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Quality Manual - Foqus, Inc.

FOQUS, Inc.
Quality Manual QM-001
Section # : 5
Page #: 1of 1
Issue Date: 1/1/95
Revision: 1/1/95
Document and Data Control
5.1 General


Foqus, Inc. has established documented procedures for the control of documents and data important to the effective operation of the QMS. Procedures include the control of external standards. All documents related to the QMS are maintained and stored electronically. Procedures QP-005 describes in how the documents and data are controlled.
5.2 Document and Data Approval and Issue

Procedure QP-005 ensures that documents and data are reviewed and approved for adequacy by authorized personnel prior to issue. The Document Matrix (QF-001) identifies the following aspects of document control:
  • the current documents that make up the QMS
  • the functions responsible for maintaining the documents
  • the level of authority required for approval

The electronic version is the current version of the document. Authorized personnel approve any changes to the electronic documents. Records of the approval are maintained electronically as well. Any hard copy can be printed but it’s valid only the day it was printed. This policy guarantees that the employees will not use any invalid and/or obsolete copies.

Procedure QP-005 ensures that:
a) the pertinent issues of appropriate documents are available at all locations where operations essential to the effective functioning of the quality system are performed;
b) invalid and/or obsolete documents are promptly removed from all points of issue or use;
c) any obsolete documents retained for legal and/or knowledge-preservation purposes are suitably identified.

The method for security and control of all electronic documents and data (including quality records) and the control of changes to those documents and data are also described in QP-005.
5.3 Document and data Changes

The Document Matrix (see QF-001) identifies the personnel responsible for reviewing and authorizing changes to documents and data. Procedure QP-005 describes how the nature of change is identified and recorded for each new revision of the document. The procedure also documents how the changes are communicated to all employees affected by those changes.
Note: CONTROLLED DOCUMENT - refer to electronic version for current revision. Printed copy valid the day of: 12/5/10
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