| Legislative： |
1.Full text of 18 articles published by order of the Ministry of Economic Affairs Jing-Biao-Zhi No. 09004628880 on 9 January 2002
2.Amendments to Articles 2, 9, 13, 16 and 17 and the addition of Article 10-1 published by order of the Ministry of Economic Affairs Jing-Biao-Zhi No. 09304610120 on 13 January 2005
3.Amendments to Articles 3, 13 and 16 published by order of the Ministry of Economic Affairs Jing-Biao-Zhi No. 10304600520 on 6 February 2014
4.Amendments to the full text of 19 articles published by order of the Ministry of Economic Affairs Jing-Biao-Zhi No. 10404602190 on 18 May 2015
5.Abolished on Feb 1, 2021. |
| Content： |
Article 1
These Regulations are established in accordance with Paragraph 2, Article 14 of the Commodity
Inspection Act.
Article 2
The inspection authority (institution) referred to in these Regulations shall mean the Bureau of
Standards, Metrology and Inspection of the Ministry of Economic Affairs (hereinafter the “BSMI”),
its branches or other commissioned government agencies, legal entities or organizations.
Article 3
The management system certification set forth in these Regulations shall refer to the BSMI
conducting an impartial and independent assessment of the quality, environmental, safety or health
management system established by organizations and certifying that such management systems
comply with the established standards.
The standards for quality, environmental, safety or health management system certification shall be
prescribed by the BSMI in accordance with national standards, international standards or other
internationally recognized standards. BSMI may also determine the scope and period of
implementation for the different types of system certification.
The organizations referred to in these Regulations shall be a company, partnership, sole
proprietorship, legal entity, group, school or government agency.
Article 4
Organizations applying for management system certification shall possess legal documentation of
their establishment in relation to the application scopes.
Article 5
Organizations applying for management system certification shall apply to the inspection authority
(institution) by submitting their Declaration of Rights and Obligations and a completed application
form with the relevant documents attached.
If the applicant organization mentioned in the preceding paragraph is a foreign organization, an
agent that has an address or business location within the Republic of China (Taiwan) shall be
appointed to make the application.
The documents to be submitted and the regulations related to the certification procedures under the
first paragraph shall be prescribed by the BSMI according to the type of management system
certification being applied for.
Article 6
If the Declaration of Rights and Obligations is amended at any time, the registered organization
shall re-sign it within the prescribed period.
Article 7
Once an organization submits an application, the inspection authority (institution) shall review the
documents and assign auditors to conduct an assessment.
Article 8
The inspection authority (institution) may reject an application even before conducting an
assessment if the applicant organization has any of the following situations:
1. The application documents do not comply with the requirements mentioned in Article 5, or if the
scope of application does not comply with Article 3-2 as set forth by the BSMI.
2. The applicant organization is unable to arrange for the assessment to be conducted within six
months after its application is accepted.
3. If a previous application did not comply with the standard of certification, the period of the
current application is within six months of receiving the non-conformity notice of the previous
application.
4. If BSMI revoked or rescinded the application due to a violation of Article 16, 17-10 or 11, the
period of the current application is within three years of the rescission or cancelation of the previous
application.
5. If BSMI rescinded the application based on any other reason not mentioned in this Article, the
period of the current application is within six months of such rescission.
Article 9
The BSMI shall approve certification registration and the use of the certification mark based on the
certification type or scope of products, services or activities specified in the application documents
of the organizations that are assessed to be in compliance with certification requirements and then
shall issue a certificate.
The certificate in the preceding paragraph shall be valid for three years, which may be amended by
BSMI when necessary. However, if BSMI designated the implementation period for a type of
certification in accordance with Article 3-2, the validity period for certification in the preceding
paragraph shall be shorter than the implementation period.
The format of the certificate and the certification mark mentioned in the previous paragraph will be
prescribed by the BSMI.
Article 10
Registered organizations shall use the certificate and certification mark in a manner that observes
the following requirements:
1. Use the name, address, and scopes of registration specified in the certificate within the period of
validity.
2. Use the certification mark together with the first seven digits of the certificate number identified
below the mark.
3. Identify the appropriate scopes when using the certification mark, if the scope of registration
covers only a part of the organization’s products, services or activities.
4. Affix the certification mark, certificate number, texts and inscriptions in a visible and easily
legible form.
5. Do not affix the certification mark on the outside packaging of the product.
6. Do not interpret the certification mark in such a way that associates it with the usage of the
product.
7. Do not promote the certification mark in a manner that could potentially mislead another party
into believing that the product is certified.
Article 11
Registered organizations that intend to make changes to the items specified in a certificate, thus
requiring a revised certificate, shall apply to the BSMI by providing relevant documents to seek
such changes and the subsequent re-issuance of the certificate.
The inspection authority (institution) may conduct surveillance of the organization’s management
system regarding the changes under the previous paragraph if necessary. If the management
system continues to comply with certification standards, the inspection authority shall approve the
changes and issue a revised certificate.
Article 12
Where the management system certification standards or scope of registered organizations are
revised by the BSMI in accordance with Paragraph 2, Article 3, the registered organizations shall
comply with the new certification standards before the end of the transitional period designated by
the BSMI.
Article 13
Registered organizations may apply to the BSMI for a replacement of the original certificate if the
original certificate is lost or damaged.
Article 14
Registered organizations shall be subject to regular surveillance visits by the inspection authority
(institution) at least once a year and random surveillance visits from time to time. The quantity of
samples for the surveillance may be increased when necessary.
Organizations shall use raw materials that comply with the relevant regulations and shall keep a
record of raw materials and their suppliers, which may also be inspected by the inspection authority
(institution) as it deems fit.
Upon occurrence of any significant event related to the compliance of the management system that
may lead to any concern that a registered organization may have breached certification standards,
the BSMI may conduct an on-site audit of the organization and may prescribe a period for the
organization to take corrective action depending on the status of the aforementioned
non-compliance.
Article 15
Registered organizations that suspend production or business for more than one month shall report
to the inspection authority (institution) within one month of the suspension. However, registered
organizations who were ordered to suspend production or business shall report to the inspection
authority (institution) within five days of said order.
The suspension of production or business by the registered organization's own decision in the
preceding paragraph may not exceed six months.
If the suspension of production or business by the registered organization's decision or order does
not exceed six months, the registered organization shall report to the inspection authority (institution)
one month before termination of the suspension for inspection.
Article 16
The BSMI shall revoke registration that was acquired through fraudulent means.
Article 17
Registration shall be rescinded by the BSMI if a registered organization has any of the following
situations:
1. Significant event related to the compliance of the certification standard found after second
surveillance, on-site audit or failure to rectify within the designated period in accordance with
Article 14-3.
2. If a registered organization fails to comply with new certification standards before the end of the
given transitional period in accordance with Article 12.
3. If a registered organization fails to make payments for regular and random surveillance or any
other payments in accordance with related requirements after receiving notice to make overdue
payments.
4. If a registered organization fails to report to the inspection authority (institution) regarding its
suspension of production or business or has received orders to suspend production or business for a
period exceeding six months.
5. If a registered organization fails to apply for inspection within one month before termination of
suspension of production or business or fails to resume production or business by the end of the
suspension period.
6. If related licenses or certificates of the registered organization have been revoked, cancelled or
rescinded by the relevant authorities
7. If a registered organization applies for cancellation of registration
8. If a registered organization fails to make proper arrangements to allow the inspection authority
(institution) to conduct regular surveillance, random surveillance, on-site auditing, sampling or raw
material and supplier record inspection.
9. If a registered organization fails to use the certificate and certification mark in the manner
prescribed in Article 10 and fails to take corrective actions after receiving a notice from the
inspection authority (institution)
10. The violation of the management system is detrimental to public social interests and the BSMI
deems that the situation is significant.
11. Violation of any provision under the management system Declaration of Rights and Obligations
or concealment of any fact or provision of any false information during regular surveillance, random
surveillance, on-site auditing or raw material and supplier record inspection.
12. If a registered organizations fails to re-sign within the designated period in accordance with
Article 6 in case of any amendments to the Declaration of Rights and Obligations.
13. If a registered organization fails to apply for amendment in case of amendments to certifications
and fails to take corrective actions after receiving a notice.
14. If a registered organization fails to use raw materials in accordance with Article 14-2, or if raw
material and supplier records are found to be incorrect after inspection.
Article 18
If the registration of an organization has been revoked or rescinded, it must stop using the certificate
and certification mark and shall return the certificate within a given time limit. The BSMI shall
automatically cancel the registration should the certificate not be returned by the deadline
Article 19
These Regulations shall take effect from the date of promulgation. |