Company Quality Policy Statement

ROBER LIMITED is a company based in Chesterfield, UK that develops and manufactures medical devices that are sold in the UK, European Union, Australia and emerging markets (ROW).
It is the absolute policy of the company to provide products that fully and consistently meet the agreed requirements of our customers and ensure that products are manufactured to defined standards of content and fitness for purpose.
To demonstrate to both customer and staff the company commitment to quality, it is the policy of the company to achieve and maintain recognition as a company of assessed quality capability under the requirements of: BS EN ISO 13485-2016, EU Medical Devices Directive 93/42/EEC, and EU MDR 2017/745 Regulation.

We will strive for continual improvement in all areas of operation. The Quality Policy of the company is implemented through the operation of the Company Management System. The methods of ensuring that standards are consistently implemented are contained in the document procedures. They are mandatory for all company personnel and no
unauthorised alterations or deviations are permitted. It is the responsibility of every employee to identify any element, which is detrimental to our policy.
It is that person’s responsibility to take action to remedy the situation by bringing it to the attention of those directly accountable for the specific function and also bringing it to the attention of the Company’s executive management.
Quality Objectives are established at a company level to assist in the necessary process of Continual Improvement in company management in general and quality matters in particular.
It is the responsibility of the Managing Director to co-ordinate matters such that relevant personnel throughout the company organisation are aware of company objectives and that these are reviewed during management review.
The company is committed to consistently meeting customer requirements and expectations and regulatory requirements, by working from a risk based approach ensuring delivery of products that meet or exceed relevant harmonised quality standards. It is the responsibility of Senior Management to ensure that the Quality Policy is implemented and referenced within both training and induction packs for new hires.

The Senior Management team will:
• Implement and maintain a formal QMS
• Ensure these requirements are always met
• Review the quality manual at least annually to ensure the objectives are appropriate and that it is effective and suitable
• Ensure the quality manual is communicated and understood by all employees, contractors and critical suppliers to ensure a culture committed to quality
• Training and development of all of our staff