| Legislative： |
1.Adopted and promulgated by Bureau Order on 19 April 2002.
2.10 Clauses amended and promulgated in full by Bureau Order on 12 August 2003, and enforced on 1 September 2003.
3.10 Clauses amended and promulgated in full by Bureau Order on 24 June 2005, and enforced on the same date. (Original Name: Directions Governing Factory Inspection of Registration of Product Certification)
4.Clauses 8, 9 and 10 amended, and Clause 11 added and promulgated by Bureau Order on 14 September 2009, and enforced on 1 January 2010.
5.Clauses 3, 5, 6, 7 and 10 amended and promulgated by Bureau Order on 16 July 2011, and enforced on the same date.
6.Clauses 3 and 5 amended and promulgated by Bureau Order on 3 August 2012, and enforced on the same date.
7.Clauses 5 amended and promulgated by Bureau Order on 9 February 2017, and enforced on the same date.
8.11 Clauses amended and promulgated in full by Bureau Order on 2 March 2021, and enforced on the same date. |
| Content： |
1. These Directions are established by the Bureau of Standards, Metrology and Inspection, Ministry
of Economic Affairs (hereinafter referred to as the BSMI) in order to implement factory inspection
under the conformity assessment procedures for product certification.
2. The applicant for factory inspection shall be the factory of products. If a factory is located outside
the territory of Taiwan, the applicant shall appoint an agent that has its domicile or business location
in Taiwan to approach the application.
3. The application form for factory inspection and other relevant information, as described below,
must be submitted to the BSMI, its branches, or the factory inspection bodies recognized by the
BSMI (hereinafter referred to as the Inspection Authority):
(1) A copy of the registration document of the applicant’s company or business and the registration
document of the factory unless the applicant has filled in the application form with the company or
business’s unified business number and the factory registration number. When the above-mentioned
registration document is not available for a foreign applicant, the applicant shall provide the latest
tax payment certificate as proof;
(2) A route map of the factory location and the diagrams showing the layout of the factory;
(3) A flow chart of the production processes;
(4) A brief description of the inspection and testing methods;
(5) The product type test reports of the described products and technical documents demonstrating
that the application for product type test is filed;
(6) A letter of authorization and legal identification of the appointed agents in case the factories are
not based in Taiwan; and
(7) Other relevant documents appointed by the BSMI.
If the submitted documents described previously are in a language other than Chinese, the
Inspection Authority may request the applicant to provide Chinese translations of the documents.
4. After receiving and reviewing the application documents for factory inspection, the Inspection
Authority shall designate inspectors to conduct the initial factory inspection.
If the application documents are not clear or are incomplete, and the applicant fails to give
explanations or corrections as required by the Inspection Authority or within the given time limit,
the application shall be rejected.
Technical experts may be engaged to participate in the factory inspection.
When it is impossible to conduct a factory inspection at the factory due to a special event, the
factory inspection may be conducted remotely based on the inspection items and scope approved by
the BSMI.
5. Factory inspection will be carried out in accordance with the product type test reports and the
relevant technical documents of the described products, and the inspecting items listed in the Annex
shall be covered.
The inspector shall fill out the Factory Inspection Record in duplicate which shall be confirmed and
signed by both the inspector and the Factory Representative. A copy of the record will be provided
to the Factory Representative.
If some special products are not applicable to the requirements of the Annex, the inspection items
will be designated and made known to the public by the BSMI separate public notice.
An initial factory inspection is exempted from the No. 8 inspection item listed in the Annex.
6. Factory inspection shall last half a man-day or more and may be extended after considering
factors such as the kinds of product, the complexity of the production process, the scale or risk of
the factories.
If the applicant holds a CNS 12681 (ISO 9001) certificate issued by a quality management
certification body recognized by the BSMI, and the scope of registration of the certificate covers the
factory within the scope of factory inspection, it may be exempt from the inspection items listed in
the Annex and shall attach relevant materials or supporting documents as required by the Inspection
Authority.
7. If major unsatisfactory findings are found during the factory inspection, the applicant shall apply
for re-inspection within a given time limit. If any major unsatisfactory finding remains after
re-inspection or an application for re-inspection is not made within the given time limit, the
inspection shall be considered as failing to comply with the requirements. The applications for the
re-inspection of the initial factory inspection or the follow-up factory inspection shall be submitted
respectively within sixty days or thirty days after completion of the inspection.
If minor unsatisfactory findings are found, the applicant shall submit a corrective action plan
(including the specific corrective measures and time schedule) within ten days after completion of
the inspection. The Inspection Authority may conduct inspections to verify the performance of the
corrective action plan, where necessary. If no submission is made within the required time or the
corrective action plan is reviewed as failing to correct the unsatisfactory findings effectively, the
result shall be judged as non-compliance with the requirements.
The re-inspection referred to in Paragraph 1 may be conducted remotely.
8. Major unsatisfactory findings in factory inspection shall be judged by the following principles:
(1) Finished products, semi-finished products, main components, sub-assemblies, or materials do
not conform to product type test reports, technical documents, or relevant standards;
(2) The result of on-site sampling test or carry-back inspection does not meet the requirements for
inspection;
(3) Changes in the certified products are not approved by the product certification authority;
(4) Relevant product certification marks for components, sub-assemblies, and materials are not
obtained in accordance with the regulations;
(5) Relevant product certification marks for finished products are not used correctly in accordance
with the regulations;
(6) The result of the inspection based on the specific regulation for applicable kinds of product as
established by the BSMI does not conform;
(7) Minor unsatisfactory findings are found in the previous factory inspection and have not been
improved; or
(8) Other unsatisfactory findings are found that could lead to a failure in the manufacturing
operation or substantially reduce the effects because a management system has not yet been
established or has been established but the operation procedures are not followed.
Minor unsatisfactory findings are defects that would not lead to a failure in the manufacturing
operation or that occur occasionally when a management system has been established and the
operating procedures have been followed.
9. When the result of an initial factory inspection has been reviewed and approved to comply with
the requirements, the initial factory inspection report will be issued; when an initial factory
inspection fails to meet the requirements, the Inspection Authority shall notify the applicant that a
factory inspection report will not be issued. The validity for the initial factory inspection report will
be expired in one year.
10. The Inspection Authority shall perform follow-up factory inspections at least once every year to
the factories that are granted product certification by the BSMI based on factory inspection reports.
When the Inspection Authority conducts a follow-up factory inspection, sample(s) shall be taken to
verify conformity and consistency with the originally certified type, and tests shall be conducted
whenever necessary. When the result of the follow-up factory inspection has been reviewed and
approved to comply with the requirements, the follow-up factory inspection report will be issued.
In case of special circumstances, the frequency of the follow-up factory inspections mentioned in
the preceding paragraph may be increased or the follow-up factory inspections may be combined
with those in the following year upon approval of the BSMI.
11. If there is any change in kind of product or any item listed in a factory inspection report, the
factory shall apply to the Inspection Authority for a replacement of the factory inspection report
by providing the application form, the changed documents specified in Paragraph 1, Article 3, and
other supporting documents. Follow-up factory inspections may be conducted whenever necessary.
If the change mentioned in the preceding paragraph is an addition of applicable kind of product and
the manufacturing process is different from that of the originally approved product, a new
application shall be made instead. |