ISO 9001:2008

Quality Management Systems, Requirements

This standard specifies a set of procedures to demonstrate commitment to quality and ensure continual improvement and customer satisfaction.

Utilized by regulatory affairs professionals and quality managers throughout the world, ISO 9001: 2008 is applicable to all type of companies (manufacturers, services providers…) and indutries.

The standard covers five main aspects:

• Quality Management Systems
• Management's Responsibility
• Resource Management
• Product Realization
• Measurement analysis and continuous improvement

The ISO 9001:2008 will supersedes ISO 9001:2000 in November 2010. For the standard derived from ISO 9001 that relates specifically to medical devices, please see ISO 13485.

Advantages

LNE/G-MED America has the necessary expertise and experience to provide certification to organizations under ISO 9001 in conjunction with other standards to provide fair, thorough assessment, which stands up to regulatory scrutiny. In addition, you benefit from:

• Local Washington, DC based office with qualified auditors throughout North America to increase convenience and minimize travel costs
• Simultaneous certification for CE Marking, Quality Management Systems (ISO 9001, ISO 13485, ISO 14001) and other standards often performed by a single, highly-qualified auditor, to save you time and expense
• 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