Quality Systems Requirements. Supplier must maintain a defined Quality System for Product measurement and evaluation throughout the manufacturing process. The Quality System shall monitor incoming material control, work-in-process and final Product and packaging. The Quality System shall include:
Quality Systems Requirements. 4.1.1. Alcatel requires that all Sellers shall have a Quality System that, at a minimum, is compliant to the requirements of ISO-9000. The Seller shall complete and forward a soft (or paper) copy of Alcatel’s Supplier Information & Audit Report (SIAR). Note that this document is based on TL-9000 and is to be used as both the Seller’s internal self-assessment, and the basis for any future on-site Quality System audit. Since Alcatel is a TL-9000 certified company, Alcatel’s objective is for its telecommunication suppliers to adopt the TL9000 requirement for their products and service *****.
Quality Systems Requirements. Seller will establish and maintain formal quality systems and processes that are compliant with the FDA's Quality System Regulation ("QSR") and ISO 13485, and shall use its commercially reasonable efforts to ensure that all of Seller's Suppliers are compliant therewith to the extent that compliance by such Suppliers is required thereunder. Such systems and processes will be provided and maintained at all times during the term of this Agreement by Seller and, to the extent reasonably practicable, all Suppliers to the extent required under the QSR and/or ISO 13485. Any and all special quality system requirements for the Products shall be provided by or agreed to by Buyer via the Specifications for the Product or as subsequently changed via Seller's ECO processes, in writing, at the time of Purchase Order. Seller will inform Buyer and obtain prior approval in accordance with Seller's ECO process, as described under Section 1.4, for any changes to be made, including changes with respect to Seller's Suppliers, that can affect the form, fit or function of the Products.
Quality Systems Requirements. Minnetronix will establish and maintain formal quality systems and processes that are compliant with the QSR (21 CFR 820) and ISO 13485. Such systems and processes will be provided and maintained by Minnetronix. Special quality system requirements for a Product, if any, shall be reflected in the Specifications for the Product at the time of placement of a Purchase Order, or as subsequently changed by the parties in writing via Minnetronix’ ECO process. Minnetronix will inform Client and obtain prior approval for any changes to be made that can affect the quality of the Products.
Quality Systems Requirements. The SCT shall use a MIL-Q-9858 or ISO 9000 series quality program. The SCT shall provide and maintain a quality system, as an integral part of the CDTF operations, that meets the requirements of the USACDRA Quality Assurance Program Plan (QAPP) (Section J CSDP Attachment 13) and the higher level quality assurance requirements identified in Section E and Section J Attachment 14 CDTF Sampling Plan. The quality systems procedures, planning and all other documentation and data that comprise the quality system shall be made available to the Government for review. The SCT shall examine the existing quality documentation including c-24 the Quality Assurance Plan, all procedures and plans. The Government may perform any inspections to ascertain conformance to the requirements and the adequacy of the implementing procedures. The SCT shall require their sub-tier contractors to have a quality system achieving control of the quality of the services, equipment and supplies in this contract. The Government reserves the right to disapprove or reject the quality system or any portion(s) when it fails to meet its contractual requirements. The SCT shall obtain written authorization/approval from the Contracting Officer prior to implementing any changes to the approved Quality Plan
Quality Systems Requirements. Seller will establish and maintain formal quality systems and processes that are compliant with the FDA's Quality System Regulation ("QSR") and ISO 13485. Such systems and processes will be provided and maintained by Seller. Any and all special quality system requirements for the Products shall be provided by or agreed to by Buyer via Specifications for the Product or as subsequently changed via Seller's Engineering Change Order process, in writing, at the time of Purchase Order. Seller will inform Buyer and obtain prior approval for any changes to be made that can affect the quality of the Products (hereafter referenced as "major revision; for "major revision" defined see Section 5.2 below").
Quality Systems Requirements. Seller will establish and maintain formal quality systems and processes that are compliant with the FDA’s Quality System Regulation (“QSR”) and ISO 13485. Such systems and processes will be provided and maintained by Seller. Any and all special quality system requirements for the Products shall be provided by or agreed to by Buyer via Specifications for the Product or as subsequently changed via Seller’s Engineering Change Order process, in writing, at the time of Purchase Order. Seller will inform Buyer and obtain prior approval for any changes to be made that can affect the quality of the Products.
Quality Systems Requirements. MICROPORT will maintain a quality system which satisfies LOMBARD’s existing manufacturing processes with other vendors and/or subcontractors and will be in compliance with regulations of FDA, CFDA and/or ISO 13485 standards (where applicable) , remaining subject to periodic audit by LOMBARD. In the event that these regulations are modified, amended, or otherwise updated, MICROPORT will modify, amend, or otherwise update and maintain a quality system in accordance therewith.
Quality Systems Requirements. 11.1.1. On or before the Commercial Launch Date, the parties shall enter into a form of Quality Agreement and upon execution of the Quality Agreement, it will attach hereto as Exhibit G.
Quality Systems Requirements. Supplier will maintain strict quality control criteria and maintain quality system regulations consistent with industry standards and a Product Quality Agreement, (the “Quality Agreement” executed by the Parties and incorporated herein by reference), including but not limited to the current revision of all applicable Quality Management System Regulations and/or Standards, including international industry standards such as, but not limited to, ISO 13485, Medical Device Quality Management, 21 CFR 820 and/or are registered as a medical device manufacturer. During the Term, Buyer may from time to time require changes to Supplier’s quality system that are necessary to ensure Supplier’s quality system complies with applicable law, as determined by Buyer. In accordance with Section 9.2 herein, Supplier shall ensure compliance with laws in the place of manufacture and Buyer shall be responsible for identifying and instructing Supplier on compliance with laws that may be applicable outside of the place of manufacture. Supplier shall effectuate such change in a commercially reasonable period of time. Supplier shall not make any material change to Supplier’s quality system, including without limitation Supplier’s Assembly Process and Supplier’s Assembly Process Failure Modes and Effects Analysis, without Buyer’s prior, written approval. Any material changes to the Specifications or Supplier’s quality system shall be reported to Buyer’s quality department by sending written notice to Buyer (attention: VP of Quality) at least [***] prior to the implementation of any such change. For purposes of this Section, a material change to either the Specifications or Supplier’s quality system shall mean any change that could have a material adverse effect on the safety or efficacy of the Product(s) or Device, or that would be reasonably likely to have a material effect on the proper integration of the Product(s) and Device. Examples of material changes include, but are not limited to, the following: • ISO Certifications or CE Marking status changes as applicable; • Specification changes for supplemental manufacturing processes, equipment, or materials, and • FDA registration status changes or any other required domestic or international registration or license status changes, as applicable.
