Quality Management. CONTRACTOR shall establish and maintain a Clinical Quality Management program that maintains full compliance with the FDC rules and HSBs.
Quality Management. The supplier commits themselves to permanently deploying an effective quality management sys- tem, which is established according to its structure and company size on the basis of the current revision of EN/AS 9100 and which has been certified at least according to ISO 9001 in the valid edition. The requirements of the certification standard, supplemented by the requirements of these QAA, must be implemented in the Supplier's quality management system (QMS). The contents of this QAA include the requirements of the Buyer, EN/AS 9100 and the customer-specific additional requirements of the Buyer's major customers for the supplier's quality management system (see Annex 1 for information). Suppliers that are part of a vertically integrated manufacturing chain of the Purchaser's customer must have a customer approval (OEM) for services provided to the Buyer. If the final machining of ready-to-assemble parts for an OEM is involved, the supplier must be approved by the appropriate aviation authority (e. g. LBA, JAA, FAA) to issue an airworthiness certificate. The Supplier is obliged to support the awareness of his employees regarding product conformity, product safety and ethical behaviour. The necessary qualifications of the test and inspection per- sonnel (penetrant and ultrasonic inspectors) must be maintained through regular training measures.
Quality Management. Seller shall establish and maintain a quality management system acceptable to Insitu for the Goods purchased under this contract. Seller shall permit Insitu to review procedures, practices, processes and related documents to determine such acceptability. Seller shall have a continuing obligation to promptly notify Insitu of any violation of or deviation from Seller’s approved inspection/quality management system and to advise Insitu of the quantity and specific identity of any Goods delivered to Insitu during the period of any such violation or deviation.