Quality Management

What is quality management and what is a quality management system?

What are quality standards and guidelines?

What is accreditation?

Accreditation is a recognition of the laboratory's quality and competence. Accreditation is achieved when the laboratory has a quality management system in place that complies with the requirements of the ISO 15189 quality standard. To accredit a laboratory an independent notified accreditation body assesses the laboratory to investigate if the quality management system indeed functions as it is supposed to and if it complies with the quality standard. This accreditation body itself also operates according to a standard (ISO 17011) and is affiliate/member of the International Laboratory Accreditation Cooperation (ILAC).

Accreditation is often seen as a final destination. However, this couldn't be more wrong; accreditation is only the beginning. A certificate of accreditation is usually provided for a period of 4 years. During this period the laboratory is re-assessed on a regular basis. Hence, the work doesn't end after the laboratory receives accreditation. The quality management system needs to be continually maintained and improved to be able to continually assure quality and stay accredited.

What is the difference between accreditation and certification?

Sometimes confusion exists between the terms "Accreditation" and "Certification".

  • With certification the organization is only technically assessed. An example of a question the assessor tries to answer is: "are procedures performed correctly?"
  • With accreditation an organization's competency is also assessed. A question the assessor tries to answer now is: "are procedures performed correctly, by persons that are demonstrably competent to perform the procedures?"

What is the difference between accreditation and licensing?

Another cause for confusion is the term "licensing". However, the difference between accreditation and licensing is considerable. Licensing of the laboratory is often done by national or regional government institutes. The government can institute a required licensing system for laboratories. This is a way of ensuring a certain level of quality of the laboratories by setting minimal requirements with which laboratories must comply before they are allowed to call themselves laboratories.