Quality Assurance System

FUJIFILM Wako Pure Chemical Corporation is working on various management systems.

ISO 9001 (JIS Q 9001) Quality Management Systems

We have built a quality assurance system for departments related to Laboratory Chemicals and Specialty Chemicals in the Head Office, R&D, Manufacturing, and other involved divisions, aiming to improve customer satisfaction. We have obtained the quality management system “ISO 9001” certification. We will continue to operate the quality management system effectively to ensure a stable supply of products that satisfy our customers.

Quality Management System Standards ISO 9001: 2015
Registration Date 1995.8.28(Changed to JQA from 2019.12.27 JQA-QMA16152)
Registered Organization Departments related to Laboratory Chemicals · Specialty Chemicals (Head Office, Tokyo Principal Office, regional offices, sales offices, plants, laboratories, etc.)
Scope of Activity
  1. Design / Development,Manufacture and Sales of the Following Products
    • Reagents
    • Chemical Products
    • Pharmaceutical Raw Materials
  2. Design / Development,Manufacture, Sales And Maintenance of the Following Products 
    • Inspection Equipments
  3. Instructions and Superivision Related to Quality Assurance
  • * The certification body has been changed to JAPAN QUALITY ASSURANCE ORGANIZATION, which certifies Fujifilm Group management systems.

ISO/IEC 17025 (JIS Q 17025) Laboratory Accreditation Program

Based on ISO/IEC 17025, an international standard that certifies the competence of laboratories, our plants have been certified under the accreditation system of the National Institute of Technology and Evaluation (ASNITE); the quality management department of Osaka Plant has been certified for standardization of titration solutions, and the quality management department of Tokyo Plant has been certified for quantitative analysis using nuclear magnetic resonance (NMR).
For analyses in the scope of accredition, we can offer users an analysis certificate with a logo that indicates the confidence level of the results in terms of degrees of uncertainty.

Laboratories Tokyo Plant (Kawagoe, Saitama Pref.) Osaka Plant (Amagasaki, Hyogo Pref.)
Date of accreditation 2013.3.13 (ASNITE 0044 Testing) 2001.6.20 (Certified by JCLA)
2013.4.8 (ASNITE  0082 Testing)
Accreditation body National Institute of Technology and Evaluation (NITE) National Institute of Technology and Evaluation (NITE)
Scope of accreditation Analytes: Organic specialty chemicals Analytes: Inorganic specialty chemicals
Analytical technique: nuclear magnetic resonance (NMR) spectroscopy Analytical technique: volumetric analysis (titration)
Applied analysis Measurement of geniposide by quantitative NMR Standardization of titration solution

ISO 13485 Medical Device Quality Management Systems

Divisions related to diagnostics have acquired “ISO 13485” and “MDSAP (Japan, U.S., and Canada)”, which are global standards for quality management systems for diagnostics and medical devices, to stably supply high-quality diagnostics.
We will effectively implement these internationally-recognized quality management systems in order to provide products that satisfy our customers.

Quality Management System Standards ISO 13485: 2016 MDSAP
Registration Date 2021.10.17 2021.11.14
Facilities Diagnostics-related divisions (Head Office, Mie Plant, Research laboratories, and others)
Scope of Certificate
  1. Design and development, manufacture, and distribution of in-vitro diagnostic reagents (biochemical, immunological, and microbiological reagents and related calibrators and controls)
  2. Design and development, distribution, installation, and servicing of in-vitro diagnostic instruments
Certified by TÜV SÜD Product Service GmbH, TÜV SÜD America Inc.

ILAC-MRA/JCSS Accreditation

Japan Calibration Service System (JCSS) traceability based on the Measurement Act

JCSS is an accreditation program operated by International Accreditation Japan (IAJapan) based on the Measurement Act, and is the foundation for ensuring the technical capabilities of testing and calibration institutes and for ensuring measurement data reliability. We have obtained certificates for pH standard solution, metal standard solution, ion standard solution, volatile organic compound mixture standard solution, and others, offering these products that meet the measurement standard through JCSS.

Quality Management System Standards ISO/IEC 17025
Registration Date 2005.12.26 (JCSS 0016)
Facility Tokyo Plant
Scope pH standard solution, metal standard solution, ion standard solution, volatile organic compound mixture standard solution, and others
Accreditation body National Institute of Technology and Evaluation (NITE)

Mutual recognition of “accreditation body to international standards” and “testing and calibration laboratories certification”

In general, it can be expressed and ensured that an accreditation program operated by accreditation bodies meets international standards and criteria, by becoming a signatory to international mutual recognition arrangements.
JCSS is an accreditation program operated by IAJapan, which has been a signatory to MRA with APAC and ILAC.
Therefore, certificates with the accreditation symbols issued by JCSS registered laboratories are accepted by overseas regulations. Between the signatories of mutual recognition agreements, these certificates are equally treated, leading to One-Stop-Testing.
Based on JCSS, our offered measurement standard are traceable to national measurement standards, and the analytical certificates we issue bear the following symbols issued by “ILAC” and/or “IAJapan” registered bodies, and thus they are visibly certified to meet the international criteria.

MRA : Mutual Recognition Arrangement
JCSS : Japan Calibration Service System
IAJapan : International Accreditation Japan
APAC : Asia Pacific Accreditation Cooperation
ILAC(ilac) : International Laboratory Accreditation Cooperation

Certified Reference Materials

A certified reference material (CRM) is defined as a reference material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a reference material certificate that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.
Our company obtained the “certificate of reference material producer” through the ASNITE accreditation program of NITE/IA Japan in September 2010, and has been offering “volumetric analysis reference materials” as inorganic reference materials, and offering “quantitative NMR reference materials” and “pesticide residue testing reference materials” as organic material analysis reference materials, to all of which a certificate with an “ASNITE” logo is attached. IAJapan is a signatory to the ILAC and APAC Mutual Recognition Arrangements (MRAs), enabling ASNITE “accreditation as a reference material producer” to be accepted internationally.
Furthermore, we obtained certificates as a reference material producer of standard solutions for volumetric analysis use for the Japanese Pharmacopoeia General Tests, in January 2016, and as a reference material producer of amino acids mixture standard material, in October 2019, the first domestic reagent manufacturer to have been granted accreditation.
We also obtained a JAB certificate for organism and diagnostic reference materials in the biochemical field in September 2011, as the first accredited domestic manufacturer of reagents, and have been supplying organism and diagnostics reference materials, “enzyme calibrators”, with a certificate which has a “JAB” logo attached.
We will continue to produce and stably supply certified reference materials which play a vital role in analysis and calibration.

Laboratories Tokyo Plant
(Kawagoe, Saitama Pref.)
Osaka Plant
(Amagasaki, Hyogo Pref.)
Mie Plant
(Mie, Mie Pref.)
Registration Date 2010.9.3
Accreditation body National Institute of Technology and Evaluation (NITE) National Institute of Technology and Evaluation (NITE) Public interest incorporated foundation Japan Accreditation Board (JAB)
Category Chemical reference materials Chemical reference materials Biological and diagnostics reference materials
Characteristic name Amidosulfuric acid, potassium hydrogen phthalate, sodium oxalate, sodium carbonate, potassium dichromate, potassium iodate, sodium chloride, sodium fluoride, 1, 4-bis (trimethylsilyl) benzene-d4 (1, 4-BTMSB-d4), 3-(trimethylsilyl)-1-propyne-1,1,2,2,3,3-d6, sodium sulfonate (DDS-d6), and pesticide residue analysis reference materials. For the Japanese Pharmacopoeia General Tests
For volumetric analysis
Enzyme calibrator