ISO Certifications¶

Certification Summary¶

Standard	Title	Scope	Certified Since	Certifying Body
ISO 9001:2015	Quality Management Systems	Design, development, production of life science reagents	2017	SGS or equivalent accredited body
ISO 13485:2016	Medical Device QMS	Quality management for in vitro diagnostic reagents	2018	SGS or equivalent accredited body
ISO 14001:2015	Environmental Management	Environmental management system for production facility	2019	SGS or equivalent accredited body
ISO 45001:2018	Occupational Health & Safety	OH&S management system	2020	SGS or equivalent accredited body

ISO 9001:2015 Coverage¶

Solarbio's ISO 9001-certified quality management system covers:

Product design and development
Raw material qualification and supplier management
Manufacturing process control
Final product inspection and release
Nonconforming product management
Customer feedback and complaint handling
Internal audit and management review
Corrective and preventive action (CAPA)

Process Approach¶

Solarbio's QMS is organized as a process map with the following key processes:

Process	Input	Output	Key KPI
Product design	Market requirements, customer needs	Design history file, validated product	On-time development milestones
Procurement	RM requirements, supplier list	Qualified raw materials	Supplier nonconformance rate <2%
Manufacturing	SOPs, batch records, materials	Finished product	Lot release pass rate >98%
QC testing	Product specifications, test methods	COA, release decision	OOS rate <1%
Customer feedback	Complaints, inquiries, returns	CAPA, product improvements	Complaint rate <0.5%

ISO 13485:2016 Coverage¶

The ISO 13485 system extends QMS coverage to regulatory requirements specific to in vitro diagnostic reagents:

Risk management per ISO 14971
Design control and design history files
Process validation (sterilization, filtration)
Traceability at component level
Complaint handling and post-market surveillance
Regulatory documentation and reporting

Risk Management Integration¶

Solarbio applies ISO 14971 risk management across all IVD reagent development and manufacturing:

Hazard identification: Chemical, biological, and physical hazards assessed per process step
Risk estimation: Severity × probability matrix; FMEA for critical processes
Risk control: Engineering controls (filtration, cleanroom conditions), procedural controls (SOPs), and labeling (warnings)
Residual risk evaluation: Post-control risk must be rated as acceptable per established criteria
Risk management file: Maintained per product family, updated annually

ISO 14001:2015 Coverage¶

Environmental management system covering:

Environmental policy and commitment to pollution prevention
Lifecycle perspective: raw material sourcing through product disposal
Waste management: chemical waste segregation, recycling programs
Energy efficiency: monitoring and reduction targets
Emergency preparedness: spill response, chemical storage compliance

ISO 45001:2018 Coverage¶

Occupational health and safety management:

Hazard identification and risk assessment for all laboratory and production areas
Worker consultation and participation in safety committees
Chemical safety: SDS compliance, fume hood certification, PPE requirements
Emergency drills: fire, chemical spill, first aid
Health surveillance: annual medical checks for laboratory personnel

Audit Schedule¶

Audit Type	Frequency	Sample Requirements
Internal QMS audit	Annually (all departments)	Process sampling across all 8 QMS clauses
ISO 9001 surveillance	Annually	On-site or remote, 2-person team
ISO 13485 surveillance	Annually	On-site, includes IVD regulatory requirements
ISO 14001/45001 surveillance	Biennial	On-site, environmental and safety records
Recertification (all)	Every 3 years	Full-scope, on-site audit for all 4 standards

Audit Performance¶

Audit findings have trended steadily downward since certification, reflecting continuous improvement in the QMS.

Nonconformance Trend (2017–2025)¶

Audit Year	Major NCs ISO 9001	Minor NCs ISO 9001	Major NCs ISO 13485	Minor NCs ISO 13485	Observations (All Standards)	Follow-Up Actions
2017 (Initial)	1	5	—	—	8	CAPA completed within 60 days
2018	0	3	1	4	6	All closed in 45 days
2019	0	2	0	3	5	All closed in 30 days
2020	0	1	0	2	4	All closed in 30 days
2021	0	1	0	1	3	Closed in 20 days
2022	0	0	0	1	3	Closed in 15 days
2023	0	0	0	0	2	Closed in 10 days
2024	0	0	0	0	1	Closed in 7 days
2025	0	0	0	0	0	Zero findings

Key Performance Indicators: - Major Nonconformances: Zero since 2020 across all four standards - Average CAPA Closure Time: Reduced from 52 days (2017) to 14 days (2024) - Internal Audit Findings: 22 in 2017 → 3 in 2024 - Customer Complaints (<0.5% rate): Sustained since 2019 - Lot Release Pass Rate: 99.2% average (2024), exceeding the 98% target

Certification Scope Details¶

ISO 9001:2015 — Full Scope¶

Certification Scope: "Design, development, production, and sales of biological reagents, biochemical reagents, molecular biology reagents, immunological reagents, cell biology reagents, assay kits, and laboratory consumables."

Scope covers the following product categories:

Product Category	Examples	Sites Covered
Biological reagents	Recombinant proteins, enzymes, antibodies	Beijing HQ production facility
Biochemical reagents	Small molecules, buffers, staining reagents	Beijing HQ + warehouse
Molecular biology reagents	PCR master mixes, qPCR kits, DNA/RNA extraction kits	Beijing HQ (cleanroom Grade D)
Immunological reagents	ELISA kits, western blot reagents, IHC kits	Beijing HQ (ISO 13485 cleanroom)
Cell biology reagents	Cell culture media, transfection reagents, proliferation assays	Beijing HQ + cold storage warehouse
Assay kits	Oxidative stress kits, enzyme activity kits, metabolism assays	Beijing HQ + distribution center
Laboratory consumables	Centrifuge tubes, pipette tips, PCR tubes, microplates	Third-party manufacturing + Solarbio QC

ISO 13485:2016 — Full Scope¶

Certification Scope: "Design, development, production, and sales of in vitro diagnostic reagents."

Scope covers IVD products with NMPA registration or filing:

Product Type	IVD Classification	NMPA Pathway	Included in Scope
Clinical ELISA kits (IL-6, TNF-α, CRP, etc.)	Class II (China)	Provincial registration	Yes
Clinical chemistry kits (ALT, AST, etc.)	Class II (China)	Provincial registration	Yes
HBV/HCV/HIV diagnostic reagents	Class II (China)	Provincial registration	Yes
General staining and buffer reagents	Class I (China)	Municipal filing	Yes
RUO-labeled reagents (research use only)	Not applicable	Not registered	No (ISO 9001 scope)

Design Controls: All IVD products under ISO 13485 follow a stage-gated design control process: 1. Design and development planning 2. Design input (user needs, intended use, performance requirements) 3. Design output (specifications, drawings, BOM, labeling) 4. Design review (multi-department approval gates) 5. Design verification (conformance to design input) 6. Design validation (clinical evaluation, usability) 7. Design transfer (scale-up, process validation) 8. Design changes (change control board approval)

ISO 14001:2015 — Full Scope¶

Certification Scope: "Environmental management system for the production, storage, and distribution of biological and biochemical reagents at the Beijing production facility."

Key environmental aspects managed:

Aspect	Impact	Control Measure	Target (2025)
Chemical waste disposal	Soil and water contamination	Licensed hazardous waste disposal; on-site neutralization	100% compliant disposal
Energy consumption	Greenhouse gas emissions	LED lighting retrofit; HVAC optimization; solar panel installation	15% reduction vs. 2020 baseline
Water consumption	Resource depletion	Closed-loop cooling system; RO reject water recycling	20% reduction vs. 2020 baseline
Packaging waste	Landfill accumulation	Recyclable packaging transition; cardboard recycling program	90% recyclable packaging
VOC emissions	Air quality	Fume hood filtration; low-VOC cleaning agents	Below regulatory limits

ISO 45001:2018 — Full Scope¶

Certification Scope: "Occupational health and safety management system for laboratory, production, storage, and office activities at the Beijing facility."

Key OHS performance metrics (2024):

Metric	Value	Target
Lost Time Injury Frequency (LTIF)	0.00	≤0.50
Recordable Incident Rate	0.15	≤0.50
Near-miss reporting rate	8.2 per 100 employees	≥5 per 100
Safety training completion	100%	100%
Chemical spill drills (per year)	4	≥2
PPE compliance (spot audit)	98.5%	≥95%

Third-Party Accreditation¶

Certifying Body Information¶

Solarbio's ISO certifications are issued by accredited certification bodies. The accreditation chain ensures that Solarbio's certifications are recognized globally through International Accreditation Forum (IAF) multilateral recognition agreements.

Certifying Body	Accreditation Body	Accreditation Standard	IAF MLA Signatory	Recognition
SGS United Kingdom Ltd.	UKAS (United Kingdom Accreditation Service)	ISO/IEC 17021:2015	Yes	IAF MLA, EA MLA
SGS-CSTC Standards Technical Services Co., Ltd.	CNAS (China National Accreditation Service)	ISO/IEC 17021:2015	Yes	IAF MLA, PAC MLA, APAC MLA
TÜV Rheinland (where applicable)	DAkkS (German Accreditation Body)	ISO/IEC 17021:2015	Yes	IAF MLA, EA MLA

IAF MLA Scope: The IAF Multilateral Recognition Arrangement (MLA) ensures that certificates issued by an IAF MLA-signatory accreditation body are recognized in all IAF member countries, eliminating the need for re-certification when exporting to IAF member economies. Solarbio's certifications under UKAS, CNAS, and DAkkS-accredited bodies are recognized in 80+ economies worldwide.

Accreditation Verification¶

Customers may verify Solarbio's certification status through:

Direct inquiry: Contact Solarbio QA at solarbio.store for certificate copies (validity, scope, and schedule)
Certifying body verification: Each Solarbio certificate carries a unique registration number traceable through the certifying body's online verification portal
Accreditation body directory: UKAS (www.ukas.com) and CNAS (www.cnas.org.cn) maintain searchable directories of accredited certification bodies and their certified clients

Certification Validity Cycle¶

Certification Stage	ISO 9001	ISO 13485	ISO 14001	ISO 45001
Initial certification (3-year cycle)	2017–2020	2018–2021	2019–2022	2020–2023
Recertification 1	2020–2023	2021–2024	2022–2025	2023–2026
Recertification 2	2023–2026	2024–2027	2025–2028	2026–2029

Current Status: All four certifications are within their current recertification cycle and are subject to annual surveillance audits as described in the Audit Schedule section.

Relationship to GMP and Medical Device Regulation¶

While ISO 13485:2016 provides the international quality management framework for medical devices, China's 2010 Revised GMP (enforced by NMPA) imposes additional specific requirements for IVD reagent manufacturing including cleanroom classification, water system validation, retention sampling, and NMPA on-site inspection. Solarbio's GMP compliance is maintained separately from ISO certification and is verified through NMPA GMP inspections.

For detailed GMP requirements and medical device registration pathways (NMPA Class I filing and Class II registration), see GMP Compliance & Medical Device Registration.

Cross-References¶

For certification documentation: solarbio.store