Change Audits Sample Clauses

The Change Audits clause establishes the right for one party to review and verify any modifications or changes made to a system, process, or set of records. In practice, this clause typically allows for scheduled or ad hoc inspections, where the auditing party can examine documentation, logs, or other evidence of changes to ensure compliance with agreed standards or procedures. Its core function is to provide transparency and accountability, helping to detect unauthorized or improper changes and thereby reducing the risk of errors or misconduct.
Change Audits. 3.13.1. These audits shall be performed for checking if the changes made for the quality management system by the company are performed effectively and if the system that is changed continues to conform to the requirements of (EU) 2017/745 Regulation. The company shall inform SZUTEST Konformitätsbewertungsstelle GmbH for all of the changes that may affect the quality management system.
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Change Audits. 2.15.1. These audits shall be performed for checking if the changes made for the quality management system by the company are performed effectively and if the system that is changed continues to conform to the requirements of 93/42/EEC and ISO 13485. The company shall inform SZUTEST for all of the changes that may effect the quality management system. 2.15.2. As of 26 May 2021, in accordance with Article 120(3) of the (EU) 2017/745 Regulation, in case manufacturer with CE certificate issued by SZUTEST within the scope of the 93/42/ EEC Medical Device Directive (MDD) wants to make significant changes in the design and intended use of the certified device; SZUTEST shall not accept these change assessment requests. Manufacturer with CE Certificate within the scope of the 93/42/EEC Medical Device Directive are required to adapt MDCG 2020-3 guidance document into their quality management system and take it into account when they plan to make changes to the certified device.
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Related to Change Audits

  • Payment Audit Records of costs incurred under terms of the Contract will be maintained in accordance with section 8.3 of these Special Contract Conditions. Records of costs incurred will include the Contractor’s general accounting records, together with supporting documents and records of the Contractor and all subcontractors performing work, and all other records of the Contractor and subcontractors considered necessary by the Department, the State of Florida’s Chief Financial Officer, or the Office of the Auditor General.

  • Annual Audit If Subrecipient expends Federal funds in a fiscal year which equal or exceed $750,000 (seven hundred fifty thousand dollars) as specified in OMB Circular A-133-Revised, 2 CFR Part 200.500- Subpart F-Audit Requirements Subrecipient shall cause an audit to be prepared by a Certified Public Accountant (CPA) who is a member in good standing with the American Institute of Certified Public Accountants (AICPA) of the California Society of CPA’s. The audit must be performed annually in accordance with Generally Accepted Auditing Standards (GAAS) authorized by the AICPA and Federal laws and regulations governing the programs in which it participates. Furthermore, County retains the authority to require Subrecipient to submit similarly prepared audit at Subrecipient’s expense even in instances when Subrecipient’s expenditure is less than $750,000. Subrecipient will be required to identify corrective action taken in response to any findings identified by CPA related to their funded activity or program. Subrecipient will ensure an annual financial audit is performed in compliance with the Federal Single Audit Act and will submit two (2) copies of such audit report, including a copy of the management letter, to County within six (6) months of the end of each Contract year in which Subrecipient has received federal funding (i.e., July 1 – June 30). Failure to meet this requirement may result in County denying reimbursement of funds to Subrecipient, as well as future funding qualification. Subrecipients, which are exempt from statutory audit requirements, shall maintain records, which are available for review by County or Federal officials. Subrecipient acknowledges that any and all “Financial Statements” submitted to County pursuant to this County become Public Records and are subject to public inspection pursuant to Sec. 6250 et seq. of the California Government.