Excellence Beyond Compliance:
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...
Gespeichert in:
| Beteilige Person: | |
|---|---|
| Körperschaft: | |
| Format: | Elektronisch E-Book |
| Sprache: | Englisch |
| Veröffentlicht: |
[Erscheinungsort nicht ermittelbar]
Productivity Press
2018
|
| Ausgabe: | 1st edition. |
| Schlagwörter: | |
| Links: | https://learning.oreilly.com/library/view/-/9781351032568/?ar |
| 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 today-the multiple sources of QMS requirements-the 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. |
| Beschreibung: | Online resource; Title from title page (viewed May 16, 2018) |
| Umfang: | 1 Online-Ressource (216 Seiten) |
| ISBN: | 9781351032568 |
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| spelling | White, William VerfasserIn aut Excellence Beyond Compliance White, William 1st edition. [Erscheinungsort nicht ermittelbar] Productivity Press 2018 1 Online-Ressource (216 Seiten) Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Online resource; Title from title page (viewed May 16, 2018) 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 today-the multiple sources of QMS requirements-the 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. Medical instruments and apparatus Quality control Medical instruments and apparatus Standards Quality control Equipment Design standards Total Quality Management organization & administration Equipment Safety Quality Control Médecine ; Appareils et instruments ; Qualité ; Contrôle Qualité ; Contrôle quality control Medical instruments and apparatus ; Quality control Medical instruments and apparatus ; Standards Safari, an O'Reilly Media Company. MitwirkendeR ctb |
| spellingShingle | White, William Excellence Beyond Compliance Medical instruments and apparatus Quality control Medical instruments and apparatus Standards Quality control Equipment Design standards Total Quality Management organization & administration Equipment Safety Quality Control Médecine ; Appareils et instruments ; Qualité ; Contrôle Qualité ; Contrôle quality control Medical instruments and apparatus ; Quality control Medical instruments and apparatus ; Standards |
| title | Excellence Beyond Compliance |
| title_auth | Excellence Beyond Compliance |
| title_exact_search | Excellence Beyond Compliance |
| title_full | Excellence Beyond Compliance White, William |
| title_fullStr | Excellence Beyond Compliance White, William |
| title_full_unstemmed | Excellence Beyond Compliance White, William |
| title_short | Excellence Beyond Compliance |
| title_sort | excellence beyond compliance |
| topic | Medical instruments and apparatus Quality control Medical instruments and apparatus Standards Quality control Equipment Design standards Total Quality Management organization & administration Equipment Safety Quality Control Médecine ; Appareils et instruments ; Qualité ; Contrôle Qualité ; Contrôle quality control Medical instruments and apparatus ; Quality control Medical instruments and apparatus ; Standards |
| topic_facet | Medical instruments and apparatus Quality control Medical instruments and apparatus Standards Quality control Equipment Design standards Total Quality Management organization & administration Equipment Safety Quality Control Médecine ; Appareils et instruments ; Qualité ; Contrôle Qualité ; Contrôle quality control Medical instruments and apparatus ; Quality control Medical instruments and apparatus ; Standards |
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