![]() |
4.2. Quality System |
![]() |
4.2.1. GeneralThe intention of this element is to ensure that you define, document, and maintain your quality system in a way that results in satisfaction of your customers expectations. This means that you must have a manual that incorporates the ISO 9000 standard and also references the procedures that you are using to meet the standard. In summary, the standard states that:
4.2.2. Quality system proceduresYou must prepare documented and controlled procedures that meet the ISO 9000 and any other relevant requirements. For example, if you are telling your customers that you are meeting Military standards, then your procedures and manual should reflect it. It goes without saying that your actual practices should meet your defined procedures. But, how much do you have to document? There is no easy answer. It is a balance between the dependence of the task on quality and the complexity and the level of recorded training that you have provided beforehand. An excellent training program can significantly reduce your procedural load. To adequately address this clause:
4.2.3. Quality planningThe establishment of a documented quality plan is a required element. The good news is that it can look any way that you want it to look, and in most cases all you need to do is reference your procedures that you have in place. You might also consider going a step further and define your quality plan via a relationship diagram - group of boxes (functions) that connect to other boxes, with descriptions of the relationship. This diagram should reference where your quality plans come from, where your in-process controls are established, inspection equipment is defined, where production resources and training are determined, where design review is developed as well as the test procedures, who establishes the quality control techniques, points of inspection, measures required for process capabilities, test and verification. The plan needs to address who will be responsible for the clarification of the standards for acceptance as well as how records are generated, their contents, and how they are kept. In your quality planning effort:
|
![]() |