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16. If the Registered Organization fails to take the required action by the effective date, APIQR shall decide on the action to be taken which may include suspension or cancellation of the registration. Annual Surviellance by APIQR 17. APIQR shall perform surveillance audits of the quality management system of Registered Organizations. The frequency of surveillance audits shall be at the discretion of APIQR but shall be at least once in each twelve (12) month period. The surveillance audit shall be conducted in a manner similar to that described for the initial audit and shall cover all elements of the Organization¡¯s QMS. 18. Upon receipt and evaluation of the report of the surveillance audit, APIQR shall notify the Registered Organization of the results of the audit including a request for corrective action of any nonconformance(s). The Registered Organization shall be requested to respond within thirty (30) days of receipt of the notification. 19. Following receipt of the Registered Organization¡¯s response to the request for corrective action, APIQR shall determine if any further action, which could include notification of suspension or cancellation, or if a follow-up audit may be required. Suspension of Registration 20. Registration may be suspended for a period, at the discretion of APIQR, if: (a) Annual surveillance audits indicate nonconformance to the requirements but cancellation is not considered necessary by the Registration Committee, (b) Improper use of the Registration, Certificate of Registration, API Spec Q1 Registration Mark and/or API ISO/TS 29001 Registration Mark is not immediately remedied to APIQR¡¯s satisfaction, and/or (c) If there has been a violation by the Registered Organization of any of the requirements of the agreement between the Registered Organization and APIQR. |
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