MDSAP QMS P0007.005质量记录控制程序 2019-01-11.pdfVIP

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MDSAP QMS P0007.005质量记录控制程序 2019-01-11.pdf

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Document No.: Page: 1 of 7 MDSAP QMS P0007.005 Responsible Office/Division Version Date: Effective Date: 2019-01-11 2019-01-15 Title: MDSAP QMS Control of Quality Project Manager: Kimberly Lewandowski- Records Procedure Walker, USFDA Table of Contents 1. Purpose/Policy 2. Scope 3. Definitions/Acronyms 4. Authorities/Responsibilities 5. Procedures 6. Forms 7. Reference Documents 8. Document History Approval Sign-Off Sheet 1. Purpose/Policy To control records generated by the Medical Device Single Audit Program and Quality Management System (QMS) processes. 2. Scope This outlines the procedure for controlling records related to the MDSAP Quality Management System. This procedure addresses identification, access, filing, storage, retention, and disposal of records. 3. Definitions/Acronyms Controlled Copy: A controlled copy is a formal copy of the latest, correct issue (approved version) of a document; an identified issue of a document to an individual or location of record. A controlled copy must be officially tracked, updated and stored for use. Data: Facts about an object. (ISO 9000:2015). (A data file is a set of collected facts and is related numeric, graphic or textual information that is organized in a strictly prescribed form and format. ASQ-Quality Glossary) Disposition: The action taken regarding records no longer needed for current Government business. These actions include transfer to agency storage facilities or Federal Records Centers (FRC), transfer from one agency to another, transfer of permanent records to a third party location or to the National Archives, and