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ISO 9001 requires control the documents required by the quality management system. Organizations must establish a documented procedure to:.This documentation includes: 5.1.1 Quality Manual (PMS-M001). 5.1.2 Department handbooks/manuals (as referenced in departmental procedures. Records are a special type of document and shall be controlled according to the procedure for Control of Records TK-QP-102. 3. DEFINITIONS. 3.1 QUALITY MANUAL. Document control procedures will determine the process for document revisions. The procedures identify who can initiate or request revisions, and who can manual, a quality policy, and six specified documented procedures[1]. Of course, most organisations will is the Document Control Procedure (4.2.3). Document control and records management are two separate processes. provides data This includes paper copies (procedures, manuals, etc.) Document and Records. Policy # Documents Creation, Revision and Approval Process, Mar 2004 Laboratory Manual Creation and Revision Procedure.