Quality Policy. JRI Orthopaedics Limited

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1 JRI Orthopaedics Limited October 2014

2 Contents Clause 1. Policy statement 1 2. Who is covered by the policy? 2 3. Organisation and Responsibilities 2 4. Training and Communication 4 5. Suppliers 4 6. Monitoring and review 4 Appendix 1 Amendment Record 5 October 2014

3 1. Policy statement 1.1 All employees at JRI must focus upon the needs of patients to ensure that we can provide the best solutions for joint repair and replacement. The quality of the products and services we deliver has a significant effect on patients and their quality of life. 1.2 It is JRI s policy to operate an Integrated Management System that sets out an organisational structure, systems, procedures and detailed work instructions to ensure that we deliver products and services of the highest quality, with careful regard for the environment, health and safety. We do this by ensuring that all reasonable measures are taken to manage quality aspects during the design, manufacture and distribution of orthopaedic products. 1.3 JRI will comply with all National and International applicable and relevant statutory requirements and all relevant codes of practice such as the European Commission Medical Device Directive. Furthermore, the Company will demonstrate continuous improvement in quality assurance in all business activities through compliance with the international standards for quality management systems such as ISO 9001, ISO 13485, 21 CFR Part 820 and RDC 16:2013 that includes the setting of measurable objectives. 1.4 The purpose of this policy is to: (a) set out our responsibilities, and of those working for the Company, in observing and upholding the Company s reputation through the quality of its products and services; and (b) provide information and guidance to those working for the Company on how to prevent, recognise and deal with anything which might have a potential impact upon the quality of JRI s products or services; and (c) set out a commitment to maintain the effectiveness of the management system. 1.5 We have identified that the following are particular risks for our business: Ensuring that all products are appropriately designed, tested and fit for purpose Ensuring that products are precision manufactured with the required levels of accuracy, especially mating components October

4 Ensuring that all products are cleaned correctly and that implants are supplied sterile packed Ensuring that all products have the required regulatory approvals that permit use in our target markets Ensuring that the correct products are supplied to hospitals, in optimum condition, so that they have exactly what they need, when they need it, to perform surgery To address those risks we: Follow robust design procedures that include risk assessments Develop standard operating procedures that define our manufacturing processes and controls and include precision measurement Conduct process validation studies to confirm that process parameters are optimised and consistently applied to control product quality Develop standard operating procedures that define our customer service activities, controls and customer communications Train employees on processes that are critical to product and service quality Conduct regular quality audits Implement corrective and preventative actions 2 Who is covered by the policy? This policy applies to all individuals working at all levels and grades, including all directors, managers, employees (whether permanent, fixed-term or temporary), consultants, contractors, trainees, seconded staff, homeworkers, casual workers and agency staff, volunteers, interns, agents, or any other person visiting our premises, wherever located (collectively referred to as workers in this policy). 3 Organisation and Responsibilities 3.1 The arrangements made to implement this policy are defined and documented in the Company Integrated Management System and in Departmental Work Instructions. The allocation of duties and responsibilities for quality matters and lines of reporting are defined in the Company Integrated Management System (IMS) Manual sections 2 and 3. October

5 3.2 JRI management will do everything that is reasonably practicable to: (a) ensure that all employees are customer focused and understand the importance of product quality for the Company to protect and develop its reputation (b) resolve any customer complaints promptly and to the satisfaction of the customer, implementing corrective and preventative actions (c) ensure that a culture of continuous improvement is developed, involving all employees in the generation and implementation of initiatives and that achievements are measured and reported (d) ensure that a regular programme of internal and external audits are carried out to review our procedures and controls and to identify and implement improvements to our systems to enhance quality and pursue excellence (e) provide information, instruction, training and supervision to safeguard quality (f) provide and maintain plant, equipment, and systems of work that work from, not to, quality standards and maximize the quality of our products and services (g) ensure that specific business improvement objectives are achieved, which are identified in JRI s strategic plan and described in the JRI operational plan. 3.3 You must ensure that you read, understand and comply with this policy. 3.4 Every employee has a responsibility to focus on patients needs, enhancing the quality of our products and service to protect patients and the Company s reputation. 3.5 Every employee has a clear duty to take all reasonable steps to safeguard quality by their acts or omissions during the course of their work. All employees shall follow procedures and instructions diligently, must maintain good housekeeping practices and work with care. 3.6 It is the responsibility of all those working for us or under our control to prevent, detect and report quality issues in the work place as soon as possible to their immediate superior. Every worker is expected to make recommendations for improvements. 3.7 Any employee who breaches this policy will face disciplinary action, which could result in dismissal for gross misconduct. We reserve the right to terminate our contractual relationship with other workers if they breach this policy. October

6 4. Training and Communication 4.1 This policy is on view on notice boards in all Company locations and on the Company website Management will ensure that all information, instruction, training and leadership necessary to ensure quality management are provided for all employees. Training on quality issues is an essential part of employee induction for new employees and for employees that are moving to a new work place or role. Regular training on quality procedures and quality controls will be provided to all employees. 4.3 Managers and Team Leaders will encourage and promote the cooperation of employees by consultation and discussion with them on a regular basis. 5. Suppliers JRI considers its relationships with suppliers to be one of partnership; working together sharing values, goals, resources and learning. We will encourage them continually to improve the quality of the materials and services that they provide to us. Moreover, it is our policy wherever practicable to work with suppliers that have active quality management programmes, demonstrate continuous improvement in that regard and are accredited to known and recognized international management system standards such as ISO 9001 and ISO Monitoring and Review It is the responsibility of all employees to constantly review the effectiveness of our integrated management system and to identify opportunities for continuous improvement to refine our systems and procedures to ensure that quality of the highest standard is always achieved, now and in the future. This policy will be reviewed for continued suitability at the annual Management Review Meeting and any recommendations for changes will be made to the Audit, Risk and Policy Committee of the Board. Mr K R Jackson Managing Director JRl Orthopaedics Ltd October

7 Appendix 1 Amendment Record Date Section Amendment New issue date 09/09/14 All Changed date to October 2014 throughout the document Oct /09/ RDC 59/2000 changed to RDC 16:2013 Oct 2014 October

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