If one word is (over) used to describe the implementing of an ISO 9001, Quality Management System (QMS), it's "documentation". A lot of peoples' perception is that complying with the ISO standard is all about creating and maintaining documents—lots of documents.
Although the early versions of ISO 9001 were prescriptive in making it necessary for many "documented procedures", the current International Standard doesn't rely so heavily on the need for them, leaving it up to an organization to decide what is necessary to maintain effective control over its business processes. Indeed, the ISO requirements are worded in a manner to allow an organization the freedom to decide how and what requires to be documented.
Somewhere To Bury Your Documents?
In the early years of ISO 9001 implementation, the visual metaphor of a pyramid became common to describe the multiple levels of the Quality Management System's documentation, probably because the early ISO 9001 requirements referred to procedures in nearly every section and, in one, the need for work instructions (..."where the lack would adversely affect quality").
As a result, and somewhat in line with the "Say what you do, Do what you say" mantra, many organizations chose this format (or something similar) for its Quality Management System structure:
Although the early versions of ISO 9001 were prescriptive in making it necessary for many "documented procedures", the current International Standard doesn't rely so heavily on the need for them, leaving it up to an organization to decide what is necessary to maintain effective control over its business processes. Indeed, the ISO requirements are worded in a manner to allow an organization the freedom to decide how and what requires to be documented.
Somewhere To Bury Your Documents?
In the early years of ISO 9001 implementation, the visual metaphor of a pyramid became common to describe the multiple levels of the Quality Management System's documentation, probably because the early ISO 9001 requirements referred to procedures in nearly every section and, in one, the need for work instructions (..."where the lack would adversely affect quality").
As a result, and somewhat in line with the "Say what you do, Do what you say" mantra, many organizations chose this format (or something similar) for its Quality Management System structure:
Level 1 - Quality Policy Manual
Level 2 - Quality Operating Procedures
Level 3 - Quality Work Instructions
Level 4 - Quality Forms/Quality Records
A feature of this hierarchical approach is that the amount of detail in the documents becomes greater, from the top of the pyramid to the bottom. That is to say, the policy manual says very little about the details of the processes of the organization, the procedures say what is done within a process and work instructions describe how the process is performed at a task level. As a result, the value of some of the documents is lost. Take for example the Quality Manual. Typically, the Quality Manual is a regurgitation of the ISO 9001 document, with key words changed to make it look more like the organization actually wrote it. Often, the terminology from the standard remains substantially unchanged, which is a bit like putting a square peg in a round hole!
Procedures are often written around the requirements of the ISO standard or a department, rather than describing a process, which may require multiple parts of the organization to be involved in. This writing of departmental procedures tends to reinforce the "silo effect" from which organization suffer.
Another aspect of using levels of documentation which really indicates that it's not a good "fit" is the commonly asked question; "Is this document a procedure or a work instruction?" Of course, the reply should be "Does it matter what it's called?"
The pyramid diagram even appeared in the (now obsolete) North American Automobile Industry's Supplier Quality Requirements document, known as "QS-9000", which was based on ISO 9001:1994 and, as a result, tended to add the endorsement of the "Big 3" automakers to such an approach.
Happily, ISO 9001:2000 was a major departure from the emphasis on documents and shifted away from each requirement stating a documented procedure was required, to requiring just 6 procedures—leaving the implementing organization to determine what others might be needed, if any. Emphasis is placed, instead, on having defined processes which opened up lots of opportunities to think "outside the pyramid" (so to speak) and completely revisit the whole role that documentation plays in a Quality Management System.
It's also unfortunate that many organizations - who previously implemented the procedure-heavy ISO 9001:1994 requirements—simply re-numbered their documented Quality System to align with ISO 9001:2000. In doing so, they missed a great opportunity to change the 'architecture' of the Quality System and relieve themselves of the constraints the pyramid places on them. Instead of maintaining a bureaucracy, the documentation could have been revamped into something which better represents the needs of the organization.
Beauty Is In the Eye of the Beholder
Good (product) design is a rare thing. It blends many requirements, including style, usability, performance to name just three. Consider great designs like the Fender Stratocaster guitar, original Morris 'Mini' car, Sony Walkman, Apple iPod and so on.
If the Quality Management System is considered to be somewhat similar to a product design, using a pyramid for the basis doesn't make much sense! Each organization has different needs for it's QMS and using such a "cookie cutter" can't provide for them. After all, the manner in which an organization operates is generally along its processes which:
- Add value to the Customer, in transforming materials, information etc. into what they need
- Add value to the organization, in supporting those processes needed to satisfy the customers' needs.
A clue is found in the ISO 9001 requirements for the QMS, namely 4.2.1 which states (in part) that the organization should determine the "sequence and interaction of the processes" of the QMS. By choosing to map the business processes, it can be decided what documents are needed to define the inputs, process controls and outputs for the various processes. An ISO Guidance document was created to give assistance.
A form, previously called a "level 4" document, may be completed as the input to a process which may have been created as a "level 2" document. The output of the process may be the same form, with more information added - an approval for example. No "level 3" document may have been needed by the person completing the process, because of their competence in the tasks. This vitally important influencer of documents was, previously, not considered. It may also be that to complete a process, a checklist—which might have been a "level 3" document or "work instruction"—is used to describe the various steps of a process and is completed (checked off and information recorded on it) as the process is performed. Now, we can understand peoples' confusion with how to pigeon-hole documents by level.
By approaching the task of documentation based on the needs of the organization and its processes, it's not the level in some arbitrary hierarchy that's important, but the use of the document in ensuring effective process control and (QMS) performance.
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