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.

Background:
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. Thhis need came to light trough a combination of the lack of specific regulations for this type of product, the advanced technology it incorporates and the critical nature of its environment.

In adition, there was no standard procedure for the installatioin of the Advanced EndoAlpha in hospitals, which varied according to the requirements and practices of the Olympus technicians in any given country. For this reason, the company also needed to establish detailed product-installation standards, with the ultimate goal of offering its clients the guarantee of optimum functionality. In 2006, Olympus delegated this challenge to Applus+.

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

• the materials to be used. 
• equipment placement and connections that comply with the various national and European directives.
• the installation sites.

Thanks to the role played by Applus+, Olympus was able to optimise the quality of its product by incorporating several European technical recommendations. The consultancy phase ended with the electromagnetic -compatibility and electrical-safety testing of some critical product components, in order to verify their compliance with the applicable directives, to send the product to market with all guarantees in place.

In the second phase of the project, Applus+ helped Olympus to draw up its ‘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 details the quality-control system for the entire installation, right from initial concept to its final delivery to the client. It establishes:

• the equipment to be used during the installation.
• the standardised, itemised and detailed procedure for Olympus to follow for its integrated operating room installations.
• the profile and training required of installation personnel.
• the requirement on completion, for an Applus+ technician to inspect not only the product, but also the hospital (open room) facilities, in order to verify compliance with the strictest quality-control requirements, and to certify both the product and the installation.

This proprietary certification system has been put into practice at every one of the installations carried out by Olympus Corporation 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.

Applus+ also ran customised training courses for Olympus Europe technical staff in charge of installing the product. Furthermore, 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) site.

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

key benefits for the client

• The ability to guarantee to the end customer that is, hospitals not only optimum product functionality, but also the facilities best suited to their own individual requirements. All of this thanks to on-site inspection and certification services from a leader in this sector: Applus+.
• Ease of product maintenance, repair and upgrades, even after years of use.
• Time and cost savings through contracting a single multi-disciplinary provider for product development, technical consultancy, creation of a proprietary certification system, and inspection and certification of products and installations.