Chapter I General Principles

Article 1
These Regulations are established in accordance with Paragraph 4, Article 4 of the Commodity Inspection
Act (hereinafter referred to as the “Act”).

Article 2
The commissioned commodity inspection operations shall mean the conformity assessment, issuance of
certificates (new or replacement), surveillance for the certified commodities, sampling, sealing and
examining with commodity inspection and relevant management activities for commodity certification.

Article 3
The other government agency, juristic person or organization commissioned to perform commodity
inspection activities shall perform these activities according to the relevant regulations and
requirements of the Act.

Article 4
The term “commodity certification body” (hereinafter referred to as the “certification body”) as
used in these Regulations shall mean the bodies commissioned to perform commodity certification
activities.
The categories and items of commissioned commodity certification activities shall be designated and
made known to the public by the Bureau of Standards,Metrology and Inspection of the Ministry of
Economic Affairs (hereinafter referred to as the BSMI) per public notice.
The term “commodity inspection body” (hereinafter referred to as the “inspection body”) as used
in these Regulations shall mean the bodies commissioned to perform sampling, sealing and examining
with commodity inspection.
The commodity categories, period and work content of commissioned sampling, sealing and examining
with commodity inspection shall be designated and made known to the public by the BSMI per public notice.

Chapter II Commission of Commodity Certification Activities

Article 5
The applicant applying for the certification body (hereinafter referred to as the “certification body
applicant”) shall possess the following qualifications:
1.Administrative bodies or institutions, public or private college or university, or non-profit juristic
persons of the Republic of China;
2.Having set up the product certification system compliant with the international standards and been
granted an accreditation by the Taiwan Accreditation Foundation (hereinafter referred to as the “TAF”)
for the relevant commodity fields;
3.Having obtained recognition by the BSMI as a designated testing laboratory for the relevant commodity
inspection fields,or qualification for technical body which is designated and made known to the public
by the BSMI per public notice. If above-mentioned application includes the module for the factory
inspection business, the certification body applicant shall have obtained recognition by the BSMI as a
designated factory inspection body for the relevant commodity fields; and
4.Other qualifications designated and made known to the public by the BSMI per public notice.
In case of the application for the certification category of Voluntary Product Certification, the
qualification required in the first Subparagraph of the preceding Paragraph may be exempted.
The qualification required in Subparagraph 3 of Paragraph 1 may be exempted, provided that this has
been made known to the public by the BSMI per public notice under special circumstances.

Article 6
The certification body applicant shall fulfill the following conditions:
1.One or more than one full-time professional certification personnel shall be established in each
item of commissioned commodity certification activities. The certification personnel shall possess a
college or university degree or higher in related field from domestic or foreign public or private
colleges or universities recognized by the Ministry of Education,have the professional knowledge and
capability of relevant commodity certification activities, understand the relevant government
regulations and inspection requirements, and be trained by the BSMI or the BSMI’s registered training
body,and be qualified and registered by the BSMI; and
2.Possessing the necessary equipment, facilities, personnel and management system for the specific
field of commissioned commodity certification activities;and possessing sufficient information and
understanding of the certification standards and relevant regulations for such commissioned commodity
certification field.
The condition of educational degree required in Subparagraph 1 of the preceding Paragraph may be
exempted, provided that the certification personnel of the certification body applicant have working
experience for testing, design or manufacturing of the relevant commodity, and the submitted documents
of the working experience are approved by the BSMI.
The matters governing the registration conditions and application procedures of the training bodies, and
the qualification and registration procedures of the certification personnel required in Subparagraph 1
of the first paragraph, these relevant administrative matters shall be prescribed by the BSMI.
The registered training bodies required in Subparagraph 1 of the first paragraph, these bodies shall be
registered and made known to the public by the BSMI per public notice.

Article 7
The certification body applicant possessing the qualifications and fulfilling the conditions set forth
under the preceding two Articles may apply to the BSMI by submitting the following documents:
1.The applicable items of commissioned commodity certification activities that the certification body
applicant intends to carry out;
2.Certificates and relevant documents complying with the qualifications set forth under Article 5;
3.List of the registered certification personnel and applicable items of commissioned commodity
certification activities;
4.Organization charts and function statements;
5.Layout plan and location guide map for the applying body;
6.Quality manual, system structure and overview list for quality documents; and
7.Other documents designated by the BSMI.
If the documents submitted according to the preceding Paragraph are found incomplete, the certification
body applicant shall submit supplement documents within one month from the next day of receipt of the
notice. If the certification body applicant fails to supplement the documents as required, the
application shall be rejected.

Article 8
An on-site assessment will be conducted by the BSMI for the certification body applicant mentioned in
the preceding Article whose application has passed the document review.
If the document review and on-site assessment of the certification body applicants are completed and
found in compliance with the requirements set forth in Article 5 and Article 6, the BSMI should issue
the notification that shows the compliance to the requirements set forth in Article 5 and Article 6,
and requires the certification body applicant discuss the commission contract for commodity
certification activities with the BSMI before the specified date. The BSMI may select the distinguished
ones to negotiate the price and enter into the commission contract for commodity certification activities.

Article 9
For the certification body applicant who fails the review process as prescribed in the preceding
Article, the certification body applicant may apply for a second review process within two months
from the next day of receipt of the notice. If the certification body applicant still fails the
second review process, the certification body applicant shall not re-apply within three months
from the next day of receipt of the notice.

Article 10
The certification body shall conduct commodity certification activities under his own name.
The certification body shall not reject any application for commodity certification activities
or treat the applications differently unless reasonable cause is shown.

Article 11
The certification body shall perform surveillance for the commodities that have been certified
by him.

Article 12
The certification body shall maintain sufficient resources and capability to efficiently conduct
the commissioned works,and shall not subcontract with others to conduct the commissioned works.
The certification body may subcontract a part of the certification activities to other
organizations provided that it is not the main part of the commissioned works and only with an
approval by the BSMI.

Article 13
In special circumstances, the certification body may perform witness testing or on-site testing.
The certification body shall set up the operational procedures for witness testing and on-site
testing set forth in the preceding Paragraph and submit them to the BSMI for approval.

Article 14
The certification body shall maintain the relevant documents appropriately. The minimum period
of retention of documents for each type of document shall be prescribed by the BSMI depending
on the character of the commissioned activities.
The expired documents may only be disposed after having reported to and obtained approval from
the BSMI. The certification body shall keep the record for all disposed documents.
The certification body shall handover the relevant documents in full for all certification
applications to the BSMI within seven days after the termination of the commission contract.

Article 15
For the application to expand the certification categories and items or to modify other matters
related to certification activities, the certification body shall apply to the BSMI by submitting
an application form and relevant documents.
If the scope of accreditation of the certification body has been reduced by the TAF, the
certification body shall immediately stop performing the commodity certification activities
relating to the affected area and apply to the BSMI within three months for modification of the
scope of commissioned activities.
For the modification set forth in the preceding two Paragraphs, the BSMI shall conduct on-site
assessment. However, document-review may be performed instead depending on the circumstances.
If the modifications in Paragraph 1 and Paragraph 2 are related to the content of the commission
contract for commodity certification activities, the contract shall be amended accordingly.

Article 16
Any change of the certification personnel shall be reported by the certification body to the BSMI
with the information of the new certification personnel within fifteen days after such change.

Article 17
If the certification body moves to a new location, he shall apply to the BSMI by submitting
relevant documents. In such case, the certification body shall not perform the commissioned
activities unless the document review and on-site assessment process have been completed and found
in compliance with the relevant requirements by the BSMI.

Article 18
The BSMI shall conduct routine surveillance assessment for the certification body at least once
per year. The BSMI may also conduct non-routine surveillance assessment.
The certification body shall not evade, impede or reject the assessment set out in the preceding
Paragraph unless good cause is shown.

Article 19
When the certification body has been accredited by the TAF and demonstrated compliance with the
qualification requirements set forth in Subparagraph 2,Paragraph 1 of Article 5 continuously, the
BSMI may exempt the certification body from routine surveillance assessment set out in the preceding
Article.

Article 20
If the routine surveillance assessments conducted by the BSMI toward the certification body according
to Paragraph 1 of Article 18 have shown the conformity with the requirements of this Regulations, the
BSMI may continuously negotiate the price and enter into the commission contract for commodity
certification activities with the certification body two months prior to the expiration date of the
contract.

Article 21
If the commission contract for commodity certification activities is not renewed, the certification
body may not accept any certification applications within one month prior to the expiry of the
contract. All pending certification applications that have been accepted by the certification body
shall be completed prior to the expiry of the contract.

Article 22
If a certification body has any of the following circumstances, the BSMI may temporarily suspend,
pursuant to the commission contract, the right of the certification body to perform commissioned
certification activities within a certain period of time. The BSMI shall resume the right after
the certification body has completed the corrective action and been examined and approved by the BSM:
1.Where the certification body does not fill in a vacant position of the certification personnel and
violates the requirements set out in Subparagraph 1, Paragraph 1 of Article 6;
2.Where the accreditation by the TAF has been suspended;
3.Where the recognition of the designated testing laboratory or designated factory inspection body
that belongs to the certification body has been temporarily suspended by the BSMI, or the qualification
for technical body which is designated by the BSMI per public notice according to Subparagraph 3,
Paragraph 1 of Article 5 has been lost;
4.Having violated the provision set forth in Article 11;
5. Where the certification body has failed to submit documents within the given time limit after
receiving a notice to submit by a given time limit unless reasonable cause is shown; or
6.Having failed to take appropriate actions and cooperate with the BSMI when notified by the BSMI to
cooperate with in the BSMI’s action for conducting assessment or handling appeal, complain, or
disputing case.

Article 23
If any of the following circumstances occurs, the BSMI may terminate the commission contract, in part
or in whole, pursuant to the commission contract for commodity certification activities:
1.Where an application to terminate the commission contract for commodity certification activities
has been initiated by the certification body;
2.Where the certification body’s accreditation by the TAF have been withdrawn or revoked, or
recognitions of designated testing laboratory or designated factory inspection body by the BSMI have
been revoked or rescinded, or the qualification for technical body which is designated by the BSMI
per public notice according to Subparagraph 3, Paragraph 1 of Article 5 has been lost;
3.Where the certification body losses his ability to perform certification activities or is unable
to perform certification activities impartially and effectively;
4.Where the certification body has failed to avoid conflict of interests or violated his obligation
of confidentiality;
5.Where the certification body performs certification activities beyond the scope authorized by the
commission contract for commodity certification activities or is lazy to perform certification
activities;
6.Where the certification body violates the requirements set forth in Paragraph 2 of Article 10 by
rejecting certification applications or giving different treatment;
7.Where the certification body fails to comply with the requirements set forth in Article 14
regarding retention and disposal of documents;
8.Where the certification body fails to report or apply for the modifications as required under
Article 15 or Article 16;
9.Where the certification body fails to comply with the application requirements or performs
commissioned activities before obtaining the required approval as set out in Article 17;
10.Where the certification body violates the requirements set forth in Paragraph 2 of Article 18
by evading, impeding or rejecting the assessment conducted by the BSMI;
11.Where the certification body fails to complete corrective actions and been examined and
approved by the BSMI within the prescribed timeframe as required under Article 22;
12.Where the certificate issued by the certification body is found to contain false or incorrect
information;
13.Where the procedural fees due were not paid, and have further been not paid within the given
time limit;
14.Where it is proved serious that employees of the certification body accept gifts, bribery,
banquet invitations or requests from interested parties, or seek interests for himself or for any
third parties by manipulating his power, methods or opportunities under his duty; or
15.Other violation of relevant regulations that are deemed as substantial and material events
by the BSMI.

Article 24
If the commission contract for commodity certification activities is terminated pursuant to the
preceding Article, the certification body shall return his certificate.
In the event of the preceding Paragraph, the certification body shall handover the pending
certification applications to the BSMI or other certification body designated by the BSMI.
Within 3 years after the termination of the commission contract for commodity certification
activities, the terminated certification body shall not be permitted to re-apply for the qualified
certification body, except that the certification body terminates the commission contract for
commodity certification activities voluntarily.

Chapter III Commission of Sampling, Sealing and Examining with Commodity Inspection

Article 25
The applicant applying for the inspection body (hereinafter referred to as the “inspection body
applicant”) shall possess the following qualifications:
1.Administrative bodies or institutions, public or private college or university, or non-profit
juristic persons of the Republic of China;
2.Having obtained recognition by the BSMI as a designated testing laboratory for the relevant
commodity inspection fields; and
3.Other qualifications designated and made known to the public by the BSMI per public notice.

Article 26
The inspection body applicant possessing the qualifications set forth under the preceding Article
may apply to the BSMI by submitting the following documents:
1.Certificates and relevant documents complying with the qualifications set forth under the preceding
Article; and
2.The plan including to explain origin, goal, capability, sites, equipment, human analysis, works
schedule planning, the manner of management and execution,expected benefits, demand of budget and
estimate of cost.
If the documents submitted according to the preceding Paragraph are found incomplete, the inspection
body applicant shall submit supplement documents within fifteen days from the next day of receipt
of the notice. If the inspection body applicant fails to supplement the documents as required, the
application shall be rejected.

Article 27
The BSMI carry out document review about the application of preceding Article. An on-site assessment
will be conducted by the BSMI, if necessary.
If the review of the inspection body applicants are completed and found in compliance with the
requirements set forth in Article 25 and Article 26, the BSMI should issue the notification that
shows the compliance to the requirements set forth in Article 25 and Article 26, and requires the
inspection body applicant discuss the commission contract for sampling, sealing and examining with
commodity inspection with the BSMI before the specified date. The BSMI may select the distinguished
ones to negotiate the price and enter into the commission contract for sampling, sealing and
examining with commodity inspection.

Article 28
The provisions set out in Article 10, Article 12, Article 14, Article 18 and Article 20 of this
Regulation shall apply mutates mutandis to the commission of sampling, sealing and examining with
commodity inspection.

Article 29
The inspection body shall submit monthly works statistics sheets of the commissioned operations to
the BSMI before the 10th of next month.
The inspection body shall submit summary report including goal analysis, implementation results,
analysis of outlays and achievement evaluation to the BSMI within one month after the end of the
year. Briefing of summary report or on-site assessment will be required by the BSMI, if necessary.

Article 30
If an inspection body has any of the following circumstances, the BSMI may temporarily suspend,
pursuant to the commission contract, the right of the inspection body to perform the commissioned
operations within a certain period of time. The BSMI shall resume the right after the inspection
body has been examined and approved by the BSM:
1.The qualification according to Article 25 has been lost;
2.Where the inspection body fails to maintain sufficient resources and capability or subcontract
with others to conduct the commissioned works as required under Paragraph 1 of Article 12, mentioned
in Article 28;
3.Where the inspection body violates the requirements set forth in Paragraph 2 of Article 12,
mentioned in Article 28 by subcontracting a part of the commissioned operations to other organizations
provided that it is not the main part of the commissioned works and without an approval by the
BSMI; or
4.Where the inspection body fails to submit monthly works statistics sheets as required under
Paragraph 1 of Article 29 more than twice within the expiry of the same commission contract for
sampling, sealing and examining with commodity inspection.

Article 31
If any of the following circumstances occurs, the BSMI may terminate the commission contract, in part
or in whole, pursuant to the commission contract for sampling, sealing and examining with commodity
inspection:
1.Where an application to terminate the commission contract for sampling, sealing and examining with
commodity inspection has been initiated by the inspection body;
2.Where the recognitions of designated testing laboratory by the BSMI have been revoked or rescinded;
3.Where the inspection body has failed to avoid conflict of interests or violated his obligation of
confidentiality;
4.Where the inspection body performs the commissioned operations beyond the scope authorized by the
commission contract for sampling, sealing and examining with commodity inspection mentioned in
Paragraph 2 of Article 27 or is lazy to perform the commissioned operations;
5.Where the inspection body violates the requirements set forth in Paragraph 2 of Article 10,
mentioned in Article 28 by rejecting inspection applications or giving different treatment;
6.Where the inspection body fails to comply with the requirements set forth in Article 14, mentioned
in Article 28 regarding retention and disposal of documents;
7.Where the inspection body violates the requirements set forth in Paragraph 2 of Article 18,
mentioned in Article 28 by evading, impeding or rejecting the assessment conducted by the BSMI;
8.Where the inspection report or monthly works statistics sheets issued or submitted by the
inspection body is found to contain false or incorrect information; or
9.Other violation of relevant regulations that are deemed as substantial and material events by
the BSMI.

Article 32
If the commission contract for sampling, sealing and examining with commodity inspection is terminated
pursuant to the preceding Article, the inspection body shall handover the pending inspection
applications to the BSMI or other inspection body designated by the BSMI.
Within 3 years after the termination of the commission contract for sampling, sealing and examining
with commodity inspection, the terminated inspection body shall not be permitted to re-apply for the
qualified inspection body, except that the inspection body terminates the commission contract for
sampling, sealing and examining with commodity inspection voluntarily.

Article 33
These Regulations shall take effect upon the date of promulgation.