Current issue of QMS High Level Documentation & Appendix is due for review. Please can you review below and suggest any admendments.

Clause 4.1 Understanding the Organisation and its Context

The boundaries of the QMS scope are defined as the management and maintenance of medical devices that fall under our remit within our Trust and SLA. However we have declared that clause 8.3 of the International Standard is not applicable to our business service within our QMS scope, as the Medical Engineering Department does not carry out or provide any design or development for products or services. The omission of clause 8.3 from our QMS scope in no way affects our organisations ability or responsibility to ensure the conformity of our products and services. Our primary objective is to deliver a quality and professional service to meet the requirements of our QMS or the needs and expectations of interested parties.

The Medical Engineering Department is also responsible for managing the majority of external maintenance contracts for medical, laboratory and imaging equipment. The main functions of the department are:

• Overall management of medical devices throughout their life cycle.
• Manage, negotiate, monitor and raise external maintenance contracts for medical, laboratory and imaging equipment contracts.
• Involved in the Capital Equipment Replacement/New Programme.
• Provide full management service to external Trusts within the Birmingham region.
• Develop and review Trust policies.
• Provide clinical training to all clinical users.
• Involved in the standardisation of medical devices.
• Provide an apprenticeship scheme for trainee medical engineers.
• Liaise closely with the Department of Health (DOH) and the Medicines and Healthcare products Regulatory Agency (MHRA).
• Carry out first line and planned preventative maintenance of all medical devices.
• Advise clinical areas and the Procurement department on new medical device purchases and maintenance requirements.
• Carrying out Risk Assessment on medical devices.
• Determine, monitor and review information concerning internal and external issues.
• Manage the Equipment Store services to the Trust in relation to Pressure Relieving Equipment and Infusion Devices.

Due to our continuing drive for excellence, the Medical Engineering Department has decided that a systematic approach to Quality Assurance is essential for a professional and reliable service delivery. Accordingly, the Medical Engineering Department will operate a Quality Assurance System to the standard BS. EN. ISO 9001:2015, which will be verified by a recognised Certification body. This will provide both Quality Assurance for the customers and an effective quality management for the Medical Engineering Department.

To meet these requirements, the Department has undertaken the process of accreditation under ISO 9001: 2015. In fulfilling the requirements of ISO 9001: 2015 we utilise documented Quality Procedures and Processes supported by associated Work Instructions.

STATEMENT OF POLICY

The policy of the Medical Engineering Department is to provide a managed medical equipment service to all customers which includes the maintenance, service, repair, provision of devices and consultancy service that is professional and maintains the highest standards of workmanship.

Hospital wards and departments, clinics and patients throughout the University Hospitals Birmingham NHS Trust are all regarded as our customers together with any external companies, Trusts or departments under contract.

Our objectives will be reviewed during Departmental, Team Managers and Management Review Meetings to ensure that we provide our customers with an efficient, well-organised yet economical Medical Engineering Department, adopting good workshop practices and techniques.

Consequently, a system has been adopted which is structured in such a way as to comply with the requirements of the Quality Standard ISO: 9001:2015.

The Trust Medical Engineering Manager has full authority and responsibility for the Quality System and for the very highest standards of workmanship. In addition, he/she will initiate all corrective action and is required to represent the Department in all Quality matters. Our aim is to maintain continual improvements to the system we use and to the service we provide.

The maintenance of this standard and the total commitment to this policy is an integral part of the role of each member of the Department. In addition to implementing this Policy, the Managers and all Medical Engineering Staff fully support these aims and objectives.

Quality Information	Evidence	Record / Document Reference
Scope of Organisation	QMS HL Doc	QMS HL Doc
Risks & Opportunities	Trust Risk Registers	Trust Medical Engineering Manager Doc
Internal / External Issues	QMS HL Doc & Management Review meetings & Team Manager & Departmental Meeting meetings	Management Review / Team Manager / Department Meetings Email doc
Interested Parties: Trust/patients/wards/ employees/ external contractors etc.	QMS HL Doc & Management Review meetings & Team Manager & Departmental Meeting meetings	Management Review / Team Manager / Department Meetings Email doc
Service Planning	Management Review meetings & Team Manager & Departmental Meeting meetings	Management Review / Team Manager / Department Meetings Email doc