4. GUIDE TO QUALITY MANAGEMENT SYSTEMS
4.1 GENERALThe processes, sequence and interaction plus any resources needed to efficiently run the EBME Department are described throughout this manual. By monitoring, measuring and analysing, controls are in operation throughout the system to ensure that satisfactory performance is achieved. These are directed towards continual improvement.
4.2 DOCUMENTATION4.2.1. General
A statement of Policy is included in this manual that will be made known to all personnel in the department. Any sub contractors will also be made aware of the Policy statement. The long-term objectives of the department are produced and will be reviewed and updated as the need arises. A list of procedures to supplement this manual is documented. The associated documents are recorded in the associated procedure. Appropriate records are maintained.
4.2.2 Quality Manual.The scope of this Quality System is designed to meet the objectives specified to meet the contractual requirements of the Department in providing a reliable, economical and efficient biomedical engineering service and to ensure that the Policy Statement of this manual is implemented at all levels within the department. It is also designed to ensure that the procedures, processes, and quality planning, of which this Quality Manual forms an integral part, meets the requirements of the QMS for customer.
The Quality ManualThe Quality Manual has been designed in three parts, the Policy Manual and the Processes and Procedures Manual supplemented by any appropriate Work Instructions. The Quality Manual specifies the system and procedures by which the Quality policy and objectives are met. It forms the major part of Quality planning in that all operations within the Department that affect Quality have procedures. It is intended to serve as a guide and also as a basic reference. It will be amended and developed as the need arises.
Distribution of the Quality ManualAlthough all employees are responsible to a greater or lesser extent for Quality it is not necessary to provide everybody in the Department with a copy of the Quality Manual. It is the responsibility of the Quality Assurance Manager to ensure that employees, including sub contractors are familiar with those parts of the manual for which they have responsibility.
Amendments to Quality Manual/DocumentsLists and Master copies of all Quality related documents, including the current revision list are held by the Quality Assurance Manager. All Quality related documents are numbered. The Department Manager is responsible for the authorization, issue, approval, review, layout and presentation of all data, forms and documents plus the safe custody of manufacturer's literature and appropriate Standards. Changes and updates to any document or form will only be accepted by the nominated person responsible for the document. This must be agreed and authorized by the Department Manager. When changes are made all obsolete documents are destroyed. (Unless marked and retained for legal reasons). Quality documents are located in the area where they are used and must be legible.
Changes to Manual and subsequent re-issue are properly controlled.Changes to the manual will only be made by the Quality Assurance Manager. If the changes involve working practices or improvements in the Quality System, the changed section will have its revision number updated. New issues of the Manual will only take place when a major change in the operation of the Department warrants it.
As only one manual (The Master) has been produced, all CONTROLLED documentation will be produced on GREEN paper with headers and footers appearing in RED and normal print in BLACK. All revision changes will be recorded on the Amendment Sheet at the front of the manual.
Any formal drawings are listed, indexed and numbered. Data is backed up regularly, and backed up disks are taken off site for safety. All disks are listed and indexed. The overall responsibility for Document, Drawing and Data control and the maintenance of Quality Records rests with the Quality Assurance Manager.
4.2.3 Control of documentsA procedure has been written to govern the control exercised over the maintenance of Documents and Data. This procedure covers the issue and update of controlled documents that are listed and registered. Master copies of controlled documents are held by the Quality Assurance Manager who will also be responsible for maintaining the register of controlled documents.
All documents affecting Quality will be identified by a unique number and the revision status documented. Controlled documents will be issued and approved by the Quality Assurance Manager and any changes made will also reviewed and be carried out in a controlled manner. The Quality Assurance Manager will also maintain a register of Quality related external documents (e.g. Tenders, PPMs, Acceptance tests, PPQ forms, contracts etc.).
It is the responsibility of the Quality Assurance Manager to maintain, not only an up to date copies of relevant BSI Standards, but also a register of all legal and health authority standards, plus the safe custody and update of external documents relating to Quality. Handwritten documents will be legible. It is the responsibility of the Quality Assurance Manager to ensure that Quality procedures are issued and controlled at all times.
The Quality Assurance Manager will establish, document and maintain procedures to ensure that Quality records are indexed, filed, identified, maintained, protected, collected and properly stored. A list is retained of all Quality Records, together with their retention times. Documentation which is considered to be outside the scope of the Standard and which are not Quality records will be listed.
- Undertake periodic analysis of Quality performance.
- Provide evidence of verification actions during all stages of the Department's operation.
- Refer to historical data for Quality procedures and performance.
- Dispose of Records in an organised manner
Quality related data will be backed up regularly as a controlled operation. Disks will be labelled. Whether in hard copy or electronic form, Quality records will be legible and retained for a minimum of 7 years unless a longer or shorter period is required by particular contract or Authority. The Department Manager is responsible for ensuring that computer data records are backed up and appropriately labelled and safeguarded.
It is the responsibility of the Quality Assurance Manager to ensure that Quality records are maintained.