Achieving ISO 15189 Certification assists medical laboratories in developing their quality management system and assessing their own competence. It can also be used for confirming or recognizing the competence of medical laboratories by regulating authorities, laboratory customers, and accreditation bodies. Overall, ISO 15189 certification demonstrates a laboratory’s commitment to providing accurate and reliable results. ISO 15189 in Malaysia is becoming increasingly popular as more medical laboratories are striving to become certified.

IAS provides a very simple yet efficient ISO 15189 certification process to help your organization achieve ISO 15189 certification in a timely manner!

Benefits of ISO 15189 Certification

Implementing ISO 15189 in Malaysia can improve medical laboratory processes and increase customer satisfaction. With ISO 15189 certification, medical laboratories can:

Enhance the quality of patient care by providing accurate results on tests Develop a systematic approach to management which helps in achieving efficiency Strengthen the institution’s reputation as one that provides high quality services Increase credibility and trust among customers Enhance customer confidence in the institution Benefit from better cost control and improved profits

Overall, ISO 15189 certification ensures that medical laboratories meet international standards for quality and accuracy. It also enables them to provide accurate results on tests, thereby enhancing patient care. By achieving ISO 15189 Certification, medical laboratories can be recognized for their commitment to providing quality services.

How to Achieve ISO 15189 Certification Through IAS?

Contact IAS by sending the Application Form and call us for a discussion to guide you in getting ISO 15189 certification.

Prepare your organization for ISO 15189 certification by implementing and practicing the standard, monitoring, and continually improving. You can even register for ISO 15189 Internal Auditor Training to train your employees on how to conduct effect internal audits of the medical laboratory quality management system. Majorly, the process of ISO 15189 certification includes 2 audit stages: Stage 1 Audit: Readiness Audit Stage 2 Audit: Verifying the Effectiveness of the System The organization applying for ISO 15189 certification will be audited based on an extensive sample of its sites, services, process, products functions.

If there is any deviation observed during the audit, a deviation report will be submitted along with the detailed audit report. According to the grading of the deviations, IAS determines the time required for its closure including the correction and corrective actions which have to be approved by IAS. After the effective closure of Nonconformity, ISO 15189 certification is issued with the scope that was audited.