This document outlines the process for controlling documents within a quality management system. It describes responsibilities for document control, the process for creating, reviewing, approving, distributing and revising internal documents, and controlling external documents. Document reference numbers are assigned based on document type and sequentially. Records of document revisions and a master list of documents are maintained.
This document outlines the process for controlling documents within a quality management system. It describes responsibilities for document control, the process for creating, reviewing, approving, distributing and revising internal documents, and controlling external documents. Document reference numbers are assigned based on document type and sequentially. Records of document revisions and a master list of documents are maintained.
Original Description:
Coontrol of Documented Information of Quality Management system
This document outlines the process for controlling documents within a quality management system. It describes responsibilities for document control, the process for creating, reviewing, approving, distributing and revising internal documents, and controlling external documents. Document reference numbers are assigned based on document type and sequentially. Records of document revisions and a master list of documents are maintained.
This document outlines the process for controlling documents within a quality management system. It describes responsibilities for document control, the process for creating, reviewing, approving, distributing and revising internal documents, and controlling external documents. Document reference numbers are assigned based on document type and sequentially. Records of document revisions and a master list of documents are maintained.
Page 1 of 4 Date: Doc Ref: QP-001 CONTROL OF DOCUMENTS Issue: 01 Rev: 00
1. PURPOSE
The purpose of this procedure is to ensure that all documents within the quality system are formally identified and issued, and to ensure that obsolete information is prevented from use / issue.
2. SCOPE
This procedure applies to all quality system documents, including the Quality Manual, Quality Procedure, and Quality Forms and to external documents such as technical standards or legislation.
The procedure is applicable to all staff using documents and data.
3. DEFINITIONS & ABBREVIATIONS
Internal Document - Manual, Procedure, Flowchart or Form
Revision - Amendment to an active / existing document Active Document - Latest version of a working document Data - Information recorded as a document or in electronic form MR - Management Representative QMS - Quality Management system
4. RESPONSIBILITIES
The MR has the main responsibility for controlling quality system documents. The MR shall compile a schedule of all internal and external documents, which requires to be controlled and agree the contents with the management team.
5. PROCESS 5.1 INTERNAL DOCUMENTS
All staffs are encouraged to identify the need for procedures, guidelines or standard forms. When a new document requirement is identified the staffs liaises with the MR and follow this procedure in the creation and implementation of the document. A Schedule of internal controlled documents QMS documents, Company brochures, and website will be maintained.
Page 2 of 4 Date: Doc Ref: QP-001 CONTROL OF DOCUMENTS Issue: 01 Rev: 00
5.2 CREATION & PREPARATION OF DOCUMENTS
Where the need for the document is identified a draft document is prepared, worked with and amended until it is suitable for formal issue and inclusion in the QMS. Documents are prepared in the appropriate and relevant format as agreed by the MR. Each document is assigned a unique reference number to ensure effective control and traceability.
5.3 DOCUMENT REFERENCE NUMBERS
All QMS document will be referenced by an abbreviation of the document type and a sequential number starting from 01. The table below shows document types / abbreviations examples:
Document Type Abbreviations Example of Document Reference Number
The initial revision of a draft document will be numbered as A with subsequent draft revisions identifiable by the issue date. When a document is ready for issue the initial revision is 0 with subsequent revisions numbered as 1, 2, 3……etc.
5.4 REVIEW AND APPROVAL
To ensure that documents are accurate and fit for purpose, a person with suitable knowledge of its content/ purpose reviews each one. The MR approves all documents. All approvals are recorded in the master list of documents.
5.5 ISSUE / DISTRIBUTION
Controlled and Approved documents are issued and distributed to those staff that requires using them. One controlled copy of the Quality Manual; Quality Procedures will be retained in the office. Printed documents are uncontrolled.
Page 3 of 4 Date: Doc Ref: QP-001 CONTROL OF DOCUMENTS Issue: 01 Rev: 00
5.6 REVISION OF DOCUMENTS
Staff is encouraged to highlight the need for any update or amendment to internal quality documentation. Amendment may also be identified through internal / external audits. Any need for amendment is advised to the MR, who reviews the requested change and instructs to arrange for documents to be revised (amended/ updated and reviewed/ approved). The reason for a document revision is recorded and maintained.
5.7 EXTERNAL DOCUMENTS
Receipt and filing/ distribution of external documents which affect quality and may be updated are controlled by the MR.
5.8 BACK-UP Offices In charge make regular back-ups electronic data. 6. RECORDS Document Control Sheet QF-MR 01 Master List of Documents QF-MR02
