a very typical convention in the medical device manufacturing and other regulated industries to call the second-level documentation Standard Operating Procedures, known as SOPs. Unless one has a level called "Non-standard Operating Procedures," I really do not see a practical or economical reason for long titles like those. As long as the short title conveys the idea and leads a user to the right place, let's use it. I will promote this optimization and reduction of waste approach throughout this publication. Let's not make things more complicated than they practically need to be.
Numbering your ISO 13485 documents
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.
Once I worked with an ISO 13485 certified company of less than 100 people, manufacturing fairly simple implantable devices. Their quality documentation system included a few numeration systems depending on the type of document. One of the procedures had a number 000023-001, which they simply called "twenty three." Drawings were numbered in a format like 987-323-11-02.
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.
An alternative approach to ISO 13485 system part numbering is a "no designation" system. In such a system, 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 a couple of companies that did not use even document numbers. Their documents were simply identified by unique titles and a two-digit revision level, like Quality Manual 01.
If you are working on your ISO 13485 quality management system, and want to avoid common mistakes, check out our ISO 13485 Quality Management ISO 13485 consulting services page.
Article Source: http://www.earticlesonline.com/Article/Documentation-Structure-for-ISO-13485-QMS/533492
ISO professional (home video)