ISO 9000 & Quality Management
ISO 9000 was conceived to bring about an improvement in product quality. It was believed that if organizations were able to demonstrate they were operating a quality system that met international standards, customers would gain greater confidence in the quality of products they purchased. It was also believed that by operating in accordance with documented procedures, errors would be reduced and consistency of output ensured. If you find the best way of achieving a result, put in place measures to prevent variation, document it and train others to apply it, it follows that the results produced should be consistently good.
The requirements of the standard were perceived to be a list of things to do to achieve quality. The ISO co-ordinator would often draw up a plan based on the following logic:
1. We have to identify resource requirements so I will write a procedure on identifying resource requirements
2. We have to produce quality plans so I will write a procedure on producing quality plans
3. We have to record contract review so I will write a procedure on recording contract reviews
4. We have to identify design changes so I will write a procedure on identifying design changes
The requirements in the standard were often not expressed as results to be achieved. Requirements for a documented procedure to be established resulted in just that. Invariably the objectives of the procedure were to define something rather than to achieve something. This led to documentation without any clear purpose that related to the achievement of quality. Those producing the documentation were focusing on meeting the standard not on achieving quality.
Those producing the product were focusing on meeting the customer requirement but the two were often out of sync. As quality assurance became synonymous with procedures, so people perceived that they could achieve quality by following procedures. The dominance of procedures to the exclusion of performance is a misunderstanding of the implementers. The standard required a documented system that ensured product met specified requirements -- a clear purpose. Once again the implementers lost sight of the objective. Or was it that they knew the objective but in order to meet it, the culture would have to change and if they could get the badge without doing so, why should they?