BioTeknica is an ISO 9001:2015 Certified Company

 ISO 9001 TUV

“… every engineer and team member throughout our organization is responsible for delivering innovative customer-focused engineering and regulatory solutions.”

BioTeknica has successfully achieved ISO 9001:2015 certification, the highest standards of its kind, for its Quality Management System.   Life science manufacturers can further benefit from the knowledge that every engineer, scientist and team member throughout our organization is responsible for delivering innovative customer-focused engineering and regulatory solutions.

We received certification from TÜV SÜD AMERICA, a global leader in independent ISO testing, inspection and certification, by demonstrating that we have an effective Quality Management System (QMS) in place.  Given our 20-year proven track record of assisting life science manufacturers with our proprietary S3:  Simple, Systematic and Sustainable solutions, our goal is to continue improving our internal management processes to better serve our medical device, pharmaceutical, biologic and IT health customers.  BioTeknica’s rigorous QMS is predictable and consistent and focuses on an evidence-based approach.

The International Organization for Standardization (ISO) helps organizations develop quality management systems, and the ISO 9000 group of quality management standards is designed to help companies, like BioTeknica, meet the needs of its life science customers while meeting regulatory requirements. The 2015 standards were developed around important QM principles:

  1. Customer focus
  2. Process approach
  3. Continuous improvement
  4. Evidence-based decision-making
  5. Leadership

Committed to achieving the ISO 9001:2015 standards, BioTeknica began the certification process by preparing specific documents that define the firm’s QMS, including:

  • A Quality Manual
  • Control of Documents Procedure
  • Control of Records Procedure
  • Control of Nonconformance Procedure
  • Corrective Action Procedure
  • Preventive Action Procedure
  • Internal Audit Procedure

Once the QMS documents were developed, BioTeknica implemented the QM system throughout its organization, from the company’s leadership and engineers, to its HR and Business Development groups and administrative staff.  Senior management monitored and tracked the implementation and addressed any needed changes.

The company’s internal auditors then conducted a thorough audit to confirm that the QM system is working and effective. As a last step, the independent ISO registrar, TÜV SÜD AMERICA, audited BioTeknica and awarded us with the ISO 9001:2015, the highest standards of its kind.

Contact us to find out how working with BioTeknica can benefit your organization.

Standard:            9001:2015

Scope:                  Quality Management System in Engineering and Consulting Services