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20240329122006.0 |
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201031s2015 wiu o ||| 0 eng d |
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|a EBLCP
|b eng
|c EBLCP
|d YDX
|d K6U
|d OCLCO
|d OCLCF
|d OCLCO
|d OCLCQ
|d OCLCO
|d HF9
|d OCLCQ
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| 019 |
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|a 1178649449
|a 1202476655
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|a 9781953079497
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|a 1953079490
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|z 9780873899178
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|z 0873899172
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|b 000068485825
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|a (OCoLC)1202462536
|z (OCoLC)1178649449
|z (OCoLC)1202476655
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| 050 |
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4 |
|a HF5738
|b .S557 2015
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| 082 |
0 |
4 |
|a 651.50285
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| 049 |
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|a UAMI
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| 100 |
1 |
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|a Skipper, Stephanie L.
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| 245 |
1 |
0 |
|a How to Establish a Document Control System for Compliance with ISO 9001
|h [electronic resource] :
|b A Comprehensive Guide to Designing a Process-Based Document Control System.
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| 260 |
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|a Milwaukee, WI :
|b Quality Press,
|c 2015.
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| 300 |
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|a 1 online resource (156 p.)
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| 336 |
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|a text
|b txt
|2 rdacontent
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| 337 |
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|a unmediated
|b n
|2 rdamedia
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| 338 |
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|a volume
|b nc
|2 rdacarrier
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| 500 |
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|a Description based upon print version of record.
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| 505 |
0 |
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|a Intro -- Title Page -- CIP data -- Dedication -- Table of Contents -- List of Figures and Tables -- Foreword -- Applicability to ISO 9001:2015 and ISO 13485:2016 Updates -- Acknowledgments -- Chapter 1: Document Control in the Quality Management System -- Chapter 2: Document Management versus Document Control -- 2.1 ISO and US FDA Regulatory Document Control Requirements -- Chapter 3: Manual Document Control Systems versus Electronic Document Control Systems -- Chapter 4: Foundational Concepts -- Foundational Concept: Controlled -- Foundational Concept: Controlled Document
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| 505 |
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|a Foundational Concept: Proactively Managed -- Foundational Concept: Document Life Cycle -- Foundational Concept: Process -- Foundational Concept: Process Steps -- Foundational Concept: Procedure -- Foundational Concept: Document Control -- Foundational Concept: Standard Operating Procedure -- Chapter 5: Process-Based Approach -- Chapter 6: The Document Life Cycle -- 6.1 Scope of Document Control -- Chapter 7: Organization of Controlled Documents -- 7.1 Document Levels and Families: Basic Organization Model -- 7.2 Document Family Rules
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| 505 |
8 |
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|a 7.3 Purpose and Scope of Controlled Documents by Controlled Document Level -- 7.3.1 Purpose and Scope of Level 1 Policies (Top Level-Directives) -- 7.3.2 Purpose and Scope of Level 2 Manuals and Master Plans (High Level-Informative) -- 7.3.3 Purpose and Scope of Level 3 Standard Operating Procedures (Mid Level-Process) -- 7.3.4 Purpose and Scope of Level 4 Work Instruction/Procedures (Low Level-Detailed Instructional) -- 7.3.5 Purpose and Scope of Level 5 Supporting Documents (Specific, Detailed, Functional) -- Chapter 8: Document Identification: Numbering, Versioning, and Naming -- 8.1 Numbering
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| 505 |
8 |
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|a Example #1 -- Example #2 -- 8.2 Versioning -- 8.3 Naming -- Chapter 9: Incorporating Document Control Objectives and Requirements into the Document Control Procedural Set -- Chapter 10: Structure, Format, and Content of Controlled Documents -- 10.1 The Minimum Content Standards -- 10.1.1 Document Identification -- 10.1.2 Purpose -- 10.1.3 Scope -- 10.1.4 Roles and Responsibilities -- 10.1.5 Related Documents -- 10.1.6 Supporting Documents -- 10.1.7 Document/Version History -- 10.1.8 Process Steps -- 10.1.9 Quality Records
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| 505 |
8 |
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|a 10.2 The Minimum Content Standards for External Documents and Other Documented Information -- Chapter 11: Writing the Document Control Policy, SOPs, and Work Instructions/Procedures -- Chapter 12: Writing the Document Control Policy (POL) -- 12.1 Document Identification Information -- 12.1.1 Header -- 12.1.2 Footer -- 12.2 Document Sections -- 12.2.1 Purpose -- 12.2.2 Scope -- 12.2.3 Roles and Responsibilities -- 12.2.4 References and Related Documents -- 12.2.5 Supporting Documents -- 12.2.6 Requirements Section -- 12.2.7 Exceptions -- 12.2.8 Quality Records -- 12.2.9 Document/Version History
|
| 500 |
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|a Chapter 13: Writing the Document Control Standard Operating Procedure.
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| 590 |
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|a ProQuest Ebook Central
|b Ebook Central Academic Complete
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| 650 |
|
0 |
|a Records
|x Management
|x Data processing.
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| 650 |
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0 |
|a Electronic records
|x Management.
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| 650 |
|
0 |
|a Quality control.
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| 650 |
|
0 |
|a Information storage and retrieval systems.
|
| 650 |
|
0 |
|a Database management.
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| 650 |
|
2 |
|a Quality Control
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| 650 |
|
2 |
|a Information Systems
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| 650 |
|
6 |
|a Archives électroniques
|x Gestion.
|
| 650 |
|
6 |
|a Qualité
|x Contrôle.
|
| 650 |
|
6 |
|a Systèmes d'information.
|
| 650 |
|
6 |
|a Bases de données
|x Gestion.
|
| 650 |
|
7 |
|a quality control.
|2 aat
|
| 650 |
|
7 |
|a Database management
|2 fast
|
| 650 |
|
7 |
|a Electronic records
|x Management
|2 fast
|
| 650 |
|
7 |
|a Information storage and retrieval systems
|2 fast
|
| 650 |
|
7 |
|a Quality control
|2 fast
|
| 650 |
|
7 |
|a Records
|x Management
|x Data processing
|2 fast
|
| 776 |
0 |
8 |
|i Print version:
|a Skipper, Stephanie L.
|t How to Establish a Document Control System for Compliance with ISO 9001:2015, ISO 13485:2016, and FDA Requirements
|d Milwaukee, WI : Quality Press,c2015
|z 9780873899178
|
| 856 |
4 |
0 |
|u https://ebookcentral.uam.elogim.com/lib/uam-ebooks/detail.action?docID=6356747
|z Texto completo
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| 938 |
|
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|a ProQuest Ebook Central
|b EBLB
|n EBL6356747
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| 938 |
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|a YBP Library Services
|b YANK
|n 301389672
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|a 92
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