Quality and Environmental Issues

The Company Objective at TayCare Medical Ltd is that all products will be manufactured to the standards required for the supply of orthoses to the N.H.S, and that we meet or better target dates.

What does this mean for our patients?

You can be assured that your orthoses is manufactured to the highest standard and the criteria for your product/orthoses is met. Your product will be made by a team of skilled technician, using the highest quality materials and the environment it is made in is clean .

To achieve this major objective it is the management policy that a Total Quality Assurance approach is utilised throughout all company activities and that a high degree of Quality consciousness is encouraged through all levels of Personnel Staff. It is the belief that the quality of products manufactured, and the prevention of waste in the use of materials, production time and individual effort are essential to the creation and continuation of successful business.

This policy is reflected in the commitment of the company to ensure that in addition to satisfying appropriate technical requirements for the supply to the N.H.S the minimum standards of Quality Assurance acceptable are those defined in EN ISO 9001:2000. It is mandatory that the documentation system described and identified in the Company Quality procedures are understood, implemented and maintained by all the Company personnel. Each technician checks the product once manufactured and then again in the Quality Control and Inspection department. Any product that does not conform to the process will be withdrawn and then rectified. These products that do not conform to the correct standard will be brought to the attention of both the Production Manager and the Quality Control Manager to make a decision on how to proceed. Any trends will be discussed at Management Review.

The solutions adopted by TayCare Medical Ltd for design and construction of the products conform to safety principles, taking account of generally acknowledged state of art.

In selecting the most appropriate solutions TayCare Medical applies the following principles in the following order

• Will work to the statutory and regulatory requirements as defined in EC Directive 93/42/EEC Medical Devices Regulations 2002
• Will ensure that all our Customers requirements are fully understood and entirely satisfied
• Eliminate or reduce risks as far as possible (inherently safe design and construction)
• Where appropriate, take adequate protection measures including alarms if necessary in relation to tasks that cannot be eliminated
• Inform users of the residual risks due to any shortcomings of the production measures adopted
• Will involve all staff in the continuous commitment for the improvement quality management system through on going training

Quality Objectives

The management shall ensure that quality objectives including those needed to meet requirements for products are established at all relevant levels and functions within the company. They shall be measurable and consistent with the quality policy.

The management shall consider

• Current and future needs of the company and the markets involved
• Findings that are relevant from Management Review
• Satisfaction of interested parties
• Self assessment results
• Benchmarking opportunities for improvement
• Resources needed to reach objectives

The management is responsible for ensuring the setting up of the Quality System in accordance with requirements ISO9001:2000. They shall ensure that there is a planned approach when undertaking any changes to the quality system. Management review shall be carried out to check on performance. Day to day matters will be discussed and passed on to the management.

All staff are made aware of the quality objectives and their part in what is required. Competence shall be determined for specific requirements showing qualifications and experience. Training records are kept for all staff.

The Management regularly hold review meetings for both all general matters and also every 6 months we hold a Quality Review meeting.

We also hold internal training sessions every 6 months for our technicians. The sessions are hosted by our Orthotists and we cover a range of topics. These sessions have proved hugely successful and it gives the opportunity for our technicians to understand how the Orthotist undertakes a clinical assessment and to gain a greater understanding of how the orthoses work and how it improves the patients well being.

Environmental Policy

We all know about the current concerns with global warming and we aim to do our part for the environment.

Our environmental policy sets out the principle and standards for the company, which all employees must comply with.

Improvement in its environmental impact

The aim is to work towards continuous improvement in environmental management and performance by employees and to encourage support from customers.

Approach to the environment is guided by a number of principles with which all personnel are required to comply.

Principles

• Senior management sets out the responsibility for environmental performance and develops and maintains an adequate system of management, measurement and improvements.
• All actions comply with relevant regulations.
• Business is conducted with due regard to the environment, its habitats and biodiversity.
• The business operations are regularly assessed for compliance with policy, performance and achievement of targets.
• Environment considerations are taken into account in all major business decisions.
• Employees are encouraged to work in an environmentally responsible manner.
• Suppliers are encouraged to operate in an environmentally responsible manner and such encouragement is made a condition of any supply.
• Where appropriate, encourage support from customers by providing them with products and services that are environmentally responsible in use.
• Customers are made aware of all environmental policies in the specific areas where they are in direct contact.
• The company reports annually on environmental management.