We passed ISO13485 system certificate, and own CE certification for many products.
In terms of quality control, it includs multiple aspects, such as:
1. Regular maintainance of production equipment, as well as good records
2. Annual verification of key equipment
3. The raw material inspection records are classified and archived according to category, semi-finished and finished product inspection records are archived according to product items and batches, and the production records are archived accordingly
4. Purchase: Review and evaluate suppliers, conduct on-site audits when necessary, and sign a quality agreement with the suppliers after passing the audit to clarify the quality responsibilities of both parties
5. Sales: establish product sales records for traceability
6. Carry out management review annually.