The international standard ISO 15189 describes the standards for a medical laboratory's quality management system and competence. To be more consistent with ISO 17025:2017, the benchmark for the proficiency of testing and calibration laboratories, the standard underwent its most recent revision in 2022.
While medical laboratories seeking to be reaccredited to ISO 15189 must adhere to the 2022 version, those certified to ISO 15189:2012 have three years to move to the 2025 edition.
The ISO 15189 Certification Procedure
Following our discussion of the advantages of obtaining ISO 15189 accreditation, let's look at how to finish the procedure and obtain ISO 15189 certification.
Pre-assessment
Your medical laboratory might need to go through a pre-assessment after submitting an initial application to a conformity assessment body (CAB). A CAB may advise the pre-assessment to assess how prepared your operation is for ISO 15189 accreditation.
The CAB will analyse your QMS documentation during a pre-assessment visit to find any substantial gaps or misinterpretations of the standards of the ISO 15189 standard.
Assessment
After you have passed the pre-assessment, the actual evaluation process can start. There are a few phases to take into account.
- Document Analysis
Usually, there are two steps to this initial evaluation, each of which takes place on a different day. The document review may be conducted either before or after the Stage 1 audit.
The assessor will ask for your quality management system (QMS) documentation as part of the document assessment to ensure that it complies with ISO 15189's requirements.
The assessor will note any flaws on your Stage 1 audit report if they are discovered.
- On-site Analysis
The terrifying part is now! Two on-site evaluations of your lab operation will be performed by your assessor: Stage 1 and Stage 2.
Your medical laboratory's implementation and documentation of each element of ISO 15189 compliance are evaluated during the Stage 1 audit, sometimes known as a "desktop audit," which is sometimes conducted.
To confirm that the processes around various components of the ISO 15189 standard are applied, the Stage 2 audit involves a more thorough examination of the QMS evidence.
Choice Regarding Accreditation
Now that the assessment is complete, it's time for your auditor to conclude.
They will decide whether to grant your medical laboratory ISO 15189 accreditation once they have received your report on corrective action.
One of the following outcomes could result from the decision:
- Recognition of accreditation
- Accreditation will only be granted if the necessary corrective measures are taken.
- a requirement for a later follow-up audit or visit to confirm that the corrective measures have been implemented.
- No accreditation is granted, so the medical laboratory must undergo a thorough re-audit.
Monitoring and Revaluation
A medical laboratory that has received ISO 15189 accreditation is required to submit to surveillance audits every 6 to 12 months and a thorough reassessment or re-certification audit every 2 to 4 years. The surveillance audit determines whether internal audits, management reviews, continuous improvement initiatives, and operational control are in line with ISO 15189 criteria. The reassessment audit covers every aspect of the laboratory's quality management system, procedures, ISO 15189 documents, physical space, level of technical expertise, and general compliance.
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ISO 15189 aids medical labs in enhancing the standard of their procedures, enhancing the effectiveness of their quality management systems, and ensuring accurate test results delivery.
On the other hand, without top-notch tools and technology, getting the ISO 15189 accreditation can be significantly more challenging. Its absence might hinder your lab in several ways.
Accreditationconsultancy.com provides a comprehensive solution for ISO 15189:2022 Accreditation for medical laboratories, assessing their competence, management system, technical practices, personnel qualifications, equipment, reagents, quality assurance, and analytical factors.
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