![]() ![]() Printed copies are Reference Only of 13ĥ.5.2.d the organizational freedom to resolve matters pertaining to quality. Proprietary and Confidential -All rights reserved See notes made in ISO 9001 section above. The organization shall establish, document and maintain a configuration management process appropriate to the product.ĪS9100 is identical to ISO 9001 for this clause. Records shall be available for review by customers and regulatory authorities in accordance with contract or regulatory requirements. The documented procedure shall define the method for controlling records that are created by and/or retained by suppliers. ![]() The organization shall coordinate document changes with customers and/or regulatory authorities in accordance with contract or regulatory requirements. ImplementedĤ.2.2.b when referencing the documented procedures, the relationship between the requirements of this International Standard and the documented procedures shall be clearly shown. Customer and/or regulatory authorities’ representatives shall have access to QMS documentation.ĪS9100 is identical to ISO 9001 for this clause. CovĤ.2.1 Documentation Requirements: GeneralĤ.2.1.f quality system requirements imposed by the applicable regulatory authorities.Ĥ.2.1 Documentation Requirements: General The organization shall ensure that personnel have access to QMS documentation and are aware of relevant procedures. ![]() When the requirement is identical to ISO 9001, then the requirements will not be listed. AS9100 Element Questions Note: Not all requirements are documented here. ![]()
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