Once a quality system has been implemented, it is necessary to examine whether this system is working effectively, including the corresponding rules, processes , products and services. This examination is accomplished by means of audits. A laboratory can regularly perform these audits for itself. These are referred to as internal audits.

Auditing can also be performed by other, independent institutions. These are referred to as external audits. Accreditation by CCKL is covered by the external audits, and it is mandatory for these to be repeated every four years. Following accreditation, laboratories are obliged to participate in external quality control programmes, referred to as peer reviews. The laboratory is also required to cooperate with the visitation by its own professional association.

An audit is a checking tool for management. In an objective manner, it will expose whether and to what extent reality deviates from the objectives within a laboratory. The audit gathers information, identifies potential improvements, and offers suggestions to accomplish these. The purpose of an audit is not to assign blame for observed shortcomings, but rather to propose improvements that can help to avoid and eliminate them. The purpose of internal audits is mainly to determine whether commitments have been fulfilled. Audits are essential. Otherwise there will soon be just a paper system, giving a distorted view of reality.

Management reviews are a type of internal audit that emphasises the functioning of the quality system itself, and whether it generates adequate management information. Laboratory management carries out a management review once annually. Key aspects to be reviewed are:

• quality image (of the facility) research;
• audits by customers or other external assessors;
• results of internal audits and corrective measures;
• accumulated data concerning customer complaints, remarks and the handling of these, including feedback from specialists from the hospital and (if applicable) physicians;
• quality indicators, including those related to patient care;
• process performance and product conformity;
• measures resulting from previous management reviews;
• training plan and refresher courses taken by all employees;
• results of external peer validations and any visitations (see also point c below);
• changes in the volume and nature of the work;
• participation in patient-related activities;
• monitoring of the turnaround time;
• changes that may affect the quality management system;
• suitability (number, quality) of the present staff/employees and instruments;
• evaluation of (the quality of) the suppliers of products or instruments.