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IFCC News: Exchange of experiences about the interpretation of ISO 15189

IFCC News: Exchange of experiences about the interpretation of ISO 15189

by Carlos Rozas -
Number of replies: 0

by Rosa Sierra-Amor
Corresponding Member, IFCC WG News
Maria Amelia Acuña
Argentinan Accreditation Body
Milena Monari
Chilean Society of Clinical Chemistry
Imilce Zuta, PTB Germany

Latin America is a large region formed by countries from North, Central, South America, and the Caribbean. In the effort of implementing ISO 15189 in laboratory accreditation, accreditation bodies and professional societies in laboratory medicine were invited to exchange experiences on the interpretation of ISO 15189.
Almost a year ago, the Chilean Society of Clinical Chemistry, a full member society of IFCC, in conjunction with the PTB (Technical Cooperation) from Germany,
organized a meeting in Santiago de Chile on 4-6 August 2014, where professional societies, accreditation bodies and metrology institutes met to discuss how accreditation was conducted and how metrology institutes were addressing laboratory medicine requirements. Those present decided to organize a workshop on exchange of experiences on laboratory accreditation in the region.
This task was jointly accomplished with the Inter-American Accreditation Cooperation (IAAC) in collaboration with the PTB and the 4 day workshop programme
was organized, in Guatemala City, on 12-15 May 2015, by the host organization, the Guatemala Accreditation Body (OGA).

The following countries were represented by a team formed by representatives each from an accreditation body and a professional society: Argentina, Colombia, Costa Rica, Cuba, Chile, Ecuador, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Paraguay, Peru and Uruguay.
During this workshop, the requirements for achieving laboratory accreditation were discussed by representatives from most of the accreditation bodies of the
region. In addition, assessors of ISO 15189 and laboratory professionals from professional societies were invited to speak about “the standard”. Issues related
to management and technical requirements were also highlighted. The main idea was to learn and to listen to other accreditation entities, about their experiences
and development of accreditation programs.
Problems and solutions, metrology issues, reference materials, and other aspects of the standard were discussed. For the 2015-2017 period, the need to continue working on harmonization of the interpretation of the standard was emphasized. The training and strengthening of the assessor competence in applying the standard were highlighted as key aspects, which could also be extended to other relevant sectors of the clinical laboratory because the expert members of professional societies also collaborate with the accreditation bodies.
The speakers and facilitators came from Argentina, Chile, Mexico, Spain and Peru discussed how countries had achieved this. Mexico implemented the standard on a voluntary basis but recently, more laboratories have become interested in applying ISO 15189. Other countries, e.g., Argentina and Chile
were the first to initiatiate the process; in the case of Argentina, laboratories have become motivated to work on adapting activities for compliance with the
standard, but this process for is mostly in early days of implementation. Others are now moving forward, e.g. Uruguay, and few more, e.g. Ecuador, have government
interest as well.