Registration No.: JMAQA-1327
Sinanen Zeomic (the entire departments) acquired its quality system certification under ISO9001 on April 19, 2002.
ISO9001 is a system to promote the development of quality management systems conforming to international standards for products and services and ensure their objective examination and certification by authorized independent accrediting organs. Last several years, an increasing number of Japanese businesses including not only large companies but also small- and medium-scale companies have been actively pursuing the registration of their systems and ISO9001 has gained publicity through advertisements, newspaper articles and company brochures.
ISO means International Organization for standardization, which defines various standards such as ISO9001s for Quality Management System and ISO14000s for environment management system.
The characteristic points of ISO9001 system are in that (1) it is a top-down style management system operated under the lead of the top management, (2) it clarifies management policies, responsibilities and authorities, standardized work processes, and documentation through routine management, and (3) it has incorporated check systems such as internal audit and examination by dedicated organs.
As a result of the acquisition of registration certification at our company, the following advantages were noted:
1. We could win trust from our customers both in Japan and overseas. Product quality is considered to be of vital importance particularly in the medical and food-related application areas overseas, but the physical distances of these markets impaired us from ascertaining the state of affairs directly on the spot at our local affiliates. Through examination by examining organs accredited under the ISO standard, we believe we can obtain assurance substituting an on-the-spot check. In our company's case, we received from our customers including AK Steel responses to the effect that they were assured of our product quality, when we notified them of our registration through Sciessent LLC.
2. It helped us clarify responsibilities and authorities in our operations. Responsibilities and authorities are clearly documented in the system. At the same time, a performance review is conducted at each operation level and operations are performed with their conformity checked from time to time. More specifically, the achievement of goals and the validity of operations are checked on a regular basis between staff members and their superiors in development work for new antimicrobial agents and application technology, product manufacturing and quality management processes. A system also ensures its proper operation based on the rules through an annual internal audit by auditors from another department.
3. It helped us standardize our work processes. We had prescribed procedures to follow in our operations before, but we documented them in order to standardize our work processes in a more tangible form in this system. In consequence, it has become easier for everybody to follow one and the same procedure in performing assigned tasks. This has led to the improvement of performance standards and productivity of our operations.
4. It helped us single out problems. As a manufacturer, quality issues are vital to us. This system requires the documentation of corrective action taken upon detecting nonconformity in three steps, namely a step to take action for products, a step to formulate recurrence prevention measures and a step to check recurrence prevention measures' effect. Through these steps, in which the cause is analyzed and corrective action and preventive action is taken, we single out problems, learning what is at the bottom of the nonconformity and whether chosen measures are effective.
We aim to operate this system actively in the future for more efficient corporate activity.