Transcription of Global SOP - DOCUMENTATION MANAGEMENT …
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Global SOP - DOCUMENTATION MANAGEMENT …
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).
Complete the ‘Does this change affect the Compliance Matrix?’ Field (Yes or No) and if the answer is ‘Yes’, update the appropriate Compliance Matrix. Determine if new procedure is required or if an existing procedure should be revised. In an event where QSO needs to be implemented prior to 30 days communicate the
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