Quality Management System Requirements Process
2 Requirements process 2.1 Overview and process diagram This process links closely with the design and development process and provides essential inputs to it. From a quality viewpoint, it is important that everything we do is based on a clear understanding of what the customer wants, and the other factors that must be taken into account when designing, developing, producing, testing, releasing and supporting our products and services. The key to establishing the requirements for products and services is customer communication, and this takes place in several ways, including pre-sales enquiries, regular contact as part of ongoing service delivery and via more formal methods such as surveys and complaints. From this managed communication, a set of detailed requirements are identified that the products and services must meet if they are to be acceptable to the customer. Other factors are also considered, such as legal and regulatory guidance in order to arrive at a full set of requirements. These requirements are then reviewed to ensure that they can be delivered and that we, as an organization, are not placing ourselves in a situation of unacceptable risk. As part of this, the requirements are confirmed with the customer before design and development commences. Lastly, changes to the requirements, which may occur at any stage, are managed so that their implications are recognised and allowed for. The process of establishing requirements is shown in Figure 1.
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