Excellence beyond compliance: establishing a medical device quality system
"Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious k...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Elektronisch E-Book |
| Sprache: | English |
| Veröffentlicht: |
Boca Raton
CRC Press, Taylor & Francis Group
2018
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| Schlagworte: | |
| Online-Zugang: | Volltext |
| Zusammenfassung: | "Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of todaythe multiple sources of QMS requirementsthe book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers:Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS."--Provided by publisher |
| Beschreibung: | 1 online resource (xix, 216 pages) |
| ISBN: | 9781351032582 1351032585 9781351032575 1351032577 |
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| author | White, William I. |
| author_facet | White, William I. |
| author_role | aut |
| author_sort | White, William I. |
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| building | Verbundindex |
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| ctrlnum | (ZDB-7-TFC)9781351032582 (DE-599)BVBBV047014516 |
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| dewey-hundreds | 600 - Technology (Applied sciences) |
| dewey-ones | 610 - Medicine and health |
| dewey-raw | 610.28 |
| dewey-search | 610.28 |
| dewey-sort | 3610.28 |
| dewey-tens | 610 - Medicine and health |
| discipline | Medizin |
| discipline_str_mv | Medizin |
| format | Electronic eBook |
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| illustrated | Not Illustrated |
| index_date | 2024-07-03T15:58:15Z |
| indexdate | 2024-07-10T09:00:10Z |
| institution | BVB |
| isbn | 9781351032582 1351032585 9781351032575 1351032577 |
| language | English |
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| physical | 1 online resource (xix, 216 pages) |
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| publishDate | 2018 |
| publishDateSearch | 2018 |
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| publisher | CRC Press, Taylor & Francis Group |
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| spelling | White, William I. Verfasser aut Excellence beyond compliance establishing a medical device quality system by William I. White Boca Raton CRC Press, Taylor & Francis Group 2018 1 online resource (xix, 216 pages) txt rdacontent c rdamedia cr rdacarrier "Many companies limp along from day-to-day treating the quality side of the business as a necessary evil, and doing only what is minimally necessary for compliance to regulations. This kind of approach to compliance almost always results in inefficiencies and sometimes can result in a curious kind of noncompliance. Documentation created with compliance as the sole consideration often ends up confusing the employees who must use the documentation. This book looks beyond what is necessary for compliance alone to address what makes a quality management system (QMS) both effective and efficient. This book also never forgets that real people must make any QMS work; the book provides a blueprint for creating a QMS that real people will find useful. After a review of the challenges that any medical device company faces in the world of todaythe multiple sources of QMS requirementsthe book poses a question: are we satisfied with the QMS we have now, or could we do better? If we want to do better, this book can help. This book offers:Advice that will lead to an effective and efficient QMS. Detailed guidance on the key decisions to be made regarding the quality system being established. Detailed ideas on how to execute those decisions. Up-to-date information on compliance to current regulations and standards and guidance on staying up to date. Specific examples of procedures. Information regarding requirements for combination products, such as a drug + device combination. Advice on incorporating risk management in the QMS."--Provided by publisher Medical instruments and apparatus / Standards Medical instruments and apparatus / Quality control https://www.taylorfrancis.com/books/9781351032582 Verlag URL des Erstveroeffentlichers Volltext |
| spellingShingle | White, William I. Excellence beyond compliance establishing a medical device quality system Medical instruments and apparatus / Standards Medical instruments and apparatus / Quality control |
| title | Excellence beyond compliance establishing a medical device quality system |
| title_auth | Excellence beyond compliance establishing a medical device quality system |
| title_exact_search | Excellence beyond compliance establishing a medical device quality system |
| title_exact_search_txtP | Excellence beyond compliance establishing a medical device quality system |
| title_full | Excellence beyond compliance establishing a medical device quality system by William I. White |
| title_fullStr | Excellence beyond compliance establishing a medical device quality system by William I. White |
| title_full_unstemmed | Excellence beyond compliance establishing a medical device quality system by William I. White |
| title_short | Excellence beyond compliance |
| title_sort | excellence beyond compliance establishing a medical device quality system |
| title_sub | establishing a medical device quality system |
| topic | Medical instruments and apparatus / Standards Medical instruments and apparatus / Quality control |
| topic_facet | Medical instruments and apparatus / Standards Medical instruments and apparatus / Quality control |
| url | https://www.taylorfrancis.com/books/9781351032582 |
| work_keys_str_mv | AT whitewilliami excellencebeyondcomplianceestablishingamedicaldevicequalitysystem |