Content 16-9: Writing a Quality Manual
Structure and content Although there is considerable flexibility in how to prepare a quality manual, the content and structure should address the elements listed below.
Introduction The quality manual should begin with an introduction that contains a brief overview of the quality manual and laboratory. Examples of information to include in the introduction are:
• a description of the laboratory including its history and its activities. This is helpful for users and new staff, and shows how changes occur over time.
• a description of the processes for how updates will be managed, and why they need to occur.
Organization and management The description of the laboratory organization should include:
• an organizational chart depicting the hierarchy of responsibility and authority;
• the legal identity of the laboratory—This will differ with local situations, and may include a statement of who has legal responsibility for the laboratory, whether there is mandated certification, and other such information.
Quality policy A section describing the quality policies should be one of the first topics to address in the quality manual because it forms the basis for the quality system: the mission, objectives, and roles, from which all the activities of the laboratory will be focused.
In this section, the management commitment to quality should be stated. All future actions of the laboratory will be directed by the quality policies.
A quality policy should be written for each of the 12 quality elements.
Personnel The quality manual should address personnel policies. The management of personnel requires that a number of documents be referenced, but the actual documents are usually kept separate from the quality manual itself. Some of the important information that needs to be referenced includes:
• job descriptions — All persons working in the laboratory must have an accurate and clearly defined job description; some positions, such as interns and students, will require only a simple statement. It is important that job descriptions include all jobs the person might be required to do, so that in the absence of staff, substitutions can be made to ensure that necessary work can be accomplished.
• a personnel list that includes for each staff member: contact information, such as name, address, and telephone number; education and training; qualifications for the position; responsibilities (including quality system responsibilities); and other information as needed by the laboratory.
• an organizational chart and conditions of recruitment—Recruitment of adequately trained personnel is a very important element of personnel management, and is essential to assure success of a quality management system.
If students and interns work in the laboratory, personnel policies should clearly show how their work will be managed. It will be important to develop a guide for interns/students, showing expectations or terms of reference, and explain who will review and supervise their work.
Document control The policies and processes needed for document control should be described in the quality manual. Careful document control is very important in the laboratory, and is needed to:
• assure up-to-date and accurate descriptions and procedures;
• assure proper archiving;
• produce accurate and reliable reports;
• follow trends in the laboratory;
• maintain confidentiality of patient records and information.
Accommodation and
environment This section should include information about the facilities and environmental requirements for the laboratory. A quality system requires that adequate facilities and environmental conditions be maintained. The quality manual might include:
• a map of the laboratory premises, showing all space that the laboratory uses, and restricted points of access.
• requirements for laboratory signage. For example, signs might be needed for the specimen collection or sampling room. Safety instructions and emergency exits will require signs or charts of instructions. Use of biological hazard signs should be defined.
• environmental requirements for the laboratory. These requirements will need to be defined, including provision for verifying that the requirements are met. The definitions of environmental needs, or standards, should reflect how much variation can be tolerated.
Instruments, reagents, and consumables management Requirements for instrument/equipment management should be addressed, including:
• instrument logbooks;
• written procedures for use;
• quality control procedures;
• maintenance procedures;
• procedures for instrument replacement and disposal.
The management of reagents and supplies in the laboratory is often a challenging task. The reagent section might address order procedures, storage requirements, preparation, and quality control of reagents.
For both reagents and supplies, the stock management procedures will need to be defined.
Safety Defining practices, processes, and procedures to maintain a safe environment in the laboratory is very important. Safety considerations are of concern to staff, to all who might come in contact with the laboratory, and with the community. All staff should be aware of the manual and should proceed according to its contents.
Preexamination procedures All elements of the preexamination procedures should be defined and described in the specific standard operating procedures (SOP). SOPs are generally referenced in the quality manual, but kept separately. SOPs should be written by specialized technical staff in the operating units, revised by their immediate supervisor, and approved by the Laboratory Director.
Examination procedures Examination procedures are detailed in an SOP. For the description of the use and management of equipment, instructions should be used instead of standard operating procedures.
Postexamination processes The postexamination processes are sometimes not given as much attention in the laboratory, but they are very important and need to be addressed in the quality manual.
Quality control The quality control procedures are normally included in each specific testing procedure, or SOP. However, the quality manual should have a statement regarding the commitment of the laboratory; there should be a reference to the link with other control procedures. Legal or ethical considerations should be mentioned.
Corrective/
preventive actions, internal audits An essential part of the quality system is continuous improvement, and this is accomplished in part by reviewing and understanding all problems and errors. The processes for this (detailed in Module 14: Occurrence Management) need to be referenced in the quality manual.
Both internal and external audits provide a means for continuous improvement of the system. Internal audits are required under the ISO 15189 scheme, and how they will be conducted must be described in the quality manual.