Purpose:

To detail the approval, listing, circulation, issuing and updating of the Quality Manual, Operating Procedures, Work Instructions and EBME forms used to specify and control quality.

 

Scope:

This procedure shall apply to all new documents, amendments, or re-issues made to existing Operating Procedures, Quality Manual, Work Instructions and forms affecting quality.

 

Document and Data ControlDefinitions

  • Controlled Documents: Master Copies of the Policy, Procedures, Forms, Work Instructions and other quality documents which are 'marked appropriately' will be regarded as 'CONTROLLED'
  • All uncontrolled copies will be marked UNCONTROLLED. Any other copies will be assumed to be uncontrolled.
  • Data: Quality related information held on individual or networked computers which if lost would affect the professionalism of the Department

 

Responsibilities

It is the responsibility of the Quality Assurance Manager to administer and control the approval and issuing system and to ensure that Operating Procedures represent complete and correct methods of operation. It is the responsibility of the Quality Assurance Manager to hold a master copy of the complete EBME Quality System and to keep up to date the List of Quality System Documents, to ensure that Procedures, forms and documents are available in locations where they are to be used. It is the responsibility of the EBME Manager to ensure that all personnel are working with up-to-date editions of EBME documentation and work instructions and to understand the use of the documents.

 

Control of the Issue of (& Amendments to) the Policy Manual

It is the responsibility of the Quality Assurance Manager to ensure that the EBME Policy Manual contains at least the following:

  • Issue Number
  • Revision number
  • Date of Issue
  • Record of who holds a copy
  • Signed Policy Statement
  • Organisation Structures
  • Processes
  • Management Responsibilities
  • Indication of how each Paragraph of the Standard will be addressed
  • List of Quality Procedures

 

The Quality Assurance Manager will issue Controlled copies of the Quality Manual to appropriate personnel. When the Quality Manual is amended or updated, the Quality Assurance Manager will revise the Date and Revision Number, complete the amendment sections and ensure all obsolete controlled copies are removed from circulation.

 

Control the Issue of Operating Procedures

Operating procedures will not only reflect the processes involved in running a successful EBME Department, but also the associated support procedures such as purchasing, contract review, maintenance of test equipment and document control etc. It is the responsibility of the Quality Assurance Manager to produce and review all Operating Procedures, in close liaison with all relevant Managers.

The Quality Assurance Manager will ensure that each Procedure includes at least:

  • Title
  • Procedure Number
  • Person Responsible for Issue
  • Purpose
  • Scope
  • Amendment Record
  • Responsibilities

 

Details of Processes Covered:

Each page of a Procedure should indicate:

  • TitleĀ·
  • Issue NumberĀ·
  • Revision Number
  • Date of Issue
  • Page Number

 

The master copies of all Operating Procedures will be held by the Quality Assurance Manager who will ensure that the revision number is sequenced by one following amendments.  The Quality Assurance Manager will issue any revised Operating Procedures to the personnel concerned and will retrieve the superseded copies or arrange for the old copies to be destroyed.

 

Control the Issue of Work Instructions

Work Instructions in the operation of the EBME department will include:

W.I. Number - prefixed by a W

  • Title
  • Revision Number
  • Date of Revision
  • Signature of Responsible Manager
  • Date of Issue

 

Control and Issue of New or Redesigned Quality System Documents and Forms

The Quality Assurance Manager will hold a master copy of all current editions or versions of Quality System documents and forms. All approved documents and forms, the person responsible for them and their retention time are listed. All Quality System forms and documents will be produced by the Quality Assurance Manager, following a similar layout and design to existing documents and forms wherever possible.

All forms and documents will include:

  • Document or Form Number
  • Title
  • Revision Number
  • Revision
  • Date

It is the responsibility of the Quality Assurance Manager to update the 'List of Quality System Documents' - to reflect any new forms and documents or revisions to existing.

 

Proposed Changes

Any employee may suggest an alteration to any Operating Procedure, Work Instruction or to a document or form by filling out a Document Change Request Form and passing this to the EBME Manager who will discuss the proposal with the person responsible and the QAM then decide if the change is to be adopted. It is not necessary for the EBME Manager to complete a document change request for documents that he is responsible for, but the person responsible should be made aware of any changes. The Quality Assurance Manager will retain copies of Change Requests. The originator will be recorded by the Quality Assurance Manager.

 

External Documents and other Data

There are some documents which are in use that are issued and administered by agencies or NHS Trusts which are outside the control of the EBME Department and therefore over which the Department has little or no control.

 

Manufacturer Supplied Information

It is considered to be impossible to maintain an up to date register of Manufacturers' Handbooks etc, as this relies on the quality of manufacturing companies over which the EBME Department has no control.  Consequently all Manufacturers' Handbooks, Maintenance Manuals, Parts Lists for Medical and Test Equipment and associated documents will be considered to be UNCONTROLLED documents and will not form part of the Quality System Documentation. Nevertheless every effort will be made by the Department to ensure that the best possible control of these documents is carried out.

 

SAFETY/HAZARD Warnings

Occasionally due to the nature of the business, Safety bulletins and hazard-warning notices may also be issued by the Trust and External authorities. As this operation is carried out by an organisation outside the control of the Department, their issue and update falls outside the scope of the relevant ISO Standards. When issued they will be complied with if appropriate, and filed for reference.

 

NHS/TRUST Documents and Hospital Technical memoranda

There may be a number of documents in use which are originated by the Trust or by the NHS where EBME personnel are in operation which may affect the way we function. The Department has no control over the quality of these documents and though every effort will be made to ensure that quality is maintained, they cannot be considered as part of the Quality System.

 

Electronic Data

All quality related information which is held on the computer system will be backed up automatically daily. In addition a weekly database back up will be made. All back up will be held on a secure off site server or cloud based system. A back up copy of the ISO Quality Assurance system will be held off site.

 

Superseded Documents

Whenever an Operating Procedure, Document, Form or section of the Quality Manual is re-issued, all copies of the superseded document are retrieved. The Quality Assurance Manager decides whether to retain a copy of the superseded document and mark it Superseded (or similar) and retain it for reference.  All other copies are destroyed. Obsolete documents are not to be used. Obsolete documents may be retained as part of the Quality system when they are required for Quality records purposes without concession.

 

Standards

The Quality Assurance Manager will check the current status of current and relevant ISO standards. All other standards which are used as guidance within the Department will be listed.