DNA GTx Receives The ISO 15189:2022 Quality Standard Certification

Home > News > DNA GTx Receives The ISO 15189:2022 Quality Standard Certification

The International Organization for Standardization certified DNA GTx with the ISO 15189, related to Quality Management Systems (QMS). The procedure for obtaining the ISO 15189 involves the development and implementation of a QMS, followed by a gap analysis by comparing it to the ISO Standard. After the necessary adjustments are made, an application is submitted, and an auditing process occurs.

In this case, that standard is aimed at medical laboratories, and it confirms that DNA GTx can:

Clearly document its processes for ensuring quality,
Identify and manage key risks,
Detect areas for continual improvement,
Demonstrate appropriate training of all personnel

And other tasks of importance to assure its quality and risk management, competence, patient safety and regulatory compliance. Although other general quality system ISOs are important, ISO 15189 encompasses the importance of managing testing process and extra-analytical phases, of focusing on costumer’s needs and technical abilities and knowledge.

“We are proud to announce that our laboratory has achieved ISO 15189 certification. It reflects the hard work and dedication of our entire team, who strive every day to meet the highest standards in our area. This not only enhances our credibility and trust with patients, healthcare providers, and partners but also ensures that we are delivering reliable and precise results that are crucial for patient care and scientific research.” Says Prof. Sandro de Souza, CSO of DNA GTx.

Obtaining the ISO 15189 is a great milestone achieved and it shows our dedication to maintaining and improving our standards of quality. This accreditation demonstrates we are leaping towards ever better patient care and trust.

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