All departments have an influence on quality in the primary process. Good apparatus, workrooms and financial resources are critical success factors for the work of laboratory staff. The same also applies to the Personnel Department, administration, technical services and purchasing. Bottlenecks and shortcomings in supporting services invariably lead to interruptions in the primary process. CCKL therefore believes that quality must be approached as an integrated project throughout the entire laboratory.

The entire organisation must focus on one common objective: the achievement of sustainable high quality. This quality level must not be allowed to depend upon the motivation and competence of individual employees. The management of a laboratory must therefore formulate the quality policy. This policy describes the current situation, the desired situation and the route from one to the other. Based on that policy, a concrete quality plan (implementation plan) will be prepared. This plan states the activities that are required to achieve and sustain the desired situation.

This approach ensures a permanent, properly functioning quality system. One way this is achieved is by implementing quality assurance points throughout the entire organisation. In particular, at those places where quality-impacting steps take place (interface control). Then, if an established standard or limit is not met, action must be taken to restore the quality to an acceptable level.

Quality assurance also consists of ensuring that the quality system is objectively evaluated by means of an internal or external inspection (audit). An important resource for total quality assurance in an organisation is the quality manual. This book states the basic principles of the quality policy for e.g. human resources, purchasing, complaints and accessibility of key people and functions. The manual also contains data that is rarely subject to change, such as name, address, location and number of permanent positions. Procedure descriptions are the next subject covered by the manual. The manual also covers tasks, responsibilities and authorities. Lastly, it may also refer to prescribed work instructions.

The description of the entire quality system may be viewed by everyone, even third parties. In many cases, besides the quality manual, it may be useful to compile one or more procedure manuals. These manuals contain detailed, department-specific work information. These instructions enable employees to carry out their assigned tasks with minimal supervision and with a consistent result.