Laboratory Quality Stepwise Implementation tool
The quality manual describes the complete quality management system of the laboratory. It describes the structure of the quality management system, how it is implemented and how it is functioning. It further refers to all SOPs of the laboratory for more in-depth instructions.
It is recommended to read ISO 15189:2007 article 4.2.4 or ISO 15189:2012 article 4.2.2.2 as these provide a clear explanation on the quality manual and its required contents. The WHO Laboratory Quality Management System (LQMS) handbook also contains information on the quality manual which is provided in the right-hand column.
The quality manual always contains an introductory paragraph in which the laboratory management and higher management (e.g. the management of the organization the laboratory is part of) is documented including signatures of all managers. The Quality System Essentials (QSE) framework can provide a logical outline of the quality manual.
- Facilities and Safety
Including a description of the facilities (floor plan/map, description of location, etc.). - Organization
Include the scope of the quality management system, a description of the organizational structure and management structure, the roles and responsibilities of the Laboratory Manager, and the Quality Policy written earlier in this phase. Also include a copy of the document from the national/regional authorities recognizing the laboratory as reference laboratory or refer to the place where this document is archived. This document was obtained in phase 2. Also describe the complete management cycle as established in phase 3. - Personnel
Including a statement that personnel is not allowed to participate in activities that could cause a conflict of interest with the work of the laboratory. Also include a reference to personnel regulations when available (e.g. the occupational and safety law of the Ministry of Health). - Equipment
Describe the system of equipment management and validation (validations are started in phase 4). - Purchasing and Inventory
Including a description of how budgets are made and decided. Also describe the policy on selecting and purchasing items, and to which quality requirements these should generally comply. - Process Control
Describing which examinations are performed and which steps are taken to control the quality of the outcome of the examinations, including validations (validations are started in phase 4). Also include a table showing the maximum allowed turnaround time for each examination performed (see the activity in phase 3 on determining the turnaround times). - Information Management
Describes the measures taken to manage the information produced by the laboratory. - Documents and Records
Describing which types of documents are present in the laboratory and how the laboratory treats its documents, which is a description of the document control system without the technical explanations (written in a way that somebody without knowledge of document control can also understand this). - Customer Service
Describing what the laboratory does to ensure proper customer service. - Assessment
Describing the various assessment techniques used by the laboratory to check functioning of the quality management system and the laboratory as a whole. - Occurrence Management
Describe the procedures in place for handling of nonconformities, complaints, etc. - Process Improvement
Describe (among others) what the laboratory does on process improvement. Examples are the management review, Quarterly Reports, internal audits, etc.
Describe for each QSE the global measures in place regarding the management of quality in the laboratory. Details for specific techniques and measures are provided in SOPs to which the quality manual must refer.
A template for a quality manual together with useful appendices is provided HERE. This quality manual template will help you to understand what the content of the quality manual should be. However, the quality manual of each laboratory is unique. If this, or any quality manual template is used, the Laboratory Manager and Quality Officer must adapt the text of the template to the local situation. If this is not done, the meaning of having a quality manual is lost, as a quality manual describing a quality management system other than that of the laboratory itself is not useful, and auditors will pick this up quickly.
The quality manual is part of the document control system. This means that this manual will need to be reviewed periodically (and revised where necessary) and therefore has a version number and is verified and authorized by different staff members before printing and use (following the procedure described in the laboratory’s SOP of SOPs/Master SOP). This also means that the quality manual must be both accessible to all staff members and properly stored protected from damaging influences.
