Quality System Requirements definition

Quality System Requirements means the quality requirements for Factories, as determined and amended from time to time by the Board, the version thereof in force as at the Signature Date being annexed hereto as Annexure “B”.

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Quality System Requirements. The Contractor shall provide and maintain a quality system that, as a minimum, adheres to the requirements of ANSI/ASQC Q9001-1994 Quality Systems-Model for Quality Assurance in Design/Development, Production, Installation, and Servicing and supplemental requirements imposed by this contract. The quality system procedures, planning, and all other documentation and data that comprise the quality 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 system achieving control of the quality of the services and/or supplies provided. The Government reserves the right to disapprove the quality system `* portions thereof when it fails to meet the contractual requirements. USE OF CONTRACTOR'S INSPECTION EQUIPMENT (NAVSEA) (MAY 1995) (5616)

Quality System Requirements. Quality System Requirements includes those standard operating procedures ("SOP's") and other policies and procedures issued from time to time by Symphonix to enable compliance by Symphonix and Distributor with Regulatory Requirements, the Symphonix Quality System and with good business practices. "Regulatory Requirements" Regulatory Requirements include those laws, regulations, standards, guidelines that are applicable or become applicable during the Term of this Agreement to the distribution of the Products in the Territory as set forth on Exhibit D, which exhibit may be changed from time to time during the Term.

Examples of Quality System Requirements in a sentence

In addition, Seller shall comply with all quality requirements and procedures specified by Buyer, as the same may be revised from time to time, including those applicable to Seller as set forth in Quality System Requirements QS-9000.
Each Party shall ensure that its Listed Inspection Service maintains a Quality System in compliance with the current PIC/S Quality System Requirements for Pharmaceutical Inspectorates.
The Business is in material compliance with all applicable Laws enforced by FDA or foreign Governmental Authorities, including with respect to labeling, establishment registration, device listing, Quality System Requirements submission of Medical Device Reports, submission of reports of corrections and removals, marketing and promotion, and conducting clinical studies or investigations.
Each Party's quality program will be in accordance with the current revision of HP's Supplier Quality System Requirements.
Distributor shall assist SynCardia in complying with applicable Quality System Requirements as detailed by (i) U.S. FDA, (ii) European Union (CE Marked) or (iii) the regulatory governing body within the Distributor’s country(ies) of origin in the Territory, as amended from time to time.
Seller agrees to participate in Buyer’s supplier quality and development program(s) and to comply with all quality requirements and procedures specified by Buyer, as revised from time to time, including those applicable to Seller as set forth in Quality System Requirements QS-9000.
Fulfilment of the MAQMSR requirements (Minimum Automotive Quality System Requirements for Sub-Tier Suppliers) is the first step towards the IATF 16949 certificate.
Seller agrees to participate in Buyer’s supplier quality and development program(s) and to comply with all quality requirements and procedures specified by Buyer, as revised from time to time, including those applicable to Seller as set forth in Quality System Requirements ISO 9001:2015.
Manufacturer shall manufacture, prepare, store and label according to procedures set forth on Schedule C, Manufacturer Quality System Requirements, Testing and Records.
UBS shall establish a Quality Plan being a controlled document defining Quality System Requirements set-forth in this agreement and the details of how UBS shall fulfill these requirements.

More Definitions of Quality System Requirements

Quality System Requirements means those system requirements for assuring quality set forth in Exhibit B.

Quality System Requirements means current Good Manufacturing Practices; the then-current good manufacturing practices and standards for the manufacture, testing, filling and/or preparation for delivery of drug substance pursuant to (a) the U.S. Federal Food, Drug and Cosmetics Act as amended (21 USC 301 et seq.), (b) relevant U.S. regulations found in Title 21 of the U.S. Code of Federal Regulations (including but not limited to Parts 11, 210, 211, and (c) the EC Guide to Good Manufacturing Practice for Medicinal Drug Products, including respective guidance documents and any comparable laws, rules or regulations of any of the above jurisdictions, as each may be amended from time to time. cGMP also includes adherence to any applicable product license requirements, to the current requirements of the United States Pharmacopoeia/National Formulary, the current requirements of the European Pharmacopoeia and the relevant current International Conference on Harmonization (ICH) guidance documents, including without limitation the ICH Guidance Q7 Good Manufacturing Practices Guidance for Active Pharmaceutical Ingredients and including the Japanese Pharmaceutical Affairs Law (PAL) in the cGMP, all as applicable.

Quality System Requirements means the requirements related to the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management for the manufacturing of medical devices, as set forth in 21 C.F.R. Part 820 and relevant international standards for quality management systems, including ISO 13485.