Quite often we are asked about ISO 15189 and whether it is worth the time, effort and cost to get accreditation. So here’s a short FAQ that will hopefully help you make the decision of whether 15189 is right for your organization.
What is it? ISO 15189, introduced in 2003, is an internationally recognized standard designed specifically for 1) establishing quality management in a clinical laboratory, and 2) assessing a laboratory's technical ability to provide reliable and accurate test results. It is a critical initiative providing best-practice quality and competence standards for harmonizing global practices toward a common measure of quality assurance and safety. It has been implemented in over 200 countries.
Does it replace CLIA? If not, how are they different, complementary? ISO 15189 does not replace CLIA. CLIA is more specific in some areas, (e.g. complexity models; specialties and sub-specialties; personnel categories / qualifications / responsibilities; QC / calibration materials / frequency; proficiency testing; record / specimen retention). ISO is more general and more comprehensive, (e.g. applies to all regardless of complexity; addresses quality manager / manual / policy, management review, continual education, contract review, internal and external assessments, continual improvement, process improvement). Accreditation for CLIA uses discipline-specific checklists and focuses on procedural excellence and GLP. The ISO audit is less prescriptive in nature and emphasizes operational systems improvement, risk mitigation, and quality management.
ISO 15189 has taken greater hold abroad. In the US, 15189 remains optional, but interest is growing in response to CAP’s formal launch of an ISO 15189 accreditation program. Abroad, ISO 15189 has gained standing as mandatory accreditation in Australia, the Canadian province of Ontario and some EU countries including France, Belgium for molecular virology and oncology testing, Germany for newborn screening, and Latvia for hospital labs. Swiss labs are subject to fewer inspections when accredited. In Belgium it is the standard by which molecular diagnostic tests are reimbursed.
The current EU IVDD exempts development and use within the same health institution, but the proposed recast restricts this exemption to institutions compliant with ISO 15189 or another equivalent recognized standard. This change aims to ensure that all tests used clinically have been fully validated, either by the manufacturer as part of the CE-marking process or by the lab as part of its ISO 15189 quality system. This will help ensure quality of innovative high value diagnostics such as genetic testing where no such tests are CE-marked and reliance is on the health institution exemption to provide these valuable diagnostics. Under the new EU IVD regulations, only accredited labs would be allowed to do this.
So, what can ISO 15189 compliance do for my lab? Consider these advantages.
- An international reputable image for quality assurance and management, differentiating your lab at a high level for global competitiveness
- Improved workflow and processes with implementation of standardized procedures and root cause analysis
- Decreased operating costs with increased efficiency via automation, control of process variation, waste elimination
- Growth of customer satisfaction with better service provided
Many are beginning to believe that ISO 15189 will ultimately become the world standard for laboratories to be measured up to and necessary for competing on a global scale. How long will it be before payers cite 15189 accreditation to justify high reimbursement rates? Inexpensive, it is not, but the return on investment can be considerable.
Will you be a pioneer?