ISO Certification Overview

The International Organization for Standardization (ISO) develops standards that help companies monitor and improve their processes and products, in terms of quality, environmental impact, safety, reliability, efficiency and interchangeability.

Recognized worldwide by regulatory affairs professionals and quality mangers, ISO bridges the national standards institutes of 159 countries. A company that demonstrates adherence to specific standards can earn credibility with its customers, investors, employees and other stakeholders. In addition, many countries mandate certain ISO certifications prior to granting a manufacturer approval to sell products.

Demonstrate Adherence to World Standards through Independent Certification

Regulators rely on the work of accredited third parties to audit companies to ISO standards. LNE/G-MED is authorized to certify a variety of ISO standards, including:

• ISO 9001: 2008:  Quality management systems, Requirements
• ISO 13485: 2003:  Medical devices, Quality management systems, Requirements for regulatory purposes
• ISO 15378: 2006:  Primary packaging materials for medicinal products, Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
• ISO 14001: 2004:  Environmental management systems, Requirements with guidance for use

Advantages

LNE/G-MED America has the necessary expertise and experience to provide certification for organizations under ISO 13485 alone, or in conjunction with CE Marking, CMDCAS, Third Party FDA Inspection and other certificates, to save you the time and cost of multiple audits. In addition, you benefit form:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Widely recognized LNE/G-MED expertise as a European Notified Body (CE 0459), as an Accredited Certification Organization by France's accreditation body COFRAC, as a Registrar accredited by the Standards Council of Canada under the Canadian Medical Devices Conformity Assessment System (CMDCAS) and recognized by Health Canada and as a Third Party Accredited Person by the U.S. FDA
• Added services, such as product testing (EMC, electrical, mechanical, CB Scheme), product certification, pre-assessment audits and fast-track or onsite review for CE Marking

Find Out More

LNE/G-MED America offers in-person, online and other customized training on a wide range of certification and quality topics. For details, check out our training schedule or request a customized program.

Contact LNE/G-MED America

• For proposals or other service questions: contact customer service
• Ask our experts to submit specific questions to our technical team