2.2 Organisational structure

The laboratory should have a clear organisational structure with the roles and managerial responsibilities of all staff members made explicit. The Laboratory Director has overall responsibility and leadership for the running of the laboratory. The Laboratory Manager is responsible for organising the work of laboratory technologists and for maintaining quality standards and safety aspects.

The Quality Manager takes responsibility of the QMS, and for approving all the relevant documentation and processes. Depending on the size of the laboratory, additional roles dealing with biosafety, equipment, supplies, training etc. may be delegated (Figure 3).

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Figure 3 An example of an organisational chart.
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At the top of the organisational chart is a Laboratory Director; beneath them, a Quality Manager and Biosafety Officer, and beneath them, boxes labelled ‘Immunology Department’, ‘Microbiology Department’ and ‘Haematology Department’. A line from the Microbiology Department leads to a Microbiology Laboratory Manager, and then to Microbiology Laboratory Staff, such as laboratory technologists and laboratory assistants.

Figure 3 An example of an organisational chart.

(Figure 3 is an example with a focus on the microbiology department of a clinical laboratory. Your workplace may be considerably larger with more sections or considerably smaller with staff members having more than one role. Note that the Quality Manager and Biosafety Officer advise the Laboratory Manager, but do not necessarily directly line-manage staff if resources are scarce or the laboratory is small.)

Activity 4: Your role and responsibility in the workplace (part 1)

Timing: Allow about 5 minutes

Take some time now to think about how your workplace is organised and how your role fits into the organisational structure. You might find it helpful to discuss this with your colleagues using the following questions as a guide:

  1. Who is responsible for quality policies and standards?
  2. What responsibilities do you have?
  3. Do you have more than one role?
  4. Who is responsible for biosafety?

Discussion

Table 1 summarises the roles and responsibilities regarding the management of quality in a microbiology laboratory.

Table 1 Roles and responsibilities of key laboratory personnel
RoleResponsibilities
Laboratory director
  • Consider the organisation of the laboratory when implementing new activities or new diagnostic techniques in the laboratory
  • Maintain up-to-date records of job descriptions and personnel competencies
  • Designate biosafety and safety officers
Quality manager (or safety officer)
  • Develop a thorough description of basic safety rules and protocols, and develop and maintain the Quality Manual
  • Ensure that personnel are trained in their specific duties
  • Know the basics of safety and biosafety management issues and requirements when working with chemicals and pathogens
  • Perform risk assessments and develop a safety programme to meet all requirements
  • Validate and maintain documentation relating to quality (see Section 3.6)
Microbiology staff
  • Understand safety and biosafety management issues when working with chemicals, biological samples and physical hazards
  • Comply with safety rules and processes, including the use of appropriate PPE
  • Advise on unsafe conditions
  • Report accidents and incidents

2.1 Meeting basic standards: facilities and safety

2.3 Good microbiological technique