ISO 13485
Quality management system certification and documentation support according to approved scope.
- Home
- Product
- About
- Execution Excellence
- Contact
- Blog
Menu
A documented, process-based quality management system for disposable infusion therapy and enteral nutrition products, designed to support global regulatory compliance, stable batch production, validated sterilization, traceable records and continuous improvement.
BQ Plus Medical maintains a quality management system that incorporates applicable requirements from ISO 13485, EU MDR, FDA QMSR, NMPA China GMP, KGMP and EN ISO 11135 for EO sterilization. The system connects regulatory compliance, production control, supplier management, batch traceability, complaint handling and CAPA.
Quality is managed by cross-functional teams covering quality assurance, quality control, laboratory testing, production, R&D, sterilization, purchasing, warehouse/logistics, sales and management review.
Our QA and QC teams support document control, incoming inspection, in-process control, final release, complaint handling, internal audits, regulatory documentation and continuous improvement.
Certificates and regulatory documentation are managed according to issued approvals, certificate scope and applicable product registration requirements. Site and product scope are updated only after formal approval or certification.
Quality management system certification and documentation support according to approved scope.
Controlled certificate scope and supporting quality documentation.
MDR certificate issued by TÜV Rheinland in June 2025. View PDF
Applicable CE documentation support according to certified scope. View PDF
FDA registration, FDA 510(k) cleared products and FDA inspection passed with zero Form 483 observations.
KGMP-related documentation support where applicable.
ANVISA-related documentation support where applicable.
NMPA / China medical device documentation support where applicable.
Certification and product scope are controlled according to formally issued certificates and regulatory approvals. Products or manufacturing sites under extension review are not represented as certified until the approval process is completed.
BQ manages quality through a process-based QMS, from customer requirement review and product realization to production control, batch release, post-market feedback and continuous improvement.
Contract, technical and regulatory requirements are reviewed before order commitment.
Product files and technical documentation support applicable regulatory requirements.
Supplier selection, monitoring and re-evaluation are based on performance, product impact and risk.
Production is performed under documented procedures, qualified infrastructure and monitored process parameters.
Validated EO sterilization parameters and batch records support sterile product control.
Inspection, DHR review and release controls support product conformity before shipment.
Customer feedback, complaints and post-market information are evaluated and trended.
Corrective and preventive actions are reviewed for effectiveness and continuous improvement.
BQ tracks quality and delivery through measurable objectives. These indicators connect quality management with customer experience, production stability and continuous improvement.
Internal QMS target: OTD >=95%. In recent years, BQ has maintained 99%+ on-time delivery from 2023 to 2025.
Final inspection first-pass yield target: >=98%, supporting stable release quality and batch consistency.
Cost of Non-Quality target: <=1%, covering scrap, rework, complaint-related cost, logistics recall or claim-related cost where applicable.
Production and service provision are operated under controlled conditions, including documented procedures, qualified infrastructure, monitoring of process parameters and product characteristics, defined labeling and packaging operations, controlled release and post-delivery activities.
For sterile products, EO sterilization is performed using validated parameters. Sterilization process records are maintained for each sterilization batch and traceable to production batches. EO validation and routine control are managed in accordance with EN ISO 11135.
Traceability and risk control are core requirements in BQ's quality management system. The system supports lot-based identification, controlled product status, DHR records, sterilization records, inspection records, complaint investigation and corrective / preventive action.
Production lot identification, product status control and DHR records support traceability from manufacturing to release.
Risk management is applied throughout product realization and maintained across the product life cycle.
Supplier monitoring, purchasing verification and significant change control are managed according to product impact and risk.
Feedback and complaints are recorded, evaluated and investigated where required, with reporting, PMS, recall and CAPA processes applied as applicable.
For customers looking for a reliable medical device manufacturing partner, BQ Plus Medical combines regulatory documentation, controlled production, validated sterilization, traceable records and continuous improvement.
Contact BQ Plus Medical