Quality Assurance System

Quality Assurance System and Product Management

1. Quality Assurance System

Nichiryo is accredited with quality management system standard ISO 9001 (JIS Q 9001) certification, and responsibly execute manufacturing and quality control of our products. We maintain our quality assurance system to the high level for our products and services that satisfies users.

2. Product Standard and Performance Test

Nichiryo, a member of the drafting committee of Japan Industrial Standards JIS K 0970 (Piston operated microvolumetric apparatus) standards for the standardization of pushbutton type pipettes, develops pipettes based on this standard. In addition, the performance test by international standard ISO8655 (Piston operated volumetric apparatus) is executed by the customer's demand.

3. Traceability Management

Nichiryo guarantees the accuracy performance of products systematically with calibration traceability to clarify the accuracy of the measured value of Nichiryo's reference standard apparatus, such as the balances, weights, and thermometers, to agree with the national measurement standard. Nichiryo manages pipettes by the serial number, and to facilitate the traceability of them, we have constructed the consistent record system from manufacturing to repair in our company.

ISO/GLP/GMPSupport system

Nichiryo is certified according to environmental management system standard ISO14001 of International Organization for Standardization.

Nichiryo is keenly aware that the global environment protection and the pollution prevention are the most important tasks through all business activities and incidental services, and we fulfill our responsibilities to the society and regions by environmental protection activities.

CE marking

In vitro diagnostic medical devices (IVDs) distributed within the EU are required to have CE marking to indicate compliance with the European In Vitro Diagnostic Medical Devices Regulation (IVDR) established by the EU.
In recent years, the number of countries and companies requiring CE marking not only for EU members but also for exports to Asia and the Middle East is increasing, and it is becoming a mandatory requirement worldwide.
Our pipettes are self-declared with CE marking (IVDs), and when it is sold within the EU, these are manufactured and shipped under appropriate management in accordance with the requirements.

Products