Table Of ContentExcellence Beyond
Compliance
Excellence Beyond
Compliance
Establishing a Medical Device
Quality System
By
William I. White
Routledge
Taylor & Francis Group
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© 2018 by William I. White
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Library of Congress Cataloging–in–Publication Data
Names: White, William I., author.
Title: Excellence beyond compliance : establishing a medical device quality
system / William I. White.
Description: Boca Raton : Taylor & Francis, 2018. | Includes bibliographical
references and index. |
Identifiers: LCCN 2018002607 (print) | LCCN 2018010579 (ebook) | ISBN
9781351032582 (eBook) | ISBN 9781138491472 (hardback : alk. paper)
Subjects: LCSH: Medical instruments and apparatus–Standards. | Medical
instruments and apparatus–Quality control.
Classification: LCC R856.6 (ebook) | LCC R856.6 .W45 2018 (print) | DDC
610.28–dc23
LC record available at https://lccn.loc.gov/2018002607
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To Evelyn Ampofoa,
my inspiration for more than 50 years
Contents
Preface ....................................................................................................xi
About the Author ................................................................................xiii
Acknowledgments ................................................................................xv
Introduction ........................................................................................xvii
Chapter 1 The Challenge .....................................................................1
Objective: Good Products ..........................................................1
Compliance is Fundamental ......................................................2
The Moving Target ......................................................................3
Worldwide Requirements ...........................................................6
United States ............................................................................6
Canada .....................................................................................7
Europe ......................................................................................8
Latin America .......................................................................10
Asia .........................................................................................10
Australia .................................................................................11
Middle East and Africa ........................................................12
More Requirements ...................................................................12
Product Approval/Registration ..........................................12
Internal Requirements .........................................................12
Exceptions ..............................................................................13
Beyond Requirements ...............................................................13
Employee Perspective ...........................................................13
Quality and Regulatory Perspective ..................................14
Chapter 2 The Path ............................................................................17
Are We Satisfied? .......................................................................17
Top Management Support? ......................................................19
Steering Committee .................................................................20
Key Decisions ............................................................................20
Establishing the Improvements ...............................................21
Maintenance ...............................................................................22
vii
viii • Contents
Chapter 3 Key Decisions ...................................................................23
Level of Control .........................................................................23
Small Company: Straightforward Documentation
Structure ................................................................................24
Large Company: Several Options .......................................24
A Single QMS? ......................................................................27
Choosing Among the Options ...........................................28
Framework..................................................................................29
Customized Framework .....................................................30
FDA CGMP Framework ......................................................31
FDA QSIT Framework .........................................................31
ISO 13485 Framework .........................................................32
ISO 9001:2015/Annex SL Framework ................................33
Essentially Two Choices .......................................................36
Choosing Between FDA and ISO Frameworks ................37
Chapter 4 A Quality Plan ..................................................................43
Background to the Plan ...........................................................43
Quality Plan ..............................................................................44
Documentation Transitioning ................................................44
Human Resources ....................................................................46
Quality Council ...................................................................46
QMS Support Staff ................................................................47
Software Infrastructure ...........................................................48
Approval .....................................................................................50
Chapter 5 Documentation, the Big Picture. .....................................51
Structure .....................................................................................52
Right Number of Levels ............................................................53
Format ........................................................................................54
Cautions .....................................................................................56
Flexibility ..............................................................................56
Language ................................................................................57
Content ...................................................................................57
Electronic Documentation .......................................................58
Covering All Markets ...............................................................58
Ensuring Full Coverage ............................................................61
Contents • ix
Chapter 6 Level 1 Documentation ....................................................65
Quality Policy ............................................................................65
Content ...................................................................................67
Implementation ....................................................................68
Translations ...........................................................................69
Quality Manual..........................................................................70
Look and Feel ........................................................................72
External Value .......................................................................72
Challenges ..............................................................................73
Chapter 7 Level 2 Documentation ....................................................75
Value to the Employee ..............................................................76
The Principles Applicable to Each Process ............................77
Appendix ....................................................................................78
Chapter 8 Level 3 Documentation ....................................................79
Corporation-Wide Level 3 ........................................................79
Complaints ............................................................................79
Medical Device Reporting/Vigilance ...............................80
CAPA ......................................................................................81
Quality Audits .......................................................................81
Format .........................................................................................82
Flowcharts ..............................................................................82
Playscript Procedures ...........................................................83
Language ................................................................................83
Software .....................................................................................84
Keeping Current .......................................................................84
Chapter 9 Level 4 Documentation ....................................................85
Records ........................................................................................85
Forms .........................................................................................86
Guidelines/Guidances ..............................................................86
Training Materials .....................................................................87
External Documentation ..........................................................87
