Australian medical technology company Proteomics International Laboratories (ASX:PIQ) reports the National Association of Testing Authorities (NATA) of Australia has approved the continuation of the company’s ISO 17025 accreditation.
The company also says the British Standards Institution (BSI) has renewed the company’s ISO 13485 certification. Both renewals will benefit the upcoming global product launch of the PromarkerD test for predicting diabetic kidney disease, and underpin Proteomics’ analytical testing services and its pipeline of innovative diagnostic tests under development.
ISO 17025 accreditation for laboratory testing demonstrates and promotes national and global confidence in a laboratory’s standard as being deemed technically competent and ensures the delivery of accurate, valid, and reliable results. The certification facilitates cooperation with other international laboratories and regulatory organisations.
Proteomics received the world’s first ISO 17025 laboratory accreditation for proteomics services in 2009.
ISO 13485 certification ensures safety and quality management from design and development to manufacture and sale of medical devices. The company says it has been adopted globally including in the European Union (EU), Australia, Japan, Singapore, and the US as a primary standard for quality assurance. Proteomics first achieved ISO 13458 certification in 2021.
Commenting on the approvals, Proteomics International Managing Director, Richard Lipscombe says regular accreditation and certification of the organisation by these independent bodies (NATA and BSI) demonstrates that practices from testing in the laboratory and delivery of results, to the successful manufacturing and sales of medical diagnostic tests are held to globally quality standards.
“The breadth of our accreditation speak to our company’s world class capabilities across analytical services, biomarker discovery and developing innovative diagnostic tests.”
Proteomics International is a wholly owned subsidiary and trading name of PILL, a medical technology company at the forefront of predictive diagnostics and bio-analytical services. The company specialises in the area of proteomics, the industrial scale study of the structure and function of proteins.
The company’s mission is to improve the quality of lives by the creation and application of innovative tools that enable the improved treatment of disease.