Title

Develop a quality manual

Why

As stated before: quality management is about "writing what you do and doing what you write". Most procedures needed to be standardized in SOPs. It is now time to also start describing the quality management system in a quality manual.

What

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.

  1. Facilities and Safety
    Including a description of the facilities (floor plan/map, description of location, etc.).
  2. 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.
  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).
  4. Equipment
    Describe the system of equipment management and validation (validations are started in phase 4).
  5. Purchasing and Inventory
    Including a description of how budgets are made and decided upon. Also describe the policy on selecting and purchasing items, and which quality requirements these should generally comply with.
  6. 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 later in phase 3 and 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).
  7. Information Management
    Describes the measures taken to manage the information produced by the laboratory.
  8. 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).
  9. Customer Service
    Describing what the laboratory does to ensure proper customer service.
  10. Assessment
    Describing the various assessment techniques used by the laboratory to check functioning of the quality management system and the laboratory as a whole.
  11. Occurrence Management
    Describe the procedures in place for handling of nonconformities, complaints, etc.
  12. 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 the quality manual is provided in the right-hand column. This may give you the best idea of what the content of the quality manual should be. However, the quality manual of each laboratory is unique. The Laboratory Manager and Quality Officer are required to adapt the text of the template to the local situation. If this is not done, the complete meaning of having a quality manual is lost (a quality manual describing a quality management system other than that of the laboratory itself is useless and auditors will pick this up immediately).


The quality manual is part of the document control system. This means that this manual will need to be reviewed annually (and revised where necessary) and therefore has a code and version number and is verified and authorized by different staff members before printing and use (following the procedure described in the laboratory's SOP for Document Control). This also means that the quality manual must be both accessible to all staff members and properly stored protected from harmful influences.

How & who

Laboratory Manager:

  1. Familiarize yourself with what a quality manual is, what it serves for, and what the contents should be. Use the template quality manual provided in the right-hand column to get an impression of the contents of a typical quality manual.
  2. Organize a meeting with the Quality Project Team and the Quality Officer for:
    • Developing an approach for writing the quality manual, including a task division detailing who will write which chapter
    • Making an overview of the contents of the quality manual per chapter in bullet points
    • Setting deadlines for finalizing the draft and final quality manual chapters and the quality manual as a whole
  3. After finalization of the quality manual, present it to all laboratory staff in a weekly staff meeting. Explain what it is, why it was developed and what it should be used for. Explain that all staff members must read and sign the quality manual.


Quality Officer:

  1. Familiarize yourself with what a quality manual is, what it serves for, and what the contents should be. Use the template quality manual provided in the right-hand column to get an impression of the contents of a typical quality manual.
  2. Make sure that the quality manual has the same style/layout as other laboratory quality documentation, including, for each chapter: a version number, authorization/verifier signatures, page numbers, etc. (following instructions provided in the SOP for Document Control). Note that each chapter should be regarded as a separate document. This is more convenient, environmental friendly and less resource demanding; if one chapter needs to be adapted it won't be necessary to print the whole manual again, but only the chapter that is changed. This should also be specified in the SOP for Document Control.
  3. Print the quality manual and put this in the folder Organization (made earlier in this phase).
  4. Add the separate quality manual chapters to the Read and Understand List, indicate which staff member should read which chapter (not all staff members have to read all chapters, only those which are relevant to them) and monitor if all staff members read and understand the manual. If not, notify the Laboratory Manager who must take action.

Back to Roadmap Activity Overview
This activity belongs to the QSE Organization
ISO15189:2007: 4.2.3 4.2.4
ISO15189:2012: 4.2.2.2
ISO15190:2003: