Setting up and implementing a quality system is a painstaking task. For example, all the primary processes of a laboratory have to be documented. This would include e.g. specimen collection and receipt of materials, administration, analysis or assessment, report preparation and despatch to the submitter, and archival. The secondary processes, too, have to be clear. Examples of these are personnel policy, maintenance and calibration of apparatus, analytical methods, safety and security, complaint handling, internal assessment and peer validations.

Describing all these processes takes considerable time. Several employees will therefore have to be assigned to the task of documentation. But to more tasks as well. Structured work consultations must be established to go through the described procedures and instructions with the personnel. Experience has taught that they can interpret things in many ways, which can hinder execution. So, achieving a common understanding is of great importance. Implementation of a quality system will cost between two and five man-years. The exact number of years will depend on the size and complexity of a laboratory.

The work does not end with the implementation of a quality system. Time and capacity must continuously be made available for maintaining the system. For example, periodic verification that commitments have been met, evaluation of control samples and calibrations, execution of improvement actions and measures, amendments to documentation, and archiving. Maintenance is required after e.g. organisational changes, internal movements of personnel, or changes to the services that are offered.

As a general rule of thumb, for every forty laboratory personnel, one person will be occupied full-time performing maintenance. Multiple persons may be responsible for the continuity and upkeep of a quality system. A good functioning quality system therefore depends on the distribution of duties between the quality officer, administration and chief analyst.

It is important to realise that a quality system is only as good as the people who develop, establish and run it. So the system can fall short of its objectives. Common causes of weaknesses in the quality system are:

• lack of management commitment;
• lack of training;
• lack of facilities;
• lack of organisation;
• lack of employee commitment;
• and lack of time.