Tool Technology Inc. Case Study

27 June 2024

Discover how a family-owned contract manufacturing powerhouse partnered with NQA to elevate its standards and expand into the medical device manufacturing sector.

Tool Technology, Inc. is a family-owned leading contract manufacturer located in Middleton, MA, with a stellar reputation for precision and rigorous quality control.

Catering to industries such as aerospace, defence, medical, and semiconductor, the company excels in CNC machining, Swiss turning, Wire and Conventional EDM.

Motivated by a commitment to fostering enduring partnerships through superior manufacturing, engineering prowess, competitive pricing, and punctual delivery, Tool Technology Inc. maintains an unwavering dedication to achieving the highest standards of excellence.

Recently, the company expanded its certification portfolio by achieving ISO 13485:2016 (Medical Devices Management), positioning itself to pursue more opportunities in the medical industry. This case study explores Tool Technology Inc.'s journey to this certification, highlighting the motivations, preparations, and anticipated impacts.

Why ISO 13485 certification?

The decision to pursue ISO 13485 certification was driven by Tool Technology Inc.’s strategic vision to expand its footprint into the medical device manufacturing sector.

As a contract manufacturer with existing ISO 9001:2015 (Quality) and AS9100:2016 (Aerospace Quality) certifications, the addition of ISO 13485 enabled the company to meet the specific quality management standards required by OEMs in the medical industry.

This certification is essential for Tool Technology Inc. to access new business opportunities and ensuring compliance with the stringent regulatory landscape of medical device manufacturing.

Choosing NQA for over 20 years

Returning client, Tool Technology Inc. has been with NQA for over 20 years and "our experience has been excellent."

Tool Technology Inc.'s choice to engage NQA for the ISO 13485 certification process reflects their confidence in our services and expertise, and the trust we have cultivated through many years of collaboration. We at NQA are proud to be continuing this partnership and look forward to many more successful years together.

Preparation & the audit experience

Preparation for the ISO 13485 audit was seamless, thanks to Tool Technology Inc.'s existing ISO 9001 and AS9100 certifications. With the guidance of a dedicated consultant, the team ensured all necessary adjustments were made efficiently.

A spokesperson for the company explained, “Assessor Steve Marquedant's insightful and perceptive approach ensured a smooth audit process, marked by efficient execution and productive engagement. His thoroughness and supportive demeanour facilitated a stress-free audit, enabling a constructive dialogue for improvement.
Overall, the preparation and audit process underscored Tool Technology Inc.'s commitment to maintaining high standards and continuous improvement.”

System Integration and Audit Schedules

While Tool Technology Inc. decided to retain separate audit schedules for the different certifications, they successfully integrated the majority of their processes. This integration ensures that their quality management system aligns with the requirements of ISO 9001, AS9100, and ISO 13485.

The benefits of this integration include:

Enhanced consistency and efficiency across different standards
Improved operational effectiveness
Simplified management of quality procedures
Reducing duplication
Streamlining operation
Making more effective use of senior management time
Achieving more cost efficient certification
Reducing audit fatigue

Path to growth: The future of Tool Technology Inc.

Although it is too early in their journey to fully quantify the impact of the ISO 13485 certification, Tool Technology Inc. is optimistic about the future. With the certification in hand, the company is poised to expand its machining services to the medical device industry and plans to utilize this certification to attract more clients in the medical sector with the aim of significantly boosting business growth in the coming years.

These efforts align with their strategic goal of diversifying their client base and increasing market share in high-precision manufacturing industries.

Paving the way to new opportunities

Tool Technology Inc.’s journey to ISO 13485 certification exemplifies their commitment to quality and continuous improvement. By achieving this certification, the company is well-positioned to expand its services and pursue new business opportunities.

The seamless integration of their quality management systems and the positive audit experience reflect their dedication to maintaining high standards. As Tool Technology Inc. continues to grow and innovate, their partnership with NQA remains a cornerstone of their success in meeting and exceeding industry expectations.

Final thoughts from NQA

NQA congratulates Tool Technology Inc. for achieving ISO 13485:2016 Certification, and their ongoing success with ISO 9001:2015 and AS9100:2016 certifications.

Tool Technology Inc. stands as a stellar example of best practices in the manufacturing industry, serving the aerospace, defence, and medical sectors. We look forward to witnessing their future achievements and continued success!