Basic Policy
We shall offer products and services with superior quality at reasonable prices that provide maximum value to customers.
General Policy
(1) Pursuing Customer Satisfaction
We shall offer safe and secure products and services with high added value that prioritize customer value.
(2) Creating New Value Jointly with Customers
We shall create new value by sincerely considering customer views and wishes.
(3) Ensuring Thorough Quality Control and Safety Management
If a quality control or safety management problem occurs, we shall strive to solve the problem quickly and implement thorough measures to prevent recurrence.
Efforts
Basic Quality Assurance Policy
In an unceasing effort to supply quality that increases customer satisfaction at all stages of the product life cycle for all products manufactured and sold by the Shimadzu Group, we have established "provide quality which satisfies customers around the world at each stage of the product life cycle through the diligent efforts of all our employees" as our basic corporate policy for quality assurance.
We are working to improve customer satisfaction by establishing capabilities that ensure work measures and systems at each stage of the product life cycle can be changed flexibly in response to changes in market and customer requirements.
To improve the quality of Shimadzu Group products, systems, and services, customer satisfaction surveys are periodically conducted to obtain feedback from customers.
We share the valuable opinions and requests received from customers with applicable personnel so that we can implement improvement measures that will result in improved customer satisfaction.
necessary, such as to express their views or requests, as part of a system able to respond quickly.
- The product life cycle includes 12 stages (1 marketing and market surveying, 2 product design and development, 3 process planning and development, 4 procurement, 5 production, 6 verification, 7 packaging and storage, 8 sales and distribution, 9 installation and initial use, 10 technical support and service, 11 post-sales surveying, and 12 end-of-life disposal or recycling).
Quality Control Policy: Guaranteeing Product Quality and Taking Responsibility for Manufactured Products
In an unceasing effort to supply quality that increases customer satisfaction at all stages of the product life cycle for all products manufactured and sold by the Shimadzu Group, we have established a basic corporate policy for quality assurance stating, "At each stage of the product life cycle, all employees shall make every effort to supply quality that satisfies customers internationally." Consequently, we are engaged in a variety of activities intended to achieve that policy.
Also, in an effort to improve product safety, which is fundamental and important for increasing customer satisfaction, and fulfill our social responsibility, we have established a basic position on taking responsibility for all products manufactured within the Shimadzu Group. It specifies improving product safety, providing appropriate information to customers about product safety, and striving to resolve any product accidents appropriately and quickly.
Taking Responsibility for Manufactured Products and Basic Policy for Product Safety
In an effort to increase customer satisfaction by improving product safety, a fundamental and important product feature, and to fulfill our social responsibility, we have specified a basic policy of taking responsibility for the safety of all products manufactured within the Shimadzu Group. The policy species improving product safety, providing customers with appropriate product safety information, and resolving any product accidents appropriately and quickly.
In addition, the basic policy for product safety for the entire Shimadzu Group states that the entire Group will act in a unified manner for prioritizing the safety and trust of customers.
1. Comply with all applicable laws and regulations.
2. Design safety into products.
3. Prevent improper use.
4. Ensure product safety throughout the entire product life cycle.
5. Disclose information about product safety.
6. Resolve any product accidents.
7. Improve quality assurance systems.
For the purpose of coordinating such activities at business divisions and subsidiaries and maintaining/improving quality and safety throughout the entire Shimadzu Group, the director in charge of CS chairs corporate quality assurance meetings and meetings of the PL Committee, which is involved in product liability (PL) issues, where product safety and quality issues are discussed in more depth. In addition, we implement strategic measures intended to share information about unique activities and expertise of individual business divisions and subsidiaries and deploy the information horizontally throughout the entire Shimadzu Group.
Ensuring Product Safety and Disclosing Information to Customers
As a specific example of activities based on the basic policy for product safety, we have been conducting a risk assessment of products, from a customer perspective by anticipating various ways the customer might use the products, to assess whether products are fundamentally designed to ensure safety. (Risk assessment is conducted for all products.) In addition, we also perform endurance testing and environmental testing to verify that products will continue to perform reliably and safely without any functional damage even if they are subject to impacts during transport or are exposed to temperature or humidity variations.
To ensure products can be used without worry, we specify that information about how to use the product correctly and other useful information must be included. Such information must be included not only in instruction manuals prepared using our internally-developed manual creation system, but also in caution or warning labels that are the same throughout the world and affixed directly to products.
Improve quality throughout all stages, from development and design to manufacturing
A Quality Center was established at the Head Office/Sanjo Works site to improve quality throughout all stages, from development and design to manufacturing, and to also strengthen and quickly improve quality in the marketplace. Serving as the center of quality for the entire Shimadzu Group, it consolidated various equipment and functions in one location and was equipped with six functional capabilities, including materials characterization, physical property analysis, and EMC measurement* capabilities.
For EMC measurements, the center was equipped with four small and large anechoic chambers, including one that supports the 10-m method, so that it can perform tests as a testing facility with international ISO/IEC 17025 certification that is compliant with standards specified in respective countries and regions.
Furthermore, the center is registered as an accredited agent of the international third-party testing laboratory TÜV Rheinland Japan (TRJ). As a highly trusted EMC testing laboratory, the TÜV certification also provides additional credibility to the reliability of Shimadzu products in general.
* Electromagnetic compatibility (EMC) measurements evaluate both whether electromagnetic waves emitted from instruments affect surrounding devices and whether instruments are resistant to malfunction from exposure to electromagnetic waves from surrounding areas.
Comments from a Stakeholder
TÜV Rheinland Japan Ltd. (TRJ) has been performing EMC tests for Shimadzu medical products as an independent certification service provider for a long time. Since Shimadzu was designated as a TRJ appointed EMC testing laboratory, it has become easier to obtain the measurement equipment, anechoic chambers, and measuring personnel. As a result, it has become possible to conduct tests according to the schedule requested by Shimadzu.
Now Shimadzu's EMC Center can conduct tests according to a test plan prepared at TRJ. Consequently, the tests can be performed to the same testing criteria as before without delaying Shimadzu's development schedule. This arrangement is mutually beneficial not only for Shimadzu and TRJ, but also for users that are waiting expectantly for the release of new products.
Some Shimadzu products do not necessarily require TRJ certification, but even for such products we hope Shimadzu will adopt TRJ's quality standards as a means of helping to improve quality. Furthermore, we look forward to the use of TÜV certification expanding in the future, as customers increasingly use it as a criterion for selecting products.
Junho Lee,
Team Leader, Medical Section,
Products Department TÜV Rheinland Japan Ltd
Obtaining quality management system (QMS)
Shimadzu Corporation’s Sanjo Works has obtained ISO9001 certification, the international standard for quality management systems (QMS), for each division since 1994. They are also obtaining ISO 13485 certification required for medical devices and JIS Q 9100 certification required for the aircraft equipment industry.
QMSs are also being introduced at relevant subsidiaries in Japan and other countries. As of March 2019, 14 subsidiaries have obtained certification in Japan and 17 subsidiaries outside Japan.
These QMSs are used to assess the effectiveness of measures and processes for ensuring product quality and safety based on the Basic Quality Assurance Policy indicated above. Then the PDCA cycle is repeated to achieve further improvements.
In this way, we are increasing customer satisfaction through constant improvements at each stage of the product life cycle.
- Status of Shimadzu obtaining quality management system certification (Year of Approval)
- Analytical & Measuring Instruments Division (ISO9001:1994, ISO13485:2011)
- Medical Systems Division (ISO9001:1994, ISO13485:1994)
- Aircraft Equipment Division (ISO9001:1999, JIS Q 9100:1999)
- Industrial Machinery Division (ISO9001:1998)
- Manufacturing Center (ISO9001:2000)
- Device Department (ISO9001:2005)