ISO 17025:2017 UKAS Ready Continuous Improvement Quality Assured

Quality Assurance & ISO 17025 Compliance

Comprehensive quality management system ensuring the highest standards of accuracy, reliability, and professional competence in EEG-based deception detection. Our ISO 17025:2017 compliant framework supports UKAS accreditation and demonstrates unwavering commitment to quality excellence.

Quality Management System Status - September 2025

Implementation Status: ISO 17025:2017 Quality Management System fully operational

UKAS Application: Submitted September 2025 - Assessment scheduled Q4 2025

Document Control: Version 5.0 quality manual with controlled distribution

Last Management Review: September 2025 - All objectives met or exceeded

Audit Status: Internal audits current - External surveillance planned

ISO 17025:2017 Quality Management Framework

Organizational Requirements

  • Legal entity with defined responsibility and authority
  • Impartiality policies preventing conflicts of interest
  • Confidentiality agreements protecting client information
  • Risk-based thinking integrated throughout operations
  • Management system documentation and control
  • Corrective action procedures for non-conformities
  • Internal audit program with independent assessment
  • Management review process ensuring effectiveness

Resource Management

  • Personnel competency requirements and qualification
  • Facilities suitable for testing activities
  • Environmental conditions monitoring and control
  • Equipment validation and calibration programs
  • Metrological traceability to national standards
  • Externally provided products and services control
  • Information management systems and security
  • Continuous training and professional development

Process Requirements

  • Review of requests, tenders and contracts
  • Selection and verification of methods
  • Sampling procedures and representative protocols
  • Handling of test items and data integrity
  • Technical records maintenance and control
  • Evaluation of measurement uncertainty
  • Ensuring validity of results through quality control
  • Reporting of results with appropriate detail

Improvement Requirements

  • Options for improvement identification
  • Customer feedback collection and analysis
  • Analysis of data for system effectiveness
  • Nonconformities identification and correction
  • Corrective actions addressing root causes
  • Preventive actions reducing future risks
  • Management system updates and revisions
  • Continuous improvement culture development

Quality Performance Dashboard

99.8%
Test Completion Rate
↗ +0.3% vs Q2 2025
95.2%
Detection Accuracy
↗ +2.1% vs baseline
0.02%
Calibration Drift
↘ -50% improvement
4.9/5
Client Satisfaction
↗ +0.2 vs Q2 2025
24hrs
Avg Report Time
↘ -25% faster delivery
0
Quality Incidents
→ Zero tolerance maintained

Key Performance Indicators (KPIs):

  • Technical Competence: 100% of staff maintain required certifications
  • Equipment Reliability: 99.95% uptime with preventive maintenance
  • Measurement Uncertainty: Within ±0.15% of specified limits
  • Turnaround Time: 95% of reports delivered within committed timeframes
  • Client Complaints: Zero valid complaints in last 12 months
  • Proficiency Testing: Satisfactory performance in all schemes

Audit & Review Timeline

September 15, 2025

Management Review Q3 2025

Comprehensive review of QMS effectiveness, performance against objectives, and identification of improvement opportunities. All quality objectives met or exceeded with two system enhancements implemented.

August 22, 2025

Internal Audit - Equipment & Calibration

Focus audit on calibration procedures, equipment maintenance logs, and measurement traceability. No non-conformities identified. Two opportunities for improvement documented and addressed.

July 18, 2025

Document Control Review

Complete review of document control system including version control, distribution lists, and obsolete document removal. System updated to version 5.0 with enhanced tracking capabilities.

June 12, 2025

Internal Audit - Process & Procedures

Systematic audit of testing procedures, data integrity controls, and reporting processes. Minor non-conformity addressed regarding record retention timelines. Corrective action implemented successfully.

May 8, 2025

Competency Assessment

Annual competency assessment for all technical staff completed. 100% pass rate achieved. Three staff members completed advanced training in P300 analysis techniques.

April 15, 2025

Risk Assessment Update

Comprehensive risk assessment updated including new technology risks and mitigation strategies. Risk register updated with 15 identified risks, all with appropriate controls in place.

Document Control Matrix

Controlled document status and review schedule ensuring current, accurate documentation:

Core Quality Documents

Document Version Status Next Review
Quality Manual 5.0 Current Dec 2025
SOPs Compact 2.0 Current Jan 2026
Technical Specs 9.0 Current Nov 2025
Risk Assessment 3.1 Reviewed Mar 2026

Supporting Procedures

Document Version Status Owner
Calibration Procedure 4.2 Current Tech Manager
CAPA Procedure 2.1 Current QA Manager
Complaints Policy 1.5 Approved Operations
User Manual 3.0 Current Technical

Records & Logs

Record Type Retention Status Location
Test Records 7 years Current Secure Archive
Calibration Certs 5 years Current QA Database
Maintenance Logs Equipment Life Current Asset System
Training Records Employment +2 Current HR System

Risk Management Framework

Systematic identification, assessment, and mitigation of risks affecting quality and operations:

HIGH RISK
Equipment Failure
Critical equipment malfunction during testing potentially affecting results accuracy and client commitments.
Mitigation Strategy:

Redundant systems, preventive maintenance, backup equipment available, comprehensive service contracts with 4-hour response.

MEDIUM RISK
Staff Competency
Loss of key technical staff or inadequate training affecting technical competence and service delivery.
Mitigation Strategy:

Cross-training programs, succession planning, continuous education budget, competitive retention packages, knowledge management system.

MEDIUM RISK
Data Security
Unauthorized access to confidential client data or system compromise affecting privacy and regulatory compliance.
Mitigation Strategy:

Multi-layer security protocols, encryption, access controls, regular security audits, GDPR compliance framework, incident response plan.

LOW RISK
Environmental Factors
Environmental conditions (temperature, humidity, EMI) affecting measurement accuracy and equipment performance.
Mitigation Strategy:

Environmental monitoring systems, controlled testing environment, backup facilities, EMC shielding, portable environmental controls.

LOW RISK
Regulatory Changes
Changes in standards or regulations affecting compliance requirements and operational procedures.
Mitigation Strategy:

Active monitoring of regulatory developments, professional body membership, standards committee participation, flexible QMS design.

LOW RISK
Supply Chain
Disruption to critical supplies or calibration services affecting operational continuity and service delivery.
Mitigation Strategy:

Multiple supplier relationships, strategic inventory management, alternative calibration sources, long-term service agreements.

Continuous Improvement Program

Improvement Initiatives 2025:

  • Process Automation: Implementation of automated calibration routines reducing manual intervention by 75%
  • Data Analytics: Advanced statistical process control for real-time quality monitoring
  • Client Portal: Secure online portal for result delivery and status tracking
  • Training Enhancement: Virtual reality training modules for complex procedures
  • Environmental Monitoring: IoT sensors for continuous environmental condition tracking

Quality Objectives 2025-2026:

  • Detection Accuracy: Maintain >95% accuracy with target of 96% by Q2 2026
  • Client Satisfaction: Achieve 95% satisfaction rating in quarterly surveys
  • Turnaround Time: Reduce average report delivery time to <20 hours
  • Zero Defects: Maintain zero quality incidents for 24 consecutive months
  • Competency: 100% of technical staff achieve advanced certification
  • Innovation: Implement 3 significant process improvements annually

Benchmarking & Best Practices:

  • Industry Comparison: Performance metrics compared against international best practices
  • Peer Networks: Active participation in professional quality management groups
  • Academic Collaboration: Research partnerships for methodology improvement
  • Technology Watch: Monitoring emerging technologies and industry trends
  • Standards Development: Contribution to national and international standards

UKAS Accreditation Preparation

Application Status:

  • Submission Date: September 11, 2025
  • Application Reference: UKAS-25-DET-EEG-001
  • Scope Applied For: EEG-based deception detection using P300 response analysis
  • Assessment Team: Lead assessor with EEG expertise assigned
  • Planned Assessment: Q4 2025 (preliminary schedule)

Readiness Assessment:

  • Documentation Review: ✅ Complete - All required documents prepared and reviewed
  • Technical Competence: ✅ Demonstrated - Multiple validation studies completed
  • Management System: ✅ Operational - 18 months of effective operation
  • Measurement Traceability: ✅ Established - NPL-traceable calibrations current
  • Quality Control: ✅ Implemented - Statistical process control active
  • Staff Qualification: ✅ Verified - All personnel meet competency requirements

Assessment Preparation Activities:

  • Mock Assessment: Independent consultant review identifying zero major findings
  • Witness Testing: Live demonstration of complete testing process prepared
  • Record Sampling: Representative sample of 50 test reports prepared for review
  • Staff Interviews: Technical staff prepared for competency assessment
  • Facility Preparation: Testing areas organized for optimal assessment flow
  • Corrective Actions: All identified minor issues resolved prior to assessment