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Notification of the Thai Industrial Standards Institute  
Amendment of the Rules on Conformity Assessment for Licensing  
--------------------------------------------  
Whereas it is expedient to have the Rules on Conformity Assessment for 
Licensing in order to make the licensing process correct, clear, transparent, fair, efficient and 
in line with international practices.  
By virtue of clause 3 of the Ministerial Regulation B.E. 2549: Rules and 
Procedures of Product Certification and Licensing to display the s tandard mark on industrial 
products, to manufacture and to import for sale industrial products which are required by 
the Royal Decree to conform with the standard thereof; and the section 44 (1) of the 
Industrial Product Standards Act B.E. 2511; in associa tion with the resolution of the 616 -
3/2557 meeting of the Industrial Product Standards Council on 18th June B.E. 2557, the Thai 
Industrial Standards Institute (TISI) hereby issues the notification to amend the Notification 
dated 20th April B.E. 2554 as fol lows: 
Cancel the statements on clause 2.2 and replace with these following 
statements:  
2.2 Conformity assessment for licensing as to 2.1 (1) comprises of:  
     2.2.1 Product testing can be carried out by either case as follows:  
   Case 1   Take samples of p roduct from manufacturing premise for 
testing as specified in applicable standard by TISI or the inspection body designated under 
section 5 of the Industrial Product Standards Act B.E.2511. The samples may be tested by:  
(a) Testing laboratory designated under section 5 of the Industrial 
Product Standards Act B.E.2511  
(b) Domestic and foreign testing laboratory that is approved by the 
Institute. The laboratory shall be accredited to the ISO/IEC 17025 standard with applicable 
relevant scopes. (In case of no testing l aboratory designated under section 5).  
(c) In-house testing laboratory of the manufacturer of such product 
under the supervision of the TISI competent officials and use the testing facilities of the 
manufacturer. The testing laboratory shall be verified its co mpetence by the TISI competent 
officials prior to conducting the test. (In case of no  testing laboratory designated under 
section 5 and no ISO/IEC 17025 accredited testing laboratory).  
 
 
 
 
2/7 
  
   Case 2  Consider to accept the test report that the license applicant 
who take samples of product by himself and deliver such samples to be tested by the 
testing laboratory designated under section 5.  
In this case, the test report shall be valid within one year from 
the date of report approval by the testing laboratory to the date of application submission.  
2.2.2 Conformity assessment of the manufacturer’s quality control system can 
be carried out by either case as follows:  
   Case 1   Assess the quality control s ystem of the manufacturer of such 
product in accordance with Appendix A: The Particular Requirements for Conformity 
Assessment for Licensing; by TISI or the inspection body designated under section 5 of the 
Industrial Product Standards Act B.E.2511  
Case 2  Consider to accept the certification of TIS 9001 or ISO 9001 
issued by a certification body who is approved by TISI or under the Multilateral Recognition 
Arrangement (MLA).  Additional assessment shall be performed to ensure that such 
manufacturer is comp etent to manufacture products in conformity with the applicable 
standard, as follows:  
(a) Document review: carried out by the Institute  
(1) Plan of manufacturing process in brief  
(2) List of equipment and instruments to be used in 
manufacturing such product  
(3) 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  
                      All mentioned -above documents shall be in Thai or English language s 
and endorsed by legal authority of the manufacturer of such product.  
                      In case of no document or incomplete document to prove the 
manufacturer’s competence  to manufacture product in conformity with the applicable 
standard as mentione d above, the Institute shall operate (b)  
(b) Additional assessment on the quality control system of the 
manufacturer: carried out by the competent official or the inspection body designated under 
section 5, at least for these particular requirements:  
No.4: Purchasing and control of raw materials  
No.5: Process control  
No.6: Control of finished products  
No.7: Control of nonconforming products  
No.10: Control of monitoring, measuring, and testing devices  
Details of these particular requirements are shown on App endix A.  
 3/7 
  
Case 3  Consider to accept the inspection report issued by the 
inspection body designated under section 5 who inspects the domestic and foreign 
manufacturer before the applicant submits the application to the Institute. The inspection 
body shall  assess the quality control system in accordance with Appendix A: The Particular 
Requirements for Conformity Assessment for Licensing (12 requirements).  
In this case, the inspection report shall be valid within one 
year from the date of final report appro val to the date of application submission.  
  2.2.3 Consider to accept the assessment result of the quality control system 
of the foreign manufacturer registered by the Institute. The foreign manufacturer shall 
conform with the Rules and Conditions for Regi stration of Foreign Manufacturer which will 
be notified by the Institute later on.  
 The notification shall come into force from 1st September B.E. 2557  
       
    Given on 19th August B.E. 2557  
                 Mr. Urit  Srinongkote  
     Secretary -General of Thai Industrial Standards Institute   
 
 
 
 
  4/7 
 Appendix  A 
Attachment to the Rules on Conformity Assessment for Licensing  
Particular Requirement s for Conformity Assessment for Licensing  
----------------------------------------------  
1. Organi zation 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 f unctions.  
1.2 Have clear job descriptions for personnel in each position  
1.3 Have appropriate and sufficient personnel to ma nufacture  license d 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 ma nufacturi ng product 
appropriately and capable to ma nufacture product in conformity with applicable 
standard consistently and regularly . 
2.2 Have repair and maintenance system to ensure the manufacturer capability to 
manufacture p roduct in conformity with  applicable sta ndard.  
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 ea ch 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 ma terials  
Raw material means parts and components of the product, consumables, packaging, 
outsourced work, and customer asset used in ma nufactur ing such product, etc.  
The manufacturer shall  5/7 
 4.1 Have purchasing system to ensure that raw materials and services pur chased 
meet the purchasing requirements.  
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, me asuring and testing devices.  
(5) Measure and monitor process es and product s. 
(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 applicabl e 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/test ing necessary at specified stages 
and the results are in co nformity  with all requirements of the applicable 
standard.  
6.2 Maintain records of inspection/testing as the evidences of co nformity . 
7. Control of nonconforming product  
The manufacturer shall  
7.1 Control th e 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 nonconf orming product detail and relevant arrangement to 
deal with such nonconforming products.  6/7 
  
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 co nformity  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 ver ify 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 s tatus 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 co nformity . 
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.  7/7 
 11.2 Handle complaints from customer or others with undue delay, and maintain 
records of complaint handling and the results as evidences of co nformity . 
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 cancell ed 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, e lectronic media, etc.