Modality Solutions’ Quality Management System is ISO 9001:2015 Certified by Intertek

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Modality Solutions, a biopharmaceutical cold chain engineering firm, achieved ISO 9001:2015 certification on December 10, 2019.

Modality Solutions ISO 9001:2015

The scope of the Modality Solutions' QMS certification covers consulting, design and engineering services and testing for supply chain logistics related to transport-sensitive food and drug products.

With our ISO 9001:2015 certification, our clients are confident in knowing the services we provide will meet or exceed the requirements of this internationally recognized quality management standard,” said Gary Hutchinson

Modality Solutions, a leading biopharmaceutical cold chain engineering firm, is pleased to announce it achieved its ISO 9001:2015 registration by certification body Intertek. Modality Solutions’ Quality Manager, Hannah Anderson, spearheaded the year-long process. In preparation for the audits, she reviewed and revised all existing Standard Operating Procedures (SOPs) and created ten new SOPs. Anderson trained staff on the new standards, conducted internal audits, and managed the Intertek audits at the Modality Solutions corporate office in Houston and the company’s Advantage Transport Simulation Laboratory™ in Bloomington, Indiana.

The scope of Modality Solutions’ ISO 9001:2015 Quality Management System certification covers consulting, design and engineering services and testing for supply chain logistics related to transport-sensitive food and drug products.

According to the independent non-governmental international ISO organization, the ISO 9001:2015 Quality Management System (QMS) is internationally recognized as the world’s leading quality management standard. It has been implemented by more than one million organizations in over 170 countries globally.

"It was a great experience to help Modality Solutions navigate and achieve ISO certification and a privilege to continue in my position to lead our quality objectives overall,” said Anderson. “Before achieving the certification, many clients requested on-site audits of our transportation simulation laboratory and quality management systems. With the certification, I think Modality Solutions will save our clients both time and money as we continue to build their confidence in our overall quality management approach. ISO 9001:2015 increases efficiency for our clients.”

ISO 9001:2015 specifies requirements for a Quality Management System when an organization:

  • needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory as well as regulatory requirements
  • aims to enhance customer satisfaction through the assurance of conformity to customer and applicable statutory and regulatory requirements.

“With our ISO 9001:2015 certification, our clients are confident in knowing the services we provide will meet or exceed the requirements of this internationally recognized quality management standard,” said Gary Hutchinson, President of Modality Solutions. “By demonstrating our ongoing commitment to our quality management systems, both GDP and ISO 9001:2015, we will continue to implement improvements towards increased efficiency and maximum client satisfaction.”

To learn more about Modality Solutions, visit https://www.modality-solutions.com.

About Modality Solutions, LLC
Founded in 2011, Modality Solutions, a leading biopharmaceutical cold chain engineering firm, specializes in integrating cold chain operations, developing transport validation strategies, supporting global regulatory applications, and supporting global clinical trial operations. By combining the best practices of process validation, systems qualification, and risk assessment, Modality Solutions has earned the reputation of ensuring regulatory compliance, product quality, and patient safety. As a 2019 Inc. 5000 company, Houston Business Journal Fast 100, Entrepreneur 360™, and Forbes Technology Council company, Modality Solutions’ team of engineers are experts at delivering cold chain thermal packaging design and qualification, conducting transport simulation testing with its Advantage Transport Simulation Laboratory™, and designing controlled-environment logistics solutions. For more information, visit https://www.modality-solutions.com.

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Susan Almon-Pesch
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