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Development of a quality standard for integrated operation rooms

Sector: digital optical technology.

Size: >3000 employees.

Mission: Founded in 1919, Olympus Corporation is one of the leading manufacturers of optical instruments. The mission of its Medical Systems division is to provide hygiene professionals with equipment for a wide variety of medical and surgical applications.

During the final design and implementation phase of its "Advanced Integrated Operating Room" product (Advanced EndoAlpha), Olympus discovered the need to create its own demanding quality standard for the new product. The lack of a specific regulation for this type of product, the advanced technology which it incorporates, and the criticality of its environment brought this need to light.On the other hand, the Advanced EndoAlpha lacked a specific standardized procedure for its installation in hospitals, and was ultimately dependent upon the diverse criteria of the Olympus technicians in each country. For this reason, the company also needed to establish detailed product installation standards, with the goal in mind of offering its clients all the guarantees of optimum functionality.In 2006, Olympus delegated this challenge to Applus+.

Applus+ solutions
The collaboration between Olympus and Applus+ was gradual, in a manner that implemented a flexible action plan, adapted to the various project stages.The primary service phase offered by Applus+ was engineering consultancy for development of the product. Applus+ guided Olympus in defining:

  • Materials used.
  • Equipment placement and connections in compliance with the various national and European directives.
  • Installation sites.

Thanks to contributions from Applus+, Olympus was able to optimize the quality of its product by incorporating several European technical recommendations. The consultancy phase ended with electromagnetic compatibility and electrical safety testing of some critical product elements, to verify compliance with essential requirements of the applicable directives, in order to launch the product with all guarantees.

The second phase of the complete service offered by Applus+ was the creation of a Proprietary Certification System. The company drew up the‘Proprietary Certification System (035)’, a guide establishing the quality control standards for Olympus to follow in order to obtain certification for its Advanced EndoAlpha installations. This document covers the quality control system for the entire installation, right from start up to its final delivery to the client. It establishes:

  • Materials employed during the installation.
  • The standardized, itemized and detailed procedure for Olympus to follow for its integrated operating room installations.
  • Profile and training required of installation personnel.
  • Upon completion, an Applus+ technician inspects not only the product, but also the installation at the hospital (open room), in order to verify compliance with the strictest quality control requirements, and certify both the product and the installation.

This Proprietary Certification System has been implemented at every one of the Olympus Corporation installations in Europe, and the on-site inspection and certification of the product by Applus+ guarantees the safe and reliable operation of the operating room under possible adverse conditions.

It is also noteworthy that Applus+ conducted customized training courses for Olympus Europe technical staff in charge of installing the product. Applus+ experts held several training conferences for professionals from more than ten European countries, gathering a heterogeneous group of more than 100 technicians at the Bellaterra (Barcelona) facilities of the company.

To date, more than 80 Advanced EndoAlpha integrated operating rooms have been successfully installed, inspected and certified in all of Europe, thanks to the collaboration between Olympus and Applus+.

Advantages for our client

  • To guarantee to the end customer -that is, hospitals- not only optimum functionality of the product, but also the best suited for their own individual facilities. All this thanks to on-site inspection and certification services from a leader in this sector: Applus+.
  • Facilitate maintenance, repair and later upgrades of the product, even after years of use.
  • Save time and expense by contracting one, multi-disciplinary provider for product development technical consultancy, creation of a Proprietary Certification System, and inspection and certification of products and installations.
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