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Quality Policy

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

Environmental Policy

August 2022

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 Laboratories 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.
  • Enhancing environmental performance through use of environmental objectives and targets and continually improving our Environmental Management System (EMS).
  • Integrating the EMS throughout all business processes.
  • Sustainable procurement of raw materials, equipment, and energy supply.
  • Considering life cycle environmental requirements during procurement, design and development of products and services.
  • Preventing waste being 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

 

Tax Policy

Randox Holdings Limited:  Tax Strategy

Randox is one of the largest diagnostics companies in the world and has a significant and expanding presence in a number of territories. This tax strategy is aligned with the Group’s values and commitment to meeting high ethical standards and observing all applicable local, national, and international laws wherever it does business.

This document sets out the tax strategy for Randox Holdings Limited and its subsidiaries (“Randox”, “the Group”) as required by Part 2 Schedule 19 of Finance Act 2016. The document is effective for the year ending 30 June 2022 and will be periodically reviewed and updated. All international companies within the Randox group are subject to the same strategy.

The document outlines the Group’s policy and approach to conducting its tax affairs and dealing with tax risk. The strategy applies to UK taxation, including corporation tax, indirect taxes (including customs and excise duties) and employment taxes which are payable and reportable to HM Revenue & Customs (HMRC).

The strategy is consistent with the Randox Code of Ethics, which sets out Randox’s approach to responsible and ethical business behavior, and has been approved by the Board of Directors.

Randox’s overall tax strategy is to ensure that it complies with all tax laws and that it pays all taxes that it is legally required to pay as and when they fall due. All entities within the global Randox Group, and its branches around the world, file UK corporation tax returns.

Management of tax risks

The Group is led by the Board of Directors, supported by a strong senior management team, which is responsible for the Group’s overall strategy and governance.

The Group’s experienced finance team, in conjunction with appropriate support from external advisors, ensure that:

  • The tax strategy is adopted and followed consistently across the Group, with clear lines of responsibility and accountability;
  • There is alignment of the strategy with the Group’s overall approach to corporate governance and risk management; and
  • The Group pays the correct amount of tax required of it as determined by law.

The Board of Directors considers sufficient controls and processes are in place to deliver the Group’s tax strategy.

 

Attitude to tax planning

The Group uses tax incentives and reliefs where appropriate and where doing so is aligned to the intention of the relevant legislation and the Group’s commercial activity.

The Group does not participate in any artificial or contrived tax planning arrangements that are not commercially driven and that do not comply with either the letter, or the spirit, of the relevant tax legislation.

The global group structure includes entities and branches in a number of jurisdictions outside the UK, including the holding company for the UK Group, Randox (IOM) Limited.  However, all group entities are treated as UK resident for corporation tax purposes.

Randox seeks support from professional advisors when tax matters arise that meet the following criteria:

  • They are sufficiently complex or material to the Group,
  • Where there is a significant degree of tax uncertainty,
  • The available published guidance from tax authorities is unclear, or
  • There is not the in-house expertise or knowledge to adequately assess the tax risks and consequences of transactions under consideration.

 

The level of risk the Group is prepared to accept for UK taxation

Randox has a very low appetite for tax risk and seeks to mitigate tax risk by ensuring that it complies with its tax obligations in full.

The complexity of tax legislation in the UK and around the world means that there can often be uncertainty or scope for interpretation within the rules.  As far as possible the Group seeks to reduce this inherent risk by seeking professional advice in a timely way wherever appropriate, and seeking approval from the relevant tax authorities where possible.

The Group’s tax strategy ensures that all transactions undertaken by the Group are commercially driven, and not entered into in order to secure a tax advantage.  and always undertaken with the intent to comply with all relevant and applicable tax laws.

 

Working with HMRC

HMRC has not allocated a Customer Compliance Manager to the Group. Therefore, interactions with HMRC are usually instigated by the Group where necessary.  However, the Group routinely works with HMRC to overcome any points of uncertainty and is committed to cooperation and transparency in its dealings with tax authorities in respect of all relevant taxes and duties.

This tax strategy was approved by the Directors of Randox Holdings Limited on 6 June 2022.

Sustainability Policy

Sustainability Policy

August 2022

Randox is an international clinical diagnostics company, manufacturing in-vitro diagnostic reagents, quality control materials and clinical chemistry and immunoassay analysers. Distributing to over 130 countries, Randox has the opportunity to positively influence and impact on a global scale.

We believe our business activities must be aligned with and adopt the principles of sustainable development and environmental stewardship in order to allow business development whilst protecting the environment, conserving valuable resources and ensuring a positive legacy for future generations.

We recognise that our activities can impact on the environment, and we are committed to reducing these. By incorporating sustainable development into business activities, it allows us to further build and strengthen customer and supplier relationships.

Randox Laboratories is committed to:

  • Protecting the environment and preventing pollution.
  • Fulfilling our compliance obligations.
  • Enhancing our environmental performance through the implementation and continual improvement of our Environmental Management System.
  • Promoting the sourcing of environmentally friendly products during procurement.
  • Minimising waste and following the waste hierarchy (reduce, recycle, dispose).
  • Engaging and communicating with staff to improve awareness of sustainability and good environmental practice.
  • Promoting energy efficiency measures for improved resource efficiency and purchasing electricity from suppliers with commitment to renewable energy.
  • Reducing paper consumption and using electronic alternatives where practicable.
  • Continually reviewing practices to identify inefficiencies improve processes and conserve resources.

 

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

Energy Management Policy

Energy Management Policy

August 2022

As part of our overall environmental strategy and management system Randox seek to manage energy consumption responsibly, promote energy efficiency throughout the organisation and reduce energy use where possible. We aim to create a culture of improvement within the company where all staff take responsibility for energy management, carbon emissions and the resulting environmental impacts associated with global climate change.

Under the policy energy management will play a key role in protecting the environment, reducing negative environmental impacts, identifying inefficient processes and improving Randox environmental performance.

 

Randox Laboratories is committed to:

  • Reducing carbon emissions.
  • Investigating the use of energy efficient alternatives and technologies.
  • Reducing energy costs.
  • Sourcing electricity from environmentally sustainable and renewable sources.
  • Engaging with staff, promoting awareness, and encouraging energy efficient behaviour.
  • Measuring and monitoring energy consumption and identifying areas for improvement.
  • Managing building heating and cooling to ensure room temperature is maintained at an optimum level.
  • Complying with applicable energy laws, regulations, and codes of Practice.

 

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

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