Quality Assurance

Quality Assurance

Our Vision

We are the Top-runner of analytical laboratories.

Our certificates are the best choice for practical global use. 
Our quality is based on the deep knowledge, diverse experience and good technology.
Our quality consists of consistent quality control system from sample reception to the issue of certificates.
In addition, we practice training programs and PDCA cycle for daily analytical activities.
 
The head of Quality System Committee 
Executive Director Tsutomu Nishimura

 

The High Quality test data

The most important for the analytical service is precision.
We started quality assurance design in our organization about 30 years ago.
The first step was internal quality control and equipment maintenance, and now all of our laboratories are certified by ISO9001.  
Many analytical methods are certified and evaluated by ISO/IEC17025.
In addition, our laboratories are certified by GLP (Medical devices and Pesticides) & GMP (Drugs and Medical devices) regulations. (CERTIFICATION &ACCREDITATION)
Our aim is providing high-quality data to our clients in various fields.
We have been continuing to improve our reliability.

 To provide the reliability data

ClientReceptionTraceabilityMethod controlApparatus controlReference standard controlSample controlMethod controlApparatus controlInternal quality controlTest reportClient 

The PDCA cycle of a Quality system

           Plan
                   Quality policy (Our goal)         
             Training program  
 Do  
   Laboratory management
   (Sample control ・Apparatus control・
     Reagent contro l・Traceability)  
   Control of documents and records 
   Human resources   
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              Act      
                 Corrective and preventive action
                 Quality System Committee
                          Management review
  Check    
        Internal audit    
        Internal quality control
        Proficiency testing  
        Information from client

Reception

uketuke1m2.jpg    As soon as we receive a sample, we register it in our computer system.  
How to order

Each sample is recognized with eight digit unique number and barcode on the sample label. 
Photos of the sample records the current conditions.
The electronic data of the order information is sent to our laboratories. 
     
Laboratories section personnel also check the order information and samples.
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Analysis

Method control

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We select the analytical method according to the purpose of clients. Each method is validated and verified by ourselves.

Sample control

Storage condition is indicated on the sample label.
We keep the sample in a temperature-controlled refrigerator or freezer to meet requirement of the assays.
 
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Sample preparation for analysis

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According to the matrix, a sample is prepared by the appropriate method.
We develop techniques to prepare various types of samples.

Reference standard control

Every reference standard has the management number for traceability.
  
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Apparatus control

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In order to meet requirements of clients, we have a variety of analytical instruments.
Every apparatus has the management number. 
We achieved the total equipments control plan (DQ, IQ, OQ, PQ).

Assay

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Our personnel are well trained and qualified for all analytical service.
To avoid crossing samples, we use the barcode on the sample label.
Internal quality control system using reference materials and recovery tests confirms quality of our tests. 

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Test report

The test data certified by the section head of laboratory are transmitted electronically to the section of analysis documentation. We issue the report and send it to the client.

 

Internal audit

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Based on ISO9001 quality management system, the head of Department of Quality Assurance submits an annual audit plan. The trained members audit all sections and confirm the conditions of quality management system.
If nonconformity is found in the audit, a corrective action is done as soon as possible.
PDCA cycle develops our Quality control system.

Training

We have the annual training program. The textbook and the trainer is designated by the Training Committee. Also each section has the OJT training program. Our laboratory manager confirms the skills and knowledge of personnel by skill evaluation test.
 
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Quality Assurance