True Indicating is a privately held organization established in 2017, providing the highest quality products and expert services to manufacturers of medical devices and healthcare products, pharmaceutical and biotechnology companies. We provide strategic guidance and support to help clients develop, monitor and advance their sterilization and disinfection monitoring products and processes.
With over 35 years of combined experience, our focus is science based service allowing for identification of True solutions and True partnership with our clients.
Accreditations and Certifications
True Indicating plans to achieve ISO 13485 certification in 2021. (Due to the Covid-19 pandemic, the timeline for certification has been delayed.)
US FDA Establishment
True Indicating has obtained our FDA Registration (number is pending issuance).
True Indicating will be registered with the CRDH division of the FDA, thus will be subject to focused audits under 21 CFR Part 820.
True Indicating strives to conduct its business with a total commitment to our Clients and their requirements. We define quality as conformance to our Client's needs, both internal and external; and conformance to all quality requirements. We are committed to comply with requirements and to maintain effectiveness of our Quality Management System through the following principles and behaviors:
Commitment to thoroughly understand the needs of our Clients in order to build mutually beneficial relationships ensuring long-term success
Honor our commitments for quality, cost and timeliness
Standardize and document best practices through lessons learned, at all levels, to predict future results and manage risk
Drive continuous improvement and innovation based on efficient business processes, well-defined measurements and Client feedback
Commitment to develop staff competencies through empowerment, appropriate training and accountability.
True Indicating is committed to providing the highest level of quality, value and service experience to every Client, every time.
Quality objectives are established, communicated, implemented, and reviewed throughout the organization to ensure objectives our clearly understood and performed.
We believe that superior service is the result of listening, learning and responding. Our mission is to serve and meet the needs of our clients by working together as partners. Our foundational values are integrity, quality, and efficiency and we are committed to those values in every interaction we have with our clients, staff and other stakeholders.
True Integrity, True Quality and True Efficiency is True Indicating's Mission.