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QUALITY MANUAL
Demonstration of compliance with ISO 13485: 2012
RANDOX LABORATORIES LTD. & RANDOX TEORANTA
QUALITY SYSTEM ELEMENT
21
SECTION
5.0
Revision
21
Date Effective
23 May 2017
Page 9 of 73

5.3 Quality Policy (continued)

Randox Laboratories Limited and Randox Teoranta are privately owned Companies specialising in the design and development, manufacture and distribution of in vitro diagnostic reagents/test kits, quality control materials and automated clinical chemistry and immunoassay analysers.

Key markets for the Company’s products are clinical pathology and veterinary laboratories where the analysis of blood or urine samples can be used to assist in the diagnosis and treatment of disease states and metabolic disorders.

An external quality assessment scheme, RIQAS, is also provided by Randox Laboratories to facilitate inter-laboratory comparisons of precision and accuracy.

The Management of Randox Laboratories Limited and Randox Teoranta is committed to the provision of a quality product, a high level of customer service and the operation of a continuous quality improvement programme that will enhance product quality, ensure on time delivery and generate customer satisfaction. To reinforce this commitment Randox Laboratories Limited and Randox Teoranta operate a Quality System, which satisfies the requirements of ISO 13485:2012, the In Vitro Diagnostic Medical Devices Directive 98/79/EC, the Canadian Medical Device Regulations, the Quality System Regulation as set out in Part 820 of Title 21 of the Code of Federal Regulations, ROC (Taiwan) Medical Device Regulations, GMP Regulations (Brazil) RDC 16/2013 and ISO 17043:2010.

We recognise that by continuously improving the effectiveness of our quality system, processes and procedures we ensure efficiency and quality at all levels and stages of our business so sustaining the profitability of the Company and ensuring that we meet customer expectations and Regulatory and Statutory requirements.

Through the development of a culture that is participative, open and accountable, and by implementing effective staff training programmes the success of the Company and the satisfaction of our customers is assured.

Signed:
S.P FitzGerald
Print: Dr. S. Peter FitzGerald
Managing Director

Environmental Policy

3rd January 2018

Randox is an international clinical diagnostics company specialising in the development, manufacture and distribution of in-vitro diagnostic reagents, quality control materials and automated clinical chemistry and immunoassay analysers.
We recognise that our activities can impact on the environment and we are committed to reducing these through the identification of significant environmental aspects, compliance obligations and considering risks and opportunities. We aim to promote practices which supports sustainable development, environmental protection, and efficient resource use.

Randox is committed to:

  • Assessing the environmental risk from our activities, preventing pollution and protecting the environment.
  • Compliance with all applicable environmental legislation and other requirements.
  • Improving environmental performance through implementation and continual improvement of our Environmental Management System (EMS).
  • Integrating the EMS throughout all business processes.
  • Sustainable procurement of raw materials, equipment, and energy supply.
  • Improving resource efficiency throughout the design, development, and manufacture of products.
  • Minimising waste sent to landfill and encouraging waste prevention, reuse and recycling.
  • Increasing environmental awareness of staff through training and internal communications.

Signed:
S.P FitzGerald
Print: Dr. S. Peter FitzGerald
Managing Director

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