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Quality Assurance / ISO Certification

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Quality Policy

Company-wide Policy

  1. We will comply with customer requirements and legal regulations/standards applicable to our business activities, and provide products and services that satisfy them.
  2. We will establish and maintain a quality management system and continuously improve its effectiveness through the PDCA cycle.
  3. Based on our business policy and this quality policy, each department will set quality objectives and implementation plans, and work towards their achievement.
  4. All employees will understand this quality policy and practice quality-advancing activities, while recognizing their respective roles and responsibilities.

Additional Policy for Medical Device Business


　
  1. Departments involved in medical devices will comply with the following items as top priorities, in addition to the above policy.
  2. In all aspects of medical device design, manufacturing, and supply, the safety of patients and users, and the effectiveness of the product will be given top priority.
  3. We will appropriately manage risks throughout the entire product lifecycle, from design and development to manufacturing and post-market surveillance, to provide safe and effective medical devices.

ISO Certification

Management Standard: ISO9001: 2015Certification Body: Japan Quality Assurance Organization

Certificate Number:
JQA-0700
Registration Date:
December 9, 1994
Organization:
Orbray Co., Ltd.
3-8-22 Shinden, Adachi-ku, Tokyo Japan
Scope of Registration:
  • Design / Development, Manufacture and Sales of Pumps and Those Related Parts, Sapphire Wafers, Scribers and Watch Parts.
  • Design / Development, Manufacture and Sales of DC Micro Motors and Those Related Parts.
  • Jewel Parts Processing, Quartz Microfabrication and Manufacture and Sales.
  • Design / Development, Manufacture and Sales of Precise Processing Parts for Optical Communication and Electronic Devices.
  • Provider of Outsourced Production and Sales.
  • Manufacture of Phonograph Styli.
Associated Organization:
  • Orbray Co., Ltd. Headquarters
    3-8-22 Shinden, Adachi-ku, Tokyo, Japan
  • Orbray Co., Ltd. Orbray Business Office
    6F Kawaguchi Center Building, 4-1-8 Honcho, Kawaguchi-shi, Saitama, Japan
  • Orbray Co., Ltd. Yuzawa Factory
    4-6-56 Atago-cho, Yuzawa-shi, Akita, Japan
  • Orbray Co., Ltd. Yuzawa Factory-2
    372-1 Fukushimabiraki, Aza-Yamada, Yuzawa-shi, Akita, Japan
  • Orbray Co., Ltd. Kuroishi Factory
    5-1 Aza-koyashikizoe, Oaza-shimomenaisawa, Kuroishi-shi, Aomori, Japan
  • Orbray Co., Ltd. Yokote Factory
    12-1 Kamisakurazawa, Sotonome, Yokote-shi, Akita, Japan
  • Orbray Co., Ltd. Orbray [TRAD]
    8-29 Kitsunezaki, Iwasaki, Yuzawa-shi, Akita, Japan

Certificate Number:
JQA-QMA14886
Registration Date:
September 27, 2013
Organization:
Yabuki Precision Jewel Co., Ltd.
271-5 Shinmachi, Yabuki-machi, Nishishirakawa-gun, Fukushima Japan
Scope of Registration:
  • Manufacture of ceramic parts related to precision equipment (connecting parts for optical communications, precision parts for bonding equipment, watch parts, etc.)

Management Standard: ISO14001: 2015Certification Body: Japan Quality Assurance Organization

Certificate Number:
JQA-EM2005
Registration Date:
December 21, 2001
Organization
Orbray Co., Ltd.
3-8-22 Shinden, Adachi-ku, Tokyo Japan
Scope of Registration:
  • Design / Development, Manufacture and Sales of Pumps and Those Related Parts, Sapphire Wafers, Scribers and Watch Parts.
  • Design / Development, Manufacture and Sales of DC Micro Motors and Those Related Parts.
  • Jewel Parts Processing, Quartz Microfabrication and Manufacture and Sales.
  • Design / Development, Manufacture and Sales of Precise Processing Parts for Optical Communication and Electronic Devices.
  • Provider of Outsourced Production and Sales.
  • Manufacture of Phonograph Styli.
Associated Organization:
  • Orbray Co., Ltd. Headquarters
    3-8-22 Shinden, Adachi-ku, Tokyo, Japan
  • Orbray Co., Ltd. Orbray Business Office
    6F Kawaguchi Center Building, 4-1-8 Honcho, Kawaguchi-shi, Saitama, Japan
  • Orbray Co., Ltd. Yuzawa Factory
    4-6-56 Atago-cho, Yuzawa-shi, Akita, Japan
  • Orbray Co., Ltd. Yuzawa Factory-2
    372-1 Fukushimabiraki, Aza-Yamada, Yuzawa-shi, Akita, Japan
  • Orbray Co., Ltd. Kuroishi Factory
    5-1 Aza-koyashikizoe, Oaza-shimomenaisawa, Kuroishi-shi, Aomori, Japan
  • Orbray Co., Ltd. Yokote Factory
    12-1 Kamisakurazawa, Sotonome, Yokote-shi, Akita, Japan
  • Orbray Co., Ltd. Orbray [TRAD]
    8-29 Kitsunezaki, Iwasaki, Yuzawa-shi, Akita, Japan

Management Standard: ISO13485: 2016Certification Body: TÜV SÜD Product Service GmbH

Certificate Number:
Q5 086458 0003
Registration Date:
January 22, 2014
Organization:
Orbray Co., Ltd.
3-8-22 Shinden, Adachi-ku, Tokyo Japan
Scope of Registration:
  • Design and Development, Production and Distribution of Dental Ceramics for Cutting.
  • Design and Development, Production of Medical Infusion Pump.
Associated Organization:
  • Orbray Co., Ltd. Headquarters
    3-8-22 Shinden, Adachi-ku, Tokyo, Japan
  • Orbray Co., Ltd. Orbray Business Office
    6F Kawaguchi Center Building, 4-1-8 Honcho, Kawaguchi-shi, Saitama, Japan
  • Orbray Co., Ltd. Kuroishi Factory
    5-1 Aza-koyashikizoe, Oaza-shimomenaisawa, Kuroishi-shi, Aomori, Japan
  • Orbray Co., Ltd. Yokote Factory
    12-1 Kamisakurazawa, Sotonome, Yokote-shi, Akita, Japan

Management Standard: ISO9001: 2015Certification Body: TÜV SÜD Asia Pacific TÜV SÜD Group

Certificate Number:
TUV 100 11 2152
Organization
Orbray (Thailand) Co., Ltd.
Scope of Registration:
Manufacture of Motors, Fiber Optic Products and Precision Jewel Products

Management Standard: ISO14001: 2015Certification Body: TÜV SÜD Asia Pacific TÜV SÜD Group

Certificate Number:
TUV 104 11 2152
Organization
Orbray (Thailand) Co., Ltd.
Scope of Registration:
Manufacture of Infusion Pumps, Motors, Fiber Optic Products and Precision Jewel Products

Management Standard: ISO13485: 2016Certification Body: TÜV SÜD America Inc.

Certificate Number:
QS2 087281 0004
Organization
Orbray (Thailand) Co., Ltd.
Scope of Registration:
Production of Infusion Pumps