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BioTeknica Earns ISO 9001:2015 Certification
[January 11, 2018]

BioTeknica Earns ISO 9001:2015 Certification

BioTeknica, Inc., a regulatory compliance and engineering consulting firm for life science manufacturers, announced that it received ISO 9001:2015 certification, the highest standards of its kind, for its Quality Management System. For clients, it means BioTeknica has rigorous quality management systems and standards in place throughout its operations and that its top priority is customer satisfaction.

The International Organization for Standardization (ISO) helps companies develop management systems that focus on quality, risk-based thinking and accountability. The ISO 9000 group of quality management standards is designed to help organizations, like BioTeknica, meet the needs of customers while meeting regulatory requirements. These latest standards, adopted in 2015, help to improve communications, efficiency, implementation of continuous improvement and ultimately, higher customer satisfaction. BioTeknica received its certification from TÜV SÜD AMERICA, a global leader in independent ISO testing, inspection and certification.

Medical device, pharmaceutical, biologic and IT health companies must comply with FDA regulations, and BioTeknica specializes in helping manufacturers adhere to them. "We have a 20-year proven track record of assisting life science manufacturers with regulatory compliance," said Braulio Ortiz, Principal and Co-Founder of the firm. "We've always known that our Simple, Systematic, Sustainable solutions delivered results for our clients; it only made sense that we independently confirmed, enhanced and documented these bet practices."

Through TÜV SÜD AMERICA, a world-class third-party notification body, BioTeknica embarked on a journey and commitment to continuously improve its internal processes in all service areas, including Regulatory Compliance, Quality Engineering, FDA Inspection Readiness and Validation, as well as operations and staffing - hiring the right people with the best technical and soft skills. The ISO standard requires a constant internal re-evaluation of the system and promotes a continuous improvement process.

"We wanted clients to feel confident that every engineer, scientist and team member throughout our organization is responsible for delivering innovative, high-quality customer-focused engineering and regulatory solutions. We don't just talk about quality, it's the lifeblood that runs through our organization," said Mike Neaves, BioTeknica's Principal and Senior Quality Engineering Consultant, who spearheaded the certification project. "This is just the beginning," he added. "It will be a process of continuous improvement."

About BioTeknica

BioTeknica, Inc. ( is a consulting firm that specializes in the quality systems and engineering services for the medical device, pharmaceutical and biologic industries. BioTeknica has a solid track record of providing companies with resolution to regulatory compliance, software, process, validation and facility commissioning issues.


TÜV SÜD AMERICA, Inc. ( provides testing, inspection and certification services. It offers services in the areas of auditing and system certification, global market access, inspection, knowledge solutions, product certification, testing, training, digital service, embedded systems, functional safety and IT security. The company serves clients in a variety of industries from aerospace, automotive, chemical, consumer products, food, beauty, healthcare and medical device, to telecommunications and information technology industries worldwide. TÜV SÜD AG was founded in 1866 and is based in Munich, Germany, with locations worldwide.

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