Quality Manual Concerning Antibacterial Proficiency Testing Program
Table of Contents
1. Objective
2. Scope of Application
3. Words and Terms
4. Quality Policy
5. Normative References
6. Conceptual Diagram of Proficiency Testing Program
7. Organizations for Operations Management
8. Fairness and Confidentiality
9. Management System
10. Operation of Antibacterial Proficiency Testing Program and its Process
11. Improvement
12. Complaint Handling

1.

Objective
This quality manual concerning antibacterial proficiency testing program (hereinafter referred to as“quality manual”) is stipulated as the primary document for effectively operating the proficiency testing
program in the antibacterial field provided by Society of International sustaining growth for
Antimicrobial Articles (hereinafter referred to as “this society”).
2.

Scope of Application
This manual is applicable to the proficiency testing program in the antibacterial field (other thanfiber products) provided by this society.
3.

Words and Terms
The words and terms defined in “JIS Q 17043” and “Policy Concerning IAJapan Proficiency Testing”
are applied to major words and terms used in this manual.
4.

Quality Policy
This society establishes a quality policy concerning the antibacterial proficiency testing program.
The quality manager of this society shall disseminate the quality policy described below to the people
involved in the antibacterial proficiency testing, including the members of the antibacterial proficiency
testing implementing committee described in Term 6.2-(1). The chief of the secretariat of this society
shall serve as the quality manager(1) To provide a high-quality service which satisfies the test laboratories participating in theproficiency testing(2) To observe related provisions, guidelines and this manual and provide a fair, harmonious, andtransparent proficiency testing program for the purpose of ensuring the reliability of the testingevaluation results and expanding the use of the proficiency testing in the antibacterial field(3) To maintain and enhance the proficiency testing management and operation capacities
appropriately, thereby improving its quality
5.

6.

Normative References
The standards, etc. cited in this manual are as follows:
ISO/IEC 17043 (JIS Q 17043)
ISO/IEC 17025 (JIS Q 17025)
ISO 13528 (JIS Z 8405)
Policy Concerning IAJapan Proficiency Testing (IAJapan, National Institute of Technology andEvaluation)Conceptual Diagram of Proficiency Testing Program

KG1－1➢ Quality policy➢ Standard requirements and policies➢ Proficiency testing implementation plan

Providing highquality services tothe organizations
participatingintheproficiencytesting➢ Implementation of proficiency testing➢ Analysis and feedback of testing result➢ Management review➢ Improvement and corrective actions➢ Preventive action➢ Internal audit➢ Feedback from the organizations which
participated in the proficiency testing

7. Organization for Operations Management
7.1 Organization Chart

Chairperson

Executivedirector

Qualitymanager

Antibacterial proficiency testingimplementing committee(including external members)

Evaluation technology committee

7.2 Operation Undertaking System(1) As an organization for operating the antibacterial proficiency testing program, the antibacterial
proficiency testing implementing committee including external members shall be established inthis society. The person chiefly responsible for program development shall be the chairperson ofthis society, and the evaluation technology committee of this society shall provide technical support
for developing the program.
(2) The antibacterial proficiency testing implementation committee shall conduct preparations for theantibacterial proficiency testing such as planning, implementing the testing, analyzing andcompiling the results, and preparing the testing report. This implementing committee shall avoid
prioritizing a specific representative of the interest in order to preserve the fairness, considering thebalance of interests. The details of the administrative affairs under the jurisdiction and operation ofthis committee are stipulated in Term 10.
(3) The antibacterial proficiency testing implementing committee may consult with the evaluation
technology committee about technical issues as needed. The evaluation technology committee shallstudy them and answer back with the results.
8.

Fairness and Confidentiality
The following shall be observed to maintain the fairness and confidentiality in operating theantibacterial proficiency testing program:

KG1－2

(1) When a corporation participates in the antibacterial proficiency testing program, unfair conditions
which restrict use, such as restricting the size of the corporation and requiring them to be a memberof a certain group shall not be made.
(2) The antibacterial proficiency testing implementing committee shall be properly separated fromother activity organizations in terms of both organizational management system and decisionmaking, in order to ensure that other committees and project activities in this society do not affectthe confidentiality, objectiveness, and fairness of the proficiency testing. However, this does notpreclude the employees of the member companies of this society from serving as both a memberof the antibacterial proficiency testing implementing committee and a member of anothercommittee.
(3) No commercial, fiscal, and other pressures, which may affect the result of the antibacterial
proficiency testing, shall be received. If coming under pressure occurs, it shall be rejected
immediately and reported to the chairperson of this society, and the chairperson shall ensure toeliminate the pressure. The chairperson may entrust this operation to an appropriate board memberof this society.
(4) All confidential information on corporations, individual organizations and persons obtained in theoperation of the antibacterial proficiency testing program shall be protected and not be disclosed
outside of this society without written consent of the relevant party. However, a case where thedisclosure of information is required by a law or the government is excluded.
9. Management System
9.1 General
This society shall establish the quality document architecture as shown below as the management
system for operating the implementation of antibacterial proficiency testing program, so that all relevant
personnel can utilize it.

Quality manual

Basics of the establishment ofquality system

Antibacterial testing implementing procedure

Externaldocument

Homogeneity evaluation testing procedure

Implementation

Recording of results
9.2 Management System Documents(1) Types of management system documents
As described in Term 9.1, the types of the management system documents are as follows:(i) Quality manual: Primary document among management system documents(ii) Proficiency testing implementation procedure: A document which describes the content ofproficiency testing specifically and is distributed mainly to organizations participating in the
proficiency testing.
(iii) Homogeneity evaluation testing procedure: A document stipulating the testing procedure for
examining the homogeneity of a sample(iv) Operation instruction document: A document which is prepared for temporary use and may
be issued when giving the followings:a) Instructions with regard to the matters which are not stipulated in the management system
documentsb) A supplementary explanation for understanding the management system documents(2) Approval of the management system documents

KG1－3

The management system documents shall be approved by the following approvers concerning theirappropriateness before issuance or amendment:(i) Quality manual: Chairperson(ii) Antibacterial testing implementing procedure, homogeneity evaluation testing procedure, andoperation instruction document: Executive director
9.2 Internal Audit(1) An internal audit shall be planned and implemented after proficiency testing in order to verify thatthe antibacterial proficiency testing program management system is properly implemented andmaintained, as well as to have the opportunity for improvement.
(2) The quality manager shall be responsible for planning and implementing an internal audit.
(3) An internal auditor shall be a person qualified as internal auditor for ISO 9001 or ISO 14001 in theorganization to which the person belongs and shall be appointed by the quality manager.
9.3 Management Review
A review on activities related to the proficiency testing program shall be conducted afterimplementing the proficiency testing, in order to ensure that the management system related to theantibacterial proficiency testing is continuously operated properly and effectively, as well as fornecessary change or improvement. The management review may be implemented in the executives’
meeting or board meeting, etc. held by this society. The following shall be considered in the review:(1) Policy and procedure(2) Result of proficiency testing(3) Result of the immediate internal audit(4) Corrective and preventive measures(5) Feedback from the participants in the proficiency testing(6) Proposal for improvement(7) Other matters which are deemed necessary by the quality manager
9.4 Operation Check
The quality manager shall check whether the operations related to the proficiency program are
conducted according to the management system, and shall take improvement measures in accordancewith Term 11 if there is any problem.
9.5 Record Management
Necessary records shall be stored and managed based on the “document control procedure of thissociety”, in order to demonstrate the appropriateness and effectiveness of the operation of theantibacterial proficiency testing program as well as conformance with the requirements for theparticipants in the proficiency testing.
9.6 Release of Documents Related to the Recruitment of Participants in the Proficiency Testing
The documents explaining the outline of the antibacterial proficiency testing program shall be
released in a manner which enables wide dissemination, such as a website, for recruitment of anddissemination to the participants in this program. If there is any change in their contents, they shall be
updated immediately, including transitional measures, etc.
10. Operation of Antibacterial Proficiency Testing Program and its Process
10.1 Frequency of Implementing the Antibacterial Proficiency Testing Program
The antibacterial proficiency testing shall be implemented every two years, as a rule.
10.2 Corporations Participating in the Antibacterial Proficiency Testing Program
The corporations participating in the antibacterial proficiency testing program shall fall under anyof the following:(1) JNLA-registered test laboratories in the antibacterial field (excluding fiber products)(2) Corporations which are in the process of application for JNLA registration or planningregistration in the antibacterial field (excluding fiber products)(3) Corporations which have ever used a testing method adopted in proficiency testing in theantibacterial field (excluding fiber products), and wish to participate in the antibacterial
proficiency testing program
10.3 Testing method adopted for use in the Antibacterial Proficiency Testing Program and Performance
Evaluation of Participants
The testing method adopted for use in this program shall be JIS Z 2801, and the performance ofparticipants shall be evaluated based on interlaboratory comparison. As a rule, the results shall beKG1－4

evaluated using the “z score” stipulated in Appendix B of JIS Q 17043, andsatisfaction/dissatisfaction with the result shall be determined using the index stipulated in the sameappendix.
10.4 Reporting of Results
The results of the antibacterial proficiency testing program shall be reported using “ProficiencyTesting Report Related to the JNLA, Test Laboratory Registration System Based on the Industrial
Standardization Act (Antibacterial Testing)”.
10.5 Confidentiality of Results
The confidentiality of the participating corporations shall be preserved, excluding reporting toIAJapan, National Institute of Technology and Evaluation.
10.6 Antibacterial Proficiency Testing Program Implementing Procedures and Organizations
As a rule, the processes of and the organizations implementing the antibacterial proficiency
testing program stipulated by this society in order for effective and efficient implementation ofthis program shall be as follows:

Action items for proficiency testing program

Antibacterial
proficiency
testing
implementing
committee

Planning of the proficiency testing program
Preparation of the samples for the antibacterial
proficiency testing

○

○

The
secretariat
places orders withmanufacturers
The
secretariat
places orders withtest laboratories

○

○

○
○

○

Distribution of the antibacterial proficiency
testing report to the laboratories participatedin the testing and submission of the report toIAJapan of NITE

Remark○Check of the homogeneity of the samples forthe antibacterial proficiency testing
Recruitment of test laboratories participatingin the antibacterial proficiency testing
Distribution of the samples for theantibacterial
proficiency
testingandantibacterial proficiency testing procedures,etc. to the test laboratories participating in thetesting
Collection of test results from the laboratories
participated in the testingCompilation, statistical processing, andanalysis of the testing results collected
Preparation of antibacterial proficiency
testing reportSecretariatofantibacterial
product
engineering
councilAftertheimplementing
committee checks
the report, thesecretariat arranges
bookbinding.

○The procedures for implementing the proficiency test and for evaluating the homogeneity of thesamples for proficiency test (test item) are stipulated separately.
11. Improvement(1) The effectiveness of the management system shall be improved continuously, through the analysisof the feedback information, etc. from the participants in the internal audit, management review,
and antibacterial proficiency testing program.

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(2) Preventive measures for identifying non-compliant operations in the operation of the antibacterial
proficiency testing program, correcting and preventing their recurrence, and eliminating the causeof potential non-compliant operations.
(3) The quality manager shall determine the necessity of corrective and preventive measures, andimplement them if they are deemed necessary.
(4) The result of corrective and preventive measures shall be reflected in the management system
documents.
(5) The corrective and preventive measures shall be reported to the concerned parties, including thechairperson in the management review, and the appropriateness of the activities shall be ensured
through the feedback.
12. Complaint Handling(1) Complaints from the National Institute of Technology and Evaluation as well as concerned parties
shall be handled immediately and sincerely.
(2) Handling of complaints shall be validated under the management of the quality manager, andcorrective and recurrence prevention measures shall be taken if non-compliant operations areidentified. Additionally, the result of handling the complaint shall be reported to the party who
made the complaint.
Revision history
Reason for amendment

010203040506

Date of formulation andamendment
November 30, 2006
Preparation associated withSIAA antibacterial proficiency the initiation of the operation
testing program document
forcultivating
theantibacterialproficiency
testing program
November 25, 2008
Amendment associated withSIAA antibacterial proficiency the initiation of the operation
testing program documentfor
cultivating
theantibacterial
proficiency
testing program for fiscal2008
September 22, 2011
Amendment associated withtheinitiationof
theantibacterialproficiency
testing program for fiscal2011
December 3, 2013
Amendment associated withtheinitiationof
theantibacterial
proficiency
testing for fiscal-2013
October 8, 2019
Review and amendment
associatedwiththeintegration with the provision
fortheantibacterial
proficiency testing program
December 4, 2019
Revision associated with thereviewofdocument
approvers related to theantibacterial
proficiency
testing program

KG1－6

Preparedby
YoshiakiFujimoto

Approvedby
Shuzo
Tokumitsu

YoshiakiFujimoto

TadashiArishiro

YoshiakiFujimoto

Yoshifumi
MoriyaYoshiakiFujimoto

Yoshifumi
MoriyaToshiyuki
NagataMasataka
Mizutani

Toshiyuki
NagataMasataka
Mizutani