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...
Saved in:
| Main Author: | |
|---|---|
| Corporate Author: | |
| Format: | Electronic eBook |
| Language: | English |
| Published: |
[Erscheinungsort nicht ermittelbar]
Productivity Press
2018
|
| Edition: | 1st edition. |
| Subjects: | |
| Links: | https://learning.oreilly.com/library/view/-/9781351032568/?ar |
| Summary: | 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. |
| Item Description: | Online resource; Title from title page (viewed May 16, 2018) |
| Physical Description: | 1 Online-Ressource (216 Seiten) |
| ISBN: | 9781351032568 |
Staff View
MARC
| LEADER | 00000cam a22000002c 4500 | ||
|---|---|---|---|
| 001 | ZDB-30-ORH-053530888 | ||
| 003 | DE-627-1 | ||
| 005 | 20240228121028.0 | ||
| 007 | cr uuu---uuuuu | ||
| 008 | 200625s2018 xx |||||o 00| ||eng c | ||
| 020 | |a 9781351032568 |9 978-1-351-03256-8 | ||
| 035 | |a (DE-627-1)053530888 | ||
| 035 | |a (DE-599)KEP053530888 | ||
| 035 | |a (ORHE)9781351032568 | ||
| 035 | |a (DE-627-1)053530888 | ||
| 040 | |a DE-627 |b ger |c DE-627 |e rda | ||
| 041 | |a eng | ||
| 082 | 0 | |a 610.28 |2 23/eng/20230216 | |
| 100 | 1 | |a White, William |e VerfasserIn |4 aut | |
| 245 | 1 | 0 | |a Excellence Beyond Compliance |c White, William |
| 250 | |a 1st edition. | ||
| 264 | 1 | |a [Erscheinungsort nicht ermittelbar] |b Productivity Press |c 2018 | |
| 300 | |a 1 Online-Ressource (216 Seiten) | ||
| 336 | |a Text |b txt |2 rdacontent | ||
| 337 | |a Computermedien |b c |2 rdamedia | ||
| 338 | |a Online-Ressource |b cr |2 rdacarrier | ||
| 500 | |a Online resource; Title from title page (viewed May 16, 2018) | ||
| 520 | |a 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. | ||
| 650 | 0 | |a Medical instruments and apparatus |x Quality control | |
| 650 | 0 | |a Medical instruments and apparatus |x Standards | |
| 650 | 0 | |a Quality control | |
| 650 | 2 | |a Equipment Design |x standards | |
| 650 | 2 | |a Total Quality Management |x organization & administration | |
| 650 | 2 | |a Equipment Safety | |
| 650 | 2 | |a Quality Control | |
| 650 | 4 | |a Médecine ; Appareils et instruments ; Qualité ; Contrôle | |
| 650 | 4 | |a Qualité ; Contrôle | |
| 650 | 4 | |a quality control | |
| 650 | 4 | |a Quality control | |
| 650 | 4 | |a Medical instruments and apparatus ; Quality control | |
| 650 | 4 | |a Medical instruments and apparatus ; Standards | |
| 710 | 2 | |a Safari, an O'Reilly Media Company. |e MitwirkendeR |4 ctb | |
| 966 | 4 | 0 | |l DE-91 |p ZDB-30-ORH |q TUM_PDA_ORH |u https://learning.oreilly.com/library/view/-/9781351032568/?ar |m X:ORHE |x Aggregator |z lizenzpflichtig |3 Volltext |
| 912 | |a ZDB-30-ORH | ||
| 912 | |a ZDB-30-ORH | ||
| 951 | |a BO | ||
| 912 | |a ZDB-30-ORH | ||
| 049 | |a DE-91 | ||
Record in the Search Index
| DE-BY-TUM_katkey | ZDB-30-ORH-053530888 |
|---|---|
| _version_ | 1829007752571125760 |
| adam_text | |
| any_adam_object | |
| author | White, William |
| author_corporate | Safari, an O'Reilly Media Company |
| author_corporate_role | ctb |
| author_facet | White, William Safari, an O'Reilly Media Company |
| author_role | aut |
| author_sort | White, William |
| author_variant | w w ww |
| building | Verbundindex |
| bvnumber | localTUM |
| collection | ZDB-30-ORH |
| ctrlnum | (DE-627-1)053530888 (DE-599)KEP053530888 (ORHE)9781351032568 |
| dewey-full | 610.28 |
| 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 |
| edition | 1st edition. |
| format | Electronic eBook |
| fullrecord | <?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>03413cam a22005172c 4500</leader><controlfield tag="001">ZDB-30-ORH-053530888</controlfield><controlfield tag="003">DE-627-1</controlfield><controlfield tag="005">20240228121028.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">200625s2018 xx |||||o 00| ||eng c</controlfield><datafield tag="020" ind1=" " ind2=" "><subfield code="a">9781351032568</subfield><subfield code="9">978-1-351-03256-8</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627-1)053530888</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-599)KEP053530888</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(ORHE)9781351032568</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627-1)053530888</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rda</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2=" "><subfield code="a">610.28</subfield><subfield code="2">23/eng/20230216</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">White, William</subfield><subfield code="e">VerfasserIn</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Excellence Beyond Compliance</subfield><subfield code="c">White, William</subfield></datafield><datafield tag="250" ind1=" " ind2=" "><subfield code="a">1st edition.</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="a">[Erscheinungsort nicht ermittelbar]</subfield><subfield code="b">Productivity Press</subfield><subfield code="c">2018</subfield></datafield><datafield tag="300" ind1=" " ind2=" "><subfield code="a">1 Online-Ressource (216 Seiten)</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">Online resource; Title from title page (viewed May 16, 2018)</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">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.</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Medical instruments and apparatus</subfield><subfield code="x">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Medical instruments and apparatus</subfield><subfield code="x">Standards</subfield></datafield><datafield tag="650" ind1=" " ind2="0"><subfield code="a">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="2"><subfield code="a">Equipment Design</subfield><subfield code="x">standards</subfield></datafield><datafield tag="650" ind1=" " ind2="2"><subfield code="a">Total Quality Management</subfield><subfield code="x">organization & administration</subfield></datafield><datafield tag="650" ind1=" " ind2="2"><subfield code="a">Equipment Safety</subfield></datafield><datafield tag="650" ind1=" " ind2="2"><subfield code="a">Quality Control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Médecine ; Appareils et instruments ; Qualité ; Contrôle</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Qualité ; Contrôle</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical instruments and apparatus ; Quality control</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Medical instruments and apparatus ; Standards</subfield></datafield><datafield tag="710" ind1="2" ind2=" "><subfield code="a">Safari, an O'Reilly Media Company.</subfield><subfield code="e">MitwirkendeR</subfield><subfield code="4">ctb</subfield></datafield><datafield tag="966" ind1="4" ind2="0"><subfield code="l">DE-91</subfield><subfield code="p">ZDB-30-ORH</subfield><subfield code="q">TUM_PDA_ORH</subfield><subfield code="u">https://learning.oreilly.com/library/view/-/9781351032568/?ar</subfield><subfield code="m">X:ORHE</subfield><subfield code="x">Aggregator</subfield><subfield code="z">lizenzpflichtig</subfield><subfield code="3">Volltext</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-30-ORH</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-30-ORH</subfield></datafield><datafield tag="951" ind1=" " ind2=" "><subfield code="a">BO</subfield></datafield><datafield tag="912" ind1=" " ind2=" "><subfield code="a">ZDB-30-ORH</subfield></datafield><datafield tag="049" ind1=" " ind2=" "><subfield code="a">DE-91</subfield></datafield></record></collection> |
| id | ZDB-30-ORH-053530888 |
| illustrated | Not Illustrated |
| indexdate | 2025-04-10T09:35:18Z |
| institution | BVB |
| isbn | 9781351032568 |
| language | English |
| open_access_boolean | |
| owner | DE-91 DE-BY-TUM |
| owner_facet | DE-91 DE-BY-TUM |
| physical | 1 Online-Ressource (216 Seiten) |
| psigel | ZDB-30-ORH TUM_PDA_ORH ZDB-30-ORH |
| publishDate | 2018 |
| publishDateSearch | 2018 |
| publishDateSort | 2018 |
| publisher | Productivity Press |
| record_format | marc |
| 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 |
| work_keys_str_mv | AT whitewilliam excellencebeyondcompliance AT safarianoreillymediacompany excellencebeyondcompliance |