Developing an ISO 13485-Certified Quality Management System : (Record no. 6419)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04772cam a2200469Ki 4500 |
| 001 - CONTROL NUMBER | |
| control field | 9781003202868 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | FlBoTFG |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20240213122835.0 |
| 006 - FIXED-LENGTH DATA ELEMENTS--ADDITIONAL MATERIAL CHARACTERISTICS | |
| fixed length control field | m o d |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr cnu|||unuuu |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 211007s2022 xx fo 000 0 eng d |
| 040 ## - CATALOGING SOURCE | |
| Original cataloging agency | OCoLC-P |
| Language of cataloging | eng |
| Description conventions | rda |
| -- | pn |
| Transcribing agency | OCoLC-P |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781003202868 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1003202861 |
| Qualifying information | (electronic bk.) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781032065748 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000550689 |
| Qualifying information | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000550680 |
| Qualifying information | (electronic bk. : EPUB) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9781000550665 |
| Qualifying information | (electronic bk. : PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 1000550664 |
| Qualifying information | (electronic bk. : PDF) |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| Canceled/invalid ISBN | 9781032065731 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC)1273727255 |
| 035 ## - SYSTEM CONTROL NUMBER | |
| System control number | (OCoLC-P)1273727255 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | TS156 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | BUS |
| Subject category code subdivision | 087000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | KJMQ |
| Source | bicssc |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER | |
| Classification number | 658.562 |
| Edition number | 23 |
| 100 1# - MAIN ENTRY--PERSONAL NAME | |
| Personal name | Juuso, Ilkka. |
| 245 10 - TITLE STATEMENT | |
| Title | Developing an ISO 13485-Certified Quality Management System : |
| Remainder of title | An Implementation Guide for the Medical-Device Industry. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | First edition. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | [Place of publication not identified] : |
| Name of producer, publisher, distributor, manufacturer | Productivity Press, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2022. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 1 online resource (352 pages). |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | Chapter 1: About this bookChapter 2: IntroductionChapter 3: What to know before getting startedChapter 4: Getting startedChapter 5: Writing the quality manualChapter 6: Writing the Standard Operating ProceduresChapter 7: QMS documentation (SOP-1)Chapter 8: CAPA, monitoring & improvement (SOP-2)Chapter 9: Infrastructure (SOP-3)Chapter 10: Human resources (SOP-4)Chapter 11: Suppliers & distributors (SOP-5)Chapter 12: Auditing (SOP-6)Chapter 13: Communication, marketing & sales (SOP-7)Chapter 14: Risk management (SOP-8)Chapter 15: Clinical evidence (SOP-9)Chapter 16: Product realization (SOP-10)Chapter 17: Regulatory affairs (SOP-11)Chapter 18: Post-market surveillance (SOP-12)Chapter 19: Finalizing all the SOPsChapter 20: Writing templates, forms, records, and registriesChapter 21: Writing meeting agendas and minutesChapter 22: QMS software validationChapter 23: The launchChapter 24: TrainingChapter 25: Document reviewChapter 26: AuditsChapter 27: Management reviewChapter 28: CertificationChapter 29: Business as usualChapter 30: What to know when you are up and runningChapter 31: Conclusion |
| 520 ## - SUMMARY, ETC. | |
| Summary, etc. | This book details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. The book takes a hands-on approach -- first teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management review, and finally passing the necessary external audits and obtaining certification. The book helps you to progress from one task to the next and provides all the essential information to accomplish each task as quickly and efficiently as possible. The book does not attempt to replicate the standard but instead drills into the standard to expose the core of each section of the standard and reorganize its contents into a practical workflow for developing, maintaining, and improving a Lean QMS. The book includes a wealth of real-world experience both from my personal dive into quality management, and from the experiences of other companies in the field. The book also provides handy checklists for ensuring key documents and processes are fit for use - the emphasis here is to help ensure you have considered all relevant aspects. The book is not intended as a "cheat sheet" for the standard or as a review of the standard that only adds lengthy commentary on each of the clauses. Instead, the book fixes easy misunderstandings regarding QMS, provides insight into why the various clauses are written the way they are, and provides a great base to both understanding ISO 13485 QMS and developing your own QMS. The book is intended to serve both experts and novices audiences -- it provides special insight on the most crucial and effective aspects of QMS. |
| 588 ## - SOURCE OF DESCRIPTION NOTE | |
| Source of description note | OCLC-licensed vendor bibliographic record. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Quality control |
| General subdivision | Management. |
| 650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | BUSINESS & ECONOMICS / Production & Operations Management |
| Source of heading or term | bisacsh |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | Taylor & Francis |
| Uniform Resource Identifier | <a href="https://www.taylorfrancis.com/books/9781003202868">https://www.taylorfrancis.com/books/9781003202868</a> |
| 856 42 - ELECTRONIC LOCATION AND ACCESS | |
| Materials specified | OCLC metadata license agreement |
| Uniform Resource Identifier | <a href="http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf">http://www.oclc.org/content/dam/oclc/forms/terms/vbrl-201703.pdf</a> |
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