Cert360 provides expert ISO 15189 certification services in Australia, helping medical laboratories implement robust quality management systems that ensure technical competence, accurate testing, and reliable patient results. Our services support laboratories in meeting international standards, improving operational efficiency, and demonstrating clinical credibility to regulators and stakeholders.
Our ISO 15189 approach integrates laboratory processes, technical expertise, and risk-based management, ensuring laboratories maintain consistent, accurate, and traceable results. By aligning laboratory operations with global standards, we help organisations achieve accreditation while enhancing confidence in test outcomes and improving patient safety across clinical, diagnostic, and research environments.
ISO 15189 is an international standard specifying requirements for quality and competence in medical laboratories. It ensures laboratories implement quality management systems that maintain technical competence, reliability, and patient safety in all testing activities.
The standard addresses laboratory management, personnel competence, equipment, process validation, and quality control. ISO 15189 applies to diagnostic, clinical, and research laboratories across healthcare, pathology, biotechnology, and pharmaceutical sectors, ensuring globally recognised laboratory practices.
ISO 15189 certification demonstrates that a medical laboratory operates with high technical competence, validated processes, and reliable quality management systems. Accreditation ensures test results are accurate, reproducible, and compliant with regulatory and industry requirements
Certification enhances patient safety, strengthens confidence in laboratory outputs, and supports compliance with Australian healthcare regulations. Accredited laboratories gain recognition for quality and reliability, enabling participation in clinical trials, inter-laboratory comparisons, and regulatory reporting obligations.
We conduct a comprehensive review of laboratory processes, quality controls, and documentation against ISO 15189 requirements to identify gaps and improvement areas.
Our consultants develop tailored laboratory manuals, standard operating procedures, quality records, and test validation protocols aligned with operational activities.
We assist in implementing quality controls, process validation, proficiency testing, and staff competency programs to ensure compliance across laboratory functions.
Internal audits verify compliance with ISO 15189 requirements, assessing technical competence, procedural accuracy, and documentation effectiveness.
We provide full support during the certification audit, including evidence preparation, staff guidance, audit coordination, and corrective action resolution.
We review laboratory functions, technical operations, and regulatory requirements to define a clear and achievable ISO 15189 certification scope.
Laboratory processes, equipment, and technical procedures are evaluated to identify gaps, risks, and areas needing improvement for certification readiness.
Quality manuals, SOPs, validation protocols, and laboratory process controls are implemented across all relevant testing activities.
Laboratory staff receive targeted training on ISO 15189 requirements, technical procedures, and quality management responsibilities. Internal audits verify readiness for certification.
Certification Audit and Approval The external certification audit is conducted, non-conformities are addressed, and ISO 15189 accreditation is granted upon successful compliance verification.
ISO 15189 ensures laboratories produce reliable, precise, and reproducible test results for clinical, diagnostic, and research purposes.
Accreditation demonstrates compliance with Australian healthcare regulations and global laboratory best practices.
Risk-based controls, process standardisation, and technical audits reduce errors and improve workflow efficiency.
Certification assures patients, healthcare providers, and regulators of laboratory competence, reliability, and quality of results.
Ongoing monitoring, internal audits, and corrective actions strengthen laboratory performance and quality management over time.
Partner with Cert360 to implement a medical laboratory management system that enhances accuracy, compliance, and operational efficiency. Our consultants guide laboratories through every stage of certification with practical expertise, clear guidance, and industry-focused solutions.
Cert360 is trusted by medical laboratories across Australia for delivering structured ISO 15189 certification services. Organisations rely on our expertise to improve technical competence, reduce audit risks, and maintain accreditation confidently across clinical and research environments.
As a leading ISO 15189 service provider, Cert360 supports laboratories seeking practical, sustainable, and audit-ready quality management systems specifically designed for clinical and diagnostic operations.
Discuss your laboratory objectives, accreditation requirements, and implementation strategy with our experts. Cert360 provides tailored ISO 15189 solutions supporting consistent, reliable, and technically competent laboratory operations.
ISO 15189 certification ensures laboratories implement systems that maintain technical competence, reliability, and compliance, improving patient safety and organisational credibility.
Our team provides structured guidance, practical documentation, and full audit support from planning to certification. Speak with our consultants to understand ISO 15189 requirements tailored to your clinical, diagnostic, or research laboratory.
Quality management system, document control, internal audits, corrective actions, and continual improvement.
Staff competence, equipment validation, test method verification, traceability, and quality control.
Standardised laboratory procedures, monitoring, and record-keeping to ensure reliable and accurate results.
Identification and mitigation of potential testing errors, non-conformities, and operational risks.
Monitoring, measurement, internal audits, and management review to ensure continuous quality enhancement.
Corrective actions, quality enhancement, and continual improvement of laboratory management systems.
An international standard specifying quality management and technical competence requirements for medical laboratories.
By implementing a compliant laboratory management system and successfully completing an accreditation audit.
Improved laboratory accuracy, regulatory compliance, operational efficiency, and patient safety.
Professional support for implementing, auditing, certifying, and maintaining medical laboratory management systems.
Services supporting management system implementation, audits, certification, and ongoing compliance.
