ISO 13485:2016 — Medical Devices Quality Management
Scope
SENO's 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 diagnostic reagents meet the stringent quality, safety, and performance requirements expected of medical device manufacturers, providing clients with reliable and consistent testing materials.
IVD Reagent Product Categories
| Product Category | Examples | Regulatory Class | Production Volume |
|---|
| DNA Extraction Kits | SENO Feather DNA Kit, SENO Swab DNA Kit | Class I (IVD) | 500+ kits/year |
| PCR Master Mixes | SENO 2× Taq Master Mix, SENO 2× qPCR Probe Mix | Class I (IVD) | 1000+ kits/year |
| Primer/Probe Sets | SENO CHD P2/P8, SENO BFDV TaqMan Set | For research/diagnostic use | Custom per order |
Key Requirements by ISO 13485 Clause
| ISO 13485 Clause | SENO Implementation | Documentation |
|---|
| Design Control (7.3) | Design history file for each kit; verification + validation testing | DHF-xxx for each product |
| Purchasing (7.4) | Qualified supplier list; incoming raw material QC | QSL-001, IQC-RM-xxx |
| Production (7.5) | Master lot records; batch release testing | MLR-xxx, BRT-xxx |
| Measurement/Monitoring (8.2) | In-process QC + final QC for each production lot | IPQC-xxx, FQC-xxx |
| Nonconforming Product (8.3) | Quarantine → investigation → disposition | NCR-xxx, DISP-xxx |
| CAPA (8.5.2) | Root cause analysis for all complaints | CAPA-xxx |
| Customer Feedback (8.2.1) | Complaint log with trend analysis | CL-xxx, quarterly reports |
| Labeling and Packaging (7.5.1) | Compliance with IVD labeling regulations | Label spec sheets |
| Sterilization (if applicable) | Validated sterilization for applicable products | Validation reports |
| Traceability (7.5.3) | Lot traceability from raw material to finished product | LIMS tracking |
Design Control Process (Clause 7.3)
| Design Phase | Activities | Deliverables | Review Gate |
|---|
| Planning | Define design objectives, team, timeline | Design plan | Phase review 1 |
| Input | User needs, regulatory requirements, specifications | Design input requirements | Phase review 2 |
| Output | Detailed design, manufacturing instructions, test methods | Design output documents | Phase review 3 |
| Verification | Confirm output meets input requirements | Verification test report | Phase review 4 |
| Validation | Confirm device meets user needs | Validation test report | Phase review 5 |
| Design Transfer | Transfer to production | Manufacturing specs, training | Phase review 6 |
| Design Changes | Change control for all post-release modifications | Change notice, re-validation | As needed |
Production Batch Release Criteria
Each batch must pass the following before release:
| Test | Method | Acceptance Criteria | Sample Size |
|---|
| Visual inspection | Manual | No particulates, correct labeling | 100% of units |
| pH (if applicable) | pH meter | Within specification ± 0.1 | 3 units |
| Functional test | Positive control amplification | Expected Ct ± 1.5 | 3 replicates |
| Sterility (if applicable) | Membrane filtration | No growth after 14 days | 10 units |
| Endotoxin (if applicable) | LAL test | < 10 EU/mL | 3 units |
| Lot packaging integrity | Seal test | Pass | 5 units per pallet |
| Label accuracy | Visual check | All fields correct | 100% of labels |
Supplier Management
| Supplier Type | Qualification Process | Monitoring | Re-qualification |
|---|
| Raw material suppliers | Audit + sample testing | Quarterly performance review | Every 2 years |
| Custom oligo synthesis | Certificate of analysis per lot | Incoming QC (mass spec, purity) | Annual |
| Plasticware/consumables | Supplier questionnaire | Annual review | Every 2 years |
| Calibration services | Accreditation verification | Certificate review | Annual |
| Severity | Definition | Action | Timeline |
|---|
| Critical | Could cause incorrect test results | Immediate quarantine, full investigation, client notification if affected | < 24 hours |
| Major | Deviation from specification but unlikely to affect results | Quarantine, investigation, disposition | < 5 business days |
| Minor | Cosmetic issues, documentation errors | Correction or rework | < 10 business days |
Complaint Handling
| Complaint Type | Examples | Investigation Depth | Response Time |
|---|
| Performance | Failed positive control, inconsistent amplification | Full quality investigation | ≤ 5 business days |
| Quality | Precipitation in reagent, packaging damage | Root cause analysis | ≤ 5 business days |
| Labeling | Incorrect concentration, missing information | Document review | ≤ 2 business days |
| Service | Delayed delivery, communication issue | Process review | ≤ 5 business days |
Production Environment Control
| Parameter | Specification | Monitoring Frequency | Control Method |
|---|
| Temperature | 20-25°C | Continuous (data logger) | HVAC + alarm |
| Humidity | 40-60% RH | Continuous (data logger) | HVAC + dehumidifier |
| Air pressure | Positive pressure (clean rooms) | Daily check | HVAC system |
| Particulate count | ISO Class 8 (where applicable) | Quarterly | Particle counter |
| Surface contamination | < 1 CFU/contact plate | Monthly | Contact plates |
| Staff gowning | Lab coat, gloves, hair net | Every entry | SOP compliance |
Lot Numbering System
SENO uses a standardized lot numbering system for traceability:
| Format Component | Example | Description |
|---|
| Product code | KIT-EXF-001 | SENO Feather DNA Extraction Kit |
| Lot number | 2026-07-001 | Year-Month-Sequence |
| Expiry date | 2028-07 | Lot expires 2 years from manufacture |
| Full lot ID | KIT-EXF-001-2026-07-001-EXP2028-07 | Complete traceable identifier |
Sterilization and Clean Room Control
For IVD products requiring sterility assurance, SENO implements validated sterilization protocols:
| Sterilization Method | Application | Validation Parameter | Frequency of Validation |
|---|
| Gamma irradiation | Plastic consumables, packaging | Dose: 25-40 kGy | Annual dose audit |
| Ethylene oxide (EtO) | Heat-sensitive components | Concentration, time, humidity | Per batch |
| Aseptic processing | Liquid reagents (filtration) | 0.22 µm filter integrity test | Pre- and post-use |
| UV sterilization | Surface and air | Exposure time, distance | Monthly verification |
Document and Record Control for Medical Devices
| Document Type | Approval Authority | Review Cycle | Retention |
|---|
| Device Master Record (DMR) | R&D Manager | Annual | Life of device + 5 years |
| Device History Record (DHR) | QC Manager | Per batch | 5 years |
| Design History File (DHF) | CEO | Per project | Life of device + 5 years |
| Risk Management File | R&D Manager | Annual update | Life of device |
| Supplier Qualification File | QC Manager | Every 2 years | Current + 1 archived version |
| Validation/Verification Reports | R&D + QC | Per validation event | Life of device + 5 years |
Post-Market Surveillance
| Activity | Frequency | Purpose |
|---|
| Customer complaint review | Monthly | Identify recurring issues |
| Adverse event monitoring | Continuous | Reportable event detection |
| Performance trend analysis | Quarterly | Detect shifts in product performance |
| Literature surveillance | Annual | Monitor new scientific findings |
| Regulatory intelligence | Quarterly | Track regulatory changes affecting IVD products |