Interstate Specialty Products Attains Certification for Medical Device Quality Standard ISO 13485:2003

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Interstate Specialty Products attains the certification ISO 13485:2003 certification that is a standard specific to medical device quality systems that supplements the requirements ISO 9001:2008 standard. Interstate Specialty Products provides precision custom die cutting services and high performance gaskets.

The ISO: 13485:2003 certification demonstrates ISP’s commitment to continuous improvement; the ability to consistently meet our customer’s needs, and advance our growth in the global marketplace.”

Interstate Specialty Products is proud to announce that the company’s Quality Management System has been certified to ISO 9001:2008 and ISO 13485:2003 applicable to the provision of precision die cutting and specialty gasket fabrication services to the commercial and medical industry.

The certification was awarded to Interstate Specialty Products by National Quality Assurance, U.S.A. of Acton, Massachusetts. Interstate went through a rigorous audit and, according to John Savickas, President of Interstate Specialty Products, “The ISO 9001:2008 and ISO: 13485:2003 was a milestone that was achieved by full engagement of all of our employees. The certification demonstrates ISP’s commitment to continuous improvement; the ability to consistently meet our customer’s needs, and advance our growth in the global marketplace.”

ISO 13485:2003 is a standard specific to medical device quality systems that supplements the requirements ISO 9001:2008 standard. Additional requirements relate to process controls (including environmental controls), special processes, traceability, record retention, and regulatory actions, which are critical concerns in the medical device industry. Companies receiving the ISO 13485:2003 certification must demonstrate their ability to provide medical devices and related services that consistently meet customer expectations and regulatory requirements.

ISO 9001 was originally published in 1987 by the International Organization for Standardization, a worldwide federation of national standards bodies, headquartered in Geneva, Switzerland. The Organization was founded in 1946 to develop a common set of standards for manufacturing, trade and communications. Today more than 150 countries are members, each with a representative. The representative for the United States is the American National Standards Institute (ANSI). In addition to ISO 9001, more than 17,000 other ISO standards exist. ISO 9001:2008 is the current version of this standard.

NQA, the agency that certified and registered Interstate’s management system is a leading global independently accredited certification body (registrar), providing assessments (audits) of organizations to various Management System Standards since 1988. Headquartered in Acton, Massachusetts, NQA, USA was established in 1992 as a joint venture between National Quality Assurance (NQA), Limited (headquartered in London, England) and National Technical Systems, Inc. .

NQA, USA has expertise in many diverse industries including aerospace, telecommunications, electronics, information technology, professional services, transportation and distribution, automotive, plastics, metal and machinery, foods and supply chain management.

Interstate Specialty Products manufactures high-performance custom gaskets and offers precision custom die cutting services, and now adds the quality management system certification ISO 9001:2008 and ISO 13485:2003. Founded in 1963, Interstate Specialty Products (ISP) serves blue-chip clients in the scientific, medical, industrial and many other industries. For over 45 years, Interstate Specialty Products has continually set new standards in custom gaskets and die cutting. Interstate offers clients an unbeatable combination of industry expertise, state-of-the-art equipment and facilities, competitive pricing and impeccable customer service. ISP is where innovation takes shape. For more information on Interstate Specialty Products, visit their website at interstatesp.com

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John Savickas

Bob Grant
Grant Marketing
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