Quality Management
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.
Built for Medical Device Compliance and Reliable Delivery
BQ Plus Medical maintains a quality management system that incorporates applicable requirements from ISO 13485, EU MDR, FDA QMSR, KGMP and EN ISO 11135 for EO sterilization. The system connects regulatory compliance, production control, supplier management, batch traceability, complaint handling and CAPA.
QA and QC Teams Supporting Daily Quality Control
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.
- Quality Assurance and regulatory system control
- Quality Control, laboratory and inspection activities
- Batch release and traceability support
- Complaint investigation and CAPA follow-up
Certificates and Regulatory Documentation
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.
ISO 13485
ISO 13485:2016 quality management system certificate SX 2087599-1, issued by TÜV Rheinland LGA Products GmbH in August 2026.
ISO 13485 Scope
Certified scope and manufacturing-site coverage are controlled according to the formally issued ISO 13485 certificate and attachment.
EU MDR
EU MDR Quality Management System certificate HZ 2087599-1 under Regulation (EU) 2017/745, Annex IX Chapters I and III, issued by TÜV Rheinland LGA Products GmbH in August 2026 and valid until June 2, 2030.
EU MDR Scope
MDR certificate scope covers selected medical device product categories according to the issued certificate attachment. Contact BQ for product-specific regulatory status and documentation support.
ISO 13485 – Suzhou EO Sterilization
Certificate SX 2445082-1 covers the provision of ethylene oxide sterilization services for medical devices by BQ Plus Medical (Suzhou) Co., Ltd., in accordance with EN ISO 11135:2014. Effective November 25, 2025; valid until November 24, 2028.
FDA 510(k) Clearances
FDA substantial equivalence determinations cover I.V. Administration Set and I.V. Extension Set devices under K210381, K223645 and K242126, subject to the indications and scope stated in each clearance.
510(k) clearance is not the same as FDA approval.
FDA Establishment Registration
FDA establishment records show active 2026 registration status for BQ Plus Medical in Shanghai Songjiang (FEI 3013023255) and BQ Plus Medical Co., Ltd. in Huaian, Jiangsu (FEI 3036978618).
Establishment registration and device listing do not denote FDA approval.
FDA Inspection Record
The FDA inspection database result for BQ Plus Medical shows an inspection dated March 26, 2025 with “FDA 483: No.”
The FDA database notes that not all inspections are included.
KGMP
KGMP certificate TRK-BABA-23413 lists BQ Plus Medical Co., Ltd. and KZBQ (Jiangsu) Medical Co., Ltd. as manufacturers for the approved product groups stated in the attachment. Issued April 4, 2025; valid until April 3, 2028.
ANVISA
ANVISA-related 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.
Process-Based QMS Governance
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.
Customer Requirements
Contract, technical and regulatory requirements are reviewed before order commitment.
Design and Technical File
Product files and technical documentation support applicable regulatory requirements.
Supplier Control
Supplier selection, monitoring and re-evaluation are based on performance, product impact and risk.
Production Control
Production is performed under documented procedures, qualified infrastructure and monitored process parameters.
EO Sterilization
Validated EO sterilization parameters and batch records support sterile product control.
Batch Release
Inspection, DHR review and release controls support product conformity before shipment.
Post-Market Feedback
Customer feedback, complaints and post-market information are evaluated and trended.
CAPA and Improvement
Corrective and preventive actions are reviewed for effectiveness and continuous improvement.
Measurable Quality Objectives
BQ tracks quality and delivery through measurable objectives. These indicators connect quality management with customer experience, production stability and continuous improvement.
On-Time Delivery
Internal QMS target: OTD >=95%. In recent years, BQ has maintained 99%+ on-time delivery from 2023 to 2025.
FQC First-Pass Yield
Final inspection first-pass yield target: >=98%, supporting stable release quality and batch consistency.
Cost of Non-Quality
Cost of Non-Quality target: <=1%, covering scrap, rework, complaint-related cost, logistics recall or claim-related cost where applicable.
Controlled Production, Validation and Sterile Product Management
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.
- Production and service control procedures
- Process validation and software validation where applicable
- Sterile barrier and EO sterilization validation controls
- Release, delivery and post-delivery activity controls
Traceability, Risk Management and CAPA
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.
Batch Traceability
Production lot identification, product status control and DHR records support traceability from manufacturing to release.
Risk Management
Risk management is applied throughout product realization and maintained across the product life cycle.
Supplier and Change Control
Supplier monitoring, purchasing verification and significant change control are managed according to product impact and risk.
Complaint, PMS and CAPA
Feedback and complaints are recorded, evaluated and investigated where required, with reporting, PMS, recall and CAPA processes applied as applicable.
Quality Built Into Every Batch
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.