Quality Management
Basic Approach
In accordance with our corporate philosophy and Sustainability Policy, we define our Basic Policy for Quality Assurance as follows.
- 1We contribute to society by providing high-quality products, goods and services with excellent reliability and safety to the market.
- 2We fully understand and predict user demands and provide products, goods and services that users can use with satisfaction.
- 3In each quality assurance step, we establish an internal system that can assuredly evaluate high-quality products, goods and services with excellent reliability and safety.
- 4We establish technologies that can produce products, goods and services with the target quality in terms of reliability and safety.
Structure and System
To consistently provide products and services that reflect customer needs and perspectives and to ensure product quality, Zeon is advancing integrated, company-wide quality assurance activities across its manufacturing, sales, and engineering functions by strengthening cooperation among plants, business divisions, and research laboratories.
Key Initiatives
| Initiatives (issues) |
Targets | Results | Assessment |
|---|---|---|---|
| Timely responses to customer dissatisfaction and feedback | Complete responses within a single year | No cases exceeded one year. In addition, a new complaint management system was launched. | ✓ |
| Enhance customer satisfaction | Analysis of customer satisfaction and initiatives for improvement | A new system is in operation to analyze customer satisfaction surveys efficiently, and is being used to identify issues both company-wide and within each division. | ✓ |
Framework supporting quality assurance
To ensure a consistent supply of high-quality products and services to our customers, we have established quality assurance systems in accordance with internal quality assurance regulations that conform to ISO 9001:2015, the international standard for quality management systems. In 2010, we obtained Group-wide consolidated ISO 9001 certification and have maintained it since then. Zeon Group companies have also obtained certifications under international quality standards. To help prevent quality issues, our annual compliance e-learning includes commentary on quality problems that could realistically occur, followed by checks of all employees’ understanding. We work to ensure that every employee understands quality assurance accurately and performs their duties accordingly. Client query first: confirm whether the ISO 9001 certificate held from 2010 until FY2025 covered Zeon Corporation only or the Zeon Group. If Zeon Corporation only: 'In 2010 we obtained a single consolidated ISO 9001 certificate covering the Company… In FY2025, in order to build a quality assurance system better able to adapt to changes in the external environment, we changed our ISO 9001 certification from company-wide certification to worksite (plant)-level certification.'
Status of Zeon Group certifications for international quality standards
| Organization covered | ISO 9001:2015*1 | ISO 13485:2016*2 | IATF 16949:2016*3 | FSSC 22000v5*4 |
|---|---|---|---|---|
| Japan | ||||
| Zeon Corporation | ✓ | ✓*6 | ||
| Zeon Kasei Co., Ltd. | ✓*5 | |||
| Zeon Polymix Inc. | ✓ | |||
| Zeon Opto Bio Lab Co., Ltd. | ✓ | ✓ | ||
| Tokyo Zairyo Co., Ltd. | ✓ | |||
| Tohpe Corporation | ✓ | |||
| Zeon Medical Inc. | ✓ | |||
| Zeon North Co., Ltd. | ✓ | |||
| Zeon Chemicals Yonezawa Co., Ltd. | ✓ | ✓ | ||
| Outside Japan | ||||
| Zeon Chemicals L.P. | ✓ | |||
| Zeon Chemicals (Thailand) Co., Ltd. | ✓ | |||
| Zeon Advanced Polymix Co., Ltd. | ✓ | ✓ | ||
| Zeon Chemicals Singapore Pte. Ltd. | ✓ | |||
| Zeon Europe GmbH | ✓ | |||
| Zeon Chemicals Asia Co., Ltd. | ✓ | |||
| Zeon Kasei (Changshu) Co., Ltd. | ✓ | |||
| Zeon Kasei Mexico S.A. de C.V. | ✓ | |||
- *1ISO 9001 is an international standard designed to increase customer satisfaction by ensuring the quality of products and services through the continuous improvement of quality management systems.
- *2ISO 13485 is an international standard for quality management systems in the medical device industry. It is designed to ensure the consistent manufacture and provision of safe and effective medical devices. The standard adds requirements specific to medical devices while omitting some ISO 9001 requirements.
- *3IATF 16949 is a standard issued by the International Automotive Task Force (IATF) for the automotive industry. It supplements the ISO 9001 requirements for automotive manufacturers.
- *4FSSC 22000 (Food Safety System Certification 22000) is a standard developed by the FSSC 22000 Foundation to certify management systems for the production of safe food.
- *5The Logistics Materials Division holds certification limited in scope to certain transport containers.
- *6The Mizushima Plant has obtained FSSC 22000 certification for the manufacture of food-grade synthetic aroma chemicals.
Framework to achieve product safety
- 1. Product safety reviews
- We strive to ensure product safety in every respect by conducting product safety reviews (PSRs)* using our own checklists, which address product safety at every stage of the product lifecycle, from initial product development through planning, design, manufacturing, sales, use, and disposal.
- *PSR: Product safety review
- 2. Chemical substance regulatory compliance
- Overseas — not only in Europe and the United States but across Southeast Asia as well — laws and regulations on chemical substances continue to be enacted and amended, and the environment for chemical substance management, including within Japan, is changing significantly. As a result, the number of regulations with which we must comply is rising sharply. At Zeon, we are creating a database of substances contained in our raw materials and products, including those present only in minute quantities, and building a chemical substance management system capable of continuously tracking the latest regulatory, safety, and other relevant information.
Audits
- PL audits
- PL audits comprise two components: self-audits carried out at business divisions and plants using checklists, and on-site audits covering product liability (PL) and product safety, headed by the General Manager of the Quality Assurance Department. They are applied to the PL activities for products handled by Zeon’s business divisions across every stage of the product lifecycle, from development and manufacturing through use, final consumption, and disposal.
- Quality audits
- Quality audits are conducted when a serious quality problem arises. They are led by the General Manager of the Quality Assurance Department and focus on checking how quality improvement activities are being carried out. They are conducted at Zeon’s business divisions, plants, laboratories, and Group companies.
- Internal quality audits
-
Internal quality audits are conducted to evaluate whether Zeon’s quality management system operates effectively and efficiently in accordance with ISO 9001:2015 and to promote ongoing improvement. They are structured to ensure that compliance with Zeon’s internal regulations satisfies the requirements of ISO 9001. The audits also address customer satisfaction and overall optimization. Through internal quality audits, we identify issues and use the findings to improve our systems.
Quality data management
At Zeon, we define all customer comments or expressions of dissatisfaction with our products or services as “complaints” and use a complaint response system to report, review, approve, and manage response deadlines. We have also implemented a specification management system to ensure compliance with customer specifications by aligning customer, product, and product inspection specifications. Inspection data are checked against product test criteria in the product testing system, which assigns a pass/fail decision and automatically forwards the results to the ERP system. Process changes and process abnormalities are reliably managed through a system that reports, reviews, and distributes effectiveness evaluations, emergency measures, and corrective actions, thereby ensuring robust process change and abnormality management.
Risk reduction for new products
Zeon conducts a comprehensive Product Stage-gate Transfer Review (PSTR)*1 from a quality assurance perspective when transitioning from the production preparation stage to full-scale production.
This review confirms 3D-QFD, which uses data to clarify the cause-and-effect relationships among product quality, information on the chemical substances contained in products, and manufacturing information; FMEA*2, which seeks to prevent potential abnormalities after full-scale production begins; and testing methods and facilities used to measure quality characteristics and critical process characteristics. Through this review, Zeon ensures that new products meet customer quality requirements and that it can fulfill its supply responsibilities.
- *1PSTR: Product Stage-gate Transfer Review
- *2FMEA: Failure Mode and Effects Analysis
Communicating safety information
Safety information for the chemical products Zeon handles is published under Home > Products & Business > About SDS/chemSHERPA.