5.1 RESPONSIBILITY, AUTHORITY & COMMUNICATION
Authorised Senior Manager
The Authorised Senior Manager is ultimately responsible for ensuring that the Quality System associated with the EBME Department functions correctly and is committed to ensuring that customer requirements are met and hence for the implementation and maintenance of the Quality policy and the continued implementation of the QMS. He ensures that manpower and resources are made available to satisfactorily meet the requirements of the Quality Standard. He is responsible for the smooth running and operation of the Department.
5.2 CUSTOMER FOCUS
He is responsible for ensuring that the Quality System is reviewed at regular intervals.
He will set annual objectives for the EBME Manager which will include reference to customer focus ensuring that requirements are not only determined but met, thus maintaining customer satisfaction.
5.3 QUALITY POLICY - STATEMENT OF POLICY
The policy of the EBME Department is to provide a maintenance, repair and consultancy service to all customers that is both professional and maintains the highest standard of workmanship. Hospital, wards and departments, clinics and patients throughout the Hospital are all regarded as our customers together with any external companies or departments under contract. Our objectives are to provide our customers with an efficient, well-organised yet economical EBME Department adopting good workshop practice techniques. Consequently, a system has been adopted which is structured in such a way as to comply with the requirements of Quality Standard ISO 9001 : 2000.
The EBME Manager has full authority and responsibility for the Quality System described in parts 1, 2 and 3 of this manual and for the very highest standards of workmanship. In addition he will initiate all corrective action and are required to represent the Department in all Quality matters. Our aim is on continual improvement.
The maintenance of this standard and total commitment to this policy is communicated to all staff, and an integral part of the role of each member of the department. In addition to implementing this Policy, the Managers and all technologist staff fully support the goals and objectives.
5.4.1 QUALITY RELATED OBJECTIVES
The objectives of EBME Department are to provide a service to the customer that is based on continual measurable improvement in the service provided. Improvement will be measured by sampling customer feedback regularly over three month periods, analysing trends and carrying out appropriate action to maintain improvement.
- Provide objective evidence that services conform to specified requirements.
- Ensure that requirements are determined and satisfied throughout all stages of the workshop process.
- Develop and maintain Quality consciousness amongst management, staff and sub contractors.
5.4.2 Quality Management System planning
Planning the Quality Management system will be carried out to meet the requirements of the Quality Objectives. This manual and the associated processes and procedures will be updated appropriately.
5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION
5.5.1 EBME Manager
The EBME Manager is responsible for the smooth running and operation of the EBME Department. He reports directly to the Authorised Senior Manager in all work related issues. He is also fully responsible for the Quality function within the Department and hence for the implementation and maintenance of the QMS: 2000 within the Department, purchase of stock and spares, ensuring contracts are met and appropriately reviewed and verifying personnel and resources. He is responsible for planning and organising the Quality function with the support of a team of Technologists and clerical staff who carry out the day-to-day running and administration of the department. He will carry out an efficient EBME service to a range of Hospitals, Trusts and Private Sector Customers. He will be responsible for ensuring that all personnel are adequately trained and for ensuring that Good Workshop Practice techniques are implemented.
He is responsible for ensuring that the EBME operational processing complies with any Department of Health Guidelines. He will comply with appropriate MHRA documentation, comply with hazard warnings and safety bulletins and he will enforce strict Health and Safety controls. He will monitor the PPM process and report any irregularities to the Authorised Senior Manager.
He will ensure that staff are adequately trained and will personally represent the Department in Management issues. In addition he is responsible for Quality Planning (which includes provision of and updating of these manuals, resource allocation, controls, processes and skills within the EBME department) and with the Authorised Senior Manager for ensuring that the Quality System is reviewed at regular intervals. He will meet annual objectives set for the department and set appropriate objectives for all other technologists. He will ensure that resources exist for auditing the system and for taking action as appropriate. He will also ensure that communications are maintained at all levels of the Department on the importance of meeting customer, statutory and regulatory requirements.
The Chief technologist will assist the EBME Manager in running the total EBME Processing operation. He oversees the Technologists. He oversees the day-to-day running of the workshop and ensures that the workmanship of the biomedical staff is of the highest standards and carries out on the job training for new and less experienced employees. He acts as Quality Assurance Manager in the absence of the EBME Manager
It is the responsibility of the EBME technical staff to maintain the highest standards or workmanship appropriate to a professional workshop operation. Good workshop practice techniques are paramount. This includes ensuring that all documentation and paperwork are completed satisfactorily, equipment is correctly labelled and stored appropriately, the correct test equipment and tools are utilised, work benches are efficient, one piece of equipment is worked on at any one time, manuals are kept up to date, training is meaningful, non conforming products and parts are segregated and labelled and that the workshop indicates an area of efficiency and professionalism.
Clerical Assistant/Quality co-ordinator
The Clerical Assistant/Quality Co-ordinator reports directly to the EBME Manager and is responsible for maintaining the department's databases and for ensuring that the Department's operational computer system operates and functions to meet the needs of the department. The Clerical Assistant/Quality Co-ordinator ensures that all work is entered onto the database and is aware of the job status of any particular piece of equipment while in the department and will interface with the customer when appropriate and ensure that customer queries (not complaints) are answered appropriately. He/She will follow up on ordered stores and stock for jobs awaiting spares and ensure that the biomedical staff are kept up to date with orders (or delays) She will assist the Quality Assurance Manager in running the administration side of the Quality system.
5.5.2 Management Representative
The EBME/Quality Assurance Manager is the Management Representative for Quality. He has the responsibility and authority for the implementation, co-ordination and delegation of Quality throughout the department and personally monitors customer requirements and complaints and takes any necessary action. He takes responsibility for all Quality related matters, including the identification, recording and solving any Quality problems.
The Quality Assurance Manager will establish, implement and maintain all Quality aspects relating to ISO 9001:2000. This includes total responsibility for all aspects of Quality assurance including, the maintenance of the Quality Assurance Manual and system, plus the issuing of all amendments and liaison with outside bodies on all Quality Assurance matters.
He is also responsible for the identification, investigation and documentation of all non-conformance's, plus the initiation and implementation of action to prevent recurrence of non-conformance's and the implementation of Quality related solutions.
He is also responsible for ensuring that non-conforming processes are controlled and corrected. He will analyse the system and report on the overall performance and suggest improvements at Management Review Meetings
5.5.3 Internal Communication
The EBME Manager will hold regular communications meetings if and when appropriate with the objective of improving customer satisfaction by reviewing aspects of the service being provided, initiate improvements and demonstrate commitment to the Quality system and ensuring that legal and statutory are being complied with. The Quality Assurance Manager will take any appropriate Quality related action as the result of these meetings.
5.6 MANAGEMENT REVIEW
The Quality Assurance Manager will establish, document and maintain processes or procedures to ensure that the Quality system is meeting its objectives. Consideration will always be given to ensure that the policy is reviewed and all necessary changes are made.
A Management Review meeting is conducted regularly which is concerned with every aspect of the Quality system. It will be documented and will include Customer Complaints, Customer satisfaction (and dissatisfaction), Training, Suppliers, Changes to the system and Standard, Audits, Quality, Contract changes, improvements and where appropriate, trend analysis. Actions to maintain improvement will also be documented.
5.6.2 Review Input
Information on review input will be documented in the associated procedure.
5.6.3 Review Output
Improvements and resources required to maintain continual improvement are documented in the appropriate procedure. Associated procedure
EBME 1 Management review
EBME 7 Non conformances and customer Complaints
EBME 10 Corrective and preventive Action