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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: 2

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Sample ISO 9001 Quality Manual - American Society for Quality

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: 51

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Quality Planning Procedure - CAPAtrak

Quality planning shall take place during product and/or process design and development. ... Quality Manual Electronic, maintained on company intranet.

http://www.capatrak.com/Files/Templ%20-%20Word%20-%20Procedure%20-%20QualityPlanning.doc

Date added: August 18, 2016 - Views: 9

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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: 15

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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: 17

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www.who.int

This quality manual template provides guidance for public health and clinical laboratories on writing policies and procedures that support a quality management system.

http://www.who.int/entity/ihr/training/laboratory_quality/Quality_Manual_template.doc?ua=1

Date added: August 18, 2016 - Views: 9

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OPERATION AND MAINTENANCE PLAN - New Jersey

The O&M manual is one of a water purveyor’s most crucial documents. ... Water Quality Monitoring Plan ... OPERATION AND MAINTENANCE PLAN Author: WS ...

http://www.nj.gov/dep/watersupply/doc/ops_plan_temp.doc

Date added: August 18, 2016 - Views: 29

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QUALITY MANAGEMENT SYSTEM MANUAL - elsmar.com

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

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

Date added: November 16, 2016 - Views: 2

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SOP on Document Control and Management - pSMILE

Quality Manual, Standard Operating Procedures (SOPs) and forms, Quality Plans and Test Plans. Work instructions. Regulations, standards and other reference materials.

http://resources.psmile.org/resources/documents-and-records/Doc0.0-14%20Document%20Control%20and%20Management.doc

Date added: August 18, 2016 - Views: 6

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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: 14

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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: 15

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QUALITY POLICY - FP&M SETA

Quality Policy Policy QP/MC/001. Business Systems. ... This Quality Manual and its associated procedures establish and document the means by which we implement, ...

http://www.fpmseta.org.za/downloads/Generic_QMS_Template_Nov_2012.doc

Date added: August 18, 2016 - Views: 18

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Quality Manual DS GMP 2007 Contents - ep.yimg.com

Quality Manual. In compliance with. Dietary Supplement Current Good Manufacturing Practices (cGMPs 21 CFR part 111, 2007) Document Number: QM01-00

https://sep.yimg.com/ty/cdn/yhst-66749609830114/QM01-1-00-Quality-Manual-DS-GMP-Contents.doc

Date added: September 24, 2016 - Views: 3

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RECALL MANUAL - ssfpa.net

Recall Program and Procedures This Recall Manual outlines the requirements and steps to be taken in the event of a product recall and/or withdrawal.

http://www.ssfpa.net/images/stories/fsi/food_safety_docs/Generic%20GMPs/F%20Recall/Recall%20Manual/RECALL%20MANUAL.doc

Date added: August 18, 2016 - Views: 7

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

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: 15

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Standard Operating Procedures and Shipping Guidelines for ...

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: 17

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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: 28

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QM Quality Management - İTÜ

Overview. Functions and Features of the Quality Management Module. Quality Management in the Logistical Processes. Quality Planning in the QM Module

http://web.itu.edu.tr/~durucumur/US/QM.doc

Date added: August 18, 2016 - Views: 8

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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: 6

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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: 3

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Guidance for Industry - Food and Drug Administration

Guidance for Industry. ... manufacturer instruction manual in its written procedures if the manual ... Test Results for Pharmaceutical Production was ...

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

Date added: August 18, 2016 - Views: 29

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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/00d1538/00d-1538-lst0012.doc

Date added: August 18, 2016 - Views: 8

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Good documentation Practices

Introduction: In a facility that uses . G. ood . M. anufacturing . P. ractices (GMP), numerous types of documentation exist and serve a variety of functions.

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

Date added: August 18, 2016 - Views: 18

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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: 22

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Auditing of Quality Systems of Medical Device Manufacturers ...

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: 8

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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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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: 2

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Sample Group Training Company Manual

Documentation of policies in a quality manual is a fundamental for any organisation’s quality management system. ... Sample Group Training Company Manual

http://www.training.nsw.gov.au/forms_documents/industry_programs/industry_initiatives/gto/manual.doc

Date added: August 18, 2016 - Views: 40

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Audit Report with GMP Questionnaire - Tli Development

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: 20

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Checklist – Good Laboratory Practice Requirements of the ...

Checklist – Good Laboratory Practice Requirements of the Michigan Regional ... The laboratory will utilize a comprehensive procedure manual. ... Quality Control ...

http://www.michigan.gov/documents/mdch/GLP_Checklist_359367_7.doc

Date added: August 18, 2016 - Views: 11

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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: 8

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Yours sincerely - Complementary Medicines Australia

Active pharmaceutical ingredients Pharmaceutical excipients Herbal raw materials Nutritional raw ... please provide the table of contents of the quality manual.

http://www.cmaustralia.org.au/Resources/Documents/Codes%20and%20Guidelines/Supplier%20Vendor%20Qualification%20Questionnaire.doc

Date added: August 18, 2016 - Views: 1

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Standard Operating Procedure - PV Toolkit

Pharmaceutical companies. Patients or patient representatives. ... depending upon the seriousness of the event and the quality of the information. (WHO)

http://pvtoolkit.org/toolkit/readers/sop_spontaneous_reporting.doc

Date added: August 19, 2016 - Views: 7