 |
| In 1995, our Chiba Laboratories became the first contracted
analysis service business in Japan to receive ISO 9001 certification (the quality
assessment system for design, development, manufacture, installation, and ancillary
services). Our laboratories in Osaka, Ehime, Okayama, Tsukuba and Oita soon followed
suit. |
| In 1999, our Chiba Laboratories became the first laboratory
in Japan’s chemical analysis industry to be certified as complying with
ISO/IEC Guide 25 (general requirements for the competence of testing and calibration
laboratories), according to Japan Chemical Laboratory Accreditation (JCLA) with
respect to specific testing for the chemical and environmental sectors. It was
followed by our Ehime Laboratory, which was JCLA-accredited in April 2000 as
a laboratory meeting ISO Guide 25 for the environmental sector. At present, ISO
Guide 25 has been replaced by ISO 17025 (general requirements for the competence
of testing and calibration laboratories). Both the Chiba and Ehime Laboratories
have upgraded to ISO 17025. |
| Pharmaceutical Good Laboratory Practice (GLP) |
|
| In July 1998, in a GLP compliance survey conducted by the
Organization for Pharmaceutical Safety and Research, our Pharmaceutical Science
Department was A-rated for toxico-kinetic measurement. In April 2001, it was
again A-rated A system is also in place that allows other contract-based analysis
tests in pharmaceutical-related sectors to be implemented in accordance with
reliability standards. |
In August 2000, the Osaka Laboratories
underwent inspection by the Agricultural Production Bureau (Ministry of Agriculture,
Forestry and Fisheries’) to have its GLP compliance status assessed, and
received confirmation of compliance with the relevant standards concerning the
appropriate implementation of tests on toxicity of agrochemicals.”
| 1. |
Oita Laboratory: |
ISO 9001, Reliability Standard |
| |
Pharmaceutical Science Department (Oita): |
Reliability Standard |
| 2. |
Ehime Laboratory: |
ISO 9001, ISO 17025 |
| 3. |
Okayama Laboratory: |
ISO 9001 |
| 4. |
Osaka Laboratory: |
ISO 9001, Reliability Standard, Agrochemical GLP |
| |
Pharmaceutical Science Department (Osaka): |
Pharmaceutical GLP, Reliability Standard |
| 5. |
Tsukuba Laboratory: |
ISO 9001 |
| 6. |
Chiba Laboratory: |
ISO 9001, ISO 17025, Reliability Standard |
|
The following is an easy-to-understand three-dimensional illustration that
shows, the scope to which various quality assurance systems apply, as well as
the scope of their requirements. The X axis shows the extent of the sectors to
which the quality assurance system applies; the Y axis shows the extent of the
scope of requirements for the systems and technological management of quality
assurance system; and the Z axis shows the content of these requirements in details.
| Requirement scope of quality assurance system and object fields |
 |
|
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