GSO Procedure For Designation Of The Conformity
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)HISTORY OF MODIFICATIONSRevision NoDateResponsibleObject of modification0101/05/2014Moteb Al-MeezaniFirst issue0214/02/2016Ibrahim Al-HashafGeneral revision Updating Article 18 to match the certification tracking process as per the electronic system Add Annex (8) Rules for the use of the Gulf Logo to track conformity Add definitions (26-27-28-29) to Article 4 (Tracking - Gulf Tracking Certificate - GulfCertificate Tracking System - QR Code) Add paragraph (b) in Article (16) on the contribution of the designated bodies to providefree services to the Authority0301/06/2016Ibrahim Al-Hashaf Updating Article (32) paragraph (2) for the costs of implementation of the preliminary orperiodic assessments, by adding the technical assessment and the technical committee forthe final review and recommending the appointment and updating Annex 4 of these costs. Updating Paragraph (f) of Article (1) of Article (14) by removing the words when theCommission so requests, Updating paragraph (a) of Article (1) of Article (28) by making regular technical follow-upevaluations (3 months) for periodic evaluations from the date of the previous evaluation. Add responsibilities to the appointment chart in Annex)1( Article 4: Update the definitions Article 5/2: Add the clause of non-discrimination obligation of GSO to update NBsabout changes in its policies Article 7: Deletion of article “Use third party for technical assessment” Article 8/5: Add the possibility of unannounced visits from GSO to NBs Article 9: Update “Impartiality” as per the common elements of new ISO/CASCOstandards add the specific requirements of ISO/IEC 17065 Article 13/1: Remove the requirement of annual report Add other mandatoryinformation to be communicated in case of changes related to the NB Article 14: Update “Confidentiality” as per the common elements of new ISO/CASCO0423/12/2018Ibrahim Al-Hashafstandards Article 15: Rephrase the article “Participation in standardization activities” Article 19: New article about required profile and duties of Legal Representative Article 21/3: Consider the signed application for notification a formal commitment toundergo GSO rules Article 23: Replace “Administrative assessment” by “Application and document review” Article 23/8: For applicant already designated for another TR and having the requiredtechnical competencies, the notification could be granted based on documentaryassessment (with condition to conduct early surveillance within 6 months) Article 24: Replace “Technical assessment” by “Assessment” and align the requirementsto the new ISO/IEC 17011 statement Article 25: Replace “Review” by “Final review and recommendation”Revision: 4Date of issue: 23-12-2018Page: 2 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)Revision NoDateResponsibleObject of modification Article 26: The decision-maker for designation is the Director of GSO conformityassessment department Article 28: Set GSO rules for considering extension requests for notification scope Article 28: Define margins for notification cycle set conditions for extending the validityof notification / Replace the term ‘follow-up visit’ by ‘surveillance visit’ Article 30: Define the period of suspension (3 months renewed once) Remove Annex 2 (Chart of the technical evaluation procedure) and Annex 4 (Notificationand Registration Costs) Remove annex 8 (Rules for use the GSO Conformity Tracking Symbol (GCTS) from NP01), as it is issued as separate document.Revision: 4Date of issue: 23-12-2018Page: 3 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)CONTENTSCHAPTER ONE: Framework – Definitions . . . 6Article (1): Objective . . . 6Article (2): scope . . . . 6Article (3) Complementary Reference . . . 6Article (4): Definitions . . . 7CHAPTER TWO: General requirements for designation of the conformity assessment bodies . . .11Article (5): General . . .11Article (6): Information obligation on GSO for Member States . . .11CHAPTER THREE: Requirements for Notified bodies 12Article (7): General . . . . 12Article (8): Impartiality for Notified Body . . . . .12Article (9): Resources for the notified body . . . .13Article (10): Presumption of conformity for CAB . .14Article (11): The operational obligations of the conformity assessment procedures for the notified body . .14Article (12): Subsidiaries of and subcontracting by notified bodies . . 15Article (13): Information obligation on notified bodies to the GSO and the relevant bodies. . 15Article (14): Confidentiality . . .16Article (15): Participation in standardization activities . .16Article (16): The multi-branches applicant bodies . . .16Article (17): Tracking of certificates issued by the notified body . 17Article (18): Insurance and Bank Guarantee . .18Article (19): Legal Representative . . .18CHAPTER FOUR: Procedures for the designation process .19Article (20): General . . . .19Application for Notification . . .19Article (22): Initial review of the application and announcement to Member States . 19Article (23): Application and document review . .20Article (24): Assessment . . .22Article (25): Final Revie and Recommendation . .22Article (26): Designation Decision . .23Article (27): Registration of the Notified Body . .23Article (28): Follow-up of the efficiency of the notified bodies . .23Article (21): SubmitRevision: 4Date of issue: 23-12-2018Page: 4 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)Article (29): Changes Affecting Designation .25Article (30): Withdrawal, Reduction or Suspension of Notification . 26Article (31): Complaints and Appeal . 26CHAPTER FIVE: Costs of Notification and Registration . . .27Article (32): Notification costs.27Article (33): Registration costs . . 28CHAPTER SIX: Final Provisions . 29Article (34): Coordination with the competent authorities of Member States to implement this procedure . 29Article (35): Cancellation .29Article (36): Effective Date 29Annex 1/ Chart of designation process procedures . .30Annex 2/ Notification Cycle . .31Annex 3/Insurance requirements . .32Annex 4/Mechanism of dealing with bank guarantee . . 34Annex 5/Appeals . . .36Revision: 4Date of issue: 23-12-2018Page: 5 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)CHAPTER ONEFramework - DefinitionsArticle (1):ObjectiveThe aim of this procedure is to identify the criteria and mechanism for the designation of conformity assessmentbodies which submitted to become notified bodies in order to provide conformity assessment services inaccordance with the approved GSO technical regulations.Article (2):ScopeThis procedure is concerned with the designation of conformity assessment bodies for products subject to theGCC scheme to control the safety of products in the markets of the GSO member states.Article (3)Complementary References General Product Safety Regulation BD09100504 Conformity Marking for the GCC Countries BD09100501 GSO ISO/IEC 17020: Conformity assessment — Requirements for the operation of various types of bodiesperforming inspection. GSO ISO/IEC 17025: General requirements for the competence of testingand calibration laboratories. GSO ISO/IEC 17065: Conformity Assessment - requirements for bodies certifying products, processesand services GSO ISO/IEC 17067: Conformity assessment - Fundamentals of product certification and guidelines for productcertification schemesNote: Consider the final versions of the complementary references referred to above.Revision: 4Date of issue: 23-12-2018Page: 6 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)Article (4):DefinitionsFor the implementation of the rules of this procedure, the following terms shall have the meanings assigned toeach of them unless the context requires otherwise1. The Cooperation CouncilThe Gulf Cooperation Council countries.2. The OrganizationThe GCC Standardization Organization "GSO" of the Cooperation Council.3. The Member StatesThe Member States of the Standardization Organization for the Cooperation Council for the Arab States ofthe Gulf (United Arab Emirates, Kingdom of Bahrain, Saudi Arabia, Sultanate of Oman, State of Qatar, Stateof Kuwait and Republic of Yemen).4. Gulf standardA document approved by the Board of Directors which, for normal and repeated use, establishes the rules,instructions, or characteristics of the products, processes and methods of production that are not mandatoryand may include or specifically consider terms, definitions and packaging, and requirements for placing badgesor marks applicable to products Services, operations, production methods or otherwise.5. Gulf Technical RegulationsA document approved by the Board of Directors that provides the characteristics of the products and the relatedprocesses and their production methods, includes the administrative provisions in force, with which thecompliance is mandatory. It could include in particular terminology and definitions, packaging and labelingrequirements or labels that apply to the products or services, processes or production methods.6. ConformityThe fulfilment is for specific requirements. This means that the requirements product, service, process,system, body or person are fulfilled. These requirements may be standards, technical regulations, contractualclauses, consumer requirements, etc.7. Conformity assessmentDemonstration that specified requirements related to a product, process, system, person or body are fulfilled.Revision: 4Date of issue: 23-12-2018Page: 7 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)8. conformity assessment bodiesBodies that perform conformity assessment activities, including testing, calibration, certification and inspection.9. DesignationAcceptance of the applicant body that applicate to perform conformity assessment services in specific field inaccordance with the rules of this procedure.10. Applicant bodiesA conformity assessment body that applies for Designation to the GSO in accordance with the rules of thisprocedure.11. Notified bodyThe body designated in accordance with the rules of this procedure to provide conformity assessment servicescontained in the adopted GCC technical regulations, within a specific technical regulation, or a specific list ofproducts, risks or categories of products in accordance with this procedure.12. AccreditationThird-party attestation related to a conformity assessment body (8) conveying formal demonstration of itscompetence to carry out specific conformity assessment tasks.13. GCC Accreditation CenterCenter for Accreditation of the GSO member states.14. Gulf Conformity MarkingA specific marking of the Cooperation Council for the Arab States of the Gulf which is affixed on the productor/and the Declaration of Conformity to indicate that the product is in conformity with the requirements set outin the applicable Gulf Technical Regulations.15. Place on the marketMeans put the product for the first time on the Gulf Common Market.16. ManufacturerAny natural or legal person who manufactures a product, design or mandates another natural or legal personto do it, and then markets it under its own name or under its own trademark.17. Authorized RepresentativeA natural or legal person based in one of the Member States who has received a written mandate from aManufacturer to act on his behalf.Revision: 4Date of issue: 23-12-2018Page: 8 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)18. ImporterAny natural or legal person within one of the Member states who places a product on the market from a thirdcountry outside the Member states.19. DistributorAny natural or legal person in the supply chain, other than the Manufacturer or the Importer, who makes aproduct available on the market.20. Economic OperatorThis includes manufacturer, official representative, importer, and distributor.21. The multi-branch applicant bodyIs a conformity assessment body with one legal entity, one head office and multiple branches involved inconformity assessment activities Some specific activities may be implemented or managed, in whole or in part,within a network of sites. All sites need to have direct or contractual legal contact with the head office of theentity and are subject to a common quality system, within the specific geographical area.22. BranchAnybody that conduct conformity assessment activity on a temporary or permanent basis and administrativelyor legally is following the main conformity assessment body.23. Main branchIs a branch in which one or more of the main activities of the conformity assessment are carried out (policydevelopment, conformity assessment processes, management review, decision making of conformityassessment processes).24. AppealA request submitted by the applicant body or the notified body to the Gulf Steering Committee for notificationto review the decisions taken by the GSO regarding the designation for CAB in accordance with the provisionof this regulation.25. The appellantThe applicant or the notified body that submitted the complaint to the Gulf Committee for notification.26. SurveillanceAll subsequent actions carried out by the notified body to ensure that the conformity of the products to whichidentical certificates have been granted is continued.27. GSO Certificate Tracking SystemAn electronic system in which all products bearing the Gulf conformity marking, that subject to the notifiedbody, are registered.Revision: 4Date of issue: 23-12-2018Page: 9 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)28. GSO Conformity Tracking Symbol (GCTS)A symbol provided by the GSO, consisting of the Gulf Conformity Marking, with four-digits notified bodynumber, located below it, and the QR Code. This symbol is generated by GSO Certificate Tracking System.Revision: 4Date of issue: 23-12-2018Page: 10 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)CHAPTER TWOGeneral requirements for designation of the conformity assessment bodiesArticle (5):General1. Responsibility for designation a notified body:The General Secretariat of GSO is responsible for the designation of the applicant bodies that have fulfilledthe requirements stipulated in the rules of this procedure.2. General obligations of the GSO:1. The GSO shall ensure transparency, impartiality and objectivity in the procedures of notification activitiesand shall take all measures to ensure that there is no conflict of interest. The GSO’s policies, processesand procedures are non-discriminatory and shall be applied in a non-discriminatory way. The GSOmakes its services accessible to all applicants whose application for notification falls within the scope ofits notification activities as defined within its policies and rules. Access shall not be conditional upon thesize of the applicant conformity assessment body or membership of any association or group, nor shalldesignation be conditional upon the number of conformity assessment bodies already designated.2. The GSO shall ensure the confidentiality of the information obtained through the designation process.3. The GSO shall establish a documented system of procedures for such action.4. The GSO encourages the notified bodies to participate in the sectorial cooperation groups in the fieldsof Gulf technical regulations facilitating the exchange of information and experiences among them.5. The GSO shall undertake the coordination of the experience exchange among Member States withregard to the notification activities and capacity building for the national staff with competence in thefield of the notification.6. The GSO shall inform the applicants and the notified bodies about any relevant decision pertaining toits status as notifying authority.Article (6): Commitment to inform member statesThe GSO shall inform Member States of the following:1. Lists of notified bodies and continuous updating of these lists and making them available to the public.2. The applicant bodies that have not designated or the notified bodies for which any action has beentaken in accordance with the rules of section (2) of article (26) and article (30) of this procedure.3. Non-conforming products within the scope of the notification that are ensured to be Non-conformingfurther the results of the surveillance according to section (5) of article (12) of this procedure.Revision: 4Date of issue: 23-12-2018Page: 11 of 37Note: Only the Arabic version of this Regulation is authentic in law and is applicable where there are differences with this translation.
GSO Procedure for Designation of the ConformityAssessment bodies )NP-01)CHAPTER THREERequirements for Notified BodiesArticle (7):General1. The Notified body shall be of a legal persona
8. conformity assessment bodies Bodies that perform conformity assessment activities, including testing, calibration, certification and inspection. 9. Designation Acceptance of the applicant body that applicate to perform conformity assessment services in specific field in accordance with the rules of this procedure. 10. Applicant bodies
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