Required Functions of a QMS
A quality system needs to include tools, processes and resources that enable a company to fulfill quality management requirements. The following are key functions of a QMS:
Ensure that only current documents are used. Changes must be reviewed and approved. Documents and records must be kept for the required length of time.
Corrective and Preventive Action (CAPA) Management:
Actions to identify, resolve and prevent product compliance issues.
Processes for identifying training needs. Includes ensuring that all required staff training is up to date and recorded.
Processes for conducting quality audits. Required to ensure the QMS is effective in the manufacture of safe and compliant products.
A proactive means to identify and control quality issues. Must be part of new product development, design change, manufacturing, CAPA and postmarket oversight.