1. Quality management systems are designed to produce consistent outcome at consistent cost. A critical component is monitoring of customer needs and desires so the product or service may be changed to accommodate or pre-empt changing customer requirements.
2. It is common for quality management systems to be neglected, with a flurry of activity to bring documentation and supporting evidence up-to-date just before audits. This is not how an ISO 9001 quality management system is supposed to operate.