Quality System Regulation Sample Clauses

Quality System Regulation. Lake Region warrants that it will manufacture the Product in accordance with current Quality System Regulations (“QSR”) for medical devices as mandated by the FDA and in compliance with International Standard ISO 13485 and with any and all other applicable federal, state and local laws, rules, and regulations.
AutoNDA by SimpleDocs
Quality System Regulation. To the Knowledge of Seller, the Company has designed and developed the LipoSonix Product and all other Products in commercial distribution in material compliance with the applicable provisions of the Quality System Regulation set forth in 21 C.F.R. § 820.30, including Design Control provisions.
Quality System Regulation. The Supplier and the Customer shall each maintain a Quality Management System (QMS) that conforms to the requirements of the FDA’s Quality System Regulation (QSR) as stated in 21 CFR Part 820. Should the Supplier determine that a requirement of 21 CFR Part 820 is not appropriate or not applicable to the product delivered, the Supplier shall notify the Customer within thirty days of making that determination. The list of agreed not appropriate or not applicable requirements is shown in Appendix 1.
Quality System Regulation. The Customer shall maintain a Quality Management System (QMS) that conforms to the requirements of EN ISO 13485:2003. Supplier is NOT required to meet EN ISO 13485, but is required to meet ISO 9001:2015 and the requirements specified in this Quality Agreement.

Related to Quality System Regulation

  • Quality Standards Each Party agrees that the nature and quality of its products and services supplied in connection with the other Party's Marks will conform to quality standards set by the other Party. Each Party agrees to supply the other Party, upon request, with a reasonable number of samples of any Materials publicly disseminated by such Party which utilize the other Party's Marks. Each Party will comply with all applicable laws, regulations, and customs and obtain any required government approvals pertaining to use of the other Party's marks.

  • Contract Work Hours and Safety Standards Act The following clauses apply to any Federal-aid construction contract in an amount in excess of $100,000 and subject to the overtime provisions of the Contract Work Hours and Safety Standards Act. These clauses shall be inserted in addition to the clauses required by 29 CFR 5.5(a) or 29 CFR 4.6. As used in this paragraph, the terms laborers and mechanics include watchmen and guards.

  • CONTRACT WORK HOURS AND SAFETY STANDARDS As per the Contract Work Hours and Safety Standards Act (40 U.S.C. 3701-3708), where applicable, all Customer Purchase Orders in excess of ,000 that involve the employment of mechanics or laborers must include a provision for compliance with 40 U.S.C. 3702 and 3704, as supplemented by Department of Labor regulations (29 CFR Part 5). Under 40 U.S.C. 3702 of the Act, each contractor must be required to compute the wages of every mechanic and laborer on the basis of a standard work week of 40 hours. Work in excess of the standard work week is permissible provided that the worker is compensated at a rate of not less than one and a half times the basic rate of pay for all hours worked in excess of 40 hours in the work week. The requirements of 40 U.S.C. 3704 are applicable to construction work and provide that no laborer or mechanic must be required to work in surroundings or under working conditions which are unsanitary, hazardous or dangerous. These requirements do not apply to the purchases of supplies or materials or articles ordinarily available on the open market, or contracts for transportation or transmission of intelligence.

  • Quality Service Standards Price Services and the Fund may from time to time agree to certain quality service standards, as well as incentives and penalties with respect to Price Services’ Services hereunder.

  • Quality Management System Supplier hereby undertakes, warrants and confirms, and will ensue same for its subcontractors, to remain certified in accordance with ISO 9001 standard or equivalent. At any time during the term of this Agreement, the Supplier shall, if so instructed by ISR, provide evidence of such certifications. In any event, Supplier must notify ISR, in writing, in the event said certification is suspended and/or canceled and/or not continued.

  • System Requirements Apple Software is supported only on Apple-branded hardware that meets specified system requirements as indicated by Apple.

  • Alcohol and Drug-Free Workplace City reserves the right to deny access to, or require Contractor to remove from, City facilities personnel of any Contractor or subcontractor who City has reasonable grounds to believe has engaged in alcohol abuse or illegal drug activity which in any way impairs City's ability to maintain safe work facilities or to protect the health and well-being of City employees and the general public. City shall have the right of final approval for the entry or re-entry of any such person previously denied access to, or removed from, City facilities. Illegal drug activity means possessing, furnishing, selling, offering, purchasing, using or being under the influence of illegal drugs or other controlled substances for which the individual lacks a valid prescription. Alcohol abuse means possessing, furnishing, selling, offering, or using alcoholic beverages, or being under the influence of alcohol.

  • Quality Requirements Performance Indicator Heading Indicator (specific) Threshold Method of Measurement Frequency of monitoring Consequence of Breach QUALITY Patient Safety - Incidents I1 Number of incidents Adverse incidents include the following: clinical or non clinical adverse events that have potential to cause avoidable harm to a patient, including medical errors or adverse events related to medical devices or other equipment. Clinical or non- clinical accidents, accidental injuries to staff and members of the public, verbal, physical or psychological abuse or harassment, unusual or dangerous occurrences, damage to trust property, plant or equipment, fire or flood, security, theft or loss, near misses are identified as any event where under different circumstances significant injury or loss may have occurred Number of recorded incidents in the contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed I2 Number of Sis Definition of SUI according to trust policy and national guidance Number of Serious Untoward Incidents reported in contract month Monthly Remedial Action Plan brought to Performance Meeting following breach; action under Module C Clause 32 if needed S1 Percentage of eligible staff received child safeguarding training at level 2 (as identified in LSCB training strategy) 95% Number received training/ Number of identified staff requiring training Monthly S2 Percentage of eligible staff received adult safeguarding awareness training at level 2 ( as identified in K&M Safeguarding Vulnerable Adults training strategy) 95% Number of staff trained/ Number of identified staff requiring training Monthly

  • Technical Regulations 1. The rights and obligations of the Parties in respect of technical regulations, standards and conformity assessment shall be governed by the WTO Agreement on Technical Barriers to Trade.

  • Alcohol and Drug Testing Employee agrees to comply with and submit to any Company program or policy for testing for alcohol abuse or use of drugs and, in the absence of such a program or policy, to submit to such testing as may be required by Company and administered in accordance with applicable law and regulations.

Time is Money Join Law Insider Premium to draft better contracts faster.