Ideally, the implementation of a quality plan or a quality management system (QMS), is recommended to integrate all aspects of laboratory processes and management. A well-functioning QMS not only oversees quality assurance and quality control activities but encompasses all operations within an organization that affect laboratory performance. Setting up a QMS in a laboratory requires an analysis of the organizational structure, responsibilities, procedures, processes and resources to achieve the highest accuracy and reliability possible.
By adopting a QMS model, activities along the path of workflow across departments are systematically analysed and quality policies can be built into all processes in a step-wise and eventual, integrated whole. Coordination of policies across departments with the aim of quality improvement only be achieved with a dedicated QMS.
It is the responsibility of the head of the laboratory to establish, implement and ensure compliance with the requirements of the QMS. However, the success of a QMS is the responsibility of all laboratory personnel. A strong supporting organizational structure with the commitment of management is crucial. In addition, a quality manager is recommended to coordinate all the activities of implementation and documentation.
When all the laboratory procedures and processes are organized into an understandable and workable structure, the opportunity to ensure that all components are appropriately managed is increased. A well-functioning QMS enables standardization to ‘best practices’ in all areas of an organization that influence quality. This comprehensive approach directs and controls the organization with regard to quality.
The implementation of a QMS can be initiated at different starting places, adding on building blocks which are each continually refined and expanded. A set of coordinated activities, or quality system “essentials” are often identified as the building blocks for the establishment of a QMS. The WHO Handbook, Laboratory Quality Management System (2011), describes 12 building blocks for planning and implementing a QMS [1]. An additional web-based resource, Laboratory Quality Stepwise Implementation (LQSI) tool, provides a practical guide for laboratories to implement a quality management system by following a stepwise plan [2].
There are several international organizations which are involved in the promotion of laboratory quality. The largest of these is the International Standards Organization (ISO) which is the developer and publisher of international standards applicable to many kinds of organizations, including clinical and public health laboratories. Many laboratories in the GMRLN have undergone ISO accreditation to the ISO standard 15189:2012. This standard specifies the requirements for quality and competence in medical laboratories and can be used by network laboratories in developing their quality management systems and assessing their own competence.
Although there are many parallels between the WHO accreditation programme and ISO 15189, the ISO standard is considerably more comprehensive, especially in relation to the documentation of quality systems and management. Other international organizations include Clinical and Laboratory Standards Institute (CLSI), a standards-developing organization that promotes the development and use of voluntary consensus standards and guidelines within the healthcare community.
Some countries have also established a certification process for medical laboratories to regulate testing and reporting such as Clinical Laboratory Improvement Amendments (CLIA) in the USA and National Association of Testing Authorities (NATA) in Australia. It is encouraged that all laboratories in the GMRLN consider becoming accredited to ISO and/or any national accreditation authority, as an adjunct to the WHO Measles and Rubella accreditation programme.