Quality System Requirements. The Device has the following classifications for FDA, CMDR, and MDD classification. Resection Device II III IIb
Quality System Requirements. Quality system requirements are specified as part of 21 CFR Part 820, Quality System Regulation.
Quality System Requirements. Health Canada requires manufacturers of Class II, III and IV device to demonstrate that their devices are manufactured in accordance with internationally recognized standards. Demonstration of compliance with the quality system requirements will be required at the time an application is made for a medical device license.
Quality System Requirements. Bovie Medical Corporation (“Bovie”) has been certified to ISO13485
Quality System Requirements. 7.1. Manufacturer shall obtain and maintain all registrations and approvals necessary to manufacture Customer’s Product. Manufacturer must remain compliant with the requirements set forth in 21 U.S.C. § 360J (f), 21 C.F.R. § 820, all related guidance issued by the FDA, ISO 13488 and/or ISO 13485 (collectively, “Good Manufacturing Practices”). Manufacturer’s performance of this Agreement shall be in compliance with these Good Manufacturing Practices.
7.2. Manufacturer agrees to permit Customer or its authorized representative, and government officials as required by law, to conduct inspections and test audits of Manufacturer’s facilities, operations, and procedures, at appropriate and reasonable time intervals, to verify that the quality and performance of the Product produced by Manufacturer are in compliance with the Company’s Product Specifications. The Company may also inspect the facilities of Manufacturer at any time during business hours to ensure compliance with Good Manufacturing Practices. Manufacturer shall cooperate with any inspection performed under this section.
7.3. Manufacturer agrees to make appropriate Manufacturer personnel available for audits at either Customer’s or Manufacturer’s offices. All reasonable expenses related to the conduct of inspection and test audits of the Product and/or Quality System (as defined below in Section 7.6) by Customer or, if Customer so chooses, a qualified third party, that are directly and specifically related to Customer’s Product shall be borne by Customer. Such audits and inspections must take place during normal business hours and with reasonable notice.
7.4. If the facilities or processes of Manufacturer are inspected or audited by any regulatory agency such as but not limited to the FDA, OHSA, EPA, or ISO Registrar, Manufacturer will immediately inform Customer of that fact and of all findings of such agency that relate to or affect the Product or Device Master Record, which includes all information necessary to produce the Product.
7.5. Manufacturer shall maintain a complete and current Device Master Record for Customer’s Product. Copies of the Device Master Record shall be made available to Customer at Customer’s request. Customer shall have the right from time to time to request that changes be made to the Device Master Record. Changes to the Device Master Record are to be communicated formally by the Customer’s change order and will be subject to Manufacturer’s acceptance, which acceptance shall...
Quality System Requirements. Seller shall provide within their quality management systems, as a minimum, provisions to comply with the following ISO 9001/AS9100 clauses:
Quality System Requirements. 3.1.1. CM will maintain an FDA registered facility and ISO 13485 quality system certified by a Notified Body or CMDCAS Registrar for the manufacture of Products.
Quality System Requirements. The contractor shall establish, maintain, and operate a quality system in accordance with ISO 9001:2015, or an equivalent quality system. The contractor shall provide the Government an overview of their quality management system plan and approach as a briefing at the PAC, to include FWS-I unique areas. Quality Assurance, including reliability shall be addressed at each contractually required review, to include Statistical Process Control (SPC), Pareto charts and other metrics employed by the prime contractor and their major suppliers to control critical processes. The contractor shall maintain a calibration system in accordance with ANSI/NCSL Z540.3-2006, ISO 10012-2003, or equivalent to ensure that all test/inspection, measurement, and diagnostic equipment, including all accessories and ancillary test equipment, are properly calibrated, identified by appropriate labeling, and are traceable to national measurement standards.
Quality System Requirements. Both Parties agree to the following listed responsibilities for all the operations that are marked with “√ “ in the respective column that bears their name. 1.1 [***]
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Quality System Requirements. It is expected that Xxxxx supplier shall have basic minimum quality management system implemented which is ISO 9001:2015 by accredited certification body or any other system approved by Xxxxx. Unless otherwise specified by Xxxxx following sequence shall be applied to achieve this requirement
1. Compliance to ISO 9001:2015 through second-party audit
2. Compliance to ISO 9001:2015 through third-party audit Supplier shall ensure that ISO 9001:2015 certification shall have the accreditation xxxx of recognized IAF MLA (International Accreditation Forum Multilateral Recognition Arrangement) member and where the accreditation body’s main scope includes management system certification to ISO/IEC 17021. It is recommended to have IATF 16949:2016 certification which will be added advantage to supplier.
