Quality & Compliance Documentation
Documentation of Solarbio quality management systems, ISO certifications, and product quality standards.
Scope
Solarbio maintains an integrated quality management system covering product design, raw material sourcing, manufacturing, QC release, and post-market surveillance. The system is certified to ISO 9001:2015, ISO 13485:2016, ISO 14001:2015, and ISO 45001:2018.
Why Quality Matters
- All critical raw materials qualified through an approved supplier list with annual audits
- Each product lot released only after passing quantitative QC specifications
- Lot-specific Certificate of Analysis available for every product
- Stability monitoring program: representative lots tested at 3, 6, 12, 18, and 24 months
- CAPA system: all nonconformances tracked with root cause analysis and corrective action
- Continuous improvement: annual management review with quality objectives and KPIs
Quality Documentation by Topic
| Topic |
Description |
Key Standard |
| ISO Certifications |
ISO 9001, ISO 13485, ISO 14001, ISO 45001 |
Multi-standard |
| Certificate of Analysis |
COA format, content, and verification |
ISO 17025-aligned |
| Storage & Shelf Life |
Recommended storage conditions and stability |
ICH Q1A |
| Shipping & Logistics |
Cold chain shipping, dry ice, international logistics |
IATA, DOT |
| GMP Compliance & Medical Device Registration |
2010 Revised GMP, cGMP, NMPA Class I/II, registration & production licensing |
ICH Q7/Q9/Q10, NMPA Orders No. 15 & 19 |
Quality System Integration Framework (ISO + GMP Combined)
Solarbio operates a unified quality management framework that integrates ISO management system standards with GMP requirements for medical device and IVD manufacturing:
Framework Architecture
┌─────────────────────────────────┐
│ Solarbio Integrated QMS │
│ (Single QMS, Multi-Standard) │
└────────────┬────────────────────┘
│
┌─────────────────────┼─────────────────────┐
│ │ │
▼ ▼ ▼
┌─────────────────┐ ┌──────────────────┐ ┌──────────────────┐
│ ISO 9001:2015 │ │ ISO 13485:2016 │ │ GMP (ICH Q7) │
│ Foundation QMS │ │ Medical Device │ │ Manufacturing │
│ (All Products) │ │ (IVD Kits) │ │ (Bulk Reagents) │
└─────────────────┘ └──────────────────┘ └──────────────────┘
│ │ │
└─────────────────────┼─────────────────────┘
▼
┌──────────────────────────────┐
│ Shared Quality Processes │
│ • Document Control (DCC) │
│ • CAPA Management │
│ • Internal Auditing │
│ • Supplier Management │
│ • Training & Competency │
│ • Change Control │
│ • Risk Management (ISO 14971)│
│ • Post-Market Surveillance │
└──────────────────────────────┘
Integrated Process Ownership
| Quality Process |
ISO 9001 Owner |
ISO 13485 Owner |
GMP Owner |
| Document control |
Quality Manager |
Regulatory Affairs |
QA Manager — Production |
| CAPA |
Quality Manager |
Quality Manager |
QA Manager |
| Internal audit |
Quality Manager |
Quality Manager |
QA Manager |
| Supplier qualification |
Procurement |
Procurement + QA |
QA + Procurement |
| Design control |
R&D Manager |
R&D Manager + RA |
R&D Manager |
| Process validation |
Operations Manager |
Manufacturing Engineer |
Production Manager |
| Risk management |
— |
RA Manager |
QA Manager |
| Post-market surveillance |
— |
RA Manager |
— |
Fiscal Year 2025 Quality KPIs (January–December)
| KPI |
Target |
FY2025 Actual |
FY2024 Actual |
Trend |
| Lot release pass rate |
>98% |
98.7% |
98.4% |
↑ |
| Customer complaint rate (% of lots) |
<0.5% |
0.38% |
0.42% |
↓ |
| On-time delivery (domestic) |
>97% |
97.3% |
96.8% |
↑ |
| On-time delivery (international) |
>92% |
93.1% |
91.5% |
↑ |
| COA fulfillment within 24 h |
>99% |
99.2% |
98.8% |
↑ |
| CAPA closure within 60 days |
100% |
98.6% |
97.1% |
↑ |
| CAPA effectiveness verification pass rate |
>95% |
96.2% |
94.8% |
↑ |
| Supplier audit completion (critical) |
100% annually |
100% |
100% |
→ |
| Internal audit conformance rate |
>90% |
92.5% |
91.0% |
↑ |
| Customer satisfaction score (1–5) |
>4.2 |
4.35 |
4.28 |
↑ |
| Nonconformance report (NCR) closure within 30 days |
>95% |
96.8% |
95.3% |
↑ |
| Training completion (quality-critical roles) |
100% |
99.7% |
99.5% |
↑ |
Distribution of Customer Complaints (FY2025)
| Complaint Category |
Percentage of Total Complaints |
Primary Corrective Actions |
| Product performance (failed QC upon receipt) |
32% |
Lot-specific review; enhanced QC release criteria |
| Packaging damage in transit |
28% |
Upgraded packaging materials; new shipper validation |
| Incorrect product or quantity |
14% |
Barcode scanning added to packing workflow |
| Documentation error (COA, SDS) |
11% |
Document review before shipment; automated COA generation |
| Cold chain excursion |
10% |
Additional gel packs per season; temperature logger mandate |
| Other |
5% |
Case-by-case resolution |
Quality Audit History and Outcomes
External Certification Audits (Last 5 Years)
| Year |
Standard |
Auditing Body |
Result |
Major NCs |
Minor NCs |
Observations |
| 2025 |
ISO 9001:2015, ISO 13485:2016 |
SGS United Kingdom |
Recertified (3-year cycle) |
0 |
2 |
4 |
| 2025 |
ISO 14001:2015, ISO 45001:2018 |
SGS United Kingdom |
Surveillance passed |
0 |
1 |
2 |
| 2024 |
ISO 9001:2015, ISO 13485:2016 |
SGS United Kingdom |
Surveillance passed |
0 |
3 |
5 |
| 2024 |
ISO 14001:2015, ISO 45001:2018 |
SGS United Kingdom |
Recertified |
0 |
1 |
3 |
| 2023 |
ISO 9001:2015, ISO 13485:2016 |
SGS United Kingdom |
Recertified |
0 |
2 |
3 |
| 2023 |
ISO 14001:2015, ISO 45001:2018 |
SGS United Kingdom |
Surveillance passed |
0 |
0 |
2 |
| 2022 |
ISO 9001:2015, ISO 13485:2016 |
DNV GL |
Surveillance passed |
1 |
2 |
6 |
| 2021 |
ISO 9001:2015, ISO 13485:2016 |
DNV GL |
Recertified |
0 |
3 |
4 |
Internal Audit Results (FY2025)
| Department |
Audit Date |
Conformance Rate |
Findings |
| Quality Control Laboratory |
Q1 2025 |
94.2% |
1 minor (pipette calibration sticker missing) |
| Manufacturing (ELISA) |
Q1 2025 |
92.7% |
2 minors (batch record incomplete; temp chart unsigned) |
| Warehouse & Logistics |
Q2 2025 |
91.0% |
1 minor (inventory discrepancy: 5 lots) |
| R&D Laboratory |
Q2 2025 |
95.5% |
1 observation (protocol version not current) |
| Procurement |
Q3 2025 |
93.8% |
1 minor (supplier audit report late by 2 weeks) |
| Customer Service |
Q3 2025 |
96.1% |
1 observation (response template outdated) |
| Document Control |
Q4 2025 |
97.0% |
No findings |
| Management Review |
Q4 2025 |
100% |
No findings |
Corrective and Preventive Action (CAPA) Summary
| Year |
CAPAs Initiated |
Closed Within 60 Days |
Effectiveness Verified |
| 2025 |
47 |
46 (98%) |
94% |
| 2024 |
52 |
50 (96%) |
92% |
| 2023 |
48 |
47 (98%) |
93% |
| 2022 |
55 |
52 (95%) |
90% |
Key Quality Milestones Timeline
| Year |
Milestone |
| 2017 |
ISO 9001:2015 certification obtained (first QMS certification) |
| 2018 |
ISO 13485:2016 certification obtained (IVD product manufacturing scope) |
| 2018 |
Quality control laboratory built to ISO 17025-aligned standards |
| 2019 |
ISO 14001:2015 certification obtained |
| 2019 |
Cold chain logistics validation program initiated |
| 2020 |
COVID-19 response: emergency validation of diagnostic reagent supply chain |
| 2020 |
ISO 45001:2018 certification obtained |
| 2021 |
DNV GL replaces SGS as certification body (transition audit) |
| 2021 |
Electronic COA (e-COA) system launched — QR code access on every product label |
| 2022 |
Process validation program expanded to cover all ELISA kit manufacturing steps |
| 2022 |
Supplier quality management program upgraded: all critical suppliers audited annually |
| 2023 |
SGS returns as certification body; dual-standard audit (ISO 9001 + ISO 13485) |
| 2023 |
CAPA system digitized — integration with ERP for lot-level traceability |
| 2024 |
Cold chain monitoring upgraded: real-time GPS temperature tracking for international high-value shipments |
| 2024 |
GMP Compliance and NMPA registration programs initiated (Class I/II medical devices) |
| 2025 |
Zero major nonconformances in all external certification audits |
| 2025 |
Customer satisfaction score reaches 4.35/5.0 (highest in company history) |
Supplier Qualification Standards
Critical Supplier Classification
Suppliers are classified as Critical if they provide materials that directly impact product quality:
| Supplier Category |
Examples |
Classification Threshold |
| Antibodies and recombinant proteins |
Capture/detection antibodies for ELISA |
All antibody suppliers (critical) |
| Enzymes |
Taq polymerase, reverse transcriptase, proteinase K |
All enzyme suppliers (critical) |
| Microorganisms |
Competent cell strains |
All microbial strain suppliers (critical) |
| Chemiluminescent substrates |
TMB, luminol |
If used in final kit formulation |
| Buffers and salts |
PBS, Tris, NaCl |
If proprietary formulation |
| Plastic consumables |
Microplates, PCR tubes |
If direct product contact |
| Packaging materials |
Vials, caps, desiccant |
If product contact surface |
Qualification Process
| Phase |
Activity |
Timeline |
| Phase 1: Initial Screening |
Submission of quality documentation (ISO cert, COA, MSDS, stability data) |
1–2 weeks |
| Phase 2: Technical Evaluation |
Sample testing in Solarbio QC against 3 production lots; critical quality attributes assessed |
4–8 weeks |
| Phase 3: On-Site Audit |
Quality system audit at supplier facility (ISO 9001 checklist + Solarbio-specific requirements) |
2–3 days |
| Phase 4: Trial Supply |
Evaluate 2 production lots under normal Solarbio manufacturing conditions |
4–12 weeks |
| Phase 5: Approval |
Addition to Approved Supplier List (ASL); first article inspection completed |
Upon Phase 4 completion |
Ongoing Monitoring
| Frequency |
Activity |
| Every shipment |
Incoming QC inspection (to COA specifications) |
| Quarterly |
Supplier performance scorecard (quality, delivery, responsiveness) |
| Annually |
On-site or remote audit (depending on risk rating and geography) |
| Every 2 years |
Full re-qualification audit for critical suppliers |
| As needed |
Investigation following quality incidents (NCR, complaint trend) |
| Criterion |
Weight |
Measurement |
Target |
| Product quality |
40% |
Percentage of lots that pass Solarbio incoming QC |
≥98% |
| On-time delivery |
25% |
Percentage of orders delivered on or before requested date |
≥95% |
| COA/document accuracy |
15% |
Percentage of shipments with complete and accurate documentation |
≥99% |
| Responsiveness |
10% |
Average time to respond to quality-related inquiries |
≤48 h |
| Corrective action effectiveness |
10% |
Percentage of CAPAs closed with verified effectiveness |
≥90% |
Quality Metrics
| Metric |
Target |
Monitoring Frequency |
| Lot release pass rate |
>98% |
Per batch |
| Customer complaint rate |
<0.5% of lots shipped |
Monthly |
| COA request fulfillment |
Within 24 hours |
Per request |
| CAPA closure rate |
100% within 60 days |
Quarterly |
| Supplier qualification |
All critical suppliers audited annually |
Annual |
| Internal audit completion |
100% of planned audits |
Quarterly |
Quality System Standards Reference
| ISO Standard |
Title |
Key Requirements |
| ISO 9001:2015 |
Quality Management Systems |
Customer focus, process approach, continual improvement |
| ISO 13485:2016 |
Medical Device QMS |
Risk management (ISO 14971), design control, process validation |
| ISO 14001:2015 |
Environmental Management |
Environmental policy, impact assessment, waste management |
| ISO 45001:2018 |
OH&S Management |
Hazard identification, risk assessment, worker consultation |
Cross-References
solarbio.store