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Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE

Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE HAEMONETICS CORP. - COMPANY CONFIDENTIAL Before using this document, please consult Agile for the latest revision. Page 1 of 26 Global : Revision: CU Purpose This PROCEDURE provides the minimum requirements for Haemonetics Document Control and Records MANAGEMENT , including issuance, review, authorization and control. Scope This PROCEDURE applies to all world-wide facilities and organizations in Haemonetics, including corporate. This PROCEDURE applies to new documents and document revisions under the MANAGEMENT and control of documents that are part of Corporate DOCUMENTATION as well as Quality MANAGEMENT System (QMS), Design History File (DHF), Device Master Record (DMR) and Device History Records (DHR).

Health Canada - Medical Device Regulations (MDR) European Union Medical Device Regulation 2017/745 (EU MDR 2017/745) Japanese Pharmaceutical Affairs Law ISO 13485: Medical Devices NOTE: the documents referenced above are shown without revision levels, unless specified, the most current version applies. Document Document Number

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