1.2 - Quality Management - What the organisation does to measure and control quality of processes, documentation and outputs. Quality management reporting is continual but may be triggered by a scheduled event (such as governance meeting). Internal audits will be triggered according to a policy or an issue or change. Supplier management and monitoring will be continual but may also be triggered by a change or addition of a supplier. The issue process will be triggered by an adverse event, incident or audit outcome. Document and SOP and Asset management are continually running. Quality management data is crucial to understanding whether the organisation is operating as intended. The quality manager role is responsible for keeping the TRE operating within risk tolerance with an internal auditor assessing the effectiveness of the TRE through the internal audit processes. Measurement is a key element to quality management all processes across the TRE will generate data, those data must be trusted, retained and be made available to the quality manager and internal auditor during an audit. Documentation is a key control across the TRE for example, policies, SoPs, work instructions and contracts. Control of these documents is critical to the operation of the TRE and maintaining quality. Quality management processes and data can be extremely complex and the ability to collate, measure, report and track data across many processes can be daunting. The implementation of an electronic quality management system that tracks all the processes within the capability and draws data from multiple sources for alerting and reporting purposes can reduce the overhead of maintaining the quality management system.