How Trinity M Consulting uses ISMS.online for ISO certification and as a mini QMS

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.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.”
May Escalona 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.”
May Escalona 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.”
May Escalona CEO and Founder, Trinity M Consulting

The Result

Trinity M Consulting successfully achieved ISO 9001 and 27001 certifications after smooth audits during which the company could easily show auditors all the necessary information and evidence to demonstrate compliance. Having all information easily navigable inside ISMS.online helped streamline and speed up the audit process.

“The auditor was very impressed with how everything was organised inside ISMS.online. It’s so helpful to have all the information in one place, allowing for easy review and maintenance.”
May Escalona CEO and Founder, Trinity M Consulting

Achieving the ISO certifications and using ISMS.online as a mini QMS has also bolstered client trust and confidence in Trinity M Consulting’s capabilities. Standardised, well-documented processes and policies help the company deliver the high-quality services its clients need to ensure regulatory compliance when developing, testing, and launching new medical, pharmaceutical, and biotech products.

“Having ISMS.online is a real benefit in being able to assure our clients that we have high standards in place for ensuring compliance, quality, and data privacy. We can show that we follow correct regulatory processes, validated by external certification.”
May Escalona CEO and Founder, Trinity M Consulting

What’s Next?

Alongside continuing its own use of ISMS.online, Trinity M Consulting is now well placed to share its experiences with clients who might be pursuing their own ISO certifications.

“Now I’ve experienced the benefits of using ISMS.online and adapting it to our needs, I can advocate for it to help our clients who might be in a similar position. It’s always great to get feedback from someone who has actually used a tool.”
May Escalona CEO and Founder, Trinity M Consulting

For more information, visit our ISO 9001 and ISO 27001 solutions pages or contact us to see how we can help your business.

Based

United States

Company Size

2 -10

Industry

Healthcare

Compliance Frameworks

ISO 9001, ISO 27001

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

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