Rabu, 30 Maret 2011

Documentation Structure For Iso 9001

By: Mark Kaganov


A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 9001 QMS. This model in the standard proposes use of a three-level arrangement. Most companies I worked with utilize four-level structures instead to include records, A typical four-level documentation structure consists of:

Quality Manual - level 1

Procedures - level 2

Instructions - level 3

Records - level 4

Actually, the documentation structure starts from the policy. The policy defines, among others, commitments with what standard 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:

Quality Policy - level 1

Quality Manual - level 2

Procedures - level 3

Instructions - level 4

Records - level 5

Document titles for your ISO 9001 QMS

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.

This tendency to use long titles and document identifiers like "Standard Operating Procedure" most likely comes from regulated industries. Even though I could not find a requirement for such title formats, many companies still use these apparently outdated and ineffective conventions. If a short name sufficiently describes a document, let's use it. I suggest streamlining all elements of management systems. Consider this and do not make your system more complicated than it can be.

ISO 9001 QMS document numbers

In addition to tiles, document numbering systems very often can be optimized too. No standard requires assigning a document its number. This practice is an industry standard. Similar to part titles that we discussed above, document numbering practices often may be simplified too. Look at the example below:

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."

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 250 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 company with 13-digit alphanumeric 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 satellites, 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. 202, 203, 204, and so on. Worked just fine!

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.

To get around this issue, there is a simple solution - a "no designation" system. Part or document numbers in such systems are assigned sequential 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. at all. That documentation system used just document name followed by a revision number, like Process Validation Protocol AB.


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5 komentar:

Anonim mengatakan...

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ISOTemplates mengatakan...

Thanks for sharing information about Documentation Structure for ISO 9001, it was awesome post. ISO 9001 documents includes quality manual, iso procedures, templates and iso audit checklist documents for Quality management system as well as ISO 9001 certification.

Anonim mengatakan...

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Anonim mengatakan...

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