Document Control Procedure Example [PDF]

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QUALITY SYSTEM PROCEDURE QP1 DOCUMENT CONTROL



[Your Company]



Signature



Position



Date



Prepared By



Reviewed By



Approved By



COMPANY PROPRIETARY INFORMATION This document is an uncontrolled copy of a controlled document held by the Quality Management System. Prior to use, ensure this document is the most recent revision by checking the Master Document List. To request changes, submit a Document Change Request to the Document Control Representative.



Quality System Procedure [Your Company]



Document Control



QP1 Version 1 Page 2 of 6



Table of Contents 1.



INTRODUCTION & PURPOSE ................................................................................................ 3



2.



TERMS & DEFINITIONS ....................................................................................................... 3



3.



APPLICATION & SCOPE....................................................................................................... 3



4.



REQUIREMENTS ................................................................................................................. 3



5.



4.1



Controlled Documents ............................................................................................ 3



4.2



Documentation Hierarachy ..................................................................................... 4



4.3



Responsibility.......................................................................................................... 4



4.4



Signature Authority ................................................................................................. 4



PROCESS .......................................................................................................................... 4 5.1



Receiving and Issuing a Controlled Document....................................................... 4



5.2



Revising a Controlled Document ............................................................................ 5



5.3



Recalling a Controlled Document ........................................................................... 5



5.4



External Documents................................................................................................ 5



5.5



Uncontrolled Documents......................................................................................... 6



5.6



Forms & Records .................................................................................................... 6



5.7



Document Change Requests.................................................................................. 6



6.



REFERENCES..................................................................................................................... 6



7.



REVISION HISTORY ............................................................................................................ 6



Quality System Procedure [Your Company]



1.



Document Control



QP1 Version 1 Page 3 of 6



Introduction & Purpose This document defines the process for the creation, verification, control, issue and amendment of all documentation in support of [Your Company’s] Quality Management System.



2.



Terms & Definitions The following terms and definitions are taken from ISO 9000:2005: Term



3.



Clause



Definition



Document



3.7.2



Information and its supporting medium



Procedure



3.4.5



Specified way to carry out an activity or a process



Quality Manual



3.7.4



Document specifying the QMS of an organization



Record



3.7.6



Document stating results or evidence of activities performed



Specification



3.7.3



Document stating requirements



Application & Scope The scope of this process encompasses all documentation utilised by [Your Company] including documents of an external origin such as customer specifications, standards, etc., that affect the quality of our products and/or services. This procedure works in conjunction with the Control of Records Procedure QP2.



4.



Requirements



4.1



Controlled Documents Controlled documents define the requirements for performance of a process and must be followed to ensure the quality of the process, product and/or service. Documents typically controlled by this procedure include but are not limited to the following: ƒ



Quality manual, policy and related procedures



ƒ



Specifications and drawings



ƒ



External documents



Controlled documents are identified with a document name and document number ƒ



Procedures are referenced according to the ISO 9001:2008 element number



ƒ



Quality procedures are prefixed QP



ƒ



Forms are prefixed F



ƒ



Work instructions are prefixed W