Quality Management System

The Quality Management System within Scientific Services supports the provision of reliable, accurate, and reproducible analytical services to QIMR Berghofer's research community.

Robust processes for all aspects of our services have been implemented, using ISO/IEC 17025:2018 General Requirements for the Competence of Testing and Calibration Laboratories, and Good Clinical Laboratory Practice (GCLP) as an internationally recognised framework. Scientific Services has received accreditation to ISO/IEC 17025 through the National Association of Testing Authorities (NATA) and is regularly audited to ensure we continue to meet the requirements of this accreditation.

Our scope of accreditation is expanding, and currently includes:

• Immunophenotyping of human and laboratory animal blood (and derivatives) using flow cytometry in support of clinical trials and pre-clinical studies;
• Immunohistochemistry and histological examination of human and animal biological samples in support of clinical trials and pre-clinical studies.

To support our accredited facilities, we have a Quality Management System that describes practices that every accredited facility will follow. In addition, each facility maintains specific standard operating procedures for their core workflows. This may include the process by which they assess a client-specific process, such as a custom flow cytometry panel.

To maintain accreditation through NATA, we ensure that:

• Our workflows are demonstrated to be fit for purpose through validation studies and ongoing monitoring through external quality assurance programs;
• Our staff have demonstrated expertise and training in the work they do;
• Equipment that contributes to our work is maintained, calibrated, and tested to ensure that it is working within defined performance criteria;
• Our processes are documented and robust, and are regularly reviewed and updated;
• Where possible, we participate in external Quality Assurance programs to ensure our processes are working correctly;
• We address problems identified within our facilities systematically and use an internal and external audit program to guide continual improvement.

ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories is an international standard useful for a laboratory that wants to demonstrate that it is competent and generates valid results. It addresses a range of topics, from the organisational structure and authorities, to resourcing, competence, records, and non-conformance. The emphasis is on fit-for-purpose systems that reduce the risks of invalid results.

Good Clinical Laboratory Practice (GCLP) is a WHO standard complementary to Good Clinical Practice (GCP), specifically intended for use in laboratories processing specimens from GCP clinical trials. This includes validation of the analysis, reporting, preservation of records and auditing.

The National Association of Testing Authorities (NATA) is Australia’s leading national accreditation body, assessing businesses for conformity to international standards and providing confidence for clients.

Accredited facilities are assessed for compliance every three years, with a surveillance visit 18 months after an assessment. These assessments provide an in-depth audit of the facility’s operations by a NATA audit team and technical assessors with significant expertise in the specific service the facility offers.