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To sustain the GOB | GCC Charter encompass programs through impartiality and competence entrusted to protect communities and consumers. Signatory and bearers to the Charter are integral part that encompass the accreditation - recognition activities, namely Regulatory Affair Activities - Practices, RAA / RAP.
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The progressive activities as signatory and toward achieving affair accreditation, Schedule “A” General:
- Application
- Initial Investigation
- Signatory to the Charter
- Review of Documents
- Office Assessment and Confirming signatory status
- Field Assessment
- Recommendation to Accreditation to Delegates
- Concurrence for Accreditation
- Granting Bearer of Accreditation
The progressive activities as signatory and toward achieving accreditation, Schedule “B”:
- Application for extension of scopes
- Investigation
- Signatory to the Charter
- Review of Documents and Reports
- Analysis and Decision
- Recommendation to Accreditation
- Concurrence for accreditation
- Granting extension of scopes and bearer status
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The criterion to benchmark the regulatory affair activities (RAA) are based on recognized specifications, generally accepted standards (based) for matters that are effectively suited for the protection of communities and consumers as these relate to quality and environment (ISO/IEC 17021) (ISO 13485); inspection programs (ISO/IEC 17020); security (ISO/IEC 27006), food safety (ISO/TS 22003); and for entities that carry out certification of person (ISO/IEC 17024). For specific laboratory testing, requires demonstration of competence through (ISO/IEC 17025) for specialty testing and Regulatory Affairs Medical Activities (ISO/IEC 15189).
As prerequisite to signatories and bearers, entities need to meet their respective legal obligations, regulatory requirements through non conflict of interest activities with integrity.
The operations for Regulatory Affairs Activities specifically for accreditation provides two operational schedules (“A” and “B”):
* Schedule A, see the protocol that the frame on the upper left shows. * Schedule B is for entities that already carry current accreditation and that wish to extend their scopes of activities as a signatory to the Charter by addressing Affairs of accreditation - recognition. Read the applicable protocol in the frame on the upper left. * Alternatively, if your organization wishes to carry signatory to the Charter it will depend on the nature of the activities, processes and role within your supply chain (of services / products).
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