HISTORY: AN ONGOING PROCESS

Back in 1999 Notocord decided to implement a quality management system. During 2000 and 2001 an action plan was undertaken to formalize the company’s processes and start building the quality management system. Since then, Notocord Quality Management System has been integrated into the company’s organization and was computerized in 2004 in order to increase its performances.

NOTOCORD selected the independent certifying company Lloyd’s Register Quality Assurance (LRQA) and obtained the ISO 9001 certification in December 2001 for its data acquisition and signal analysis software design and development activity.
This certification is the result of Notocord’ s management and employees daily involvement in the quality processes.
Every 9 months a follow up audit run by NOTOCORD’ s certifying organism: Lloyd's Register Quality Assurance is performed. The last one was in November 2007. The next one will be in September 2008.
Since 1999, about 26 customer quality audits have been performed at our headquarters site.

THE QUALITY COMMITMENT
Identified resources
An employee skills management has been introduced with great attention payed to polyvalence and performance. This was lead by the willingness to maintain a development continuity for each product.

Documented method
Notocord is undertaking the following tasks as part of their quality commitment. It acknowledges the willingness to conform to the ever demanding normalization.

• Process definition and management - mainly the Products Development one.
• Customer quote review,
• Customer orders review - written confirmation receipt provided
• Commercial products management and measurement,
• Traceability of the modifications, tests carried out and bugs detected and corrected,
• Integration and follow up of the FDA standards, community or asian ones, as well as the regulatory requirements, such as 21 CFR part 58 « Good Laboratory Practices » or 21 CFR Part 11 « Electronic data security »

Multiple and efficient tools
Internally,

• Development, test and sources management tools have been selected based upon their performance and their management capabilities.
• Source management: the internal and external source code are protected and regularly filing to a registered office.
• A reference documentation is written for each new product
• Preventive actions are undertaken in order to avoid any dysfunction or bugs (cause identification and corrective actions)
• Our information system is constantly under evaluation for risk anticipation and prevention.

Externally,

• User trainings,
• Customised assistance for qualification installations
• Customer quality process management assistance.
• Support requests management
• Claim management (bugs registration, identification and treatment)
• Corrective action and code corrections management
• Customer satisfaction is regularly checked through our satisfaction survey that we run on a regular basis.