ISO Quality Standards

ERPI Quality Standards are second-to-none

Endoscopy Replacement Parts, Inc. has raised the bar for quality standards again in an effort to continuously improve the quality of endoscopic repair components. Our experienced team here at ERPI has simultaneously completed the certification process for ISO9001:2008 & ISO13485:2003.

 

Definitions

ISO9001:2008

  • Specifies requirements for a quality management system where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements
  • Aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

ISO13485:2003

  • Specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.
  • The primary objective of ISO13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO9001:2008 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO9001:2008 unless their quality management systems conform to all the requirements of ISO9001:2008, as it does for Endoscopy Replacement Parts, Inc.
  • All requirements of ISO13485:2003 are specific to organizations providing medical devices, regardless of the type or size of the organization.

 

Updated December 12th, 2012