QP-5 Rev.0-R
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EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13 NS-EN ISO 9001-2008 . Certificate No 1221 QUALITY PROCEDURE DOCUMENT CONTROL THIS PROCEDURE CONTAINED HEREIN IS THE PROPERTY OF ITECSOLUTIONS QUALITY GROUP PTE LTD WHERE IS ISSUED AND CONTROLLED BY THE QUALITY MANAGER AND SHALL NOT BE REVISED, AMENDED OR ANYWAY ALTERED WITHOUT HIS APPROVAL. Rev Date Prepared by Reviewed & Approved by 0 23/12/2013 V.S.Naidu Technical Manager Y.ARUN Branch Manager This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
description
QUALITY
Transcript of QP-5 Rev.0-R
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
NS-EN ISO 9001-2008 . Certificate No 1221
QUALITY PROCEDURE
DOCUMENT CONTROL
THIS PROCEDURE CONTAINED HEREIN IS
T H E PROPERTY OF ITECSOLUTIONS
QUALITY GROUP PTE LTD WHERE IS
ISSUED AND CONTROLLED BY THE
QUALITY MANAGER AND SHALL NOT BE
REVISED, AMENDED OR ANYWAY ALTERED
WITHOUT HIS APPROVAL.
Rev Date Prepared by Reviewed & Approved by0 23/12/2013 V.S.Naidu
Technical ManagerY.ARUN
Branch Manager
SIGNATURE/STAMP SIGNATURE/STAMP
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
NS-EN ISO 9001-2008 . Certificate No 1221
1.0 OBJECTIVES
To control all documents that is related to IQG's Quality System.
2.0 SCOPE & REFERENCES
2.1 SCOPE
Applies to all documents in Quality System.
2.2 REFERENCES
NIL
3.0 PROCEDURE
3.1 RESPONSIBILITY
3.1.1 The Quality Manager (QM) or designate in charged of the document system is responsible for the document control system and the issuing of documents for internal use. He/she shall maintain a master copy of all controlled documents.
3.1.2 Branch Manager shall be at the discretion and authority for any further distribution to external organization or clients.
3.1.3 Company management shall review the new/revised documents for adequacy prior to approving and/or issuing.
3.1.4 Copy owner shall ensure that only the latest revision documents are in used and obsolete documents are removed from the point of use.
3.1.5 Copy owner shall ensure that issued documents are available for use and make reference to where required.
3.2 CONTROL OF DOCUMENTS
3.2.1 Definition of Controlled and Uncontrolled documents
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NS-EN ISO 9001-2008 . Certificate No 1221
Controlled documents : refer to documents which requires updating to the latest revision whenever there is a change or amendment initiated.
Uncontrolled documents : refers to documents which does not requires updating to the latest revision whenever there is a change or amendment initiated.
3.2.2 Company Management shall decide on the category of documents originated and issued by the company.
3.2.3 All documents issued under the controlled category shall be stamped with the word "CONTROLLED" in red ink on the front cover or first
page of the document.
3.2.4 Any controlled documents that are not stamped with the red word "CONTROLLED" are classified as uncontrolled documents. They shall not be subjected to control.
3.2.5 Uncontrolled copies may be issued in connection with marketing, procurement, or other activities permitted by the Branch Manager. Uncontrolled copies will not be updated on subsequent revisions. However, at the time of issue, uncontrolled copies shall be of the latest revisions.
3.2.6 Documents issued for external use shall be copied on pre-printed paper.
3.3 DOCUMENT NUMBERING & REVISION SYSTEM
3.3.1 The numbering system is in placed to uniquely identify each document. Quality Manager, or personnel in charge of document system, shall ensure
that all quality system manual and procedures numbers follow the uniform numbering system listed below.
3.3.2 A master list, to identify the current revision of procedures, forms and controlled references, shall be maintained and kept by the QM, or personnel in charge of the document system. The last updated date shall be indicated on the master list.
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
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NS-EN ISO 9001-2008 . Certificate No 1221
TYPE OF DOCUMENTS NUMBERING SYSTEM REVISION AND ISSUEQuality Manual QM Both are in sequential number starting from 0 After 5 revisions a new issue shall be issued Revision number shall start from 0 Quality Procedure QP - NN Revision sequential number starting from 0 QP - Quality Procedure Issue not applicable NN -Sequential number starting from 01 Work Instructions WI -AA – NN Revision sequential number starting from 0 WI - Work Instructions Issue not applicable AA - Test Methods NN - Sequential starting from 01
3.4 Generate New Documents / Revise Existing Documents Originator & Approving Party
3.4.1 The owner of process (originator) shall initiate new documents whenever the need arises.
3.4.2 For generating new Quality Procedure, the format given in Appendices shall be followed.
3.4.3 For revising document, brief description of the amendment
shall be indicated in the amendment record. A vertical line shall
be drawn in the right hand margin to indicate all latest revised texts.
3.4.4 The amendment record shall maintain revision description up to the last two revisions. That is, if the current revision is 5, then the record should have revision description indicating what are the change from 3 to 4 and 4 to 5. See next page table for example:
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NS-EN ISO 9001-2008 . Certificate No 1221
3.4.5 On completion of the new/revised document, it shall be submitted to the Company Management for review and approval .
3.4.6 The document shall be returned to the originator if the proposed new/revised document is not acceptable or need further amendment.
3.4.7 After approval, the document shall be forwarded to the QM for document registration.
Quality Manager I Document Personnel
3.4.8 Obtain a proper documented authorization from the client/top management for use of obsolete standard method.
Otherwise shall maintain and use only updated versions of all test methods.
3.4.9 QM or personnel in charge of documents upon receiving the proposed document, shall check for completeness prior to registering the document.
3.4.10 For new document, a new document number should be assigned per the numbering system.
3.4.11 Print the required copies of the new/revised document and stamp"CONTROLLED" in red on the front cover of the document.
3.4.12 Update the Document Master List.
3.4.13 Distribute the copied document/s to the respective copy holder using Issuing Record (see Appendices).
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
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NS-EN ISO 9001-2008 . Certificate No 1221
3.4.14 Keep a copy of the obsolete document, indicate "OBSOLETE" on the front cover of the document.
3.4.15 Quality Manager I Technical Manager and Assistant Technical Manager shall be responsible for the controlled documents receipt under their hold using a Distribution List. (See Appendices)
Copy Holder
3.4.16 Upon receipt of the new/revised documents, check that the documents are complete.
3.4.17 All obsolete documents shall be removed and destroyed promptly to prevent unintentional use.
3.5 Controlled Reference
3.5.1 Documents of external origin which need to be controlled are classified as Controlled References. Quality Manager shall be responsible to determine if the references received should be under controlled.
3.5.2 New or revised Controlled Reference, upon receipt, shall be stamped with the red "CONTROLLED" word.
3.5.3 Quality Manager or designate shall update the Master List to reflect the new addition or revision.
3.5.4 Any obsolete references required to be filed shall be stamped "OBSOLETE'' and when retained for either legal or knowledge preservation purposes are suitably marked.
3.5.5 If any extra copy of Controlled References is required for internal use, Issuing Record (See Appendix) shall be used. Approval shall be required from Quality Manager or Branch Manager.
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
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NS-EN ISO 9001-2008 . Certificate No 1221
4.0 RECORDS
The following shall be kept with the quality manager or designate in charge of documents: Obsolete Document Minimum the obsolete revision Amendment Record Minimum the last two revisions Issuing record Minimum the last valid issue ( Controlled copies )
Minimum one year(Uncontrolled copies for external bodies) Distribution List Minimum 1 Year
5.0 APPENDICES
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
Appendix 1 Format of Quality Procedure Cover Page Appendix 2 Format of quality procedure Inner PageAppendix 3 Format of Work Instruction Cover page Appendix 4 Format of work procedure Inner PageAppendix 5 Document Master List Appendix 6 Issuing Record Appendix 7 Amendment Record Appendix 8 Distribution List
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Appendix 1 Format of Quality Procedure - Cover page Itecsolutions Quality Group Pte Ltd
EFFECTIVE DATE REV : DOC NO: PAGE :1 OF
Quality Procedures <Documents Title >
THE PROCEDURE CONTAINED HEREIN IS THE PROPERTY OF ITECSOLUTIONS QUALITY GROUP SERVICES WHERE IS ISSUED AND CONTROLLED BY THE QUALITY MANAGER AND SHALL NOT BE REVISED, AMENDED OR IN ANY WAY ALTERED WITHOUT HIS APPROVAL
ISSUED BY LQG Copy No: Issued By: Date Issued: Prepared by Approved by Designation Designation Signature Signature
This document is a property of IQG. No reproduction in any form is allowed without Prior written permission from the management of IQG. Violators may be prosecuted
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
1.0.OBJECTIVE(in Bold and capital letters) State the purpose of this document
2.0.SCOPE(in Bold and Capital Letters)
Short Description stating clearly what is covered by the document
3.0.PROCEDURE(in Bold and Capital Letters)
3.1 Describe step by step action required to do the work and specify clearly who is / are responsible for the action(s).
Example: Head of Section
1. Raise and endorse the corrective & Preventive Action Form (CPA)2. ....Etc
Quality manager1. Monitor the effectiveness of the corrective action and preventive actions taken2. .....Etc
4.0 RECORDS(In Bold and Capital Letters)
List all records used in this document and state who is responsible to keep the records and for how long should the records be kept
Example: Completed CPA forms are to be kept by the qaulity manager for a minimum
period of 3 years 5.0 APPENDICES(In Bold and Capital letters)
This include any attachment or samples of form used in this procedure
Example:Appendix 1 Corrective and Preventive Action Form (CPA)
NS-EN ISO 9001-2008 . Certificate No 1221
Appendix 2 Format of Quality Procedure. Inner Page
EFFECTIVE DATE: REV: DOC NO:QP – NN PAGE NO:1 OF
This document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
NS-EN ISO 9001-2008 . Certificate No 1221
Appendix 3 Format of Work Instruction - Cover page Itecsolutions Quality Group Pte Ltd
EFFECTIVE DATE: REV: DOC NO:WI-AA-NN PAGE: 1 OF WORK INSTRUCTION TITLE: <DOCUMENT TITLE>
THE PROCEDURE CONTAINED HEREIN IS THE PROPERTYOF ITECSOLUTIONS QUALITY GROUP SERVICES WHERE IS ISSUED AND CONTROLLED BY THE QUALITY MANAGER AND SHALL NOT BE REVISED, AMENDED OR IN ANY WAY ALTERED WITHOUT HIS APPROVAL
ISSUED BY LQG Copy No:
Issued By:
Date issued:
Prepared by Approved by Designation Designation Signature Signature
This document is a property of IQG No reproduction in any form is allowed without
prior written permission from the management of IQG. Violators may be prosecuted
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
EFF DATE: REV: DOC: PAGE:
1.0.OBJECTIVE(in Bold and capital letters) State the purpose of this document
2.0.SCOPE(in Bold and Capital Letters)
Short description stating clearly what is covered by the document
3.0.PROCEDURE(in Bold and Capital Letters)
3.1 Describe step by step action required to do work and specify clearly who is / are responsible for the action(s)
Example: Head of Section
1. Raise and endorse the corrective & Preventive Action Form (CPA)2. ....Etc
Quality manager3. Monitor the effectiveness of the corrective action and preventive actions taken4. .....Etc
4.0 RECORDS(In Bold and Capital Letters)
List all records used in this document and state who is responsible to keep the records and for how long should the records be kept
Example: Completed CPA forms are to be kept by the Quality Manager for a minimum
period of 3 years.
5.0 APPENDICES(In Bold And Capital letters)
This include any attachment or samples of form used in this procedure
Example:Appendix 1 Corrective and Preventive action form (CPA)
NS-EN ISO 9001-2008 . Certificate No 1221
Appendix 4 Format of Work Instruction – Inner Page
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: REV : DOC NO :WI-AA-NN PAGE 1 OF
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Appendix 5 Document Master List
Appendix 6 Issuing RecordITECSOLUTIONS QUALITY GROUP PTE LTD
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
EFFECTIVE DATE: 23 DEC 2013 REV: 0 DOC NO:QP – O5 PAGE NO: Page 13 of 13
NS-EN ISO 9001-2008 . Certificate No 1221
This Document is property of IQG. No reproduction is allowed without prior to written permission from the management of IQG. Violators may be prosecuted.
