Regulatory & Compliance¶

SENO operates within an ISO-certified quality management framework and complies with all applicable national and international regulations for diagnostic testing, biological sample handling, and international shipping. The laboratory in Zhangjiakou, Hebei, China, is accredited under China Metrology Accreditation (CMA) and recognized as a National High-Tech Enterprise, reflecting its commitment to rigorous quality standards and innovation in avian genetic testing.

Documents¶

Document	Description
ISO 9001:2015 — Quality Management	QMS framework governing all testing services, from sample receipt to reporting
ISO 13485:2016 — Medical Devices	QMS for in-house diagnostic reagent development and manufacturing
International Shipping Regulations	Compliance with IATA, CITES, and national import/export regulations for biological samples

Regulatory Framework¶

SENO's operations are governed by the following standards and regulations:

Standard/Regulation	Scope	Application at SENO
ISO 9001:2015	Quality management systems — requirements	Laboratory operations, client management, reporting
ISO 13485:2016	Medical devices — QMS	In vitro diagnostic (IVD) reagent manufacturing
CMA (China Metrology Accreditation)	Testing laboratory qualification	All diagnostic testing services
National High-Tech Enterprise	Innovation-based enterprise certification	R&D activities, patent development
IATA Dangerous Goods Regulations	Air transport of biological substances	Sample shipping and customs clearance
CITES (if applicable)	International trade in endangered species	Legal compliance for protected bird species
National Import/Export Regulations	Customs per destination country	Import of biological diagnostic samples
Biosafety Regulations	National health authorities	Pathogen-containing sample transport

Quality Oversight¶

Function	Authority	Frequency
Internal QMS audit	SENO Quality Manager	Annually (minimum)
External QMS audit	ISO certification body	Every 3 years + surveillance
Proficiency testing	External accredited provider	Annually
Method validation review	SENO R&D + QC	Before new method launch
Equipment calibration	External calibration service	Per manufacturer schedule

Certification Scope Details¶

ISO 9001:2015¶

The ISO 9001:2015 certification covers the design and provision of avian genetic testing services, encompassing sample management, DNA extraction, PCR analysis, result interpretation, and client reporting. The quality management system is designed to ensure consistent service quality, continuous improvement, and high levels of client satisfaction across all operational areas.

QMS Element	Implementation	Verification Method
Quality Policy	Documented and communicated to all staff	Annual management review
Document Control	Version-controlled SOPs in LIMS	Quarterly audit
Record Management	LIMS-based with 5-year retention	Annual record audit
Internal Audit	Full QMS process audit	Annual schedule
Management Review	Quality performance evaluation	Quarterly meetings
CAPA System	Non-conformance tracking	Monthly review
Risk Management	Risk assessment per new method	Before method launch
Client Feedback	Post-report satisfaction survey	Monthly analysis

ISO 13485:2016¶

The ISO 13485:2016 certification covers the design, development, and manufacturing of in vitro diagnostic (IVD) reagents used in avian genetic testing, including PCR master mixes, primer/probe sets, and extraction reagents. This certification ensures that all in-house manufactured reagents meet rigorous quality and safety standards for diagnostic use.

IVD Product Category	Examples	Regulatory Class
DNA Extraction Kits	SENO Feather DNA Kit, SENO Swab DNA Kit	Class I (IVD)
PCR Master Mixes	SENO 2× Taq Master Mix, SENO 2× qPCR Probe Mix	Class I (IVD)
Primer/Probe Sets	SENO CHD P2/P8, SENO BFDV TaqMan Set	For research/diagnostic use

International Shipping Compliance¶

SENO ships biological samples from over 20 countries in compliance with IATA Dangerous Goods Regulations (Category B, UN3373) and CITES requirements where applicable. The laboratory provides full customs clearance documentation including commercial invoices, customs letters, and import permits where required.

Regulation	Authority	SENO Compliance
IATA DGR	IATA	Category B (UN3373) packaging and labeling
CITES	CITES Secretariat	Documentation for Appendix I/II species
National Import Regulations	Per destination country	Customs clearance support
Biosafety	National health authorities	Safe packaging and transport

Continual Improvement Strategy¶

SENO's regulatory compliance framework is not static. The quality management system incorporates a continual improvement cycle based on the Plan-Do-Check-Act (PDCA) methodology.

Phase	Activities	Timeline
Plan	Set quality objectives, identify risks, plan audits	Annual
Do	Implement processes, train staff, execute audits	Ongoing
Check	Monitor metrics, analyze trends, conduct reviews	Quarterly
Act	Implement CAPA, update SOPs, communicate changes	As needed

Laboratory QC Protocols — Detailed per-batch and periodic QC procedures
Proficiency Testing — External inter-laboratory comparison program
Accuracy Validation — Method validation and accuracy data
Sample Guide — Sample collection, storage, and shipping protocols

Regulatory Change Management¶

SENO maintains a regulatory change management process to stay current with evolving requirements:

Trigger	Assessment	Action	Timeline
New regulation published	Impact assessment on operations	Gap analysis, SOP update	Within 30 days of effective date
Existing regulation amended	Review scope of change	SOP update, staff training	Before effective date
Certification renewal	Self-assessment against standard	Internal audit, external audit	Per certification schedule
New service launch	Applicable regulatory determination	Pre-market compliance check	Before service launch

Data Privacy and Confidentiality¶

SENO's regulatory compliance extends to data protection and client confidentiality:

Requirement	Implementation
Client data protection	LIMS access controls, role-based permissions
Test result confidentiality	Encrypted reporting, secure email or portal
Record retention	5-year minimum for all test records
Data destruction	Secure deletion upon retention expiry
Audit trail	LIMS logs all access and modifications

Staff Training and Competency¶

Training Type	Frequency	Coverage
QMS orientation	Upon hire	All staff
SOP training	Upon SOP update	Affected personnel
GMP training (ISO 13485)	Annual	Production staff
IATA DGR training	Every 2 years	Shipping and logistics staff
CITES awareness	Annual	Client-facing staff
Biosafety training	Annual	Laboratory personnel

Accreditation and Certification Status¶

Certification	Standard	Expiry	Last Audit	Status
ISO 9001:2015	Quality management	2027	2026 surveillance	Active
ISO 13485:2016	Medical devices QMS	2027	2026 surveillance	Active
CMA	Testing laboratory	2027	2025 full audit	Active
National High-Tech Enterprise	Innovation	2027	2025 review	Active