Quality Management System Requirements Sample Clauses
The Quality Management System Requirements clause establishes the standards and procedures an organization must follow to ensure consistent quality in its products or services. It typically mandates the implementation of documented processes, regular audits, and continuous improvement measures, often referencing recognized frameworks such as ISO 9001. By setting clear expectations for quality control and accountability, this clause helps organizations minimize defects, meet customer requirements, and maintain compliance with industry regulations.
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Quality Management System Requirements. Supplier shall establish and maintain a Quality Management System that is appropriate for the activities for which the party is responsible under this Quality Agreement. Products supplied under this Quality Agreement shall be manufactured in accordance with a Quality Management System compliant with: • ISO 13485, including both EN (European) and Canadian CMDCAS, as necessary. • MDD Council Directive ▇▇/▇▇ ▇▇▇ and subsequent amendments, applicable annexes such as Annex II, V or VI, as necessary. • FDA 21 CFR, as applicable If certified, Supplier shall maintain the corresponding certificate issued by the accredited certification body. Upon request, Supplier shall provide Buyer copies of such certificates free of charge. Supplier shall notify Buyer of changes to the status of Supplier certificates that affect the status of any product or Quality System certification. Except as may be stated below, Supplier shall bear all costs associated with compliance with this section.
Quality Management System Requirements. The Contractor shall provide and maintain a quality management system that, as a minimum, adheres to the requirements of ANSI/ISO/ASQ 9001-2015 Quality Management Systems and supplemental requirements imposed by this contract. The quality management system procedures, planning, and all other documentation and data that comprise the quality management system shall be made available to the Government for review. Existing quality documents that meet the requirements of this contract may continue to be used. The Government may perform any necessary inspections, verifications, and evaluations to ascertain conformance to requirements and the adequacy of the implementing procedures. The Contractor shall require of subcontractors a quality management system achieving control of the quality of the services and/or supplies provided. The Government reserves the right to disapprove the quality management system or portions thereof when it fails to meet the contractual requirements.
Quality Management System Requirements. The Contractor shall provide and maintain a quality management system that, as a minimum, adheres to the requirements of ANSI/ISO/ASQ 9001-2015 Quality Management Systems and
Quality Management System Requirements. If applicable, requirements for a quality management system shall be specifically identified in the purchase order. If applicable, the identification and revision status of specifications, drawings, process requirements, inspection / verification instructions, and other relevant technical data shall be specifically identified in the purchase order. Seller agrees to flow down the requirements of this Purchase Order, General Terms and Conditions, and any other referenced or attached documents to the Seller’s sub-tier suppliers.
Quality Management System Requirements. Each Party shall establish and maintain a quality system that is appropriate for the activities for which the Party is responsible under this Quality Agreement and that is in substantial compliance with Quality Management System requirements.
Quality Management System Requirements. The Contractor shall provide and maintain a quality management system that, as a minimum, adheres to the requirements of ANSI/ISO/ASQ 9001-2015 Quality Management Systems and supplemental requirements imposed by this contract. The quality management system procedures, planning, and all other documentation and data that comprise the quality management system shall be made available to the Government for review. Existing quality documents that meet the requirements of this contract may continue to be used. The Government may perform any necessary inspections, verifications, and evaluations to ascertain conformance to requirements and the adequacy of the implementing procedures. The Contractor shall require of subcontractors a quality management system achieving control of the quality of the services and/or supplies provided. The Government reserves the right to disapprove the quality management system or portions thereof when it fails to meet the contractual requirements. Use of Contractor’s Inspection Equipment: The contractor's gages, and measuring and testing devices shall be made available for use by the Government when required to determine conformance with contract requirements. If conditions warrant, the contractor’s personnel shall be made available for operations of such devices and for verification of their accuracy and condition.
Quality Management System Requirements. The Contractor shall ensure that a Quality Management System is setup and fully maintained during the entire duration of the contract. The QMS shall comply with ISO 9001:2015.
Quality Management System Requirements. The Contractor shall provide and maintain a quality management system that, as a minimum, adheres to the requirements of ANSI/ISO/ASQ 9001-2015 Quality Management Systems and supplemental requirements imposed by this contract. The quality management system procedures, planning, and all other documentation and data that comprise the quality management system shall be made available to the Government for review. Existing quality documents that meet the requirements of this contract may continue to be used. The Government may perform any necessary inspections, verifications, and evaluations to ascertain conformance to requirements and the adequacy of the implementing procedures. The Contractor shall require of subcontractors a quality management system achieving control of the quality of the services and/or supplies provided. The Government reserves the right to disapprove the quality management system or portions thereof when it fails to meet the contractual requirements. HQ E-2-0017 USE OF CONTRACTOR’S INSPECTION EQUIPMENT (NAVSEA) (MAY 1995)
Quality Management System Requirements. The Quality Management System shall conform to the requirements and principles of the ISO 9001:2008 Standard and shall cover all activities, products and services related to the Project Work. The Quality Management System shall address the ISO 9001:2008 Standard’s eight principles of quality management:
(a) customer focused organization;
(b) leadership;
(c) involvement of people;
(d) process approach;
(e) system approach to management;
(f) continuous improvement;
(g) factual approach to decision making; and
(h) mutually beneficial supplier relationships.
Quality Management System Requirements. 4.14.1. The Employer's requirements for quality stem from the NNR Requirements Document RD-0034.
4.14.2. The Consultant shall establish a certified quality management system as stipulated in DSG 318- 087 [13].
4.14.3. The Consultant implements and maintains an effective, documented integrated Quality Management System adhering to the Eskom DSG 318-087 [13] (NNR RD-0034 [61]) requirements for managing the Scope of this contract in order to ensure both the quality and the effectiveness of the execution of Safety Factor Review tasks.
4.14.4. Any work sub-contracted by the Consultant shall also adhere to DSG 318-087 [13] requirements.
4.14.5. Contracted resources shall be appointed for specific work on the basis of their respective qualifications and experience, and shall be approved nuclear service providers, generally in accordance with the Eskom document DSG 318-087 [13].
4.14.6. Full details of all deviations from these specifications must be submitted to the Employer in writing for acceptance prior to development, production or delivery of the services.
4.14.7. The Consultant informs the Employer in writing of any proposed changes to the quality management system, staff or resources that will affect the execution of the services in order to obtain the Employer’s agreement prior to implementation of these changes.
4.14.8. Consultants shall be expected to work under a quality management system that is certified to the requirements of ISO 9001:2015 or its equivalent.
4.14.9. The Employer’s standard for Quality Plans (QPs) is ISO 10005. QPs are submitted to the Employer’s Agent for review and acceptance by the Employer. The Consultant obtains acceptance of the QPs from the Employer’s Agent prior to the commencement of work. The QPs shall be project, process or control plans as appropriate. Subsequent changes to the Employer approved QPs shall require the Employer’s agreement prior to the commencement of work involving an activity affected by such changes.
4.14.10. The Consultant ensures that all work is carried out in accordance with the QPs or any other specifications as per instructions from the Employer’s Agent and maintains evidence that confirms such compliance. All completed work is signed off in the QPs and all the relevant signatures are on the documentation. Requirements for QPs are further detailed in the KOU Specification Ref. No. DSG.
4.14.11. A list of applicable documents, as well as a QP, is compiled by the Consultant, prior to the starting dat...