Summary of Swedish Quality Assessment

The Swedish Board for Accreditation and Conformity Assessment, SWEDAC is a Swedish public authority, responsible to the Ministry for Foreign Affairs. In addition to its statutory duties, it also performs a number of commercially based activities. Its main duty is to be the national accreditation body. Accreditation, which involves determination of the competence of organizations to perform their duties or work, covers laboratories, certification bodies, and inspection bodies concerned with analysis, testing, calibration, certification and inspection in various sectors.

SWEDAC works nationally and internationally to further the harmonization of the principles of analysis, testing, calibration, certification and inspection in the interests of greater safety and the encouragement of free trade.

Swedish Standards Institute, SIS, is the centre for work on standards in Sweden and a working partner in the European and global networks, CEN and ISO.

EQUALIS AB (External Quality Assurance in Laboratory Medicine In Sweden) is a non-profit company jointly owned by SALAR Enterprises (52%), The Swedish Society of Medicine (24%), and The Swedish Institute of Biomedical Laboratory Science (24%). EQUALIS started in 1992 as a project named SEQLA with support from the National Board of Health and Welfare but has been a limited company since 1996.

A board consisting of the owners’ representatives runs EQUALIS. External Quality Assessment (EQA) schemes and other activities are all managed from the office in Uppsala. Each laboratory discipline has an advisory group (steering committee) consisting of leading experts in the country. These expert groups participate in the specification of content, purpose, and development of the various EQA schemes, in evaluation of results, and in the subsequent follow-ups. For primary health care, EQUALIS has initiated special laboratory medicine councils all over the country, which function as local quality assurance networks.
EQUALIS’ main objective is to increase patient safety by continuously improving the quality of laboratory medicine activities in all disciplines. This will also make the health care more cost-effective.
EQA schemes and participation
EQUALIS currently manages more than 80 different EQA schemes involving some 1600 participants. Most of these are Swedish laboratories but some foreign participants are also included. Participation is voluntary and all results are confidential. Most of today's laboratory disciplines are represented. Currently, EQUALIS has EQA schemes for:

  • Clinical immunology
  • Clinical physiology/vascular diagnosis
  • Coagulation
  • Endocrinology
  • General Clinical chemistry
  • Hematology
  • Histopathological and cytological techniques
  • Medical microbiology
  • Pharmaceuticals/drugs of abuse
  • Pathology/cytology
  • Point-of-care testing
  • Protein analyses/molecular biology
  • Transfusion medicine

Anne Berndt, IBL Sweden