Regulation No.
(2) of 2010
Regulating the
Work of Conformity
Assessment Entities in the Emirate of Dubai[1]
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We, Hamdan bin Mohammed bin
Rashid Al Maktoum, Crown Prince of Dubai, Chairman of the Executive Council,
After perusal of:
Law
No. (3) of 2003 Establishing the Executive Council of the Emirate of Dubai;
Law
No. (35) of 2009 Concerning Management of the Public Funds of the Government of
Dubai;
Local
Order No. (52) of 1990 Concerning the Requirements for Licensing Laboratories
Operating in the Emirate of Dubai; and
The
Memorandum of Understanding concluded between the Emirates Authority for
Standardization and Metrology and the Dubai Municipality on 16 May 2006; and
To
ensure quality and reliability of conformity assessment
activities in the Emirate of Dubai,
Do hereby issue this Regulation.
This
Regulation will be cited as “Regulation No. (2) of 2010 Regulating the Work of
Conformity Assessment Entities in the Emirate of Dubai”.
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. |
|
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;
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
(4)
a. No Person may conduct any of
the activities of Conformity Assessment Entities whatsoever, without first obtaining the relevant licence from the Licensing Authority and an
Activity Permit from the Competent Department. This does not apply to medical
laboratories.
b. No Conformity Assessment
Entity may conduct any activity other than the
activity stated in its Activity Permit without first obtaining the relevant
approval from 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.
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 (6)
An
Activity Permit will be valid for a period of one (1) year. The Activity Permit
may be renewed for the same period upon the application of the Conformity
Assessment Entity. The renewal application must be submitted at least fifteen
(15) days prior to the Activity Permit expiry date.
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.
A
Conformity Assessment Entity must obtain Accreditation in the mandatory fields
and tests referred to in Article (7) of this Regulation within a period not
exceeding two (2) years from the date of obtaining its
Activity Permit, failing which that
permit will be revoked, the entity will be deregistered, and the Licensing
Authority will be notified to revoke the Commercial Licence
issued to it.
The
Competent Department may extend the two-year period referred to in this Article
for an additional period not exceeding six (6) months if the Conformity
Assessment Entity provides valid technical reasons.
Notwithstanding the provisions of
Article (4) of this Regulation, the Competent Department will, in coordination
with the competent Government Entities, accredit medical laboratories in
accordance with the relevant procedures and requirements adopted by it.
A Conformity Assessment Entity
will be accredited pursuant to an Accreditation Certificate issued by the
Competent Department for a term of three (3) years, renewable once
or several times for
the same period. This certificate authorises the accredited entity to use the
Accreditation symbol consisting of the logo of the Competent
Department and the Accreditation Certificate number.
The
implementing bylaw of this Regulation will determine the requirements,
conditions, and procedures for obtaining and renewing the Accreditation
Certificate; cases warranting suspension and revocation of the Accreditation
Certificate; and use of the Accreditation symbol.
A
Conformity Assessment Entity may add other activities to those included in its
Activity Permit or Accreditation Certificate.
The added
activities will be subject to the applicable conditions and requirements
adopted by the Competent Department.
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;
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.
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.
In return for issuing the permits
and
certificates, and providing other services, under this Regulation and
the resolutions issued in pursuance hereof, the DM will charge the fees set out
in Schedule (1) attached hereto and approved by Us.
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:
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.
The
employees of the
Competent Department nominated by a resolution of the Director General of the
DM will have the capacity of law enforcement officers to record the acts
committed in breach of the provisions of this Regulation, its implementing
bylaw, and the resolutions issued in pursuance hereof.
The
DM will not be liable to third parties for any damage they may suffer as a
result of a registered or accredited Conformity Assessment Entity conducting
its activities or providing its services.
The concerned entity will be solely liable to remedy such damage.
The
DM may seek assistance from local Government departments and public authorities
and corporations in the Emirate, including police personnel. Upon request, these entities must provide prompt
support to the DM.
The fees and fines collected pursuant to this
Regulation will be paid to the Public Treasury of the Emirate.
A
Conformity Assessment Entity may submit a written appeal to the Director
General of the DM against any of the decisions or measures taken against it by
the Competent Department within thirty (30) days of being notified of the
contested decision or measure.
Submitted
appeals will be considered by a committee formed pursuant to
a resolution of the Director General of the DM for this purpose. The decisions
issued by the committee in respect of appeals will be final.
Article
(21)
All
Conformity Assessment Entities operating in the Emirate by the effective date
of this Regulation must comply with the provisions of this Regulation within
one (1) year from the date on which it comes into force.
The
Director General of the DM will issue the bylaws and resolutions required for
the implementation of this Regulation.
Any
provision in any other local legislation will be repealed to the extent that it
contradicts the provisions of this Regulation.
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.
Schedule
(1)
Fees
for Services Provided by the Competent Department
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|
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.
Schedule (2)
Violations and Fines
|
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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©2020 The Supreme Legislation Committee in the
Emirate of Dubai
[1]Every 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.