Quality in Medical Laboratories
A core quality principle is the continuous improvement of all processes and services supporting the care of patients. To support this principle laboratories incorporate comprehensive Quality Management Systems.
Accreditation is the formal recognition by an accreditation authority of the technical and organisational competence of a conformity assessment body to carry out a specific service in accordance to the standards and technical regulations as described in their scope of accreditation.
Accreditation is carried out in several countries by independent National Accreditation Bodies.
The United Kingdom Accreditation Service (UKAS) assesses Medical Laboratories to the internationally recognised standard ISO 15189:2012, Medical Laboratories – particular requirements for quality, competence.
Participation in an international standard gives a credible measure of quality and a basis for international comparison.
Under ISO15189 accreditation it is the scope of tests performed by laboratory that is accredited. This mean that even thought the laboratory has got ISO 15189 accreditation some of the tests may not be accredited and this should be clearly indicated in the reports issued by the laboratory. The schedules of accredited scope for all ISO 15189 medical laboratories can be viewed on the UKAS website http://www.ukas.com .
Other External Assessment Bodies associated with Medical Laboratories includes:
The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the regulation of medicines and medical devices and equipment used in healthcare, and the investigation of harmful incidents. The MHRA also looks after blood and blood products, working with UK blood services, healthcare providers, and other relevant organisations to improve blood quality and safety.
The Blood Safety and Quality Regulations apply to blood establishments and to hospital blood banks. The 2006 Amendment Regulations introduce requirements for a quality system in blood establishments and hospital blood banks. They also extend traceability and record-keeping requirements