ISO Certification Status

ISO 9001

Facility acquiring certification Registration body Registration No. Date of certification Registered scope
Packaging Operating Department
/ Industrial Films Operating Department
/ Plastics Production Technology Operating Department (Film Division)
/ Plastics Research and Development Center (Films Development Center)		 LRQA 0067715 Sep. 2009 Design, development, management of manufacture and sales of plastic films such as polyester film, polyolefin film and nylon film for packaging and industrial use
Membrane Research and Development Center (Research Center) LRQA 0067561 Jan. 2013 Design,development and manufacture of functional membrane for industrial and pharmaceutical use.
Tsuruga Films Plant LRQA 0065411 Jan. 1998 Manufacture of polyester films
Tsuruga Biochemical Plant
Biotechnology Research Laboratory
Bio Quality Assurance Department		 LRQA 0065402 Oct. 1997 Development and manufacture of proteins as follows:
1)
enzymes for industrial use;
2)
enzymes, antibodies and functional proteins for biochemical research use, and for materials of in vitro diagnostic reagents and biochemical research reagents;
3)
protein compounds and related reagents for materials of in vitro diagnostic reagents.
Iwakuni Membrane Plant LRQA 0066545 Jun. 1997 Manufacture of hollow fiber membrane for hemodialysis.
Manufacture of synthetic hollow fiber membrane for industrial use.
Inuyama Plant LRQA 0066549 Dec. 1996 Manufacture of plastic films
Utsunomiya Plant BVC 4504413 Sep. 2002 Manufacture of plastic films

ISO 45001

Facility acquiring certification Registration body Registration No. Date of certification Registered scope
Utsunomiya Plant BVC JP023276 Apr.2020 MANUFACTURE OF POLYESTER FILMS AND PROCESSED FILMS.
Iwakuni Production Center JICQA H114 Jan.2023 Activities related to manufacturing of polyester resin, synthetic fibers, engineering plastic, hollow fiber membrane

ISO 14001

Facility acquiring certification Registration body Registration No. Date of certification Registered scope
Tsuruga Research and Production Center JICQA E004 Dec. 1996 Activities related to production and development of synthetic fibers, biochemical products and plastic films
Iwakuni Production Center JICQA E539 Nov. 2002 Activities related to manufacturing of polyester resin, synthetic fibers, engineering plastic, hollow fiber membrane
Research Center JICQA E005 Dec. 1996 Activities related to research & development and pharmaceutical production at research center
Inuyama Plant JICQA E025 Mar. 1998 Activities related to production of plastic films
Shogawa Mill JICQA E306 Jul. 2001 Activities related to manufacturing and development of textiles
Takasago Plant JCQA E-0044 Mar. 1999 Manufacturing of Fine Chemical Products and Chlorinated Polyolefin
Research & Development of Fine Chemical Products
Research & Development of Chlorinated Polyolefin
Utsunomiya Plant BVC JP023277 Feb. 1999 MANUFACTURE OF POLYESTER FILMS AND PROCESSED FILMS.

ISO 13485

Facility acquiring certification Registration body Registration No. Date of certification Registered scope
Head Office
Biotechnology Research Laboratory
Tsuruga Biochemicals Plant		 TUV SUD JAPAN Q5 068523 0007 Apr. 2009 Design and Development, Production and Distribution of In-Vitro Diagnostic Reagents (including Bulk Products), related Control, Calibrator and Auxiliary Reagents -Biochemical Reagents, Immunological Reagents, Genetic Reagents
Design and Development, Production and Distribution of Slide, Stainer, Cleaning Solution and Control for Automated Urine Cell Analyzer used for Urinary Sediment
Production and Distribution of Urine Analysis Device.
Production and Distribution of Genetic Analysis Devise.
Distribution of Immunological Analysis Device.
Iwakuni Membrane Plant LRQA 0066544 Jun. 1997 Manufacture of hollow fiber membrane for hemodialysis.
Medical Equipment and Device Development Center TUV SUD JAPAN Q5 096031 0001 Sep. 2018 Design and Development, Production and Distribution of absorbable conduit filled with collagen for nerve regeneration-inclucing

As of February 21, 2023