Design and build includes the structure of the quality management system, the process and its implementation. It’s design must be led by senior managers to suit the needs of the organisation, and this is ideally done using a framework to lead the thinking. Design of the QMS should come from determining the organisation’s core processes and well-defined goals and strategies, and be linked to the needs of one or more stakeholders.
Deployment and implementation is best achieved using process packages, where each core process is broken down into sub-processes, and described by a combination of documentation, education, training, tools, systems and metrics. Electronic deployment via Intranets is increasingly being used.
Control of the QMS will depend on the size and complexity of the organisation. ISO is a site-based system, and local audits and reviews are essential even if these are supplemented by central reviews. Local control, where possible, is effective, and good practice is found where key stakeholders are documented within the process and where the process owner is allowed to control all of the process. Ideally, process owners/operators are involved in writing procedures.
Measurement is carried out to determine the effectiveness and efficiency of each process towards attaining its objectives. It should include the contribution of the QMS to the organisation’s goals; this could be achieved by measuring the following: • Policy definition completeness • Coverage of business • Reflection of policies • Deployment • Usage • Whether staff find the QMS helpful in their work • Speed of change of the QMS • Relevance of QMS architecture to the job in hand
Review of the effectiveness, efficiency and capability of a QMS is vital, and the outcome of these reviews should be communicated to all employees. Reviewing and monitoring should be conducted whether or not improvement activities have achieved their expected outcomes.
Improvement should follow as a result of the review process, with the aim of seeking internal best practice. It is part of the overall improvement activities and an integral part of managing change within the organisation.