JB00002-2022

Breath Alcohol Detector Verification System

July 1, 2022

JB00002-2022
Breath Alcohol Detector Verification System

アルコール検知器協議会
Japan

BreathAlcohol

Testing Consortium

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JB00002-2022

Breath Alcohol Detector Verification System

Table of Contents
Foreword ................................................................................................................................................. 4
About This Document ............................................................................................................................ 6
Chapter 1 Breath Alcohol Detector Verification System ..................................................................... 7
1.1 Purpose of the System .................................................................................................................... 7
1.2 Scope of the System ....................................................................................................................... 7
1.3 Terms and Definitions (For Overall Verification System) ................................................................. 7
1.3.1 Main Document ........................................................................................................................ 7
1.3.2 Technical Standard Document ................................................................................................. 7
1.3.3 Verification System ................................................................................................................... 7
1.3.4 JB Mark .................................................................................................................................... 7
1.3.5 Applicant ................................................................................................................................... 8
1.3.6 Certified Device Provider .......................................................................................................... 8
1.3.7 External Organization’s Audit.................................................................................................... 8
1.3.8 Technical Standard Document JB10002-2022 ......................................................................... 8
1.3.9 Technical Standard Document JB20001-XXXX (TBD) ............................................................. 8
1.3.10 Manufacturer .......................................................................................................................... 8
1.4 Position of the Verification System .................................................................................................. 8
1.5 External Organization’s Audit .......................................................................................................... 9
1.6 Applicable Products ........................................................................................................................ 9
1.7 JB Mark ......................................................................................................................................... 11
1.8 Announcing Information about the Verification System Public ...................................................... 12
1.9 Announcing the Certified Devices ................................................................................................. 12
Chapter 2 Requirements that Should Be Satisfied by Applicants and Certified Providers ............ 13
2.1 Understanding Laws and Regulations Applicable to Alcohol Detection ......................................... 13
2.2 Rule about Breath Alcohol Detector Marketing Guidelines ............................................................ 13
2.3 Requirements about the Quality Assurance System ..................................................................... 13
2.3.1 Product Quality Assurance System ........................................................................................ 13
2.3.2 Identification and Traceability ................................................................................................. 13
2.3.3 Controlling the Monitoring and Measuring Instruments ........................................................... 13
2.3.4 Monitoring and Measuring the Product ................................................................................... 14
2.3.5 Controlling Non-conforming Products ..................................................................................... 14
2.4 Accountability of Manufacturers to Distributors ............................................................................. 14
2.5 Product Requirements .................................................................................................................. 14
2.6 Instruction Manual ......................................................................................................................... 14
2.7 Marking Requirements .................................................................................................................. 15
2.7.1 General Requirements............................................................................................................ 15
2.7.2 Using the Mark on Products ................................................................................................... 15
2.7.3 Using the Mark in Documentation ........................................................................................... 15
2.7.4 Laws Related to Consumers and Representations ................................................................. 15
2.8 Certification Criteria ....................................................................................................................... 16
2.9 Procedure for Changing the Specifications ................................................................................... 16
2.10 Cancelling the Certification .......................................................................................................... 17
2.11 Disclaimer ................................................................................................................................... 17
Chapter 3 External Organization’s Audit and Technical Standard Test ........................................... 18
3.1 Initial Verification Process (Application~Initial Audit~Certification Notification~Announcement) .... 18
3.2 How to Make Application ............................................................................................................... 19
3.3 Certification Examination Committee ............................................................................................ 20

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Breath Alcohol Detector Verification System

3.3.1 Activities of the Certification Examination Committee ............................................................. 20
3.3.2 Notes on Application ............................................................................................................... 20
3.4 Collecting the Target Device Samples .......................................................................................... 21
3.5 Roles of External Organizations .................................................................................................... 21
3.6 Handling Non-conformities to the Criteria ...................................................................................... 21
3.7 Test Result Report ........................................................................................................................ 21
3.8 Surveillance Audit ......................................................................................................................... 22
3.9 Surveillance Audit Processes ........................................................................................................ 22
3.10 Recertification Audit .................................................................................................................... 22
3.11 Recertification Audit Processes ................................................................................................... 23

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Breath Alcohol Detector Verification System

Foreword
The Japan Breath Alcohol Testing Consortium was established on April 8, 2015.
The Consortium is the only domestic industry organization created by companies who are involvedin manufacture and marketing of breath alcohol detectors. It aims to raise the status of the industry
by improving the technology and quality of breath alcohol detectors and raising awareness about
them, while working together with various related governmental agencies and other organizations toeradicate drunk driving and other alcohol-related problems.

In recent years, fatal and serious injury accidents caused by drunk driving have become a majorsocial problem. To prevent seriously dangerous driving, in 2006, the criminal law stipulating thevehicular manslaughter crimes was revised to strengthen the penalties for drunk driving. In May 2011,
for the commercial transportation industry, use of breath alcohol detectors at roll call became a legal
requirement in addition to visual checking etc. to check whether alcohol has been consumed bydrivers. Today, increase of health hazards due to excessive drinking is also a serious problem.
Excessive consumption of alcohol raises the risk of lifestyle diseases and may lead to acute alcohol
poisoning and alcoholism. In these situations, the role of breath alcohol detectors is becoming
increasingly important.

The breath alcohol detector market is expanding year by year by introducing commercial products
for health management and industrial products for alcohol detection conducted by transportation
businesses. As more breath alcohol detectors are adopted for various commercial and industrial uses,
it has become a problem that some consumers and companies who purchase them are not wellinformed or well-trained to use them correctly.

With the need for establishing the verification system to certify manufacturers and distributors who
have a quality control system and meet a certain quality level, by conducting research on national
and international standards and survey on quality standards of the member companies, theConsortium established and started a trial operation of the tentative version of the “VoluntaryStandard of Breath Alcohol Detector Verification System (J-BAC Mark System) <Draft>” in July 2016.

The tentative version of the standard is not strictly binding but intended to provide easy-tounderstand criteria for consumers and companies and propose marketing guidelines that require
breath alcohol detector providers to give proper instructions about their products. It specifies only 3
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JB00002-2022

Breath Alcohol Detector Verification Systemtechnological requirements and if not improved, it may be regarded as ineffective in the world.

To prevent wrong knowledge and wrong use of alcohol concentration criteria and breath alcohol
detectors in all scenarios including retail, business, commercial, and industrial uses, the Consortium
decided to create a more general and fair system that can cover a wide range of technologicalrequirements to meet applications and purposes under various Japanese laws and regulations andcan facilitate independent testing by external organizations. To this end, the Consortium has
augmented the standard by elaborating the content that were simplified in the tentative version.
The Consortium is aiming to earn the trust of consumers and other industries by fulfilling their
responsibility to continuously announce, maintain, and operate the verification system from an
independent and fair standpoint.
In addition, by incorporating the trends of international technical standards and device certification
systems into the verification system, it prevents itself from being a bottleneck of international trading.
It also promotes competition for technological innovations among member companies andinternational leading manufacturers to energize the industry and raise its status.

As stated in the membership rule, Article 2 and Article 3, our effort to raise the status by establishingthe verification system is essential to eradicate drunk driving and other alcohol-related problems.
For details, refer to the membership rule of the Japan Breath Alcohol Testing Consortium, Article
2 (Purpose) and Article 3 (Activity).

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Breath Alcohol Detector Verification System

About This Document

Chapter 1 Breath Alcohol Detector Verification System
Chapter 2 Requirements that Should Be Satisfied by Applicants and Certified Providers
Chapter 3 External Organization’s Audit and Technical Standard Test

[Document Numbering Rule]
JB

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JB

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20XX

JB

Document category

Serial number (3-digit)

Hyphen

Revision year

JB

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Serial number 001 -Hyphen

20XX

JB

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Serial number 001 -Hyphen

20XX

JB

20 (TBD)

Serial number 001 -Hyphen20XX

JB

90 Appendix

Serial number 001 -Hyphen20XX[Document Content]
Standard
NumberDocument Title

Major Underlying
International
Standard

JB10001

Breath Alcohol Detector Technical Standard Document

EN15964, EN16280

JB20001

Breath Alcohol Detector Technical Standard Document(TBD)

EN15964, EN16280

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Breath Alcohol Detector Verification System

Chapter 1 Breath Alcohol Detector Verification System
1.1 Purpose of the System
The system is intended to facilitate correct use and application of breath alcohol detectors in society.

1.2 Scope of the System
1) The system has been established by the Japan Breath Alcohol Testing Consortium.
2) Only regular members of the Japan Breath Alcohol Testing Consortium are eligible to apply for
examination under the system and their application is voluntary.
3) The system is not meant to obstruct particular manufacturing or marketing activities.
4) Information related to the system (information about the system, technical standards, certified
devices, etc.) is made public on the Japan Breath Alcohol Testing Consortium’s website.

1.3 Terms and Definitions (For Overall Verification System)
1.3.1 Main Document
Refers to this document.

1.3.2 Technical Standard Document
Technical standard documents referred to with the JBXXXXX-XXXX numbers specified in thisdocument.

1.3.3 Verification System
The verification system is composed of the main document and the technical standard
documents. It is a comprehensive system that involves the application procedure, technicalstandards, testing method, initial audit, recertification audit, control and maintenance of thecertification mark, scope of responsibility, disclaimers by the Japan Breath Alcohol Testing
Consortium and external organizations, application forms, and all relevant documents.

1.3.4 JB MarkThe applicant is allowed to use the mark as certification that their device has satisfied all of
the technical standards and other requirements specified by the system. The JB mark consistsof a “JB logo and a standard number”. For how to use it, refer to Chapter 2 in the main document.

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Breath Alcohol Detector Verification System

1.3.5 Applicant
Regular members of the Japan Breath Alcohol Testing Consortium as defined in its
membership terms, Article 4, who are legal entities involved in manufacturing or marketing.
1.3.6 Certified Device Provider
Providers who handle the device certified under the verification system. Certified device
providers shall adhere to the maintenance and operation rule of the verification system.
1.3.7 External Organization’s Audit
Document examination or on-site examination (including collecting target device samples)
conducted by an external organization in response to a submitted application. An externalorganization conducts an initial audit, surveillance audit (document examination only), andrecertification audit.
1.3.8 Technical Standard Document JB10002-2022“Chapter 3 Breath Alcohol Detector Technological Requirements” in the voluntary standard
issued in 2016.
1.3.9 Technical Standard Document JB20001-XXXX (TBD)
This technical standard contains the content of the “Breath Alcohol Detector Verification
System (J-BAC Mark System)” standard and other essential performance specifications ofbreath alcohol detectors. The standard refers to the European standard of EN16280 (Breath
alcohol test devices for general public - Requirements and test methods) and EN15964 (Breath
alcohol test devices other than single use devices - Requirements and test Methods) andincorporates the content of related Japanese laws and regulations.
While JB10002-2022 contains only 3 test items, i.e., (1) MPE, (2) reproducibility, and (3)interfering components, this standard contains the drift test, temperature test, expiratory
volume test, drop test, and low-voltage test as well.
1.3.10 Manufacturer
Legal entities who are a brand owner of breath alcohol detector or their associatedcompanies responsible for designing, manufacturing, packaging, and labelling breath alcohol
detectors whether they conduct such processes by themselves or by outsourcing them.

1.4 Position of the Verification System
Stakeholders of the verification system are member companies, the Consortium, external

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Breath Alcohol Detector Verification Systemorganizations, and the market.
They are involved in the system from 4 different standpoints: the applicant, approver, auditor,
and user of the system and certified device. In principle, the system (including the testingprocedures, results, and examination methods) should be independent, fair, open, andtransparent. It is expected to grow while focusing on independency, fairness, and transparency
and gaining the trust of the market.
Verification system operated by the Japan Breath Alcohol Testing Consortium

ApplicantCertifieddeviceproviderExternal

The

organization

Consortium(Initial audit)(Receiving the(Surveillance

application)

audit)(Final(Recertification

examination)

audit)(Certification)

Market[Consumer][MLIT][Foreign
manufacturer]
Announcement, raise of[Industrial
awareness, gaining oforganization]
trust, and promotion of[Transportationusecompany][Other industries]

1.5 External Organization’s Audit
The verification system adopts the independent audit process conducted by externalorganizations. The audit process has the phases of initial audit, surveillance audit, andrecertification audit. Devices that passed the initial audit can retain the JB mark only by passing
the surveillance audit or recertification audit.

Externalorganization
Initial audit

1 year

JB mark is
obtained

Externalorganization
Surveillance audit
JB mark is
retained

Surveillance audit once
every year
Recertification audit
once every 5 years

Externalorganization
Recertificationaudit

1 year

JB mark is
retained

1.6 Applicable Products
The following apply to the products subject to the system.
1) The system is intended for breath alcohol detectors that are or planned to be distributed in themarket.
2) The system applies to measuring breath and not to directly collecting blood and analyzing
blood concentration.
3) The system applies to any shape, use environment, application, recording method, breathcollection method, and detection principle.

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Breath Alcohol Detector Verification System

Below is the guidance table for applicants. Applicants can check in advance the category of
their product and whether it is applicable.
Guidance Table
No.

Classification

1

Classification by distribution

2

Category (Self-Reported)

Classification by measured substanceShape

Use environment

Features specific to the device

3

Application

Recording method

Breath collection method

Detection principle

Applicability

Post-market

Yes

Pre-market (still in development)

Yes

BreathYes

Breath (disposable)

Yes

Blood

No

Large

Yes

Small

Yes

Stationary

Yes

PortableYes

In-carYes

Indoor use

Yes

Outdoor use

Yes

Self-check

Yes

Employee check

Yes

Policing

Yes

Recordable

Yes

Unrecordable

Yes

Non-contact blowing

Yes

Blowing through mouthpiece (into thedevice)Yes

Blowing into the bag

Yes

Semiconductor gas sensor

Yes

Electrochemical sensor (fuel cell type)

Yes

Catalytic combustion sensor

Yes

NDIR

Yes

Biosensor, QCMYes

The terms of classifications 1 to 3 in the guidance table are based on those commonly used in
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Breath Alcohol Detector Verification System

the commercial market. They are useful for applicants to quickly determine whether their productis applicable or not.
If the product does not fall under any classification in the table and it is difficult to determine whether
it is applicable, consult the Japan Breath Alcohol Testing Consortium.

1.7 JB MarkThe JB mark is a clear indication as a combination symbol consisting of a JB logo and a standard
number.

How to use it on a product, package, and technical and business documents is described in
Chapter 2.
Graphical specifications of the JB mark will be provided by the Japan Breath Alcohol Testing
Consortium after the product is certified.
Adhere to the following when displaying and using the mark.

I Basic Japanese laws and guidelines related to labelling◆ Consumer Affairs Agency◆ Act against Unjustifiable Premiums and Misleading Representations

II Penal rules applied to members of the verification system
Manufacturers shall bear sole responsibility for their product conformity as far as they are a JB
mark holder.

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Breath Alcohol Detector Verification System

The Japan Breath Alcohol Testing Consortium or any external organization shall not be subject
to penalty or involved in a lawsuit on behalf of manufacturers.
Applicants or certified providers will be warned of breach if their improper use of a JB markassigned by the verification system is identified. In serious cases, applicants or certified providers
will be struck off as they are regarded to fall under the membership rule, Article 4-8, “Expulsion”(refer to the attachment).

1.8 Announcing Information about the Verification System Public
People can obtain all information about the verification system at any time by accessing the
documentation about the system on the Japan Breath Alcohol Testing Consortium website.
The documentation about the entire verification system is made public in the following reasons:1)

To ensure that purchasers and the market can access the list of certified devices and thedetailed reasons of certification, and2)

To raise the status of the industry by disseminating the fact that there are proven technicalstandards harmonized with international standards for breath alcohol detectors.

1.9 Announcing the Certified Devices
The list of the certified devices is available on the Japan Breath Alcohol Testing Consortium website.

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Chapter 2 Requirements that Should Be Satisfied by Applicants and Certified
Providers
The Japan Breath Alcohol Testing Consortium member companies participating in the verification
system shall ensure that the breath alcohol detector specifications they provide are true.

2.1 Understanding Laws and Regulations Applicable to Alcohol Detection
The Japan Breath Alcohol Testing Consortium member companies participating in the verification
system should understand the background and details of the current Japanese laws andregulations underlying the main document and technical standard documents.

2.2 Rule about Breath Alcohol Detector Marketing Guidelines
Applicants for this certification shall ensure that 14 items specified, in addition to formal descriptionsof the specifications and operating method based on the specifications, are included in the instruction
manual. For details, refer to Form 2.

2.3 Requirements about the Quality Assurance System
2.3.1 Product Quality Assurance System
Applicants shall provide the necessary information in the application form (Form 2) about the origin
and manufacturing factory of the product concerned, the quality assurance system, and thetraceability system, in accordance with the quality management documents and work manuals.
Considering confidentiality, it is not an obligation to disclose confidential matters such as
subcontractors. However, since the verification system requires an on-site examination (as describedin Chapter 3), applicants shall specify a physical site (final testing (shipment) site) where the final
product quality can be assessed. Such a physical site shall be in Japan.
2.3.2 Identification and Traceability
Applicants shall ensure traceability of the breath alcohol detector concerned in the market. The
product concerned shall be uniquely identifiable in the market and traceable with its time of
manufacture, time of shipping inspection, and final site of manufacture or shipment.
2.3.3 Controlling the Monitoring and Measuring Instruments
Applicants shall specify and maintain the instruments (calibration instrument, air blower, alcohol
simulator, monitoring instrument, etc.) and materials (dry gas, ethanol, and water) that may affectthe performance and quality of the product.

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Breath Alcohol Detector Verification System

2.3.4 Monitoring and Measuring the ProductTypical breath alcohol detectors are made up of an alcohol sensor and parts other than it.
Manufacturing them may be outsourced. “Calibration” and “precision adjustment” processes, which
are important during manufacturing breath alcohol detectors, and manuals for such processes may
also be outsourced. “Monitoring for acceptance between processes” and “Monitoring foracceptance at final inspection” regarding the product concerned shall be conducted by applicants.
2.3.5 Controlling Nonconforming Products
To prevent products not conforming to the product requirements from being used or delivered
accidentally, organizations shall separate and control them properly. They shall document theprocedure for treating and controlling nonconforming products as well as the responsibilities andrights associated with them. If applicable, organizations shall treat nonconforming products in one
or more of the following ways.

a)Taking an action to remove the detected nonconformity.

b)

An authorized person or (if applicable) a customer gives permission to use, release, or
accept the products as an exception.

c)Taking an action to prohibit the intended use or application.

d)Taking an appropriate measure against actual and potential impacts caused by the
non-conformity if non-conforming products are found after delivery or start of use.

2.4 Accountability of Manufacturers to Distributors
If the applicant is a manufacturer and the product is distributed through multiple channels includingtier 1 and tier 2, the manufacturer should explain to the distributor about the marketing guidelines
described in 2.2 at the time of concluding a sales agreement or business partnership agreement.

2.5 Product Requirements
Applicants can apply for certification under the following two technical standards in the verification
system.

I JB10002-2022, Separate document, Breath Alcohol Detector Technical Standard Document
II JB20xxx-xxxx, Separate document, Breath Alcohol Detector Technical Standard Document (TBD)

2.6 Instruction Manual
An instruction manual shall contain the 14 items specified in the marketing guidelines.
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2.7 Marking Requirements
2.7.1 General Requirements
Certified device providers under the verification system shall be responsible for marking a JB logo
on their products. The Japan Breath Alcohol Testing Consortium and certified providers shallcooperate to ensure clarity for consumers, purchasers, and users, eliminate disadvantages to them,and protect them. They shall also work on preventing unauthorized use or counterfeit of the mark bymembers or non-members. Replication and display of the mark and logo without prior permission
by the Japan Breath Alcohol Testing Consortium is strictly prohibited.
2.7.2 Using the Mark on Products
The JB mark shall contain the technical standard number and the time of certification.

2.7.3 Using the Mark in Documentation
Certified device providers can display the statement of certification or the JB mark on the product,
promotional brochure, catalog, and other public documents to differentiate the certified device fromthe other devices.
Certified device providers shall submit the documents that contain a direct or indirect statementon the JB mark whenever requested by the Japan Breath Alcohol Testing Consortium.
2.7.4 Laws Related to Consumers and Representations
Certified device providers shall adhere to the following Japanese laws.
◆ Consumer Affairs Agency
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Breath Alcohol Detector Verification System◆ Act against Unjustifiable Premiums and Misleading Representations

2.8 Certification Criteria
Among the applied devices, those satisfying the following requirements can pass the examination(certification).
1) Satisfying the criteria of the “Breath Alcohol Detector Marketing Guidelines” described in 2.2.
2) Satisfying the requirements related to the quality assurance system.
3) Passing the on-site audit conducted by an external organization.
4) Passing the confirmation test specified in the technical standard document.

2.9 Procedure for Changing the Specifications
Applicants shall submit the Specification Change Notice (Form 4) to the technical committee
chairperson if they made a specification change that may impact the operation and purpose ofpurchasers.

Submission of theContent

Change Level

Specification Change
Notice1234Change in the marketing guidelines
Important change in the marketing
guidelines
Change in technical requirements
Important change in technicalrequirements

Minor

No

Change in key items that may
impact the operation andYespurposeMinor

No

Change in key items that may
result in performanceYeschangeNotes on the change level:
Minor: Change in the product color, appearance, etc. that gives no impact on the precision
Change in key items that may impact the operation and purpose and change in key items that may
result in performance change: Change in the precision of alcohol detection, indication of the result,product life, or interfering components
For any specification change requiring device evaluation regarding technical requirements, follow 3.4
below.
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2.10 Revoking the Certification
If the certified device falls under any of the following and the technical committee determines thatdoing so is appropriate, the Japan Breath Alcohol Testing Consortium may cancel the certification
and remove the device from the certified device list upon notice to the member concerned.
1) Falsification of data at the time of application was found2) False descriptions in the application form were found3) Exaggerated claims were made about the certified device4) A specification change notice was not submitted5) Improper use of the certification mark6) Intentional misleading about marked (certified) products and unmarked (conforming) products
7) False descriptions in the website, catalog, etc. were found8) The member was expulsed

2.11 Disclaimer
The system is intended to raise the status of the breath alcohol detector industry by enhancing
manufacturers and distributors to disclose the specifications, purpose, and quality criteria of the
product to the market. The mark indicates approval (certification) on the product model and not on
individual devices in the market. Any problems associated with the certified device should be
addressed by the provider concerned and the Japan Breath Alcohol Testing Consortium and externalorganizations shall not be liable for them.

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Breath Alcohol Detector Verification System

Chapter 3 External Organization’s Audit and Technical Standard Test
3.1 Initial Verification Process (Application~Initial Audit~Certification Notification~Announcement)
Below is the overall workflow.
MemberThe

External

Market(Applicant)Consortium

organization(Consumer)(Certification(Initial audit)

Downloading the application form package examinationcommittee)
Submitting the application form

manufacturer)(TruckingReceivingassociation, etc.)the(Transportation

application

Notifying of receiving the application(MLIT)(Foreign

company)(Other industries)

Requesting document examination (by e-mail, phone, etc.)

Notifying of acceptance of document examination and scheduling an audit

Confirmation of
the schedule

External organization in charge of the initial audit(1) Sampling(2) On-site audit(1)Sampling and taking devices to the lab and (2) submitting thenecessary documents

Varioustests
Reporting the test results
Notifying acceptance or rejection of certification
and assigning a certification number

Approvingupon
examination

Public announcement18

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Breath Alcohol Detector Verification System

1) An applicant downloads the application form from the membership page on the Japan Breath
Alcohol Testing Consortium website (https://j-bac.org/), fills the necessary fields and submits
the form to the Japan Breath Alcohol Testing Consortium.
2) The Japan Breath Alcohol Testing Consortium examines the content of the application form
and notifies the applicant that the application has been received.
3) The applicant requests an external organization to conduct document examination. (Contact ofexternal organization: CERI)
4) The external organization conduct document examination and notifies of acceptance orrejection. In case of acceptance, they schedule an audit.
5) After the audit schedule is confirmed by the applicant, the external organization visits the auditsite and conduct the on-site audit by referring to the submitted documents (the quality
assurance system document, manual, etc.).
6) During the on-site audit, the external organization collects samples of the device subject to thetechnical standard conformity test and take them to their lab.
7) The external organization conducts tests on the samples.
8) After completing the audit, the external organization sends the test result report to the Japan
Breath Alcohol Testing Consortium.
9) The Japan Breath Alcohol Testing Consortium holds an examination committee for
examination.
10) The Japan Breath Alcohol Testing Consortium notifies the applicant of the examination result.
They assign a certification number in case of acceptance.
11) The applicant becomes a certified device provider and obtains the license to use a JB markupon receiving the acceptance notification.
12) The applicant can publicly announce the certification in accordance with the rules regarding
certified device providers, the verification system, and JB marks.

3.2 How to Make Application
Applicants obtain Forms 1 to 8 among the certification related documents on the Japan Breath
Alcohol Testing Consortium website below, fill necessary fields, and submit them.

Certification related document

Japan Breath Alcohol Testing Consortium’s website

Submission destination

Technical committee chairperson

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Breath Alcohol Detector Verification System

Below are the certification related documents.
Form 1

Examination Application Form (Common to Initial, Surveillance and Recertification)

Form 2

Conformity Statement

Form 3

JB10 Test Conditions

Form 4

Submission of the Specification Change NoticeForm 5Cancellation NoticeForm 6

Document Examination Result

Form 7

OEM NoticeForm 8

JB20 Test Conditions(TBD)

Applicants (for initial certification and recertification) ensure that all materials specified in theapplication forms are ready and then submit them to the technical committee chairperson. Application
by mail is not acceptable. The submitted documents shall be signed (PDF).

3.3 Certification Examination Committee
The certification examination committee is set up under the technical committee and its members
are assigned by the technical committee chairperson.

3.3.1 Activities of the Certification Examination Committee
The examination committee of the Japan Breath Alcohol Testing Consortium is responsible for thefollowing activities.
1) Determination of acceptance of the application
2) Determination of acceptance of the application for the same model and the application for OEMmodel3) Examination of the test result report issued by an external organization
3.3.2 Notes on Application
1) It normally takes about 3 months from document examination (marketing guidelines examination)by an external organization to issuance of the test result report although it may vary dependingon the application conditions. The acceptance notice issued by the Japan Breath Alcohol Testing
Consortium will be sent by e-mail to the contact address given at the time of application
submission. It will not be sent by mail.
2) For examination, submission of additional materials or demonstration may be requested if
necessary.
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3) The application cost is all borne by the applicant.
4) No objection to the result by the applicant is accepted.
5) The examination committee and an external organization do not have a discussion (consultation)prior to or during the examination.

3.4 Collecting the Target Device Samples
For the device subject to the technical standard conformity test, an external organization
responsible for the test will collect samples at the factory (place of shipment) upon agreement of theapplicant at the time of the initial audit, recertification audit, and any specification change requiring
device evaluation regarding the technical requirements. The applicant shall notify its relevant
department about sampling to help the external organization complete it smoothly. The number ofsamples is specified in the relevant technical document. The applicant should ensure that nobreakage occurs while the external organization is transporting the product.

3.5 Roles of External Organizations
External organizations play the following roles in accordance with the technical standard
documents.
(1) Examination of the application documents (marketing guidelines, instruction manual, etc.)
submitted by the applicant(2) On-site audit(3) Testing of the breath alcohol detector samples collected during the on-site audit

3.6 Handling Non-conformities to the Criteria
An external organization notifies the applicant of non-conformities to the criteria if they occur during
the conformity test. Upon discussion with the applicant, if the non-conformities are not attributable tothe external organization, not due to a wrong procedure, improper material handling, etc., the externalorganization rejects the device and then ends the test.
If the applicant needs completion of the remaining part of the test, upon separate discussion, theexternal organization may continue the test.

3.7 Test Result Report
An external organization creates the test result report with no delay after the audit and submits itto the Japan Breath Alcohol Testing Consortium (the examination committee).

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3.8 Surveillance Audit
Certified device providers shall apply for and undergo a surveillance audit every year. If they are
not willing to retain the certification, they shall submit a cancellation notice. If they do not apply for asurveillance audit or submit a cancellation notice within the prescribed period, the certification may
be forcibly cancelled.
If the device fails a surveillance audit, it loses the license to use a JB mark.

3.9 Surveillance Audit Processes
1)

A certified device provider submits application documents to the Japan Breath Alcohol Testing
Consortium about 3 months before the end of the current license period so that the surveillance
audit on the device can end by the expiration date.

2)“Specification Change Notices” issued after the previous examination, if any, shall be attached.

3)

The Japan Breath Alcohol Testing Consortium checks if the application form is complete
without flaw and notifies the applicant of the check result.

4)

An external organization conducts examination on the documents (marketing guidelines)
submitted by the applicant.

5)

After notifying of acceptance of document examination, the external organization schedules
an on-site audit upon discussion.

6)

After the surveillance audit, the external organization creates a test result report with no delay
and submits it to the Japan Breath Alcohol Testing Consortium (the examination committee).

3.10 Recertification Audit
Certified device providers shall undergo a recertification audit within 5 years from the date ofcertification. If they undergo a recertification audit within 4 years from the date of certification, the next
license period is 5 years from the date of recertification.
If they are not willing to retain the certification, they shall submit a cancellation notice. If they do not
apply for a recertification audit or submit a cancellation notice within the prescribed period, thecertification may be forcibly cancelled.
If the device fails a recertification audit, it loses the license to use a JB mark.

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JB00002-2022

Breath Alcohol Detector Verification System

Surveillance
audit

Recertificati
on audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Recertificati
on audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Recertificati
on audit

Surveillance
audit

Surveillance
audit

Recertificati
on audit

Recertificati
on audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Recertificati
on audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Surveillance
audit

Initial audit

Surveillance
audit

Surveillance
audit

Initial audit

Undergoing a recertification
audit once every 3 years

Surveillance
audit

Initial audit

Undergoing a recertification
audit in 3.5 years and the nextrecertification audit in 5 years

Recertificati
on audit

Undergoing a recertification
audit at typical intervals of 5
years

3.11 Recertification Audit Processes
1) A certified device provider submits application documents to the Japan Breath Alcohol
Testing Consortium about 3 months before the end of the current license period so that therecertification audit on the device can end by the expiration date.
2) “Specification Change Notices” issued after the previous examination, if any, shall be
attached.
3) The Japan Breath Alcohol Testing Consortium checks if the application form is complete
without flaw and notifies the applicant of the check result.
4) An external organization conducts examination on the documents (marketing guidelines)
submitted by the applicant.
5) After notifying of acceptance of document examination, the external organization schedules
an on-site audit upon discussion.
6) After the recertification audit, the external organization creates a test result report with nodelay and submits it to the Japan Breath Alcohol Testing Consortium (the examinationcommittee).

23