La Palma, Calif.-based Tech Knowledge Associates (TKA) announces that its Quality Management System has earned ISO 9001 certification from Intertek. The three-year certification verifies that TKA, which provides healthcare technology management (HTM) services, maintains a quality management system that delivers the highest levels of operational and regulatory requirements, in addition to continuously improving to meet hospital partner needs.
“This certification from one of the leading global ISO registrars signifies that not only have we developed superior operating processes, but those same processes have been validated to confirm we deliver repeatedly against those exacting quality standards,” says George Hampton, president of TKA. “This certification underscores that our people consistently perform at the highest levels to uphold patient safety, which, in turn, translates into strong satisfaction from our partner organizations.”
The independent International Organization for Standardization (ISO) develops standards across traditional industries—including manufacturing—as well as for best practices and services that align with those standards. With offices in more than 100 countries, Intertek provides testing and certification services, including for ISO standards.
The ISO9001 standard specifically focuses on quality management systems, which align with TKA’s role in taking care of diagnostic and therapeutic medical equipment and devices in its healthcare system partners, company officials say.
While the HTM industry offers certification programs for biomedical technicians, no similar quality benchmarks exist for clinical engineering programs. TKA leaders identified the ISO 9001 certification as a way to provide partners and potential partners with the necessary confidence that the company and its people operate consistently and optimally to support the shared mission of quality patient care.
At the core of TKA’s quality management strategy is TeamNet, its customizable computerized maintenance management system, which tracks and documents preventative maintenance and corrective maintenance, parts ordering, equipment lifecycle, response time, and more. Building on that platform, TKA has developed processes and methodologies for repairing equipment, auditing performance, and remediating emerging issues—not to mention training and development plans to keep biomeds prepared to handle ever-more-sophisticated medical technology.
TKA’s certification comes after a trio of rigorous process reviews by ISO auditors, which verified each fundamental daily process met both expectations and requirements of the ISO 9001 standard. The final audit, conducted over five days, involved reviewing operations and practices in member hospitals.
“TKA already had proven management systems in place, and our journey toward certification focused our efforts on formalizing our best practices into procedures that aligned with the ISO 9001,” says Raymond Reid, director of quality, who joined TKA a year ago to help the HTM company achieve ISO 9001 certification. “This effort resulted in elevating what was already high-quality work to the next level across the TKA footprint.”
TKA now is looking to add ISO 13485 certification as well. Although this standard is designed specifically for medical equipment manufacturers, TKA leaders still see opportunities for the certification to apply to independent service organizations and their role in medical technology upkeep and repair, company officials say.