Medical device quality management systems : strategy and techniques for improving efficiency and effectiveness

Saved in:
Bibliographic Details
Main Author: Manz, Susanne, (Author)
Format: eBook
Language: English
Published: London, United Kingdom : Academic Press, an imprint of Elsevier, [2019]
Subjects:
Medical instruments and apparatus industry > Quality control.
elektronické knihy
electronic books
ISBN: 0128142219
9780128142219
9780128142226
0128142227
Physical Description: 1 online resource

Cover

Table of contents

LEADER 02661cam a2200349 i 4500
001 kn-on1056953763
003 OCoLC
005 20240717213016.0
006 m o d
007 cr cn|||||||||
008 181015s2019 enk o 000 0 eng d
040 |a OPELS  |b eng  |e rda  |e pn  |c OPELS  |d OCLCF  |d OTZ  |d LVT  |d D6H  |d S2H  |d OCLCO  |d OCLCQ  |d OCLCO  |d UKMGB  |d OCLCQ  |d SFB  |d OCLCQ  |d OCLCO  |d OCLCL  |d SXB 
020 |a 0128142219 
020 |a 9780128142219 
020 |a 9780128142226  |q (online) 
020 |a 0128142227 
020 |z 9780128142219 
035 |a (OCoLC)1056953763  |z (OCoLC)1229530138 
100 1 |a Manz, Susanne,  |e author. 
245 1 0 |a Medical device quality management systems :  |b strategy and techniques for improving efficiency and effectiveness /  |c Susanne Manz. 
264 1 |a London, United Kingdom :  |b Academic Press, an imprint of Elsevier,  |c [2019] 
300 |a 1 online resource 
336 |a text  |b txt  |2 rdacontent 
337 |a computer  |b c  |2 rdamedia 
338 |a online resource  |b cr  |2 rdacarrier 
505 0 |a <P><b>Part 1: An Effective Quality System </b>1. Regulatory requirements 2. Increasing Expectations 3. Establish and Maintain 4. QMS Structure</p> <p><b>Part 2: An Efficient Quality Management System </b>5. Shifting from Cost of Quality to Value of Quality 6. Avoiding Common mistakes</p> <p><b>Part 3: Roles, Responsibilities, Capabilities </b>7. Quality is Not an Organization 8. Roles: Management Representative 9. Management with Executive Responsibility 10. Process Ownership 11. Capabilities: Measure -- Metrics and Dashboards Embrace- Culture and Value Identify -- Inspection, Audit, Process Control, etc. Fix -- CAPA, Six Sigma, and more Prioritize -- Risk Management, Residual Risk Control -- Monitor and Control Share and Communicate -- Management Review and Transparency</p> <p><b>Part 4: Quality Leadership and a Seat at the Table </b>12. Value of Quality 13. Maturity Modeling in Medical Device Companies</p> <p><b>Part 5: Vision, Strategy, Quality Planning </b>14. Compelling Vision 15. Alignment 16. Translating vision to plans</p> <p><b>Part 6: Improvement: Tools and Techniques </b>17. CAPA 18. Six Sigma</p> 
506 |a Plný text je dostupný pouze z IP adres počítačů Univerzity Tomáše Bati ve Zlíně nebo vzdáleným přístupem pro zaměstnance a studenty 
590 |a Knovel  |b Knovel (All titles) 
650 0 |a Medical instruments and apparatus industry  |x Quality control. 
655 7 |a elektronické knihy  |7 fd186907  |2 czenas 
655 9 |a electronic books  |2 eczenas 
856 4 0 |u https://proxy.k.utb.cz/login?url=https://app.knovel.com/hotlink/toc/id:kpMDQMSST4/medical-device-quality?kpromoter=marc  |y Full text 

Similar Items