Skip to content

ISO 9001:2015 — Quality Management System

Scope

SENO's ISO 9001:2015 certification covers the design and provision of avian genetic testing services, including sample management, DNA extraction, PCR analysis, result interpretation, and client reporting. The certification applies to all operational processes at the Zhangjiakou, Hebei, China laboratory, ensuring consistent quality across the entire service lifecycle — from initial client inquiry through to final report delivery and post-service follow-up.

Quality Policy

SENO is committed to:

  • Accuracy — Delivering correct and reliable test results through validated methods and rigorous quality control
  • Timeliness — Meeting stated turnaround times with efficient workflow management
  • Confidentiality — Protecting client data and sample information through secure LIMS and access controls
  • Continual Improvement — Enhancing processes, methods, and client experience through systematic improvement activities

Key QMS Elements

ElementImplementation at SENOVerification Method
Quality PolicyCommitment to accuracy, timeliness, confidentialityAnnual management review
Quality ManualDocumented procedures for all laboratory processesControlled document — version tracked
Document ControlVersion-controlled SOPs, controlled distributionElectronic document management in LIMS
Record ManagementLIMS-based record keeping with 5-year retentionQuarterly record audit
Internal AuditsAnnual audit of all QMS processesAudit checklist + non-conformance tracking
Management ReviewQuarterly quality performance reviewMeeting minutes + action items
Corrective ActionCAPA system for non-conformancesRoot cause analysis + effectiveness check
Risk ManagementRisk assessment for each new test methodRisk register + mitigation plan
Client FeedbackPost-report satisfaction surveyMonthly trend analysis
Continual ImprovementAnnual quality objectives with metricsQuarterly progress review

Quality Objectives (2026)

ObjectiveTargetMeasurement MethodReview Frequency
Report accuracy≥ 99.5%Discrepant results / total reportsMonthly
On-time delivery≥ 95%Reports issued within stated turnaround timeMonthly
Client satisfaction≥ 4.5/5.0Post-service survey scoreQuarterly
Proficiency test success100%Pass rate in external PT schemesSemi-annually
Sample processing time≤ 2 working daysTime from sample receipt to result entryWeekly
Complaint resolution≤ 5 business daysTime from complaint receipt to resolutionMonthly

Quality Management System Structure

SENO's QMS is organized into four tiers of documentation:

TierDocument TypeExamplesControl Level
Tier 1Quality ManualQM-001: Quality Management System ManualVersion-controlled, CEO approved
Tier 2Standard Operating ProceduresSOP-DNA-001: DNA Extraction from FeathersVersion-controlled, QC Manager approved
Tier 3Work InstructionsWI-PCR-002: qPCR Plate SetupVersion-controlled, Lab Manager approved
Tier 4Forms & RecordsF-CUST-003: Client Intake FormTemplate-controlled, completed per use

Internal Audit Program

Audit TypeScopeFrequencyAuditor
Full QMS auditAll processes and departmentsAnnuallyTrained internal auditor
Process-specific auditSingle department or processSemi-annuallyAssigned department lead
Vertical slice auditEnd-to-end for one test typeAnnuallyCross-functional team
Supplier auditKey reagent/equipment suppliersEvery 2 yearsPurchasing + QC
Follow-up auditCAPA verificationAs neededOriginal auditor

Sample Internal Audit Schedule (2026)

QuarterAudit FocusAudited Processes
Q1Sample receipt and accessioningClient intake, sample logging, chain of custody
Q2DNA extraction and PCR setupExtraction QC, reagent preparation, plate setup
Q3Data analysis and reportingResult interpretation, report generation, report review
Q4Client service and post-serviceComplaint handling, satisfaction survey, continuous improvement

Management Review Process

Review ElementFrequencyParticipantsKey Metrics Reviewed
Quality objectivesQuarterlyCEO, QC Manager, Lab ManagerAll KPI dashboards
Audit resultsSemi-annuallyAs above + internal auditorNon-conformance count, trends
Client feedbackQuarterlyAs aboveSatisfaction scores, complaints
Process performanceMonthlyLab Manager, QC staffTurnaround times, error rates
Supplier performanceQuarterlyPurchasing, QCReagent quality, delivery reliability
Risk assessmentSemi-annuallyCEO, QC ManagerRisk register updates
Resource adequacyAnnuallyCEO, all managersStaffing, equipment, budget

CAPA (Corrective and Preventive Action) Process

StepDescriptionResponsibleTimeline
1. IdentificationNon-conformance detected (internal/external)Any staff memberImmediate
2. ContainmentImmediate action to limit impactLab ManagerWithin 24 hours
3. InvestigationRoot cause analysis (5-Why, Fishbone)QC ManagerWithin 5 business days
4. Action PlanDefine corrective and preventive actionsCross-functional teamWithin 10 business days
5. ImplementationExecute approved action planAssigned ownerPer plan timeline
6. VerificationEffectiveness checkQC Manager30-90 days post-implementation
7. ClosureDocument and communicateQC ManagerAfter verification

Risk Management Framework

Risk CategoryExample RiskLikelihoodImpactMitigation
OperationalSample degradation during shippingMediumHighStabilization buffer, expedited shipping
TechnicalPCR inhibition from poor DNA qualityLowHighInternal amplification control, retesting
ComplianceRegulatory change affecting testingLowMediumRegulatory monitoring, QMS updates
ClientMisinterpretation of resultsMediumMediumClear reporting, client support
Supply chainReagent shortageLowHighDual sourcing, stock buffer

Continual Improvement Cycle

SENO follows the PDCA (Plan-Do-Check-Act) cycle for all quality improvement initiatives:

PhaseActivitiesDeliverables
PlanSet annual quality objectives, identify improvement projects, allocate resourcesQuality plan document
DoExecute planned activities, train staff, implement new processesTraining records, process changes
CheckMonitor KPIs, conduct audits, review client feedbackPerformance reports, audit findings
ActImplement corrective/preventive actions, update SOPs, communicate improvementsCAPA records, updated documentation