Quality management

We, BQ Plus, endeavour our full passion on the concerning of patient healthy.

Mr. Jack Yang

BQ+ Vice GM & Management Representative

11-year Senior Auditor for TUV Sud

Certificates

ISO13485: 2016

MDD/93/42/EEC

FDA
KGMP
Anvisa

CFDA

Organizational structure

Quality management in phases

Planning

Production

Post-production

Improvement

Traceability

  • Traceability is one of the most important aspect for medical device and our QMS system, not only during the product realization stage, but during the whole device life cycle. For the purpose of protecting patient and avoid unlawfully misuse of the device, we care about and attach great importance to the traceability of our products. Handling of post market surveillance is one of important issue in our quality management system. Traceability ensures us to carry out our PMS system as we originally designed, through which risk can be minimized and patient benefit & customer’s interest are maximized.
  • DHR acts as central part in the whole traceability system during product realize stage. The DHR includes every process record, such as record for raw material inspection, manufacturing record according to planned schedule, process inspection and sterilization batch records etc., which is avaiable at request.
  • UDI system is under developing for the traceability of product during the whole lifetime of the product.
  • Traceability during product realization stage:

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