The international EN ISO 9000 family of standards specifies requirements for a process-based quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable regulatory requirements and where the organization aims to enhance customer satisfaction.

A key element is the continual improvement of the organization’s overall performance covering the important topics: management responsibility, resource management, product realization and process improvement.

Most common is the certification against ISO 9001. Certified laboratories have a quality management system in place and operational which complies with the ISO standards. Certification against ISO 9001 does not of itself demonstrate the competence of the laboratory to produce technically valid data and results.