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Sample ISO 9001 Quality Manual - American Society...

Sample ISO 9001 Quality Manual Subject: Example quality manual for services Author: Graeme Payne Description: Example of a ISO-9001 quality manual.

http://asq.org/2010/06/iso-9000/sample-quality-manual-service.doc

Date added: August 18, 2016 - Views: 5

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Content 16-9: Writing a Quality Manual - WHO

16-9: Writing a Quality Manual. Structure and content Although there is considerable flexibility in how to prepare a quality manual, the content and structure should ...

http://www.who.int/ihr/training/laboratory_quality/cd_rom_optional_content_16-9_quality_manual.doc

Date added: August 18, 2016 - Views: 1

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Quality Assurance Handbook: About Quality...

Quality Assurance Handbook: About Quality Assurance Author: Brian Kelly Last modified by: Brian Kelly Created Date: 5/27/2004 2:55:00 PM Company: UKOLN Other titles:

http://www.ukoln.ac.uk/qa-focus/documents/handbook/qa-handbook-qa.doc

Date added: August 19, 2016 - Views: 1

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QUALITY MANAGEMENT SYSTEM MANUAL - Elsmar

Throughout this quality manual and in every operational procedure where the specific quality system process or activity is documented; and .

http://elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/QUALITY%20MANAGEMENT%20SYSTEM%20MANUAL%20Single.doc

Date added: August 18, 2016 - Views: 1

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Pro7.1-02 SOP Checklist - Quality Management

Requirements for laboratory director or designee review of the Quality Management System, Quality Manual, and other policies, processes, ...

http://www.niaid.nih.gov/LabsAndResources/resources/DAIDSClinRsrch/Documents/labStudyData.doc

Date added: August 18, 2016 - Views: 1

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Guidance on the GMP clearance of overseas medicine...

GMP Clearance for Overseas ... such as a Plant/Equipment File or a Quality Manual, ... the production and/or quality control of pharmaceutical manufacturing processes ...

http://www.tga.gov.au/sites/default/files/manuf-overseas-medicines-gmp-clearance-17.docx

Date added: August 18, 2016 - Views: 1

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Standard operating procedures (SOP) - Back Bone of...

o Make the long-form SOP a training document or manual to ... 6.G.Kieffer Robert “Procedures Improving Their Quality”, Pharmaceutical ... 8.Standard Operating ...

http://people.stfx.ca/tsmithpa/Chem361/Labs/SOP/Standard%20operating%20procedures.doc

Date added: August 18, 2016 - Views: 3

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Section 4 - Testmetric

Quality manual presentation. Control of the manual. Distribution list. ... Industries served include Pharmaceutical, Aerospace, Manufacturing, Educational and Utility ...

http://www.testmetric.com/images/Quality_Manual2.doc

Date added: August 18, 2016 - Views: 2

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ISO 9001 Quality Manual for Services - Worksmart...

Title: ISO 9001 Quality Manual for Services Author: Authorized User Last modified by: Mike McGarry Created Date: 1/29/2007 4:49:00 PM Other titles

http://www.worksmartinc.net/iso.doc

Date added: August 18, 2016 - Views: 1

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Quality Assurance Plan - HUD/U.S.

QUALITY. ASSURANCE. PLAN. Project or System Name. U.S. Department of Housing and Urban Development. Month, Year Revision Sheet. Release No. Date Revision Description

http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_15123.doc

Date added: August 18, 2016 - Views: 2

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2-1- Purpose - Medical Device, Risk Analysis, ...

2-1- Purpose. This document defines quality system policies and procedures for governing the design & manufacture of all Sobhan Chemotherapeutical Co. products.

http://www.elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/Quality%20Manual%20En.doc

Date added: August 20, 2016 - Views: 1

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE - Cefic

Yes No Active pharmaceutical ingredients? ... Yes No N/A 9.21 Does your carrier have a Quality Manual? ... Section E Extended Quality Questionnaire. Page 11 of 15

http://www.apic.cefic.org/pub/Supplier%20Questionnare%20-%20Section%20E%20%20Quality%20Q._modified.doc

Date added: August 18, 2016 - Views: 2

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CEFIC

This template has been developed by APIC/CEFIC. ... Index of Quality Manual and / or Index of SOP’s covering ICH Q7 Chapters relevant to your operations.

http://apic.cefic.org/pub/Auditing/Auditing_Annex1_Questionnaire.docx

Date added: August 19, 2016 - Views: 1

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Sample Procedure - ISO Quality Manual

ISO-Quality-Manual.com. Good luck on your certification! Tim and Quintin. Title: Sample Procedure Author: iso-quality-manual.com Last modified by: Quintin Shalla

http://iso-quality-manual.com/QSP%208.3.1%20Nonconforming%20Product%20-Sample.doc

Date added: August 18, 2016 - Views: 4

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Project Quality Management Plan Template - DARTNet

The Project Quality Management Plan documents the necessary information required to effectively manage project quality from project planning to delivery.

http://dartnet.info/media/toolkit/FAQ%20Res%203c%20CDC_UP_Quality_Management_Plan.doc

Date added: August 18, 2016 - Views: 2

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Validation Plan Template - ISPE | GMP

Quality Assurance – Responsible for ... (including possible interim manual operations) ... Validation Plan Template Author: Bruce Lauderman Last modified by:

http://www.ispe.org/jett/vial-tray-loader-urs.doc

Date added: August 18, 2016 - Views: 4

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Standard Operating Procedures and Shipping...

Title: Standard Operating Procedures and Shipping Guidelines for Medical and Pharmaceutical Products: Author: Andy Turner Last modified by: Susan E A Gurling

http://www.docs.csg.ed.ac.uk/Procurement/Suppliers/Medical_SOPS_CitySprint_Nov_06.doc

Date added: August 18, 2016 - Views: 2

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Control of Documents & Records

XX Laboratory documents and records demonstrate that the products and services provided conform to the procedural and quality ... Manual ” binders in the ...

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/uploads/files/Resources/Lab%20Practices/Document%20Control%201.doc

Date added: August 18, 2016 - Views: 1

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行政院衛生署 - 衛生福利部食品藥物管理署

Name of Pharmaceutical Firm: (Chinese) ... 3.10 Has the original manufacturer provided the most up-to-date and valid version of quality manual, ...

http://www.fda.gov.tw/upload/133/Content/2013103011214320875.doc

Date added: August 20, 2016 - Views: 1

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Management Review Meeting Minutes template

Review the current Quality Objectives as outlined in the Quality Manual and modify goals accordingly. Complete the Objectives table on the next page.

http://www.oxebridge.com/downloads/MRMtemplate.doc

Date added: August 18, 2016 - Views: 6

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Annex 2 - Auditing Guide - Apic - Cefic

Good Manufacturing Practice Guide for Active Pharmaceutical ... Is there a Quality Manual or equivalent documentation that describes in detail how the Quality ...

http://apic.cefic.org/pub/Auditing/Auditing_Annex2_AideMemoire.docx

Date added: August 19, 2016 - Views: 1

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Radiopharmaceutical Compounding Practices

American Pharmaceutical Association (APhA) Nuclear Pharmacy Compounding Practice Guidelines_5.2 TABLE OF CONTENTS. ... Quality Control 21. Compounded Reagent Kits 21.

http://nuclearpharmacy.uams.edu/Nuclear%20Pharmacy%20Compounding%20Practices%20Guidelines_5.2.doc

Date added: August 18, 2016 - Views: 1

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SANITATION STANDARD OPERATING PROCEDURE (SSOP)

SANITATION STANDARD OPERATING PROCEDURE (SSOP) FOR. Our company. HACCP Coordinator: General Policy. The Plant Manager/ designated personnel is responsible for the ...

http://www.ssfpa.net/images/stories/fsi/Sample%20GMP%20documents/E%20-%20Sanitation%20&%20pest%20control/SSOP%20overview.doc

Date added: August 18, 2016 - Views: 4

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Guidance On Quality Systems For The Design And...

Title: Guidance On Quality Systems For The Design And Manufacture Of Medical Devices Author: GHTF Last modified by: Fletcher, Tim Created Date: 8/21/2012 3:25:00 AM

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n99-8-guidance-on-quality-990629.doc

Date added: August 18, 2016 - Views: 1

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Section 1 Quality Manual - Hygiene Manual's

QUALITY POLICY. The quality manual defines the organisation and management requirements of Hygiene in relation to the company quality management system (QMS).

http://hygienemanuals.co.uk/manuals/quality/2000%20QM-1.doc

Date added: August 24, 2016 - Views: 1

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Excipient Audit Guideline - IPEC Europe

Pharmaceutical Excipients. I. Purpose and Scope. In the pharmaceutical industry it is the responsibility of the drug product manufacturer to ensure the quality of all ...

http://ipec-europe.org/UPLOADS/IPEC_GMP_Audit-Systems_2008_Final_Printing_(3)(1).doc

Date added: August 18, 2016 - Views: 1

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Model SOP - Quality Assurance/Quality Improvement...

AR 40-68 Clinical Quality Management provides the regulatory guidance for the development of Quality Assurance/Quality Improvement Program.

https://phc.amedd.army.mil/PHC%20Resource%20Library/PHC_Model_SOP_QA-QI%20_Final.docx

Date added: August 18, 2016 - Views: 1

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Quality Agreement Template (exclusive APIs) -...

Quality Agreement Template. for. Exclusive Substances (Compliance Section only) Scope: APIs or intermediates exclusively made for one customer under a toll ...

http://www.apic.cefic.org/pub/Quality%20Agreement%20Guideline_final_December%202009_clean_appendix%20B.doc

Date added: August 18, 2016 - Views: 1

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IPEC GDP for Excipients

IPEC Good Distribution Practices Audit Questionnaire for Pharmaceutical Excipients. ... Is there a quality manual and written procedures describing all *GTDP related ...

http://ipec-europe.org/UPLOADS/IPEC_GDP_Audit_Guide_Final(1).doc

Date added: August 20, 2016 - Views: 1

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Good Manufacturing Practices (GMP’s) Policy -...

Good Manufacturing Practices (GMP’s) Policy. The purpose of this policy is to ensure compliance with current Good Manufacturing Practice (GMP) regulations for foods.

http://www.ssfpa.net/images/stories/fsi/Sample%20GMP%20documents/Other%20-%20Policies/GOOD%20GMP%20Policy.doc

Date added: August 18, 2016 - Views: 2

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SUPPLIER QUALITY EVALUATION QUESTIONNAIRE

Approximate number of employees in the Quality Unit ... Quality Policy / Manual. ... Do you supply to any other customer in the Pharmaceutical / Health care industry?

http://www.apic.cefic.org/pub/Supplier%20Questionnaire%20-%20Section%20A%20General%20Info.docx

Date added: August 20, 2016 - Views: 1

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Operational Policy and Procedure Manual About the ...

This 3rd edition of the Operational Policy and Procedure Manual and subsequent revisions have been developed to reflect the vast changes mandated by OBRA regulations.

http://mail.scmcf.org/Policy%20&%20Procedures/Heaton%20Manual%20Policy%20and%20Procedure/Heaton%202009/PandP%20Word%20Files/OPPM%20Volume1/07-AboutManual/002-AboutManual.doc

Date added: August 18, 2016 - Views: 1

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Table of Contents - ISPE

Table of Contents. I ... This item writing manual is to be used as a ... capable of fostering innovation and quality enhancements for the pharmaceutical and ...

http://www.ispe.org/certified-pharmaceutical-industry-professional/item-writing-manual.doc

Date added: August 20, 2016 - Views: 1

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Control of the quality manual -...

Title: Control of the quality manual Author: Gill Chessum Last modified by: Hygiene Created Date: 10/29/2003 5:02:00 PM Company: Dell Computer Corporation

http://hygienemanuals.co.uk/manuals/quality/2000%20QM-2.doc

Date added: August 24, 2016 - Views: 1

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No - U S Food and Drug Administration Home Page

Continually evolving to meet the current and emerging standards important to the Pharmaceutical ... in quality information management. Manual data handling is ...

http://www.fda.gov/ohrms/dockets/dockets/00d1540/00d-1540-lst0012.doc

Date added: August 18, 2016 - Views: 2

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GHTF SG3 Quality Management System - Medical...

Title: GHTF SG3 Quality Management System - Medical Devices - Guidance on the Control of Products and Services Obtained from Suppliers Author: GHTF

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n17-guidance-on-quality-management-system-081211.doc

Date added: August 18, 2016 - Views: 1

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Internal Audit Checklist Form

The quality manual shall include or make reference to the supporting procedures including ... Internal Audit Checklist Form Subject: ISO/IEC 17025:2005 Last ...

http://www.nist.gov/pml/wmd/labmetrology/upload/isoiec-17025-chklst-09.docx

Date added: August 18, 2016 - Views: 4

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Audit Report with GMP Questionnaire - Tli...

Quality Manual 14. 5.3. SOP System 14. 5 ... milling, or packaging) of highly toxic non-pharmaceutical materials such as herbicides and pesticides should not be ...

http://www.tlidevelopment.com/templates/Audit%20Report%20with%20GMP%20Questionnaire%20(template).doc

Date added: August 18, 2016 - Views: 2

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Guidance for Industry - Food and Drug...

Guidance for Industry. ... A. Responsibilities of the Quality ... A company can reference the equipment manufacturer instruction manual in its written procedures ...

http://www.fda.gov/OHRMS/DOCKETS/98fr/03d-0163-gdl0001.doc

Date added: August 18, 2016 - Views: 1

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Standard Operating Procedures and Policies (SOPs)

STANDARD OPERATING PROCEDURES AND POLICIES (SOPS) ... The purpose of the associated SOP Manual is to ensure accurate conduct of all Cell Therapy ... quality functions ...

http://c.ymcdn.com/sites/www.celltherapysociety.org/resource/resmgr/uploads/files/Resources/Lab%20Practices/Document%20Control%204.doc

Date added: August 18, 2016 - Views: 1

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IPEC GDP for Excipients

IPEC Europe Good Distribution Practices Audit Guideline for Pharmaceutical Excipients. ... Control Point 1.2 F1.1.1 Is there a quality manual and written ...

http://ipec-europe.org/UPLOADS/IPEC_Europe_GDP_Audit_Guide__-_Revision_2011_final.doc

Date added: August 19, 2016 - Views: 1

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INTRODUCTION - Mount Sinai Hospital

Quality Manual Policy QITMI00000.11 Page 2 of 4 Section: Quality Manual Subject Title: Introduction UNIVERSITY HEALTH NETWORK/MOUNT SINAI HOSPITAL, ...

http://www.mountsinai.on.ca/education/staff-professionals/microbiology/microbiology-laboratory-manual/quality-manual/Quality%20Manual%20Introduction%20QITMI00000.doc

Date added: August 19, 2016 - Views: 1

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Quality Manual - Elsmar

Quality Manual. Page 20 of 21 Production process controls. Non conforming product. Identification and traceability. Preservation. Document control. Record control.

http://elsmar.com/pdf_files/Quality%20and%20Other%20Manuals/Quality%20Manual%20example.doc

Date added: August 18, 2016 - Views: 1

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Massachusetts Board of Pharmacy Ambulatory Best...

Best Practice Recommendations. To Promote Optimum Pharmaceutical Care. In the Commonwealth of Massachusetts. In 2000, in response to medication error rates and ...

http://www.mass.gov/eohhs/docs/dph/quality/boards/pharmacy/pharmacy-best-practice.doc

Date added: August 18, 2016 - Views: 1

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Auditing of Quality Systems of Medical Device...

Guidelines for Regulatory Auditing of Quality Systems . of Medical Device Manufacturers – ... such as the quality manual, ... Pharmaceutical Affairs Law. USA.

http://www.imdrf.org/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-99-28-guidelines-auditing-device-manufacturer-quality-systems-part-one-990629.doc

Date added: August 18, 2016 - Views: 1

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Good documentation Practices - San Mateo County

... numerous types of documentation exist ... The German Government agency that must approve new pharmaceutical ... Re evaluate the Quality Policy and the ...

http://accounts.smccd.edu/kapp/bt415/sop/1000.01%20Good%20documentation%20Practices.doc

Date added: August 18, 2016 - Views: 2

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National Association of Boards of Pharmacy - NABP

National Association of Boards of ... Policy and Procedure Manual. 118. ... record of consumer perceptions of the quality of pharmaceutical products and services ...

http://www.nabp.net/publications/assets/ModelAct.doc

Date added: August 18, 2016 - Views: 2

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FDA response:

For the most part there is a lot of quality information and direction in ... pharmaceutical wholesaler ... procedures in place for this manual paper ...

http://www.fda.gov/ohrms/dockets/dailys/03/Nov03/110503/03N-0361-emc-000023-01.doc

Date added: August 19, 2016 - Views: 1

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Internal Audit Plan Template - HUD/U.S.

INTERNAL. AUDIT. PLAN. Project or System Name. U.S. Department of Housing and Urban Development. Month, Year Revision Sheet. Release No. Date Revision Description

http://portal.hud.gov/hudportal/documents/huddoc?id=DOC_15141.doc

Date added: August 18, 2016 - Views: 2