Quality manual

Quality Management System

4.2.1 General Requirements
The Department of Pathology documents, implements and maintains a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 15189.
The quality management system provides for the integration of all processes required to fulfil its quality policy and objectives and meet the needs and requirements of the users. The interaction of all pre-examination, examination and post examination activities is illustrated in QF-GEN-0063 Process Flow for the Quality Management System. Resources such as staff, facilities, equipment, process management (quality control, change control) materials, information technology, and techniques/methods are considered as part of the input resources. Also included, are strategic processes including the mission statement, leadership review and resource management. Participation in External Quality Assurance Schemes, internal audits and external assessments and monitoring quality indicators are systems used to support the output of test results.
Policies, processes, programmes, procedures and instructions are documented and communicated to all relevant personnel. The management ensures that the documents are understood and implemented. All personnel are required to read all procedures relevant to the Quality Management System and to the technical processes, including Haemovigilance & Traceability activities, in which they are involved. This is implemented through MP-GEN-0002 Management of Documentation, Preparation and Control and the MP-GEN-0017 Pathology Training Policy.

The Department of Pathology:

1. 
   Ensures the availability of resources and information necessary to support the operation and monitoring of processes as outlined in MP-GEN-0001 Management of the Laboratory, QP-GEN-0002 Evaluation and Audits, QP-GEN-0005 Control of Non-Conformances and QP-GEN-0009 Risk Management Procedure.
   

2. 
   Monitors and evaluates the criteria and methods needed to ensure that both the operation and control of pre-examination, examination and post-examination processes for the quality management system are established, implemented and maintained. The Department of Pathology has an adequate internal quality control procedure in place LM-BT-0001 Reagent Quality Control. They also participate in External Quality Assurance (EQA) Schemes which is implemented through the procedure for External Quality Assurance as per QP-GEN-0003 External Quality Assessment. They are also monitored through tracking and trending non-conformances, internal and external audit and risk assessments. Preventive actions are put in place as required.
   

3. 
   Determines criteria and methods needed to ensure that both the operation and control of these processes are effective as per MP-GEN-0001 Management of the Laboratory. Actions are implemented as necessary to achieve planned results and continual improvement of these processes. A list of quality objectives is compiled at the beginning of each year to present to the Annual Management Review as the list of goals for the forthcoming year.
   

4.2.2 Documentation Requirements

1. 
   General
   

The quality management system documentation includes:

1. 
   Statements of a quality policy and quality objectives
   

2. 
   The Quality Manual which describes the operation and management of the quality management system
   

3. 
   Procedures and records required by ISO 15189
   

4. 
   Documents and records determined by the laboratory to ensure the effective planning, operation and control of its processes
   

5. 
   Copies of applicable regulations, standards and other normative documents. These are compiled and reviewed annually as the master list of external documents and they are stored in Q-Pulse under ED-GEN. The number of the list will relate to different lists of external documents.
   

The documentation is in both paper and electronic format and is readily accessible and protected from unauthorised changes and undue deterioration. The electronic format is available in Q-Pulse. Controlled hard copy Standard Operating Procedures are used in the laboratory as a source of information. LP-GEN-0007 User Manual is available on the J drive.

4.2.2.2 Quality Manual
The Quality Manual is reviewed at regular intervals of 2 years or when required due to a change in regulations/personnel/services etc. This is implemented through MP-GEN-0002 Management of Documentation, Preparation and Control.
The laboratory has established and maintains a Quality Manual which includes:

1. 
   The Quality Policy
   

2. 
   A description of the scope of the Quality Management System (QMS)
   

A presentation of the organization and management structure of the laboratory and its place in the parent organization as shown in Appendix 1 QF-GEN-0060 Pathology Laboratory Organisational Chart for Our Lady’s Hospital, Navan

3. 
   A description of the roles and responsibilities of laboratory management (including the Laboratory Directorate and Quality Co-ordinator) to ensure compliance with ISO 15189
   

4. 
   A description of the structure and relationships of the documentation used in the quality management system. This is implemented through MP-GEN-0002 Management of Documentation Preparation and Control. The hierarchy of the documentation system is described in Figure 1. Hierarchy of QMS Documentation.
   

Figure 1. Hierarchy of QMS Documentation.

IS

ISO 15189

AML-BB


Quality Manual


Quality and Management Procedures




Technical, Haemovigilance, IT and Phlebotomy Standard Operating Procedures


Forms, Registers, Work-lists, Reports and other working documents.

5. 
   The documented policies established for the quality management system and reference to the managerial and technical activities that support them. The Department of Pathology management implements plans and procedures which regularly monitor and demonstrate proper calibration and function of instruments, reagents and analytical systems.
   

All personnel have access and are instructed on the use and application of the Quality Manual, all referenced documents and the requirements for their implementation.

2.