BioTeknica Earns ISO 9001:2015 Certification

Friday, Jan 12, 2018

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 best 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.”