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Histopathology Unit
Canossa Hospital
1 Old Peak Road
Hong Kong
Tel: 2526-0867
Fax: 2521-7081

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Diagnostix Pathology Laboratories Ltd
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Laboratory Accreditation

What is Laboratory Accreditation?

Laboratory accreditation is a formal recognition that a testing laboratory is competent to carry out specific types of tests and continue to satisfy all the criteria set by approving bodies. It is regarded as a reassurance to doctors and patients that the laboratory is performing to internationally recognised ISO 15189 standards and requirements for medical testing. As part of the laboratory accreditation process, Diagnostix Pathology Laboratories have been inspected by independent teams of technical and medical experts from two internationally recognised accreditation bodies, NATA (National Association of Testing Authorities, Australia) and HKAS (Hong Kong Accreditation Services).

What happens during accreditation assessment?

It is crucial that the laboratory is able to provide accurate and reliable test reports on patient samples. This depends on the fullfilment of the following:

qualified and experienced staff;
• properly calibrated testing equipments;
• an adequate quality assurance system;
• proper sampling procedures;
• sound testing procedures;
• valid test methods;
• traceability of measurements to national and international standards;
• accurate recording and reporting procedures;
• suitable testing facilities.

All these factors are checked during the accreditation process to make sure that the laboratory is technically competent to do your testing.

What does accreditation means for the users of the laboratory?

Accreditation by NATA or HKAS is A Recognition of Testing Competence

"NATA accreditation provides formal recognition to competent testing facilities, thus providing a ready means for customers to identify and select reliable testing, inspection, measurement and calibration services. To maintain this recognition, laboratories are re-evaluated periodically by NATA to ensure their continued compliance with requirements, and to check that their standard of operation is being maintained. The laboratory may also be required to participate in relevant proficiency testing programs between reassessments, as a further demonstration of technical competence. If a laboratory fails to consistently meet all of NATA's requirements, their accreditation is suspended or revoked."

What is ISO 9000?

Testing facilities may be checked and certified for their compliance to international management system standards such as ISO 9000. Although this will give you confidence in the laboratory's management system, it tells you nothing about its technical competence, or its ability to provide reliable and accurate test data.

Last updated: Jan 23, 2019