Quality Management System for Device Servicers

Since ISO 9001 standard was first published in 1987, many companies and countries have adopted it to attain the ultimate goal of evolving their corporate or regulated industries’ culture from reactive corrections to continually improve their products and services.  One variant of the ISO 9001 standard is the ISO 13485, which was initially established in 1996 solely for unifying the regulatory requirements of different countries for medical device manufacturers (OEMs).  Since then, some device servicers decided also to adopt it to ensure their clients that they can provide services comparable in quality to those provided by the OEMs.  By registering their quality management systems (QMS) with certification bodies for ISO 13485, service companies can provide their services not only to healthcare delivery organizations (HDOs) but also to OEMs who have difficulties in covering large or remote territories, especially where population density does not justify investment in field service infrastructure.  ISO 13485 registration also helps service companies to acquire service materials (service manuals, proprietary parts and test tools, diagnostic/calibration software access, etc.) from OEMs, some of whom have been concerned about their liability risks when they offer those materials.

Potential Beneficiaries

• Quality leaders in hospitals, health systems, service companies, etc.

• Regulatory compliance leaders in hospitals, health systems, service companies, etc.

• CE/BME/HTM leaders in hospitals, health systems, service companies, etc.