Document Control By: Neal Stiemert The ISO 9001:2000 Standard Document Control                                                                                            One of the requirements of the ISO 9001: 2000 standard is that you have a process to control documents that are used for your quality system. As an auditor, I will share with you some typical audit findings related to the document control process. I will also provide you with a sample section from a quality manual and a sample procedure that defines a simple process for approving and issuing documents created by your organization. Typical audit findings are: Documents were not properly reviewed and approved There was no distribution list for controlled documents The documents being used did not match the master documents list Documents being were not under document control ISO Requirement: 4.2.3 Control of Documents Documents required by the quality management system shall be controlled. A documented procedure shall be established to define the controls needed. to approve documents for adequacy prior to issue, to review and update as necessary and re-approve documents, to ensure that changes and the current revision status of documents are identified, to ensure that relevant versions of applicable documents are available at points of use, to ensure that documents remain legible and readily identifiable, to ensure that documents of external origin are identified and their distribution controlled, and to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. Section from a typical quality manual Control of Documents Documents required for the quality management system are controlled. A documented procedure is established to describe the following activities: the approval of documents for adequacy prior to issue the review, revision and re-approval of revised documents the identification of the current revision status of documents relevant versions of documents are available at points of use documents of external origin are identified and their distribution is controlled prevention of the unintended use of obsolete documents, and to provide suitable identification if retained Acme Manufacturing Company, Inc. Operating Procedure Title: Document Approval and Issue No. 2.1                       Rev. 0                Page 1 of 2 Approved by:               Danny Documents                 Date:           1/10/05                           SCOPE:               This procedure applies to revision of controlled documents created by               Acme which are part of the quality system. 1.0        C.N. INITIATED Any revision to an Acme issued document requires a change notice (C.N.) Anyone in the Acme organization can initiate a C.N. The initiator gets a C.N. form from Document Control, fills it out and gives it to Document Control. Document Control records the C.N. in the C.N. log. Document Control gives the C.N. form to the responsible area manager for review, the C.N. is reviewed by the area manager. Persons making document reviews and changes shall review pertinent background information. 2.0         APPROVED ?                No - go to 2.1                Yes - go to 3.0 2.1         REPLY TO INITIATOR               A reply is written on the C.N. form by the area manager that reviewed the               C.N. The C.N. form is returned to Document Control and a copy of the C.N.               form is given to the initiator by Document Control. 3.0         APPROVE C.N.                The area manager reviewing the C.N. documents the action to be taken on                the C.N. form and returns it to Document Control.  4.0         DOCUMENT REVISION               All revisions are made as indicated on the C.N. form. When all document               changes are completed, the completion date is recorded on the C.N. form               by Document Control and approvals are signed off on the document masters               or attachments in accordance with the Acme document approval and Issue               procedure.  5.0         REVISE MASTER DOCUMENTS LIST               Document Control changes the revision level for the document on the               master documents list .  6.0          PICK UP OLD DOCUMENTS                Document Control picks up the old master document, marks first page                "obsolete" and files it in an obsolete documents file if the master                document is retained. If the master document is not retained, it is                destroyed. Document Control picks up all controlled copies indicated on                the master documents list and destroys all copies. Acme Manufacturing Company, Inc. Operating Procedure Title: Document Approval and Issue No. 2.1                       Rev. 0                Page 2 of 2 Approved by:               Danny Documents                 Date:          1/10/05             7.0         ISSUE REVISED DOCUMENTS The master document (document with the original signature) is retained by Document Control and are not marked "controlled ". If any copies are needed, they are copied from the master document and are marked "controlled " on the first page of the document. Document Control issues the controlled copies to all locations indicated on the master documents list.  8.0          FILE COMPLETED C.N.                 After the document revision process is complete, Document Control                assures that all necessary signatures are on the C.N. form and files the                C.N. form as a record.                Notes: Document approvals for revised documents must be approved by the same functions that approved the original document. The master documents lists are maintained by Document Control which lists all controlled documents, their revision level and all controlled copy holders for each document. If a document is deleted, it is removed from the master documents list and all copies of the document are picked up and destroyed. The same document number may be used at a later date; however the document must have a different title. The nature of document changes are documented on the C.N. form and/or attachments. During the first quarter of each calendar year, all Acme issued documents shall be reviewed by the approving authority to assure that the documents are current. Note: If this document is printed out from the network, It is the responsibility of the user of this document to verify the correct revision status prior to use. If this document is marked “CONTROLLED”, Document Control maintains the revision control and >the user does not need to verify the correct revision status prior to use. End of Document Summary The importance of document control cannot be stressed enough. One of the very most critical processes in your quality system is document control. It is not possible to do our work correctly if we do not have the correct documents. In the next months I will provide procedures for customer issued documents and documents of external origin. Acme, Inc. Document Change Notice Log C.N. No. Date Originator Approved/ Disapproved Date Completed                                                                                                                                                                                                                                                 Acme, Inc. Document Change Notice Log C.N. #                               Date Initiated                                                       Initiator                                                                                   Change Requested                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Approved   □           Not Approved   □ Action Taken                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Documents Affected Document Current Revision New Revision Description of Change                                 Reviewed by:                                                             Date                                    Neal Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a certified lead auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article