"Where shall I begin, please your Majesty?" he asked. "Begin at the beginning," the King said gravely, "and go on till you come to the end: then stop."Never being one to follow good advice, I decided to digress a little first. I use two phrases here and in the things to follow. One is "ISO 9000 standard" and the other is "ISO 9001 standard." The ISO 9000 standard is a group of related standards that cover quality systems for various business models. The ISO 9001 standard is the particular ISO 9000 standard that covers organizations which do design work. It is the one that applies to us. The following section is common to all of the ISO 9000 standards.Lewis Carroll
4.2 Quality System 4.2.1 General
The supplier shall establish, document, and maintain a quality system as a means of ensuring that product conforms to specified requirements.
Starting at the beginning I reread the first sentence. Perhaps my problem with explaining this section was due to my focus on documentation. Consider what the ISO 9001 standard really says. The sequence is "establish, document, and maintain." It's not just document or even "document, establish, and maintain." Establishing a quality system comes first. That system must ensure that whatever we do results in a product that meets the needs of our customers. Documentation is important as we shall see in the coming days but it is secondary to meeting our customer's requirements.
Good order is the foundation of all good things.The supplier shall prepare a quality manual covering the requirements of this American National Standard. The quality manual shall include or make reference to the quality-system procedures and outline the structure of the documentation used in the quality system.Edmund Burke
These sentences are the reason we developed our on-line, quality manual and our on-line, procedure manual. Documentation certainly appears to be the main point of section 4.2. How do we square that with meeting customer needs?
While we focused on completing our quality manual and documenting our procedures, I believe we lost sight of the fact that a quality system is not the quality manual or the quality procedure documentation. Those are important stigmata of any quality system. But, the most important attribute of a quality system is that it should provide the supplier with a system that delivers quality products that satisfy the supplier's customers. It doesn't matter how this is done or if it is documented as long as it is done.
Once a quality system is in place, how the system works can be documented. The belief implied in the whole of the ISO 9000 standard is that this documentation is necessary to provide the BASE upon which improvements can be built. This is the reason for section 4.2 of the ISO 9001 standard: to ensure that we implement the means to maintain and improve upon what we are doing. Once we arrive at the point where we can and have described what we do, we will be in the position to improve what we do.
Set it down to thyself, as well to create good precedents as to follow them.This is the essence of ISO 9000: establishing the conditions that enable continuous improvement. Section 4.1 is concerned with making a commitment to quality. Section 4.2 is concerned with the base supporting the quality system. Other sections of the ISO 9001 standard cover how continuous improvement is accomplished once this base has been established.Francis Bacon
Please look at our quality system documentation again. But, this time look at it from the viewpoint that allows you to see how it should be changed to match what we actually do. Look at it from the viewpoint of how well it communicates essential information - information whose lack would adversely affect our products. Look at it from the viewpoint of what is necessary and sufficient communication; who has the information and who needs it?
Francis Bacon