Ensuring Quality with savENRG® PCM Technology

ISO9001:2015 Quality Management System

April 26th, 2024

By Anastasia Luibel

ISO9001:2015 Certification

As a globally recognized standard for Quality Management Systems, certification under ISO 9001:2015 assures international consensus on sound management practices, a commitment to meeting customer requirements, and an emphasis on risk-based thinking and process-oriented approaches.

Engineering Processes

Our engineering processes collaborate closely with customers to establish product acceptance specifications, utilizing validated data from laboratory testing and production scalability studies. Stringent pre-production planning, standardized risk responses, state-of-the-art machinery with calibrated instrumentation tools, and a skilled workforce collectively ensure that the purchased material meets required specifications and the manufacturing process consistently delivers results in line with defined product specifications.

Customer Expectations

Quality data collected throughout each production run undergoes comparative analysis to customer-specified Quality metrics during the production process. Goods not meeting the metrics are rejected during the process and we generate a Certificate of Conformance for products qualified for delivery, reaffirming our commitment to meeting and exceeding customer expectations.

Risk-Based Thinking and Process-Oriented Approaches

Each day, we cultivate a culture that revolves around standardizing our organizational processes utilizing the SIPOC tool and PDCA. With SIPOC we map these key elements: Supplier, process Input, the Process itself, process Output, and associated Customer. Following PDCA, we Plan objectives, Do as planned, Check outputs using established metrics, and Act to improve performance as necessary. We periodically review each process, recognizing risks and opportunities while taking changing business environments into consideration.

Ensuring Quality with savENRG® Technology

Working with an ISO9001-2015 Certified organization that embraces a continuous improvement mindset ensures confidence in the savENRG® technology implemented within Akuratemp® products. We pledge to deliver reusable and traceable temperature-controlled packaging technology that will enhance the reliability of temperature-sensitive biologics’ delivery, all while maintaining economic sustainability.

Contact us today to explore the benefits of working with an ISO 9001:2015 Certified company.