High Purity New England (HPNE) is a supplier of high purity products to the BioPharma, pharmaceutical, microelectronics and food industries with over 40 years of experience. Their headquarters in Smithfield Rhode Island, a short distance from one of the largest biotech hubs in the world allowed national growth with both direct and partner sales models. Their sterilization process has won business in the local biotech industry and received global exposure past their initial launch.
High Purity NE has enjoyed aggressive 30% annual revenue growth since being founded. This growth enabled facility and staff expansion, and also generated greater demands from customers and prospects. One large customer required ISO 9001 certification for a potential $300k sales opportunity. HPNE’s management team agreed that the ability to quickly prove quality practices, win new business and continue aggressive growth would be improved with ISO certification. The ability to complete the certification in the most cost effective and quickest way possible was crucial to winning this $300K sales opportunity and would strengthen HPNE’s proposals for additional new business.Situation
“High Purity NE is focused on global growth, and ISO 9000 certification is a critical tool to achieve our targets. We are now able to get the attention of larger prospects”.
-Mark Sitcoske, President
High Purity NE engaged with Polaris MEP to support the ISO Certification preparation process. Sales growth was supported by solid business processes, required as their manufacturing processes became more complex, but the company lacked experience with the requirements of ISO 9001 certification. The Polaris MEP team includes a former employee from one of the largest global 3rd party ISO auditors. This expertise was critical to support the High Purity NE preparation process in a highly efficient manner – generating only that documentation critical to the certification. The Polaris MEP team engaged with the High Purity management team to complete the Quality Manual and supporting documents, auditor trainings, and management reviews. The documentation supported existing business processes and confirmed their quality without adding unnecessary overhead. High Purity NE became ISO 9001:2008 certified for the design, development, manufacturing, and distribution of disposable assemblies. The Polaris MEP team was instrumental in supporting the High Purity NE ISO certification which, in turn, led to a $300k opportunity and future related growth opportunities.