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The Quality System for DxS Limited has been developed to ensure that the Company meets the requirements of BS EN ISO 13485: 2003 and BS EN ISO 9001: 2000, including working in compliance with relevant regulatory requirements, for the provision of products and services of the highest quality.
ISO 13485: 2003 and ISO 9001: 2000 are internationally recognised standards. They define the elements required to operate and maintain a Quality Management System i.e. Management Responsibility, Resource Management, Product Realisation and Measurement, Analysis and Improvement. ISO13485: 2003 is specific to companies manufacturing medical devices or providing related services. An external accredited body monitors compliance to the International Standards.
The Quality Management System includes procedures in the following areas:
- computer system validation;
- definition, control and recording of raw data;
- secure interim storage and formal archiving of data and materials;
- purchasing and the use of approved suppliers;
- computer system backup and integrity;
- staff training: CVs and job specifications;
- monitoring of customer satisfaction and the handling of customer complaints;
- use, calibration and maintenance of laboratory equipment;
- laboratory housekeeping;
- scheduling and performance of Quality Assurance activities.
- design control;
- QC;
- analytical validation;
- performance evaluation;
- inspection and testing;
- QA inspection and batch release;
- post-market surveillance and technical performance;
- method validation;
- preparation and authorisation of study protocols and reports;
- conduct of studies and responsibilities of key study personnel;
- receipt, transfer and destruction of samples;
- genotyping test design;
- genotyping laboratory procedures.
Please click on the links below to download the DxS ISO certificates.
 Follow this link for ISO9001 Certificate PDF
Follow this link for ISO13485 Certificate PDF
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