Iso 15189 Certification Vs Accreditation – What's The Real Difference?

By Author: Emma
Total Articles: 80
Comment this article

International Standard ISO 15189 necessitates setting requirements for quality and competence in medical laboratories. It ensures that medical laboratories operate such that the results provided to patients are accurate, reliable, and timely and observe the best international practices in safety and regulatory compliance, as well as ineffective laboratory management.

When discussing ISO 15189 certification vs. accreditation, you need to know the difference between the two in the context of this standard:

ISO 15189 Accreditation

The ISO 15189 accreditation would include international requirements for quality and competence in medical laboratories. All the labs in the world would need to comply with this international standard that allows for having great competencies during accreditations.

• Accreditation indicates the quality evaluation provided by a legally recognized authority to a laboratory or any other facility.
• Accreditation refers to the attainment of certain conditions outlined in ISO 15189, proving the right competence in undertaking medical test procedures most reliably.
...
... • Accreditation is a continuous process and often involves regular re-assessments, audits, and surveillance visits for ongoing conformity to the standard by an institution or agency.
• It is a public acknowledgment that a laboratory has been evaluated and meets international standards for medical testing.
• ISO 15189 Accreditation is often a requirement for a laboratory to qualify for reimbursement from health care payers, to meet various regulatory or legal requirements, or simply to instill confidence in patients, doctors, and others.

ISO 15189 Certification

The ISO 15189 certification means formal recognition of the qualification of a medical laboratory to meet international standards regarding the quality and competence with which it manages its testing and diagnostic services.

• Though similar to ISO 15189, certification mainly finds less use. Nonetheless, it may designate the official signification or issuance of a certificate to a laboratory indicating that it has fulfilled the conditions of ISO 15189.
• Sometimes accreditation includes certification as part of the process, but the assessment and continuing scrutiny may not be as severe.
• Some organizations may use the term "ISO 15189 certification" for initial or informal recognition of the conformity of a laboratory with the standard. In some cases, an organization may be certified to ISO 15189 by a certifying body, although this does not necessarily mean a recognized accrediting agency has accredited it.

Key Differences:

1. Procedure:

• Accreditation entails a formal, detailed, and comprehensive assessment by a recognized accreditation body along with periodic surveillance and reassessment.
• Certification may be simpler and could refer to a one-time declaration of compliance with the standard.

2. Continuing Necessity:

• Generally, the ISO 15189 accreditation is perpetual, with periodical reviews for compliance checks.
• The certificate may be single-time recognition depending on the scope and typing of authority.

3. Acknowledgement:

• There is a broader recognition of accreditation; it is mandatory by most regulatory bodies, healthcare providers, and insurance companies.
• Certification is rare in comparison and is not associated internationally to such a great extent.

In general, ISO 15189 accreditation is the more formal, thorough, and internationally recognized process for ensuring a medical laboratory's competencies while ISO 15189 certification simply indicates compliance without the essential reassessment and supervision.

In almost every context, particularly for medical laboratories, accreditation is the preferred and stronger option, as it implies both initial compliance and ongoing quality management.