Standards & Certifications

Standards & Certifications

At TEQ, we are serious about quality and work to consistently meet the most rigorous standards for sterile barrier systems.

Assuring the Highest Quality of Production

We are passionate about what we do, and we go to great lengths to maintain world class standards, including complete traceability to raw materials, full documentation, SPC monitoring and complete adherence to your specifications, through the use of state-of-the-art computerized measurement tools.

We have won several quality awards for our work. It’s something we’re proud of and the reason we can guarantee fit, form and function of every part and package we produce. Here’s how:

  • Our medical device plant is one of the only ISO 13485 Registered custom thermoforming facilities in the US (secondary facility used for specific processes)
  • ISO 9001 Registered
  • Average of six audits annually by Medical and Pharmaceutical OEMs
  • Class 100,000 controlled environment
  • Regular validation including IQ/OQ/PQ
  • PFMEA risk analysis
  • Quality records are maintained for a minimum of three years
Sterile barrier system stability study.

ISO Standards

  • ISO 9001 Registered

    ISO 9001 Registered

    According to the International Organization for Standardization (ISO), ISO 9001 specifies requirements for a quality management system where an organization:

    (1.) Needs to demonstrate its ability to consistently provide products that meet customer and applicable statutory and regulatory requirements, and

    (2.) To enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customers and applicable statutory and regulatory requirements.

  • ISO 13485 Registered

    ISO 13485 Registered (Location Specific)

    According to the International Organization for Standardization (ISO), ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

  • ISO 11607 Compliant

    ISO 11607 Compliant

    According to the International Organization for Standardization (ISO), ISO 11607-1 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.

    ISO 11607-1 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

Other Certifications

FDA Registered (Location Specific)

According to the U.S. Food and Drug Administration (FDA), being FDA registered means:

Most establishments that are required to register with the FDA are also required to list the devices that are made there and the activities that are performed on those devices. If a device requires premarket approval or notification before being marketed in the U.S., then the owner/operator should also provide the FDA premarket submission number (510(k), PMA, PDP, HDE).

cGMP Certified

According to the U.S. Food and Drug Administration (FDA), cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the CGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations.

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