ISO Certification Case Studies

Recent client results

ISO 13485 certification after an FDA warning letter

Holistic medical device company · Delaware · about 20 employees · 2023–2024 · SurePath

After receiving an FDA warning letter, and spending thousands of dollars with an attorney to respond, this medical device company found that most of the FDA’s observations could be answered by an ISO 13485 quality management system. MSI took on the project through SurePath, with design and development in scope, and worked entirely remotely.

MSI led planning, then spent a week with the team drafting 10 procedures. MSI delivered corrective and preventive action and ISO 13485 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: recommended for ISO 13485:2016 certification first time through, with a QMS that resolved most of the FDA warning letter observations. See how MSI supports ISO 13485 consulting.

ISO 9001 certification with design, and zero findings

Lab monitoring service provider · serves labs across the US · 2020–present · SurePath and SureResults

This company designs, installs and maintains equipment and environmental monitoring systems for laboratories nationwide. MSI proposed a SurePath engagement in December 2020 to build an ISO 9001 quality management system with design and development in scope.

MSI led planning, worked with the team to draft the procedures, delivered corrective and preventive action and ISO 9001 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: in September 2021 the company was recommended for ISO 9001:2015 certification, including design, with zero findings. It remains an MSI client today through the SureResults ISO Maintenance Program.

ISO 9001 certification in four months for a research marketplace

Online research services marketplace · Southern California · 2019–present · SurePath and SureResults

This company runs online marketplaces that connect pharmaceutical and biotech researchers with contract research providers. In 2019 it asked MSI for a full SurePath proposal to build an ISO 9001 quality management system. Design and development was excluded.

MSI led planning, worked with the team to draft the procedures, delivered corrective and preventive action and ISO 9001 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: within four months of starting, the company completed its registrar audits and was recommended for ISO 9001:2015 certification. It remains an MSI client today through the SureResults ISO Maintenance Program.

ISO 9001 documents written in four days to meet a customer qualification

Medical device clinical training provider · Carlsbad, CA · 2016–present · SurePath and SureResults

This company provides outsourced clinical training and education for medical device and diagnostics manufacturers. It came to MSI needing ISO 9001 to be qualified as a supplier by a major healthcare equipment manufacturer. MSI provided a SurePath proposal in 2016, with design and development excluded.

Because of the urgency, MSI learned the company’s processes in depth and wrote its documents within four days. MSI then delivered corrective and preventive action and ISO 9001 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: in October 2017 the company was recommended for ISO 9001:2015 certification. It was later acquired by a global health data and research company, and remains an MSI client today through the SureResults ISO Maintenance Program.

ISO 9001 and ISO 13485 certification for a gas control equipment manufacturer

Gas regulator and manifold manufacturer · Southern California · 2016–present · SurePath and SureResults

This manufacturer makes gas regulators, manifolds and gas control systems for medical, specialty gas and industrial markets. MSI provided a combined ISO 9001 and ISO 13485 SurePath proposal in 2016. Design and development was in scope at first, and was later removed from scope entirely.

MSI led planning, worked with the team to draft the procedures, delivered corrective and preventive action and ISO 9001 and ISO 13485 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: eight months after starting, the company was recommended for certification to both ISO 9001 and ISO 13485. It remains an MSI client today through the SureResults ISO Maintenance Program.

MindFlow Design: ISO 9001 and ISO 13485 certification for a medical device design house

Full-service medical device design house · Carlsbad, CA · 2015–2021 · SurePath and SureResults

This was MSI’s first combined ISO 9001 and ISO 13485 SurePath project, for a full-service design house with design and development fully in scope. MSI used the same procedures and process it uses today.

MSI led planning, worked with the team to draft the procedures, delivered corrective and preventive action and ISO 9001 and ISO 13485 overview training, coached implementation, performed the full-system internal audit, and coached the team through the management review, the preliminary scope audit and the full certification audit.

Result: eight months after starting, MindFlow Design was recommended for ISO 9001 and ISO 13485 certification. MSI continued to support it through the SureResults ISO Maintenance Program until it was acquired by a larger company in 2021.

Sodexo: ISO 9001 certification for an HRIS department

Sodexo HRIS department · Gaithersburg, MD · 2009–2012 · SurePath and SureResults

Sodexo’s HRIS department manages HR data, databases and data integration for about 413,000 employees. MSI focused the quality management system on HR data management only, determined which exclusions could justifiably be taken, and addressed the department’s outsourced process.

MSI developed the documentation for the department’s HR data management methodology, coached implementation, provided ISO 9001 overview and internal auditor training, coordinated registrar selection, and was present at each audit.

Result: the April 2010 registration audit resulted in a recommendation for ISO 9001:2008 certification, followed by ongoing support through the SureResults ISO Maintenance Program. “Her flexibility was one of the keys to our success.” — Cassie Vasco, Management Representative, Sodexo

St. Jude Medical (now part of Abbott): ISO 14001 environmental management system

Medical device manufacturer · Irvine, CA site · 2009 · SurePath

St. Jude Medical, already ISO 13485 certified, wanted an environmental management system that fit its ISO 13485 system and brought every employee at its Irvine site on board with its environmental programs.

MSI guided the EMS policy and objectives, identified environmental aspects and pollution prevention programs, coached the team through the environmental manual and procedures by interviewing employees in each function, trained staff on ISO 14001 and internal auditing, coached corrective and preventive action, and prepared the management review.

Result: aspect identification was completed in June 2009, the system audit in July and internal audit training and management review in August, and the site was registered to ISO 14001:2004 in October 2009, with every program milestone completed on time. St. Jude Medical became part of Abbott in 2017.

ISO 9001 with zero findings for a commercial general contractor

Commercial contractor founded in 1959 · Southern California · 2007–2020 · SurePath and SureResults

One of Southern California’s largest builders and a real estate and construction advisor to Fortune 500 and growing companies, this contractor became one of a select few general contracting firms in the United States to earn ISO 9001 certification.

MSI established the quality management system from the ground up, controlled through compliance management software. MSI trained personnel, updated the procedures and quality manual by interviewing employees, conducted internal audits at every job site, guided the management review, and was present at the pre-assessment, registration, surveillance and recertification audits.

Result: registration to ISO 9001:2008 was completed on October 30, 2008, with zero findings. MSI then maintained the system through the SureResults ISO Maintenance Program until 2020.