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Quality Assurance

HKLife’s Quality Management System is an integral part of our commitment to providing our customers the highest standards and guidelines used in laboratory testing services. HKLife sets out in place quality objectives for all aspects of laboratory operations, from sample log-in, processing, instrument calibration and method validation to data analysis and reporting.

HKLife’s Quality Management System serves as the foundation of assurance and confidence to certify our products globally. We are dedicated to ensuring the quality of our products and services that our customers deserve hence we hold the following accreditations:


HKLife has been granted the ISO 13485:2003 quality management system accreditation for the design and manufacture of its in vitro clinical molecular diagnostics. (Certificate Number: MD571271)

As a pioneering biotechnology company in Hong Kong, HKLife has long excelled in R&D and commercialization of molecular diagnostics. Our market-leading position is marked by receiving various accreditations and awards in this area of expertise.


HKLife is ISO9001 accredited, Certificate Number: FS56773. This makes us the first private biotechnology company in Hong Kong bearing this quality mark. It is important to us that our partners and clients are guaranteed of our commitment to meet the highest quality standards in all HKLife products and services.

The ISO9001 standard addresses quality management systems and reflects what an organization does to fulfill customers’ quality requirements. ISO9001 accreditation indicates that our company follows strict guidelines and procedures within our internal management and organizational operations. All our promotional literature and documentation carries the ISO logo, indicating our compliance with its recommendations.

ISO/IEC 17025:2005(E)

In January 2003, HKLife became the first laboratory in China performing qualitative and quantitative genetically modified organism (GMO) testing with PCR technology to be granted accreditation by the Hong Kong Accreditation Service (HKAS) under its Hong Kong Laboratory Accreditation Scheme (HOKLAS).

HKLife's full range capability in molecular testing techniques reflects HKLife’s strength to offer clients a unique and wide selection of testing solutions for safety and quality in Food industry.

A HOKLAS accreditation incorporating ISO/IEC 17025:2005(E) covers "General requirements for the competence of testing and calibration laboratories", concerning management systems, technical operations, and administration support. A HOKLAS accreditation is equivalent to obtaining ISO17025.


HKLife's commitment to maintaining a quality management system also involves internal laboratory audits and continuous participation in various international proficiency testing schemes and programs.


The Food Analysis Performance Assessment Scheme (FAPAS) is recognized as the comprehensive analytical chemistry proficiency testing scheme in the food sector. HKLife has joined the scheme for its animal species identifications that demonstrate the ability of our laboratory testing. The service is capable of identifying nutritional components, food ingredients, natural food contaminants, organic and inorganic contaminants, food additives and allergens, and can also determine the authenticity of food and its components.


Food Examination Performance Assessment Scheme (FEPAS) for food microbiology proficiency testing.


The Genetically Modified Materials Analysis Scheme (GeMMA) is an independent program established to monitor the quality of GMO testing labs around the world. It is administrated by the Central Science Laboratory (UK) on behalf of the Department of Environment, Food & Rural Affairs (DEFRA) to provide laboratories around the world the opportunity to conduct proficiency tests in order to protect the quality of food intended for human consumption and animal feed, which will also ensure their free and safe movement throughout the international market. In March 2001, HKLife was found to be the best among 66 testing laboratories worldwide who submitted themselves to a battery of performance tests.


Laboratory Environmental Analysis Proficiency Scheme (LAEP) for water proficiency testing.


This is the first GMO proficiency testing program organized by the CNAL (China National Accreditation Board for Laboratories), approved by the Asia Pacific Laboratory Accreditation Cooperation (APLAC), the organization of all Laboratory Accreditation bodies within the Asia Pacific area. The program aims to rigorously determine the level of accuracy and reliability of each GMO test laboratory.

Participants are required to use its qualitative and quantitative GMO tests, both of which are based on real-time PCR, to assess undisclosed samples for the presence of GMO. HKLife correctly detected the presence of Roundup Ready® Soya in the test samples for both of the qualitative and quantitative assessments. The satisfactory results in this officially approved proficiency-testing program further strengthen the leading status of HKLife's GMO testing in the Greater China region.


The College of American Pathologists (CAP) provide many proficiency samples for laboratories to conduct the blind tests on different aspects of clinical diagnosis and blood matching. Parentage Testing (PT) is one of the proficiency items where we joined annually achieve outstanding results.

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