Technical documentation section 3. Design and manufacturing:
3.3 Description of quality control
The quality control procedures implemented throughout the manufacturing process are designed to ensure that each device consistently meets the predefined specifications and requirements. Quality control forms an integral part of the Quality System and covers incoming materials, in-process checks, and final inspection prior to release.
Incoming materials inspection
All raw materials and components are subject to verification against predefined acceptance criteria upon receipt. Inspection includes visual examination, dimensional checks, and, where applicable, verification of certificates of analysis or conformity. Non-conforming materials are clearly marked and segregated.
In-process controls
Quality control activities during production include defined in-process inspections at critical stages. These inspections verify assembly accuracy, cleanliness, and compliance with process parameters. Any deviations are documented, and appropriate corrective measures are implemented.
Final inspection and testing
Prior to release, each device undergoes final inspection in accordance with the inspection plan. The inspection includes visual checks, functional tests, and labeling verification. Only products that meet all acceptance criteria are released for distribution.
Control of non-conforming product
Non-conforming products identified during any stage of production are documented and quarantined to prevent unintended use. Disposition of such products is determined based on the severity and nature of the non-conformance, and may include rework, scrap, or return to supplier. All actions are recorded in accordance with the QMS procedures.
Documentation and traceability
Quality control records are maintained as part of the Technical Documentation. These records ensure traceability and support compliance with MDR requirements. All quality control activities are subject to regular internal audits to verify continued effectiveness and compliance.
