Quality Policy

We gain our customers’ trust through quality products. Our mission as the leading manufacturer of speciality needles is to provide customers with high-quality products.

We always keep this fundamental mission in mind when responding to customer needs and providing reliable quality of our products and services.

Action Guidelines

As a manufacturer specialized in specialty needles, we provide products that can meet and deserve customers’ satisfaction and trust, both professionally and technically.
We have pride in ‘JAPAN QUALITY’ and we always seek to bring reliable products to customers, by maintaining scrupulous quality control.
‘QUALITY, COST and DELIVERY’ – we always remember to keep these aspects and do our best in all business activities.
We always seek to maintain effective and efficient quality management systems through continuous improvement to keep them up-to-date.
We work on maintenance and development of quality in cooperation with all the people who support UNISIS (doctors, customers, suppliers and all the other business partners).
We act in compliance with lows and regulations, and develop and maintain appropriate environment (including human and other business resources, organizations and education) that we consider to be necessary for maintenance and improvement of quality, and review the results of such efforts every year to work on continuous enhancement of quality.
In order to put these Action Guidelines into practice, we ensure that all departments and employees throughout the Company understand this Quality Policy and make unified efforts to fulfill the Quality Policy.
On behalf of the Company, I hereby declare that we make sure to perform and realize this Quality Policy.

In order to put these Action Guidelines into practice, we ensure that all departments and employees throughout the Company understand this Quality Policy and make unified efforts to fulfill the Quality Policy. On behalf of the Company, I hereby declare that we make sure to perform and realize this Quality Policy.

Hideya Saito
President

1989/10	Obtained import license for medical devices in Japan (BBY6379 for the Tokyo office)
1994/2	Obtained manufacturing license for medical devices (11BZ0588 for the Koshigaya factory)
1995/11	Obtained Japanese accreditation in Good Manufacturing Practices (GMP)
1996/09	US Food and Drug Administration registration (FDA Facility Registration No. 9014974/USA)
1997/06	Obtained accreditation of ISO9002/ISO13488 audited by TUV Rheinland
1999/01	Obtained license for manufacturing veterinary appliances (16 veterinary manufacturer No.344 for Koshigaya factory)
2003/06	Obtained accreditation of ISO9001/ISO13488 audited by TUV Rheinland
2004/01	Obtained manufacturing license for medical devices (11BZ6041 for Saitama Plant) Obtained manufacturing license for veterinary appliances (16 veterinary manufacturer No. 457 for Saitama factory)
2004/07	Obtained accreditation of ISO9001/ISO13485 audited by TUV Rheinland
2005/12	Obtained CE marking audited by TUV Rheinland
2009/07	Obtained Medical Device Manufacturer Permit (11BZ200120:at Logistics/sterilization center)
2010/06	Renewed CE marking that covers spinal needles, a Class III device
2011/01	Notified Body for ISO9001/ISO13485 registration changed to SGS
2012/05	Notified Body for CE Marking (EU) registration changed to SGS
2014/10	Obtained 510(k) clearance for Spinal Anesthesia Needle
2015/01	Obtained 510(k) clearance for Epidural Anesthesia Needle and Nerve Blockade Needle
2019/02	Obtained CE marking for Atraumatic Microneedle audited by SGS

Quality policy

Action Guidelines

License, registration & accreditation