Quality Management System (QMS)

A QMS usually includes document control, defined procedures, staff training, supplier checks, inspection and testing, handling of complaints and nonconformities, internal audits and management review. Its core loop is to plan, do, check and act, so that problems lead to fixes and not just repeated rework. Corrective and preventive action (CAPA) is a standard tool. Many sectors have their own rules: medicines and devices follow GMP and device quality regulations, while many manufacturers choose certification to the general ISO 9001 standard. The system is judged by evidence, so records matter as much as procedures. Auditors and regulators ask for proof that what is written is done. When something fails in the field, the QMS records show whether the firm investigated the problem and closed it properly.

A medical device maker is audited by a certification body. The auditor samples three customer complaints and traces each through the system, checking the investigation record, the corrective action and the training of the staff involved. One complaint was closed without a root cause. The auditor raises a finding, and the company reopens the case and updates its procedure.