Our Policies

QUALITY MANUAL Demonstration of compliance with ISO 13485: 2016 RANDOX LABORATORIES LTD. & RANDOX TEORANTA & RANDOX TOXICOLOGY
QUALITY SYSTEM ELEMENT MANAGEMENT REPONSIBILITY	SECTION 5.0
Revision 31	Date Effective 17 February 2025

Quality Control Policy

The Quality Policy is endorsed by the Senior Management Team and signed by the Managing Director. The Quality Policy reflects the commitment of Randox to:

• Comply with Statutory and applicable Regulatory requirements.
• Meet customer expectations.
• Maintain the effectiveness of the Quality Management System.

The Quality Policy provides the basis for establishing quality objectives, which are compliant with applicable regulatory requirements, to operate a quality improvement programme to enhance customer satisfaction and ensure on-time delivery of product. The Quality Policy is posted on the intranet of the Organisation and is displayed on bulletin boards across all sites of operation. The quality policy is reviewed annually as part of the QMS Review meeting to ensure continuing suitability.

Randox Laboratories Limited, Randox Teoranta and Randox Toxicology 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.

The management of Randox Laboratories Limited, Randox Teoranta and Randox Toxicology 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, Randox Teoranta and Randox Toxicology operate a Quality System, which is in conformance with the requirements of ISO 13485 and complies with all applicable regulatory requirements.

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, sustaining the profitability of the company and ensuring that we meet customer expectations in conformance with ISO 13485 and all applicable regulatory 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