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Quality Assurance at Proteomics International

Scientific integrity, clinical reliability and regulatory compliance - embedded across research, diagnostics and product development

Quality Philosophy

Quality at Proteomics International is a culture, not a checkbox. Every experiment, every diagnostic test, and every report is governed by internationally recognised standards, rigorous review and auditable traceability. Results are accurate, reproducible and clinically meaningful.

Integrated QMS

Our quality management system (QMS) spans document and change control, validation and verification, risk management, supplier assurance, internal audits, CAPA, and management review. Processes align with ISO/IEC 17025, ISO 13485 and ISO 15189 expectations.

Data Integrity

We protect data with access controls, audit trails, versioning and secure retention. Patient and client information is handled confidentially and ethically, with disclosure controlled and tracked.

 

Accreditations & Certifications

Independent certification demonstrates technical competence and clinical reliability.

ISO 15189 – Medical Laboratories

Accredited by NATA in conjunction with RCPA for clinical testing services (NATA/RCPA 21667; Site 25790). Supports clinical delivery of specialist proteomic diagnostics.

ISO 13485 – Design & Development

Certified quality system for the design and development of in-vitro diagnostic medical devices (MD 734669), ensuring patient-centred safety and regulatory compliance across the product lifecycle.

ISO/IEC 17025 – Testing Laboratory

WAP Facility accredited since 2009 (NATA 16838), recognising technical competence and the production of valid, traceable and reproducible analytical results.

Method Validation & QC

  • Assay validation/verification to defined performance claims
  • Batch-level internal QC with trend monitoring
  • External proficiency testing / inter-lab comparisons
  • Measurement uncertainty established and reviewed

People & Competence

  • Role-based training matrix and competency assessments
  • Auditor independence and ongoing refresher training
  • Documented authorisations for critical tasks and release

Continuous Improvement

  • Risk-based internal audits across all processes
  • Corrective/Preventive Actions (CAPA) with effectiveness checks and trending
  • Regular management review of KPIs and feedback

Client Assurance

We provide clear, timely and transparent reporting. Upon request, clients may receive method summaries, accreditation details and QC performance context appropriate to their project or clinical service. Site visits or audits can be accommodated by arrangement.