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.

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