Notification of the Thai Industrial Standards Institute
Rules and Conditions for Registration of Foreign Manufacturer
--------------------------------------------Referring to the Notification of the Thai Industrial Standards Institute on
Amendment of the Rules on Conformity Assessment for Licensing dated 19th August B.E.
2557, the Thai Industrial Standards Institute will accept the assessment result of the quality
control system of the foreign manufacturer registered by the Institute. In order to make the
registration of foreign manufacturer clear and transparent, the Institute hereby issues the
notification on Rules and Conditions for Registration of Foreign Manufacturer, as annexed
hereto.
The notification shall come into force from the date of notification.
Given on 17th November B.E. 2557
Hathai Uthai
Secretary-General of Thai Industrial Standards Institute
Rules and Conditions for
Registration of Foreign Manufacturer
1. Scope
This document provides definition, qualifications of foreign manufacturer to become
registered by the Thai Industrial Standards Institute, registration procedures,
conditions of registered manufacturer, surveillance of registered manufacturer, as
well as cancellation, scope reduction and revocation of the registration.
2. Definition
2.1 Foreign manufacturer means the manufacturer who manufactures industrial
products in conformity with Thai Industrial Standard, and is located outside the
Kingdom of Thailand, applies for being a Registered Manufacturer by the Thai
Industrial Standards Institute.
2.2 Registered Manufacturer means the Foreign Manufacturer getting registered by
the Thai Industrial Standards institute, manufacturing industrial products which
are required by the Royal Decree to conform with the standard, and such
products will be imported for sale in the Kingdom of Thailand.
2.3 Council means the Industrial Product Standards Council.
2.4 Institute means the Thai Industrial Standards Institute.
2.5 Importer means the import license applicant under the Industrial Product
Standards Act B.E. 2511
3. Reference Document
ISO 9001: Quality Management Systems - Requirements
4. Qualifications of Foreign Manufacturer
Foreign Manufacturer applying for registration shall have qualifications as follows:
(1) Manufacturing industrial products which are required by the Royal Decree to
conform with the standard, in conformity with the applicable standard and the
manufacturing premise is located outside the Kingdom of Thailand.
(2) Getting the certification of quality management system in accordance with ISO
9001 from the certification body that is approved by the Institute or under the
Multilateral Mutual Arrangement (MLA). The scope of certification shall cover
manufacturing of products applying for registration.
5. Initial Registration
5.1 Application Submission
The Foreign Manufacturer shall submit the application together with relevant
evidences as follows:
(1) Certificate of quality management system in accordance with ISO 9001
(2) Plan of manufacturing process in brief
(3) List of equipment and instruments to be used in manufacturing such product
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(4) Flow chart and details showing the process of quality control together with
specifications of testing, measuring and monitoring devices for examining the
quality of such product
5.2 Assessment for Registration
The application shall be carried out by the Institute as follows:
(1) Initial review of the application and associated evidences. In case the
document needs to be improved, the Institute will inform in writing to the
applicant within 60 working days.
(2) In case of complete document, the Institute will coordinate for scheduling of
factory assessment and informing estimation of expenditures.
(3) Assess the quality control system of the applicant factory according to these
following requirements:
(3.1) Organization management and human resource
(3.2) Control of machinery, building and facility
(3.3) Control of product design and development
(3.4) Purchasing and control of raw materials
(3.5) Control of manufacturing process
(3.6) Control of finished product
(3.7) Control of nonconforming product
(3.8) Identification and traceability
(3.9) Preservation of product
(3.10) Control of monitoring, measuring and testing devices
(3.11) Corrective action and handling of complaint
(3.12) Control of document and record
Details of requirements as shown on Appendix
(4) Make the assessment report
(5) Make the summary report and propose to the Secretary-General of the Thai
Industrial Standards Institute for approval and signing the Institute’s
Notification on Registered Manufacturer.
(6) Inform the applicant of the result, make and update the Directory of
Registered Manufacturers with the scope of registered standards, as well as
upload onto the Institute’s website.
6. Surveillance of Registered Manufacturer
To ensure that the Registered Manufacturer keeps competence to manufacture
product in conformity with applicable standard and is able to control the product
quality in accordance with the assessed quality control system regularly.
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6.1 The Registered Manufacturer shall provide a surveillance audit once a year and
be responsible for all expenditures of the surveillance audit as determined by
the Institute.
The Institute may adjust frequency and duration more or less as appropriate by
considering the competence of the Registered Manufacturer to maintain the
product quality and the quality control system in accordance with the applicable
standard consistently and regularly.
7. Renewal of Registration
The Institute will conduct the reassessment of the quality control system of the
Registered Manufacturer every 3 years by reassessing all of the requirements.
8. Conditions for Registered Manufacturer
8.1 The Registered Manufacturer shall operate in conformity with this Rules and
Conditions and its amendments throughout the period of registration.
8.2 The Registered Manufacturer shall maintain the quality control system in
accordance with the requirements shown on the Appendix.
8.3 The Registered Manufacturer shall cooperate with the Institute on surveillance.
8.4 The Registered Manufacturer shall take corrective and preventive actions for the
nonconformities or incomplete operation as informed by the Institute with undue
delay.
8.5 In case of scope reduction, revocation or cancellation of the registration, the
Registered Manufacturer shall cease delivering the industrial products which are
required by the Royal Decree to conform with the standard, for importation for
sale in the Kingdom of Thailand.
8.6 The Registered Manufacturer shall inform the Institute of any changes of notified
information that may affect to the product quality.
8.7 The Registered Manufacturer shall provide the records of disputes, complaints
and appeals on its operation to the Institute when requested.
8.8 The Registered Manufacturer shall pay the expenditures of assessment and
surveillance audit within 30 days after being informed by the Institute.
9. Cancellation, Scope Reduction, and Revocation
9.1 Cancellation
In case the Registered Manufacturer intends to be canceled of registration, the
Registered Manufacturer shall inform in writing to the Institute in advance at least
60 days.
9.2 Scope Reduction
The Institute will propose the Secretary-General of the Thai Industrial Standards
Institute to reduce the scope of standards being registered as following cases:
(1) The Registered Manufacturer submits its intention for scope reduction.
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(2) The Registered Manufacturer has problems or nonconformities in
manufacturing industrial products in accordance with the scope of standards
being registered.
(3) The complaint on manufacturing industrial products in accordance with the
scope of standards being registered is verified as true.
9.3 Revocation
The Institute will propose the Secretary-General of the Thai Industrial Standards
Institute to revoke the registration as following cases:
(1) Cessation of business operation
(2) Being bankrupt
(3) Incompetent to manufacturing industrial products as registered.
(4) Violate or not perform in accordance with the Rules and Conditions that
cause seriously adverse impact on being the Registered Manufacturer.
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Appendix
Attachment to the Rules and Conditions for Registration of Foreign Manufacturer
Particular Requirements for Conformity assessment for licensing
---------------------------------------------1. Organization management and human resource
To ensure that the product shall be in conformity with applicable standard
consistently and regularly, the manufacturer shall
1.1 Have an organization chart showing relationship of duties and responsibilities of
relevant functions.
1.2 Have clear job descriptions for personnel in each position
1.3 Have appropriate and sufficient personnel to manufacture licensed products.
1.4 Have personnel management to maintain personnel competence by
(1) Determine necessary competence
(2) Provide training and development programs
(3) Evaluate the training and development
(4) Develop and maintain the personnel history of competence
2. Control of machinery, building and facility
The manufacturer shall
2.1 Have building, facility, tool, machine, and equipment for manufacturing product
appropriately and capable to manufacture product in conformity with applicable
standard consistently and regularly.
2.2 Have repair and maintenance system to ensure the manufacturer capability to
manufacture product in conformity with applicable standard.
2.3 Develop and maintain repair and maintenance records appropriately.
3. Control of product design and development
In case of having development, design or modification of product, the manufacturer
shall
3.1 Have planning, control, and review of designs at each stage appropriately.
3.2 Have sufficient data and information for design input including applicable
standards and laws.
3.3 Have design output in an appropriate form and consistent with design inputs.
3.4 Have review, verification, and validation of design to prove that the resulting
product shall meet the requirements of applicable standard.
3.5 In case of product modification, the activities from 3.1 to 3.4 shall be repeated.
3.6 Maintain the records of design, validation and modification.
4. Purchasing and control of raw materials
Raw material means parts and components of the product, consumables, packaging,
outsourced work, and customer asset used in manufacturing such product, etc.
The manufacturer shall
4.1 Have purchasing system to ensure that raw materials and services purchased
meet the purchasing requirements.
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4.2 Have incoming inspection for raw materials and services purchased by
appropriate methods which shall be documented.
4.3 Have and maintain records of incoming inspection.
5. Control of manufacturing process
The manufacturer shall
5.1 Have flow charts showing the manufacturing processes, control of conditions,
measuring and testing at appropriate process stages including control parameters.
5.2 Manufacture, control and inspect the product according to the production flow
charts. The control factors shall be included as follows:
(1) Have information of requirements and characteristics of the product.
(2) Have work instruction as necessary for the operator at each stage.
(3) Have appropriate equipment, machines, and instruments.
(4) Have monitoring, measuring and testing devices.
(5) Measure and monitor processes and products.
(6) Implement product release, delivery, and post delivery activities.
(7) Have necessary records to prove that manufacturing processes and finished
product meet the requirements of applicable standard.
5.3 In case the product inspection result cannot directly show the product property,
the manufacturer shall have evidence to prove that manufacturing processes can
manufacture product whose quality meets the requirements of applicable
standard.
6. Control of finished product
The manufacturer shall
6.1 Inspect finished product according to specified procedures and the requirements
of applicable standard. Before product release, the manufacturer shall ensure
that the finished product passes inspection/testing necessary at specified stages
and the results are in conformity with all requirements of the applicable
standard.
6.2 Maintain records of inspection/testing as the evidences of conformity.
7. Control of nonconforming product
The manufacturer shall
7.1 Control the nonconforming products at all stages including returned products
from customer in order to prevent its unintended use or delivery to other
customers, and take corrective action by appropriate methods which shall be
documented.
7.2 Maintain records of nonconforming product detail and relevant arrangement to
deal with such nonconforming products.
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8. Identification and traceability
The manufacturer shall
8.1 Identify the product and the product status throughout product realization stages
by appropriate methods.
8.2 Identify the finished product with minimum detail as specified by the
requirements of applicable standard and law.
In case the standard or the law requires to recall the nonconforming product, the
manufacturer shall develop the method of identification and traceability to
support the product recall.
9. Preservation of product
The manufacturer shall preserve raw materials, work in process, and finished product
to be in appropriate manner and in conformity with the requirements of product
realization stages and delivery to customer. It includes handling, packaging, storage
and protection from product deterioration.
10. Control of monitoring, measuring and testing devices
The manufacturer shall
10.1 Have necessary monitoring, measuring and testing devices to control the
product quality at all stages and at least have the prescribed monitoring,
measuring and testing devices for permanent use at the manufacturer in
accordance with the applicable particular requirements on conformity
assessment for licensing.
10.2 Calibrate or verify the monitoring, measuring and testing devices affecting on
quality. The manufacturer shall
(1) Calibrate the devices as planned durations or before use and the
calibration shall be traceable to national or international traceability.
(2) Show the calibration status clearly and easily to check.
(3) Have safeguard from adjustment of calibrated devices.
(4) Protect the devices from damage and deterioration during handling,
maintenance, and storage.
10.3 Handle the devices and affected products by appropriate method, if the
monitoring, measuring and testing devices do not conform with the
requirements.
10.4 Maintain the records of calibration and verification as evidences of conformity.
11. Corrective action and handling of complaint
The manufacturer shall
11.1 Take correction and corrective action to prevent reoccurrence of the
nonconformity of the product and the quality control system.
11.2 Handle complaints from customer or others with undue delay, and maintain
records of complaint handling and the results as evidences of conformity.
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11.3 Have a method to recall the product delivered or placed in the market, if the
products do not conform with the requirements of applicable standard.
11.4 Collect and analyze nonconformities and problems relating to product and
quality control system, and use such information for improvement of the
product and the quality control system.
12. Control of document and record
The manufacturer shall
12.1 Provide correct and up to date document necessary at point of use.
12.2 Have a method to prevent from use of obsolete or cancelled document.
12.3 Identify, collect, store, and protect relevant records as evidences in conformity
with applicable law, product requirements, and quality control system as
appropriate retention times.
Documents and records may be in any format such as paper, electronic media, etc.
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