Unannounced Site Audits Sample Clauses

Unannounced Site Audits. 3.14.1. The purpose of unannounced site audits is to evaluate the conditions related to product safety by means of a risk-based audit approach.
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Unannounced Site Audits. These are the audits performed mandatory within the scope of EU 2017/745 Medical Device Regulation and carried out without informing the customer. Unannounced site audits are carried out at least once during the validity of the certificate (at least once every 5 years, at least once every 3 years for class III and implantable devices). NOTICE may increase the frequency of these inspections according to the number and nature of the nonconformities that arise in the conformity assessment activities it carries out, the frequency and nature of the complaints about the device, or the vigilance events related to the device. During unannounced site audits, NOTICE performs tests to verify the conformity of the device with the specifications in the approved technical documentation and the approved design, by taking sufficient samples from the devices released for sale or the devices on the production line and/or the devices that have been sold to the market.

Related to Unannounced Site Audits

  • Unannounced Observations i) Unannounced observations may be in the form of partial or full-period classroom visitations of not less than ten minutes duration.

  • Audits No more than once a year, or following unauthorized access, upon receipt of a written request from the LEA with at least ten (10) business days’ notice and upon the execution of an appropriate confidentiality agreement, the Provider will allow the LEA to audit the security and privacy measures that are in place to ensure protection of Student Data or any portion thereof as it pertains to the delivery of services to the LEA . The Provider will cooperate reasonably with the LEA and any local, state, or federal agency with oversight authority or jurisdiction in connection with any audit or investigation of the Provider and/or delivery of Services to students and/or LEA, and shall provide reasonable access to the Provider’s facilities, staff, agents and XXX’s Student Data and all records pertaining to the Provider, LEA and delivery of Services to the LEA. Failure to reasonably cooperate shall be deemed a material breach of the DPA.

  • Contract Audits Eligible Purchaser represents and warrants that it shall cooperate with Enterprise Services, the Office of the State Auditor, federal officials, and/or any third party authorized by law or contract, in any audit conducted by such party pertaining to any Contracts that Eligible Purchaser has made purchases from pursuant to this Agreement, including providing records related to any purchases from such Contracts.

  • Desk Audits The Department or its designee may monitor compliance of financial records by desk audits. Audits may be supplemented by phone interviews with financial staff in the juvenile probation department, county auditor’s office, and county treasurer’s’ office. Findings will result in a performance rating profile report or a Non - Compliance Citation Report (NCCR). Grantee shall ensure its agents comply with all requests for information during the course of the audit.

  • Inspections The Servicer shall inspect the Mortgaged Property as often as deemed necessary by the Servicer in accordance with Accepted Servicing Practices to assure itself that the value of the Mortgaged Property is being preserved. In addition, if any Mortgage Loan is more than 45 days delinquent, the Servicer promptly shall inspect the Mortgaged Property and shall conduct subsequent inspections in accordance with Accepted Servicing Practices or as may be required by the primary mortgage guaranty insurer. Upon request, the Servicer shall produce an electronic report of each such inspection.

  • RECORD RETENTION AND INSPECTION/AUDIT SETTLEMENT The Contractor shall maintain accurate and complete financial records of its activities and operations relating to this Contract in accordance with generally accepted accounting principles. The Contractor shall also maintain accurate and complete employment and other records relating to its performance of this Contract. The Contractor agrees that the County, or its authorized representatives, shall have access to and the right to examine, audit, excerpt, copy, or transcribe any pertinent transaction, activity, or record relating to this Contract. All such material, including, but not limited to, all financial records, bank statements, cancelled checks or other proof of payment, timecards, sign-in/sign-out sheets and other time and employment records, and proprietary data and information, shall be kept and maintained by the Contractor and shall be made available to the County during the term of this Contract and for a period of five (5) years thereafter unless the County’s written permission is given to dispose of any such material prior to such time. All such material shall be maintained by the Contractor at a location in Los Angeles County, provided that if any such material is located outside Los Angeles County, then, at the County’s option, the Contractor shall pay the County for travel, per diem, and other costs incurred by the County to examine, audit, excerpt, copy, or transcribe such material at such other location.

  • INSPECTION/TESTING All Products sold pursuant to this Agreement will be subject to inspection/testing by or at the direction of H- GAC and/or the ordering Customer, either at the delivery destination or the place of manufacture. In the event a Product fails to meet or exceed all requirements of this Agreement, and unless otherwise agreed in advance, the cost of any inspection and/or testing, will be the responsibility of the Contractor.

  • OIG INSPECTION, AUDIT, AND REVIEW RIGHTS ‌ In addition to any other rights OIG may have by statute, regulation, or contract, OIG or its duly authorized representative(s) may conduct interviews, examine or request copies of Xxxxxx’x books, records, and other documents and supporting materials and/or conduct on-site reviews of any of Xxxxxx’x locations for the purpose of verifying and evaluating: (a) Xxxxxx’x compliance with the terms of this IA and (b) Xxxxxx’x compliance with the requirements of the Federal health care programs. The documentation described above shall be made available by Xxxxxx to OIG or its duly authorized representative(s) at all reasonable times for inspection, audit, and/or reproduction. Furthermore, for purposes of this provision, OIG or its duly authorized representative(s) may interview Xxxxxx and any of Xxxxxx’x employees or contractors who consent to be interviewed at the individual’s place of business during normal business hours or at such other place and time as may be mutually agreed upon between the individual and OIG. Xxxxxx shall assist OIG or its duly authorized representative(s) in contacting and arranging interviews with such individuals upon OIG’s request. Xxxxxx’x employees and contractors may elect to be interviewed with or without a representative of Xxxxxx present.

  • Independent Review and Inspection The Owner may undertake independent inspection of the installation of the Work. Such independent inspector shall operate on behalf of the Owner and shall act to protect the best interests of the Owner.

  • Independent Audits The Department staff shall review annual independent audits for adherence to generally accepted auditing principles and to the Department’s audit instructions. Incomplete or incorrect audits may be returned to the Grantee for correction.

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