Quality Management
Quality Policy
In order to supervise quality management and continue to secure the trust of society, NOF established the Quality Management Committee in April 2019 and has maintained and enhanced the quality management level of the entire Group. NOF has decided to establish the following “Quality Policy” to indicate the Group’s quality management principle.
| Quality Policy (established on April 1, 2023） |
|---|
| The NOF Group provides the highest quality products and services that are based on our considerations of achieving harmony with society and customer satisfaction through our unrelenting quality management. １．Harmony with society We shall comply with laws, regulations and rules, respect the environment, and produce safe and secure products using manufacturing processes that themselves are safe and secure. ２． Customer satisfaction practices We shall listen to our customers’ requirements and provide products that meet their expectations and useful information. ３．Unrelenting quality management We shall maintain stable quality with continuous improvement and proper process management and enhance the management level through education. ４．Execution of quality assurance We shall fulfill our commitment with our customers and sincerely respond to inquiries and complaints. |
Development status of QMS*1
NOF is building up the optimal QMS for each product line. The Daishi Plant acquired certificates under FSSC 22000*2 (Food Safety Management System) in January 2019, in addition to ISO 9001. In addition, the DDS plant is managed in accordance with ICH-Q7 (active pharmaceutical ingredients GMP guidelines). 13 Group companies have acquired external certifications equivalent to ISO 9001.
*1:Acronym for quality management system. A system by which an organization formulates policies and sets targets in order to dictate and manage its quality, and achieve such targets.
*2:Acronym for Food Safety System Certification 22000. It comprises individual specifications established for each food industry as Prerequisite Programs (PRP) based on ISO22000 (Food Safety Management System) and original FSSC22000 standards as additional requirements. Through food defense and management including management of allergens, more reliable food safety management can be ensured. (A certification scheme recognized by non–profit organization GFSI)
| Business location | Quality management system | Certification number | Renewed | |
|---|---|---|---|---|
| Kawasaki Works | Chidori Plant | ISO 9001 | JP022495 Ver.1.0 | May-22 |
| Daishi Plant | FSSC 22000 Food Saffety |
JMAQA-FC270 | Dec-21 | |
| ISO 22000 | JMAQA-FF348 | Dec-21 | ||
| health supplement GMP | 156-C-03 | Oct-20 | ||
| DDS Plant | ICH-Q7 GMP GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS |
- |
- |
|
| Aichi Works | Taketoyp Plant | ISO 9001 | JQA-AS0183 | Jul-22 |
| JIS Q 9100 | ||||
| Kinuura Plant | ISO 9001 | JPO22549 | Jun-22 | |
| Amagasaki Plant | Functional Materials | ISO 9001 | JPO22753 | Aug-22 |
| Life Science | ICH-Q7 GMP GUIDE FOR ACTIVE PHARMACEUTICAL INGREDIENTS |
- |
- |
|
| Oita Plant | ISO 9001 | 4534002 | Oct-20 | |
| Business location | Quality management system | Certification number | Renewed | |
|---|---|---|---|---|
| Nippon Koki Co., Ltd. Shirakawa Plant | ISO 9001 | JSAQ2282 | Mar-21 | |
| Nippon Koki Co., Ltd. Shirakawa Plant |
JIS Q 9100 | JQA-AS029 | May-22 | |
| NiGK Corporation | ISO 9001 | 0066885 |
Mar-23 |
|
| JIS Q 9100 | ||||
| Showa Kinzoku Kogyo Co., Ltd. | ISO 9001 | 02479-2011-AQ-KOB-JAB | Mar-21 | |
| YUKA SANGYO CO., LTD. | ISO 9001 | 4106832 | Apr-21 | |
| JEUNE BEAUTY Corporation Amagasaki Plant |
ISO 22716 | 4578155 | Jan-21 | |
| JEUNE BEAUTY Corporation Chita Plant |
ISO 22716 | 4590045 | Mar-21 | |
| NOF METAL COATINGS ASIA PACIFIC CO., LTD. | ISO 9001 | JP023061 | Nov-22 | |
| NIKKA COATING CO., LTD. | ISO 9001 | 3357 | Jan-22 | |
| Changshu NOF Chemical Co.,Ltd. | ISO 9001 | SGS CN20/21619 | Jan-21 | |
| PT.NOF MAS CHEMICAL INDUSTRIES | ISO 9001 | SGS 00/18019 | Apr-23 | |
| NOF METAL COATINGS NORTH AMERICA INC. |
ISO 9001 | NSF ISR 66561- IS8 | Jul-22 | |
| NOF METAL COATINGS EUROPE S.A. | ISO 9001 | AFAQ 1994/2984.8 | Dec-20 | |
| NOF METAL COATINGS EUROPE N.V. | ISO 9001 | - | Oct-22 | |
| NOF METAL COATINGS SOUTH AMERICA IND.E COM.LTDA. |
ISO 9001 | DQS 320993 QM15 | Dec-20 | |
| NOF METAL COATINGS KOREA CO.,LTD | IATF 16949 | - | Nov-20 | |
Approach to pharmaceutical-related business
NOF currently handles pharmaceutical-related products and has obtained the various business licenses listed below.
| Marketing | Second-class marketing license for pharmaceuticals | NOF |
| Marketing license for quasipharmaceutical product | NOF | |
| Sales | Pharmaceutical sales (wholesale） | NOF |
| Manufacturing | Pharmaceutical manufacturing | Kawasaki Works Aichi Works, Taketoyo Plant Amagasaki Plant |
Basic Policy on Pharmaceutical-Related Business
“The NOF Group is dedicated to contributing to humanity and society as a corporate group that creates new value through the power of chemistry, from the biosphere to outer space,” NOF is developing pharmaceutical-related business that ensures high quality, reliability, and safety to all stakeholders, under our governance system that ensures thorough compliance with laws and regulations.
Officers and others responsible for pharmaceutical-related operations
Based on the aim of the Act Partially Amending the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (Act No. 63 of 2019, “Amended Pharmaceuticals and Medical Devices Act”), the officers with responsibility for pharmaceutical-related operations are clearly stated in the pharmaceutical management system. In addition, in accordance with the provisions of the Act, for marketing (second-class marketing license for pharmaceuticals, marketing license for quasi-pharmaceutical products), a general marketing manager, a quality assurance manager, and a safety management manager are appointed.
Pharmaceutical management system
As a specialized task force of the Management Committee, a deliberative body, NOF established the Pharmaceutical Management Task Force to oversee the pharmaceutical-related business of the entire company and to manage the manufacturing, marketing, and wholesaling in an integrated manner. The Pharmaceutical Management Task Force inspects the status of compliance with GQP, GVP, and GMP ordinances, and operates to ensure that the general marketing manager, manufacturing manager, and others provide appropriate opinions to the responsible officers regarding issues and problems related to legal compliance.
At NOF, all persons involved in pharmaceuticals take the required training every year.
Responsible officers：
Take the pharmaceuticals-related training (once per year)
People involved in pharmaceutical-related operations：
Take training based on GQP, GVP, and GMP ministerial ordinances as needed
After the training, a record is made and stored for use in the next fiscal year’s training plan to ensure continued acquisition of the necessary knowledge.
Internal information sharing
NOF has established an internal network to promptly confirm and evaluate customer inquiries and complaints about our products, and then take necessary corrective actions. We take customer feedback seriously.
Contact point for inquiries
Quality Management Department, Corporate Technical Division, NOF CORPORATION
Address: 20-3 Ebisu 4-chome, Shibuya-ku, Tokyo 150- 6012, Japan
Hours: 9 AM to 5:30 PM (Monday through Friday)
Tel: 03-5424-6670 Fax: 03-6837-5354
Email: Please make inquiries using the NOF website inquiry form