Quality Management System

Takara Bio Group Quality Assurance Policy

Basic Policy on Quality Assurance

• The Takara Bio Group provides high quality products and services that fulfill the trust and expectations of customers.
• The Takara Bio Group delivers products and services that are safe and that customers feel sure of.
• The Takara Bio Group complies with laws and regulations.
• The Takara Bio Group ensures the dissemination of this basic policy to each and every officer and employee in the Group and makes its execution certain.

Quality Assurance System

• The Quality Assurance Management Committee is based at the Head Office to ensure the reliability and effectiveness of the company-wide quality assurance system.
• The committee, chaired by the company’s President, determines the company-wide guidelines regarding quality with attendance of Supervisor from Corporate Management Unit, President of each Business Unit, Subsidiaries in charge of Bioindustry Business Unit and Board Member in charge of General Affairs Department.
• Each business division has its own Quality Assurance Committee and ensures the compliance of each business division with the Basic Policy on Quality Assurance.
• Compliance with the Basic Policy on Quality Assurance is also ensured at the Company’s subsidiaries, and subsidiaries establish a quality assurance system that is equivalent to the one at the Company.
• The Quality Assurance Committees assess the status of establishment and operation of the quality assurance system in each business division and provide appropriate guidance and supervision.

Quality control efforts

Takara Bio and all its major global subsidiaries have acquired ISO certification, and are striving to improve the quality of products and services. We built a GMP/GCTP* compliant quality control system at our Center for Gene and Cell Processing, which provides CDMO services, and have become licensed as a manufacturer/distributor of specific processed cells/regenerative medicine products, pharmaceutical products (drugs, etc.), and in vitro diagnostics. Our lab for gene analysis services and genetic testing is also CAP-LAP certified and licensed as a clinical laboratory. We will strive to maintain these certifications and licenses, as well as expand the scope of certification as needed.
  *GMP:Standard for manufacturing control and quality control for pharmaceutical products
  *GCTP:Standard for manufacturing control and quality control for regenerative medicine products

ISO Certification Status

Certified organization	Applicable standard
Takara Bio, Inc.	JIS Q 9001:2015 (ISO 9001:2015) JIS Q 13485 : 2018 (ISO 13485 : 2016)
Takara Bio USA, Inc.	ISO 13485:2016
Takara Bio Europe S.A.S	ISO 9001:2015
Takara Biotechnology (Dalian) Co., Ltd.	ISO 9001:2015 ISO 13485:2016
DSS Takara Bio India Private Limited	ISO 9001:2015

Appropriate publication of product information

We actively work to publish documents related to product safety. We publish and provide information as appropriate in multiple languages in accordance with laws and regulations, including user manuals, CoA (Certificate of Analysis), SDS (chemical Safety Data Sheet), poisonous and deleterious substance labeling in accordance with the Poisonous and Deleterious Substances Control Law, and LMO (living modified organism) product labeling in accordance with the Cartagena Protocol.