Press release - 5th February 2013
Business standards company BSI, today announces the launch of ISO 15189:2012, a standard intended to improve the quality and reliability of medical laboratories.
The standard, which was first published in 2003, has been eagerly anticipated by the medical industry after input from organizations including the Association of British Healthcare Industries (ABHI) and the British In Vitro Diagnostics Association (BIVDA).
It is expected that up to 1000 UK medical laboratories could adopt the standard, particularly in light of the United Kingdom Accreditation Service (UKAS) announcing a migration of all medical lab accreditation to ISO 15189:2012 .
The globally recognized standard has moved on from its predecessor, recognizing the excellence required at every touch point of medical laboratories starting with the advice to clinicians, collection, transport, reception and examination of samples and finishing with their reporting and interpretation.
Medical laboratories that adopt the standard will benefit from industry-wide recognition that the latest best practice principles underpin their performance. ISO 15189:2012 is closely aligned to the requirements for testing and calibration laboratories ISO/IEC 17025 and the widely respected quality management standard ISO 9001. This makes it an attractive option for medical laboratories operating in the fields of clinical chemistry, microbiology, biochemistry and other areas of pathology as well as those bodies involved in their assessment.
Shirley Bailey-Wood, BSI’s Director of Publishing said: “The optimal performance of medical laboratories is absolutely critical and the industry has eagerly awaited this standard to provide the very latest guidance available. The announcement from UKAS that it will be migrating its accreditation to ISO 15189:2012 underlines their confidence in this standard and serves as a call to the medical industry to promptly adopt this best practice framework”.
Lorraine Turner, UKAS’ Business Development Director said: “ISO 15189 covers the essential elements for medical laboratories to demonstrate the quality and competence of their services, as well as to consistently deliver technically valid tests. The standard, which has been developed with strong involvement from the medical, scientific and clinical community, is for use by medical laboratories in developing their management systems and maintaining their competence; it is also used by accreditation bodies as criteria to confirm the competence of these laboratories through accreditation.”
David Burnett, author of ‘A Practical Guide to ISO 15189 in Laboratory Medicine’* and contributor to the standard added: “Since it was first published in 2003 the International Standard, ISO 15189 Medical laboratories – Requirements for quality and competence has raised awareness of the importance of medical laboratories with governments throughout the world and has been used increasingly by medical laboratories to develop their quality management systems (QMS) and to assess their own competence. For laboratories who are familiar with the widely respected CPA Standards the transition to ISO 15189 will be greatly eased by the publication of the 3rd edition of the Standard which was revised by an international group of practising medical laboratory professionals who have sought to set out its requirements in a clear and unambiguous manner. ”
Notes to the editor
*publication date: April 2013, www.acb.org.uk