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 For enrollment to the GOB | GCC Platform your organizations must adhere to the principles of the Charter, as signatory / bearer.
The Regulatory Affair Activities (RAA) for accreditation and recognition provides us with an effective and efficient mean to disseminate our Charter. To this effect legal entities that bear or signatory to the Regulatory Affair Activities (RAA) must meet the requirements in the pointers that follows, whether the RAA activity is under schedule / option “A” or “B”.
- The entity must be a legally bona fide registered within the country of operations and needs to possess demonstrable competence in the programs within the scope of activities requested, when accredited - recognized is required proof-evidence.
- The entity needs to objectively demonstrate that operates under impartiality in benchmarking ISO/IEC 17021, ISO/IEC 17020, Guide 65 as primers, and for specialty laboratories ISO/IEC 15189 and ISO/IEC 17025.
- The entity must have a nondiscrimination policy on the basis of race, color, national origin, religion, age, disability, sexual orientation, or marital status.
- Objectively not to carry conflicting interest activities (i.e. development of schemes under which provides consulting and certification), whether is permitted by other benchmarks, protocols or programs.
- The entity will have to provide a confidentiality policy to participants regarding privacy of personal record, as well as part of the signatory to the Charter program.
- And GCC, for recognition, the entity will not recommend or provide a diploma or certificate to any participant who fails to meet the requirements as set by the agreement as an institution of higher learning and in benchmarking or alignment with internationally recognized and generally acceptable benchmarks based agreements .
- It would be the responsibility of the entity to inform the GOB | GCC Platform about any changes affecting the operations of their structure and matters that might cause concern to the Charter in carrying out RAA.
- An entity may only be nominated once completing and accepting and with favorable response to benchmarks ISO/IEC 17020, Guide 65, ISO/IEC 17021 encompassing ISO/TS 22003, ISO/IEC 27006, ISO/IEC 15189 and/or ISO/IEC 17025 and the nomination needs to occur through a GlobalNet delegate of the GOB, which is applicable for management specifications for food, quality, security, health, safety, testing, and medical and final acceptance by the Governance Board of Directors.
- An entity or individual Affairs such as accreditation may withdraw at any time by a tender of their resignation in writing and returning their accreditation or certification document.
- Signatories need that the Charter is demonstrably sustained through objective evidence.
To bear the GOB | GCC Platform marks the signatory require to benchmarks of the regulatory affair activity to operate, for information please contact us.
Note: “Cloud Coverage” which may encompass two or more regulatory affair activities (such as recognition and accreditation) resulting in benefits when combined.
For the guidance to the instruments based criterion, as internationally recognized and generally acceptable benchmarks, includes that the following be addressed:
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Application Forms, A-1
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The Route to the RAA
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ISO/IEC 17021 specifics to ISO 13485
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The OPS Manual provides information on the operations of the RAA byway of benchmarking
ISO/IEC 17011.
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Listing of Scopes and Categories
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Donations, Fundraising, Grants through agreements to the Charter for the RAA
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ISO 9001, General for QMS
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Scope Extension:Reduction, Three Supplemental Procedures
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RAA accreditation by sectors
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ISO 14001, Environmental Management
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Agreement to the Charter,
Form-SIA
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Recognition - Approval - Certification Manual, for ISO/IEC 17024
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FSMS ISO/TS 22003 - HACCP, specifics
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Determining Competence and Competence Decision
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Guidance Documents and Advisories, as required for bearers of the RAA
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Specifics of ISO/IEC 15189 for medical or clinic laboratories
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Complaints and Appeals
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Suspension and Withdrawals
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ISMS in addressing ISO/IEC 27006
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Peer Review ISO/IEC 17011, GlobalNet (benchmarks ISO/IEC 17040)
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Terms and Conditions of RAA - Rights and Obligations of the GOB | GCC and the Accredited - Recognized Entity.
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Reports and Reporting
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Terms of Agreement, RAA, TAA
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Charter Signatory, Part of TA
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Bylaws
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Article of Incorporation, authoritatively
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Competencies / Qualifications of Professionals
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State and Federal authority for accreditation and recognition
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For GCC enrollment visit the “Recognition” GCC Page
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