Table 5. Open in new tab Components of a...

Task

Activity

Organization

Management and organizational structure of the laboratory.

Facilities and safety

Analysis of potential harm from pathogens/chemicals and assessment of requirements for laboratory design and safety to prevent and control exposure to physical, chemical and biological hazards.

Personnel and customer focus

Choice and provision of qualified and skilled staff also in the context of interaction with potential customers (i.e. physicians, patients, public health services and community).

Purchasing, inventory and equipment

Proper equipment management to ensure reliable and timely testing to reduce variations in test results, thus maintaining laboratory performance and avoiding waste.

Process management

Control of different actions/activities (e.g. sample management and examination processes) to ensure accurate testing and valid results. It includes implementation of an internal quality control programme and participation in national and/or international external quality assurance.

Documents and records and information management

Control of safety and availability of documents and records, storage, ensuring accessibility whenever needed. The information management system is responsible for the processes needed to effectively manage data by guaranteeing unique identifiers for patients and samples, standard request forms and the patient’s privacy.

Occurrence management and assessment

Identification of errors, involving either testing or other processes, and application of appropriate corrections to prevent their further occurrence. Assessment is defined as the systematic examination of the quality management system to demonstrate that the laboratory is meeting regulatory and customer requirements through internal and external audits.

Continual improvement

Ensuring continual improvement in laboratory quality over time.

Table 5.

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Components of a laboratory quality management system, adapted from WHO³⁵ and CLSI³⁶ guidelines

Task	Activity
Organization	Management and organizational structure of the laboratory.
Facilities and safety	Analysis of potential harm from pathogens/chemicals and assessment of requirements for laboratory design and safety to prevent and control exposure to physical, chemical and biological hazards.
Personnel and customer focus	Choice and provision of qualified and skilled staff also in the context of interaction with potential customers (i.e. physicians, patients, public health services and community).
Purchasing, inventory and equipment	Proper equipment management to ensure reliable and timely testing to reduce variations in test results, thus maintaining laboratory performance and avoiding waste.
Process management	Control of different actions/activities (e.g. sample management and examination processes) to ensure accurate testing and valid results. It includes implementation of an internal quality control programme and participation in national and/or international external quality assurance.
Documents and records and information management	Control of safety and availability of documents and records, storage, ensuring accessibility whenever needed. The information management system is responsible for the processes needed to effectively manage data by guaranteeing unique identifiers for patients and samples, standard request forms and the patient’s privacy.
Occurrence management and assessment	Identification of errors, involving either testing or other processes, and application of appropriate corrections to prevent their further occurrence. Assessment is defined as the systematic examination of the quality management system to demonstrate that the laboratory is meeting regulatory and customer requirements through internal and external audits.
Continual improvement	Ensuring continual improvement in laboratory quality over time.

Task	Activity
Organization	Management and organizational structure of the laboratory.
Facilities and safety	Analysis of potential harm from pathogens/chemicals and assessment of requirements for laboratory design and safety to prevent and control exposure to physical, chemical and biological hazards.
Personnel and customer focus	Choice and provision of qualified and skilled staff also in the context of interaction with potential customers (i.e. physicians, patients, public health services and community).
Purchasing, inventory and equipment	Proper equipment management to ensure reliable and timely testing to reduce variations in test results, thus maintaining laboratory performance and avoiding waste.
Process management	Control of different actions/activities (e.g. sample management and examination processes) to ensure accurate testing and valid results. It includes implementation of an internal quality control programme and participation in national and/or international external quality assurance.
Documents and records and information management	Control of safety and availability of documents and records, storage, ensuring accessibility whenever needed. The information management system is responsible for the processes needed to effectively manage data by guaranteeing unique identifiers for patients and samples, standard request forms and the patient’s privacy.
Occurrence management and assessment	Identification of errors, involving either testing or other processes, and application of appropriate corrections to prevent their further occurrence. Assessment is defined as the systematic examination of the quality management system to demonstrate that the laboratory is meeting regulatory and customer requirements through internal and external audits.
Continual improvement	Ensuring continual improvement in laboratory quality over time.

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