Plans are in operation through documented procedures to ensure that all repairs and maintenance services carried out by the EBME Department reaches the requirements of the customer, that all staff are aware of the requirements of the quality system and that random sampling is carried out on the elements of the quality system to ensure that continual improvement is being maintained.


The EBME Department will continually monitor feedback from the customer. The Authorised Senior Manager or the EBME Manager will hold meetings with both the Trust and Customers and document this process while the EBME Manager will interact regularly with customers and review service and standards and will monitor the customer's perception of whether their requirements have been met. The Quality Assurance Manager will review all customer feedback processes and make recommendations to senior management where appropriate.


8.2.2 Internal audit

An audit of each section of the Quality manual takes place annually, or more frequently should any activity require it, to ensure that Quality performance meets customer requirements. An audit schedule will be prepared and distributed in advance by the Quality Assurance Manager as part of Quality planning. Internal Auditors will be trained to carry out the work planned in the audit schedules.


Audit reports and non-conformances will be analysed by the Quality Assurance Manager and action taken to eliminate causes of non-conformances and further action to ensure that improvements are made to the system. It is the responsibility of the Quality Assurance Manager to implement these procedures. Auditors will not audit their own responsibilities. Thus audits will be independent and unbiased. Audits will be evaluated at Management Review Meetings and at internal communication meetings.


8.2.3 Measurement and monitoring of processes

To ensure that the standard of workmanship carried out and the associated services meets the requirements of the customer, all EBME processes are monitored by competent personnel to ensure that conformity is maintained. Where products fail to pass final inspection and testing, the product will be re-appraised for further work or disposal.


The Department will however monitor and analyse the following areas and produce trends for Management Review in:


8.2.4 Measurement and monitoring of finished product and service

When it is necessary, meeting customer deadlines is monitored, and where appropriate, customers are kept up to date with information regarding the progress of the service. The progress of work is continually monitored by experienced personnel throughout all intermediate stages and product release is documented electronically.


If the request is in the form of a contract, contingency plans are brought into operation if the original contract cannot be met. Nevertheless contractual obligations will always be maintained and these plans will be communicated to the customer.


The product will not be released to the customer until all monitoring and measuring tests have been completed, and where appropriate release is authorised. Non-conforming equipment needed for an emergency may be released under concession, provided that the approval of the EBME Manager or Chief Technician has been obtained and the customer signs a concession form. However sampling is carried out by senior personnel on completed work.


The Quality Assurance Manager will establish, document and maintain procedures to ensure that non-conforming products and services are easily recognised, isolated and prevented from inadvertent use. These procedures state the methods of segregation and responsibility for authorising the disposition of all non-conforming products, and the corrective actions taken to prevent reoccurrence. Non-conformances include mistakes, errors and workmanship which fails to reach the required standard.

This procedure applies to the following operations:
  • Faulty received goods.
  • Checking equipment for serviceability
  • Disposal of items which are considered no longer serviceable or beyond repair.
  • Customer Complaints and feedback.
  • Internal Audit process.
  • Equipment taken into the workshop(or on site) which has been rejected as either not up to standard during the process or needing repair.


Care is taken to ensure that all non-conforming items are adequately segregated and in most areas marked to prevent inadvertent use. Stores, upon receipt are inspected for non-conformances. Any non-conformances are notified to the supplier immediately and corrective action taken.


During the various phases of repair, constant monitoring ensures that all non-conformances are acted upon immediately. Action will be taken to ensure that equipment which does not reach satisfactory customer requirements is not returned to the customer. Equipment found to be non conforming will not be released until fully validated.


Records are retained of all serious non-conformances. Less serious non-conformances are handled verbally. In the unlikely event that the customer requires delivery of a non conforming product for emergencies, it will be released under concession.


The Quality Assurance Manager will determine, collect and analyse appropriate data to demonstrate the suitability and effectiveness of the quality management system and will analyse where continual improvement of the effectiveness of the quality management system can be made. This shall include data generated as a result of monitoring and measurement and from other relevant sources.

The analysis of data shall provide information relating to
  • customer satisfaction (see 8.2.1),
  • ensuring the product and service conforms (see 7.2.1),
  • characteristics and trends of processes and products including opportunities for preventive action,
  • suppliers.

Using measurements received and valid data analysed from various sources, the performance of the EBME Department will therefore be analysed and appropriate action taken to redefine plans, objectives and processes. The EBME Manager will analyse the data to determine trends, customer satisfaction, effectiveness and efficiency, success of objectives, financial benefits and competitiveness.


8.5.1 Continual improvement

By continually monitoring the Quality System, trends and analysis, the Quality Assurance Manager will recommend improvements through the use of the policy, updating objectives, audit results, data analysis, corrective and preventive action and management review. Improvements will be continual. The EBME Manager will evaluate these recommendations and update the system appropriately.


8.5.2 Corrective action

The Quality Assurance Manager will establish, document and maintain procedures to ensure that non-conforming services are systematically identified and investigated. Action is taken to prevent reoccurrence. Corrective action is seen to be reactive. In taking action to prevent re-occurrence, Quality Assurance Manager will thoroughly investigate the reasons for non conformances, and then ensure that the corrective actions are meaningful, recorded and monitored as an ongoing process for trend analysis.

The procedure will include:
  • reviewing nonconformities (including customer complaints),
  • determining the causes of nonconformities,
  • evaluating the need for action to ensure that nonconformities do not recur
  • determining and implementing action needed,
  • records of the results of action taken (see 4.2.4),
  • reviewing corrective action taken.


8.5.3 Preventive action

This is the proactive analysis of the processes, whereas corrective action is the re-active action to be taken when problems arise. The process of eliminating causes of potential non conformities is the responsibility of all Biomedical Engineering Technicians while the Quality Assurance Manager will ensure that these are documented and take appropriate proactive action. The Quality Assurance Manager will implement processes which will show that continual (not continuous) improvements are made.


Customer complaints are individually handled by the EBME Manager or the Authorised Senior Manager. The Quality Assurance Manager will monitor this process and ensure that action is taken to eliminate the causes. All customer complaints are logged. The Quality Assurance Manager will monitor all customer complaints. Audit reports are used to eliminate potential problems, and controls are applied to ensure that the system works. Any action taken is discussed at the Management review meeting



John Sandham - 30/09/2014




Like what you see?

Hit the buttons below to follow us, you won't regret it...