Trinity M Consulting’s key focus is on ensuring excellence in its services to help clients successfully bring their products to market, ultimately benefiting patients. Ensuring those products are fully compliant is both critical and demanding in the heavily regulated medical sector.
The Challenge
Since its founding, Trinity M Consulting has been preparing to gain certification in both ISO 9001 (quality management) and ISO 27001 (information security management). The goals were twofold: to ensure operational efficiency through standardised, well-designed processes and policies, and to reassure potential clients of the company’s ability to deliver high-quality services.
“We wanted to show clients our commitment to quality, data privacy, and proven ways of working. Although obtaining ISO certifications was not a requirement to conduct our services, we wanted to operate at a higher level of excellence beyond what is expected.”
CEO and Founder, Trinity M Consulting
Additionally, Trinity M Consulting sought to strengthen its quality management system (QMS). They were storing documents on Google Drive, but needed a more efficient, user-friendly way to track document reviews and changes — a core requirement of ISO 9001.
The Solution
On discovering ISMS.online, Trinity M Consulting immediately recognised its benefits. The company implemented ISMS.online to help achieve and maintain certifications for ISOs 9001 and 27001. They particularly value ISMS.online’s intuitive structure and navigation, flexible modification options, and helpful dashboards for metrics management.
“The ISMS.online team were very approachable, helpful, and understanding of our company needs. It was so nice to get ongoing support, which isn’t the norm with other systems I’ve used.”
CEO and Founder, Trinity M Consulting
Trinity M Consulting adapted templates in ISMS.online to also use it as a mini quality management system. While the company stores documents outside of ISMS.online, they record all changes to documents and processes within the platform. This provides a complete change management record and a clear audit trail that is easy to navigate.
“An unexpected benefit of implementing ISMS.online is that with a minor modification to the platform we have adjusted it to function as a mini QMS. It’s our single source of truth.”
CEO and Founder, Trinity M Consulting
Based
United States
Company Size
2 -10 employees
Industry
Healthcare
Compliance Frameworks
ISO 9001, ISO 27001
Global consulting company Trinity M Consulting helps medical device, pharmaceutical, and biotechnology companies commercialise and maintain their products in compliance with regulations. The company’s end-to-end commercialisation services include regulatory affairs, clinical trial management, quality, and project management.
ISO 9001 and 27001 success
Achieved first-time ISO 9001 and 27001 certification
Easier QMS change management
Strengthened change management process using ISMS.online as a mini QMS
Enhanced client confidence
Proven commitment and processes for ensuring compliance, quality, and data privacy
