High-quality products and services are incredibly important. Doctors and patients judge laboratories mainly on precisely these elements. But high quality puts high demands on an organisation. Because it can only be achieved when there is a quality system that addresses a laboratory’s entire organisation.

CCKL promotes implementation of such a system by making it an essential part of the requirements. A laboratory that wishes to gain CCKL accreditation must be compliant with the CCKL Code of Practice. This Code specifies requirements to be fulfilled by the organisation of a laboratory in such areas as structures, rules, regulations and corporate culture. These organisational elements are the first that have to be stated and recorded within a quality system. Agreements must subsequently be made on e.g. procedures, complaint handling and policy. These agreements must be comprehensible and accessible to all employees in the form of new rules, processes and procedures.

The most important organisational elements for a quality system are the:

• personnel organisation;
• procedures and work instructions;
• recording of data;
• facilities;
• administration of received goods and services;
• administration of inspection, measurement and investigative resources;
• analysis of the specimens, from start to end;
• control of documentation;
• assessment of the quality system;
• and handling of complaints and abnormalities.

But there is more. A quality system also comprises quality activities. These activities are focused on the maintenance and continuity of the quality system. For example, it is good to regularly check whether the correct procedures are still being followed in specific situations. For accredited laboratories, CCKL specifies the requirement that this type of check is performed by an independent body on a regular basis. Top-down policy is essential to getting all this embedded in the organisation.

The three pillars of a quality system are the organisation (the business system), the competence (of the professional staff and personnel) and the laboratory processes (the technical and analytical competence).