Implementation of Quality Control and Risk Management Program Sample Clauses

Implementation of Quality Control and Risk Management Program. At all times during the Term, Supplier shall comply with SI-BONE’s vendor qualification requirements (“Qualification Requirements”), a copy of which has been provided to Supplier. In addition, Supplier shall maintain and comply with a quality control program that conforms with all applicable laws and is consistent with current good manufacturing practices applicable to Products (“GMPs”) and as effective during the remainder of the Term and as required by any governmental or quasi-governmental agency having regulatory authority over the Products, including, without limitation, 21 CFR Part 820, the current released versions of ISO 13485 and 14971 (collectively, the “Quality Management System”). In addition, Supplier shall maintain a risk management system which is integrated into its Quality Management System (the “RMS”). Supplier shall notify SI-BONE of revisions to its manufacturing procedures to the extent necessary to remain in compliance with the Qualification Requirements, GMPs or RMS, as applicable, in accordance with this Section 4.3; provided, however, that Supplier may not make any changes to its manufacturing procedures that are inconsistent with the Specifications without the prior written consent of SI-BONE. Upon SI-BONE’s request, Supplier will provide a copy of such quality agreement(s).
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Implementation of Quality Control and Risk Management Program. At all times during the Term, Supplier shall submit to and comply with Company’s vendor qualification requirements, as Company may establish from time to time (“Qualification Requirements”). In addition, Supplier shall maintain and comply with a quality control program that conforms with all applicable laws and is consistent with current good manufacturing practices applicable to Products (“GMPs”) and as required by any governmental or quasi-governmental agency having regulatory authority over the Products, including, without limitation, 21 CFR Part 820, the current released versions of ISO 13485 and 14971 and the Medical Device Directive 93/42/EEC or Medical Device Regulation (MDR EU 2017/745) (collectively, the “Quality Management System” or “QMS”). In addition, Supplier shall maintain a risk management system which is integrated into its QMS. Supplier shall notify Company of revisions to its manufacturing procedures to the extent necessary to remain in compliance with the Qualification Requirements, GMPs or QMS, as applicable, in accordance with this Section; provided, however, that Supplier may not make any changes to its manufacturing procedures that are inconsistent with the Specifications without the prior written consent of Company. Supplier shall also have a quality agreement with each Approved Vendor and Approved Subcontractor. Upon Company’s request, Supplier will provide a copy of such quality agreement(s).
Sample 1
Implementation of Quality Control and Risk Management Program. At all times during the Term, Supplier shall submit to and comply with SI-BONE’s vendor qualification requirements, including ISO 13485 certification, FDA registration, the requirements set forth in this Section 4.3, and such other reasonable requirements that SI-BONE may establish from time to time (“Qualification Requirements”). In addition, Supplier shall maintain and comply with a quality control program that conforms with all applicable laws and is consistent with current good manufacturing practices applicable to Products (“GMPs”) and is effective during the remainder of the Term and as required by any governmental or quasi-governmental agency having regulatory authority over the Products, including, without limitation, 21 CFR Part 820, the current released versions of ISO 13485 and 14971, the Medical Device Directive 93/42/EEC and the Medical Device Regulation (MDR EU 2017/745) , and shall establish and maintain procedures for identifying with a control number each unit, lot, or batch of “finished Products” and where appropriate components of such “finished Products” (collectively, the “Quality Management System”). In addition, Supplier shall maintain a risk management system (the “RMS”) which is integrated into its Quality Management System (the “QMS”). Supplier shall notify SI-BONE of revisions to its manufacturing procedures to the extent necessary to remain in compliance with the Qualification Requirements, GMPs or RMS, as applicable, in accordance with this Section 4.3; provided, however, that Supplier may not make any changes to its manufacturing procedures that are inconsistent with the Specifications without the prior written consent of SI-BONE. Supplier shall also have a quality agreement with each Approved Vendor and Approved Subcontractor. Upon SI-BONE’s request, Supplier will provide a copy of such quality agreement(s).
Sample 1

Related to Implementation of Quality Control and Risk Management Program

  • Quality Control A. Controlled Affiliate agrees to use the Licensed Marks and Name only in connection with the licensed services and further agrees to be bound by the conditions regarding quality control shown in attached Exhibit A as they may be amended by BCBSA from time-to-time.

  • Compliance Control Services (1) Support reporting to regulatory bodies and support financial statement preparation by making the Fund's accounting records available to the Trust, the Securities and Exchange Commission (the “SEC”), and the independent accountants.

  • Money Market Fund Compliance Testing and Reporting Services Subject to the authorization and direction of the Trust and, in each case where appropriate, the review and comment by the Trust’s independent accountants and legal counsel, and in accordance with procedures that may be established from time to time between the Trust and the Administrator, the Administrator will:

  • Program Management (WBS 1.1) All components of the Project Management Plan as implemented for the Base Contract and Options 1-4 will be reviewed and amended to reflect specific needs for Option 5 and the outcome of continuous process improvement evaluations.

  • Quality Control Procedures The Seller must have an internal quality control program that verifies, on a regular basis, the existence and accuracy of the legal documents, credit documents, property appraisals, and underwriting decisions. The program must be capable of evaluating and monitoring the overall quality of its loan production and servicing activities. The program is to ensure that the Mortgage Loans are originated and serviced in accordance with prudent mortgage banking practices and accounting principles; guard against dishonest, fraudulent, or negligent acts; and guard against errors and omissions by officers, employees, or other authorized persons.

  • Investment Analysis and Implementation In carrying out its obligations under Section 1 hereof, the Advisor shall:

  • Maintenance Program LESSEE's Maintenance Program

  • ANALYSIS AND MONITORING The Custodian shall (a) provide the Fund (or its duly-authorized investment manager or investment adviser) with an analysis of the custody risks associated with maintaining assets with the Eligible Securities Depositories set forth on Schedule B hereto in accordance with section (a)(1)(i)(A) of Rule 17f-7, and (b) monitor such risks on a continuing basis, and promptly notify the Fund (or its duly-authorized investment manager or investment adviser) of any material change in such risks, in accordance with section (a)(1)(i)(B) of Rule 17f-7.

  • Sub-Advisor Compliance Policies and Procedures The Sub-Advisor shall promptly provide the Trust CCO with copies of: (i) the Sub-Advisor’s policies and procedures for compliance by the Sub-Advisor with the Federal Securities Laws (together, the “Sub-Advisor Compliance Procedures”), and (ii) any material changes to the Sub-Advisor Compliance Procedures. The Sub-Advisor shall cooperate fully with the Trust CCO so as to facilitate the Trust CCO’s performance of the Trust CCO’s responsibilities under Rule 38a-1 to review, evaluate and report to the Trust’s Board of Trustees on the operation of the Sub-Advisor Compliance Procedures, and shall promptly report to the Trust CCO any Material Compliance Matter arising under the Sub-Advisor Compliance Procedures involving the Sub-Advisor Assets. The Sub-Advisor shall provide to the Trust CCO: (i) quarterly reports confirming the Sub-Advisor’s compliance with the Sub-Advisor Compliance Procedures in managing the Sub-Advisor Assets, and (ii) certifications that there were no Material Compliance Matters involving the Sub-Advisor that arose under the Sub-Advisor Compliance Procedures that affected the Sub-Advisor Assets. At least annually, the Sub-Advisor shall provide a certification to the Trust CCO to the effect that the Sub-Advisor has in place and has implemented policies and procedures that are reasonably designed to ensure compliance by the Sub-Advisor with the Federal Securities Laws.

  • Account Management A. The repayment account opened by the Borrower with the Lender (the account stipulated in Article 5) is a special capital withdrawal account, which is used to collect the corresponding sales revenue or the planned repayment fund. Where the corresponding sales revenue is settled in a non-cash manner, the Borrower shall ensure that it will be promptly transferred into the capital withdrawal account upon receipt.

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