UAE Corporate / Commercial LawRegulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai

Article (2) The following words and expressions, wherever mentioned in this Regulation, will have the meaning indicated opposite each of them unless the context implies otherwise: Emirate: The Emirate of Dubai. DM: The Dubai Municipality. ©2020 The Supreme Legislation Committee in the Emirate of Dubai 1Every effort has been made to produce an accurate and complete English version of this legislation. However, for the purpose of its interpretation and application, reference must be made to the original Arabic text. In case of conflict, the Arabic text will prevail.

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 4 of 10 Competent Department: The Accreditation Department of the DM. Licensing Authority: Any of the entities legally authorised to issue Commercial Licences to Conformity Assessment Entities. Commercial Licence: The licence issued by a Licensing Authority authorising a Conformity Assessment Entity to conduct commercial activity in the Emirate. Conformity Assessment Entity: A public or private legal person that provides testing, inspection, or calibration services; or that grants conformity certificates for products, systems, or persons in accordance with international requirements and standards. Activity Permit: A document issued by the Competent Department authorising a Conformity Assessment Entity to conduct its activity in the Emirate, upon verifying that the conditions and requirements adopted by the Competent Department are met. Registration: Registering a Conformity Assessment Entity in a special register maintained by the Competent Department, upon verifying that this entity meets the requirements and conditions prescribed by this Regulation. Accreditation: Recognition by the Competent Department, upon verifying that a Conformity Assessment Entity meets the prescribed requirements and conditions, that this entity is qualified for and capable of providing its services in accordance with the adopted international standard specifications. Accreditation Certificate: A document issued by the Competent Department recognising that a Conformity Assessment Entity is qualified for and capable of providing a service specified in that certificate in accordance with the approved standard specifications.

Article (3) The DM is the competent official entity having the exclusive authority to register and accredit Conformity Assessment Entities. For this purpose, the Competent Department will have the powers to: 1. issue Activity Permits to Conformity Assessment Entities and register these entities;

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 5 of 10 2. approve the services provided by Conformity Assessment Entities; 3. oversee the activities of Conformity Assessment Entities and monitor their compliance with this Regulation; with the resolutions and bylaws issued in pursuance hereof; and with the relevant adopted standards; 4. hold the conferences, training courses, and workshops related to its work; and conduct proficiency tests for Conformity Assessment Entities; and 5. create a database of the names and activities of the Conformity Assessment Entities registered with, and accredited by, the Competent Department.

Article (5) A Conformity Assessment Entity will be authorised to conduct its activity in the Emirate in accordance with the following procedures: 1. The applicant wishing to operate the Conformity Assessment Entity will submit an application for a Commercial Licence to the competent Licensing Authority in the Emirate, in accordance with the relevant legislation and procedures adopted by that authority. 2. The Licensing Authority will refer the application to the Competent Department to consider its technical aspects and verify that it meets the conditions and requirements adopted in this respect. The implementing bylaw of this Regulation will determine the required documents, data, and information. 3. If the application meets the prescribed conditions and requirements, the Competent Department will issue a no-objection certificate for conducting the relevant activity and will send the same to the Licensing Authority to complete the Commercial Licence issuance procedures. 4. The Conformity Assessment Entity must meet all operational requirements no later than six (6) months from the date on which its Commercial Licence is issued. 5. The Conformity Assessment Entity may not conduct its activity without first meeting all the operational requirements adopted by the Competent Department and obtaining the Activity Permit.

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 6 of 10 6. The Conformity Assessment Entity must, within the six-month time limit, submit to the Competent Department an application for an Activity Permit, failing which, its Commercial Licence will be revoked and it will be subject to the penalties stipulated in this Regulation. 7. The Competent Department will conduct an on-site inspection and audit of the Conformity Assessment Entity. Based on the findings of this audit, the Competent Department may take any of the following actions: a. where all operational requirements are satisfied and all the deficiencies identified by the Competent Department are addressed by the Conformity Assessment Entity, the Activity Permit will be granted to the entity; or b. where any operational requirements are not satisfied or any deficiencies are not addressed within the prescribed time limit, the Activity Permit will not be granted to the Conformity Assessment Entity; and the Licensing Authority will be notified to revoke the Commercial Licence issued to that entity. 8. After it obtains an Activity Permit, the Conformity Assessment Entity will be registered in the approved register maintained by the Competent Department, which records all essential information, including the name and address of the entity, name of its owner, type of the activities it conducts, and services it provides.

Article (7) A Conformity Assessment Entity must, during the first year after obtaining the Activity Permit, submit an application for Accreditation as follows: 1. For entities operating in the fields of health, safety, and environmental protection, Accreditation will be mandatory. These entities may not provide services related to such fields unless they obtain Accreditation Certificates. The Competent Department will issue a list of the tests that require mandatory Accreditation. 2. For Conformity Assessment Entities which do not operate in fields related to health, safety, or environmental protection, Accreditation will be mandatory for at least ten percent (10%) of the total tests or services provided by the entity. The number of accredited tests or services may not be less than one (1). 3. Except for the tests and services referred to in paragraphs (1) and (2) of this Article, Accreditation for Conformity Assessment Entities will be optional.

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Article (12) A registered or accredited Conformity Assessment Entity must: 1. comply with the conditions and requirements for issuance of the Activity Permit and the Accreditation Certificate granted to it, in accordance with the international, regional, and national standard specifications; and abide by the Accreditation scope in the fields in which it is authorised to operate; 2. notify the Competent Department of any changes to its activities, work regulations handbook, or operational processes;

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 8 of 10 3. participate in the proficiency testing programmes organised by the Competent Department or by the entities recognised by the Competent Department; and 4. provide all necessary support to the employees of the Competent Department conducting audit and assessment of its work and documents and evaluating its procedures.

Article (13) The activities of registered Conformity Assessment Entities will be subject to audit and assessment; and their Accreditation will be re-assessed from time to time. The Competent Department may take the following action against a Conformity Assessment Entity which fails to comply with certain Accreditation requirements based on the findings of the audit and assessment: 1. suspension of work under the Accreditation granted to the Conformity Assessment Entity and banning it from providing services in the field in which Accreditation is suspended, until the entity takes the required corrective measures within the time limit prescribed by the Competent Department; or 2. revocation of the Accreditation Certificate of the Conformity Assessment Entity, where the entity fails to take the required corrective measures within the time limit prescribed by the Competent Department. The implementing bylaw of this Regulation will determine the procedures for post- Accreditation follow-up of Conformity Assessment Entities, audit and assessment of their activities, and re-assessment of their performance.

Article (15) Without prejudice to any stricter penalty stipulated in any other regulation, a person who commits a violation of any of the provisions of this Regulation and its implementing bylaw will be punished by the fine prescribed for that violation in Schedule (2) attached hereto and approved by Us. Upon repetition of any of the violations set forth in the above-mentioned schedule within one (1) year from the date of the previous violation, the amount of the fine will be doubled. A fine must not exceed one hundred thousand Dirhams (AED 100,000.00). In addition to the penalty of a fine, the Competent Department may, in coordination with the concerned entities, take one or more of the following measures against a violating entity:

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 9 of 10 1. temporary suspension of the Activity Permit until the relevant requirements are fulfilled; 2. temporary suspension of the Accreditation Certificate; 3. revocation of the Activity Permit and the Accreditation Certificate, and deregistration of the violating entity; and/or 4. revocation of the Commercial Licence.

Article (24) This Regulation will be published in the Official Gazette and will come into force on the day on which it is published. Hamdan bin Mohammed bin Rashid Al Maktoum Crown Prince of Dubai Chairman of the Executive Council Issued in Dubai on 15 July 2010 Corresponding to 3 Shaban 1431 A.H.

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 11 of 10 Schedule (1) Fees for Services Provided by the Competent Department ـــــــــــــــــــــــــــــــــــــــــــــــ SN Description Fee (in Dirhams) 1. No-objection Certificate 500.00 2. Activity Permit 4,000.00 3. Activity Permit Renewal 500.00 4. Application for Accreditation 500.00 5. Review of Accreditation Documents 3,500.00 6. Initial Assessment 2,500.00 7. Accreditation Assessment AED 6,500.00 per day per assessor 8. Issuing an Accreditation Certificate and approving an Accreditation field 1,200.00 9. Using the Accreditation symbol 5,000.00 10. Training AED 100.00 per day per trainee 11. Proficiency Testing Programme Fee is calculated based on the actual cost of the programme. The fee must not be less than AED 500.00 or more than AED 2,000.00. 12. Reinstatement of a temporarily suspended Accreditation 1,200.00 *An additional fee of one hundred Dirhams (AED 100.00) will be charged for each service provided by the Competent Department to a Conformity Assessment Entity existing outside of the Emirate.

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Regulation No. (2) of 2010 Regulating the Work of Conformity Assessment Entities in the Emirate of Dubai Page 12 of 10 Schedule (2) Violations and Fines ـــــــــــــــــــــــــــــــــــــــــــــــ SN Violation Fine (in Dirhams) 1. Conducting the Conformity Assessment Entity activity without an Activity Permit 30,000.00 2. Conducting an activity that is not stated in the Activity Permit 10,000.00 3. Failure by a Conformity Assessment Entity to apply for an Activity Permit within the prescribed time limit 10,000.00 4. Failure by a Conformity Assessment Entity to apply for Accreditation of activities where the Accreditation is mandatory 30,000.00 5. Failure by a Conformity Assessment Entity to participate in any of the proficiency testing programmes prescribed for the activities it is accredited to conduct 3,000.00 6. Failure by a Conformity Assessment Entity to participate in any of the proficiency testing programmes prescribed for the activities it is not accredited to conduct 1,000.00 7. Non-compliance with the terms and requirements of the Activity Permit or Accreditation Certificate 15,000.00 8. Failure to notify the Competent Department of any change to the Conformity Assessment Entity’s activities, or to the work regulations or operational processes adopted by it 5,000.00 9. Obstructing the work of the Competent Department's inspectors 5,000.00

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