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Excellence beyond compliance : establishing a medical device quality system

Author: William I White
Publisher: Boca Raton : CRC Press, Taylor & Francis Group, 2018.
Edition/Format:   eBook : Document : EnglishView all editions and formats
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  Read more...
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Genre/Form: Electronic books
Additional Physical Format: Print version:
White, William I.
Excellence beyond compliance.
Boca Raton : CRC Press, an imprint of Taylor & Francis Group, 2018
Material Type: Document, Internet resource
Document Type: Internet Resource, Computer File
All Authors / Contributors: William I White
ISBN: 9781351032582 1351032585 9781351032568 1351032569
OCLC Number: 1027770072
Description: 1 online resource (xix, 216 pages)
Contents: Machine generated contents note: ch. 1 Challenge --
Objective: Good Products --
Compliance is Fundamental --
Moving Target --
Worldwide Requirements --
United States --
Canada --
Europe --
Latin America --
Asia --
Australia --
Middle East and Africa --
More Requirements --
Product Approval/Registration --
Internal Requirements --
Exceptions --
Beyond Requirements --
Employee Perspective --
Quality and Regulatory Perspective --
ch. 2 Path --
Are We Satisfied? --
Top Management Support? --
Steering Committee --
Key Decisions --
Establishing the Improvements --
Maintenance --
ch. 3 Key Decisions --
Level of Control --
Small Company: Straightforward Documentation Structure --
Large Company: Several Options --
Single QMS? --
Choosing Among the Options --
Framework --
Customized Framework --
FDA CGMP Framework --
FDA QSIT Framework --
ISO 13485 Framework --
ISO 9001:2015/Annex SL Framework --
Essentially Two Choices --
Choosing Between FDA and ISO Frameworks --
ch. 4 Quality Plan --
Background to the Plan --
Quality Plan --
Documentation Transitioning --
Human Resources --
Quality Council --
QMS Support Staff --
Software Infrastructure --
Approval --
ch. 5 Documentation, the Big Picture --
Structure --
Right Number of Levels --
Format --
Cautions --
Flexibility --
Language --
Content --
Electronic Documentation --
Covering All Markets --
Ensuring Full Coverage --
ch. 6 Level --
Documentation --
Quality Policy --
Content --
Implementation --
Translations --
Quality Manual --
Look and Feel --
External Value --
Challenges --
ch. 7 Level --
Documentation --
Value to the Employee --
Principles Applicable to Each Process --
Appendix --
ch. 8 Level --
Documentation --
Corporation-Wide Level 3 --
Complaints --
Medical Device Reporting/Vigilance --
CAPA --
Quality Audits --
Format --
Flowcharts --
Playscript Procedures --
Language --
Software --
Keeping Current --
ch. 9 Level 4 Documentation --
Records --
Forms --
Guidelines/Guidances --
Training Materials --
External Documentation --
ch. 10 Fully Incorporating Risk Management --
Quality Manual --
Level 2 --
Level 3 --
ch. 11 Implementation --
Communication --
Resources --
Human Resources --
Infrastructure --
Documentation --
Training --
ch. 12 Maintenance (and Improvement) --
Metrics --
Internal Audits --
Many or Few Auditors? --
Effectiveness --
Quality Council --
Management Review --
Working with Registrars/Notified Bodies --
Definitions --
Relationships --
Value --
Multiple Sites --
Developments to Watch --
Never-Ending Story.
Responsibility: by William I. White.

Abstract:

"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.

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