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Terumo Quality Systems

Terumo Medical Corporation (TMC) has established comprehensive Quality Management Systems that integrate compliance with the U.S. Quality System Regulations, the Canadian Medical Device Regulations, and applicable international standards (ISO 13485, Medical Device Directive, Japan’s Pharmaceutical Affairs Law).

TMC’s Quality Systems are specifically intended for the design, development, manufacture, and distribution of medical devices. An EU Notified Body and a CMDCAS Recognized Registrar regularly audit TMC. Certificates are issued based on satisfactory audit results verifying that TMC’s Quality Management Systems are maintained in compliance with ISO 13485, the Medical Device Directive, and Canadian Medical Device Regulations. Certification by the CMDCAS Recognized Registrar enables TMC to maintain valid Canadian medical device licenses. In addition, TMC products distributed in EU countries are labeled with the CE mark indicating that they are certified to meet the essential requirements of the Medical Device Directive.

Copies of these certificates can be obtained on the Terumo website at the following locations:

Quality Management System (ISO 13485) Certificate: QMS Certificate

Medical Device Directive Certificate: Medical Device Directive Certificate

CMDCAS/ISO 13485 Certificate: CMDCAS_Certificate

ISO 13485 is a recognized standard prescribing quality assurance management for the manufacture of medical devices. Numerous countries, including Canada, the European community, and Japan, have formally recognized this standard. ISO 13485 presents a basic model for quality assurance covering design and development controls, manufacturing, installation, and servicing. Certification of compliance to the Medical Device Directive is required to allow the manufacturer to create the Declaration of Conformity and to affix the CE mark with the notified body number to their product labeling.

Recognized assessment firms are contracted to perform audits to confirm compliance with the standards and, if appropriate, issue certification recognizing the status of the firm’s Quality Systems. This certification process is intended to eliminate the need for customers to perform assessments of their registered suppliers' quality systems. The standards were designed such that when all of the requirements are met, customers can be confident in the quality of products and services that they purchase.

In its most basic form, the standards require that you:

  • Say what you do: have documented procedures for the work affecting product or service quality
  • Do what you say: carry out the work in accordance with the written procedures
  • Check your own practices: confirm compliance with procedures and regulations through internal auditing
  • Implement improvements: immediately correct problems or weaknesses as they are found; then, revise the system to prevent the same problems from recurring
  • Have the records to prove it: provide documented, objective evidence of quality-related activities as proof of compliance to auditors

TMC has established Quality Systems that incorporate the elements of these standards. Some fundamental principles of the TMC Quality Systems include the following:

  1. Top Management actively supports the achievement of product and service quality by creating and deploying a written Quality Policy; defining the organization and structure of staff responsible for product and service quality; providing for inspectors, independent auditors, and reviewers; assigning a Quality System Management Representative with the authority to carry out the requirements of the standards; and personally reviewing the results of the internal audits.
  2. The TMC Quality Systems have been created and maintained by keeping a comprehensive set of controlled procedures/documents and having the resources needed to achieve quality.
  3. All phases of product design, development, and manufacture are carried out with care to ensure product and service quality. These stages span the entire process from review of the sales agreement with the customer, through all intermediate stages of product design, selection, and control of suppliers, identifying, testing, and controlling the product (during manufacturing, handling, storage, packaging, and delivery), and providing customer service.
  4. Work that affects product and service quality is carried out as controlled processes. This requires that the processes are effectively managed by establishing defined procedures, controlling documentation, maintaining records of authorizations, auditing the quality system to keep it current, taking corrective action, calibrating measuring and test equipment, and using only valid statistical techniques.
  5. Finally, in order to allow all of this to happen, people are trained to carry out their work.

TMC’s Quality Systems have been certified to be in compliance with these international standards since 1995. However, significant time and effort continues to be invested every day to implement improvements that are identified through a comprehensive corrective- and preventive-action program. As stated in our Quality Policy, it is our goal, as a supplier of medical devices, to provide products that are safe and effective, meet all government regulations, and satisfy our customers. We recognize that these needs are constantly changing, and we are determined to be appropriately responsive in order to provide our customers with the best product to do the job right.

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