Chapter 1: Setting up a Quality Management System
32
º quality objectives not measurable or inconsistent
with quality policy (5.4)
º document changes and approvals or reviews not
clear in revised documents (4.2)
º internal auditors not independent from areas being
audited (8.2)
º customer property requirements not fulfilled even
though the organization retains customer property,
such as intellectual property, patient records,
designs and drawings onsite (7.5)
Conclusion
Overall, setting up a robust quality management system
requires following compliant processes per ISO stan-
dards/regulations, adhering to continuous improvement
principles, engaging appropriate stakeholders and over-
sight from senior management. Organizations that plan
and execute strategies per the approach described above
have been successful in implementing a QMS.
Note: This chapter is from Harde A. Setting up a
Quality Management System. In Takes PA and Nozawa
S, eds. Global Medical Device Regulatory Strategy, 2nd
ed. Rockville, MD: Regulatory Affairs Professionals
Society 2020:59-92.
References
1. “What is Auditing?” American Society of Quality (ASQ) web-
site. https://asq.org/quality-resources/auditing.
2. ISO 9000:2015 Quality Management Systems:
Fundamentals and Vocabulary. International Organization
for Standardization (ISO) website. https://www.iso.org/obp/
ui/#iso:std:iso:9000:ed-4:v1:en.
3. ISO 9001 Quality Management Systems Requirements. ISO
website. https://www.iso.org/standard/62085.html.
4. ISO 13485 Medical Devices: Quality Management Systems:
Requirements for Regulatory Purposes. ISO website. https://www.
iso.org/standard/59752.html.
5. 21 CFR 820 Medical Devices: Quality System Regulation
(QSR). FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1.
6. British Standards Institution’s (BSI) BS 5750 series of standards.
7. Compare ISO 13485 and FDA QSR 21 CFR 820.
Relationship Between FDA QSR 21 CFR 820 and ISO
13485:2016. https://13485store.com/medical-device-standards/
compare-fda-qsr-21cfr820-and-iso-13485/.
8. Op cit 2.
9. Plan-Do-Check-Act (PDCA). ASQ website. https://asq.org/
quality-resources/pdca-cycle.
10. EU Medical Devices Directive (93/42/EEC, MDD). EUR-
Lex website. https://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX:31993L0042.
11. Active Implantable Medical Devices Directive (90/385/EEC,
AIMDD). EUR-Lex website. https://eur-lex.europa.eu/
legal-content/EN/TXT/?uri=CELEX:31990L0385.
12. In Vitro Diagnostics Directive (98/79/EC, IVDD). EUR-
Lex website. https://eur-lex.europa.eu/legal-content/EN/
ALL/?uri=CELEX%3A31998L0079.
13. ISO/TR 14969:2004 Medical Devices: Quality Management
Systems: Guidance on the Application of ISO 13485: 2003.
ISO website. https://www.iso.org/standard/33752.html.
14. ISO 14001:2015 Environmental Management Systems:
Requirements With Guidance for use. ISO website. https://
www.iso.org/standard/60857.html.
15. Op cit 4.
16. Japanese MHLW Ministerial Ordinance 169. Revision of
Japanese Medical Device QMS Requirements. PMDA website.
https://www.pmda.go.jp/english/review-services/regulatory-
info/0004.html.
17. Op cit 4.
18. ISO/IEC 17021-1:2015 Conformity Assessment: Requirements for
Bodies Providing Audit and Certification of Management Systems
Part 1: Requirements. ISO website. https://www.iso.org/obp/
ui/#iso:std:iso-iec:17021:-1:ed-1:v1:en.
19. Medical Device Single Audit Program (MDSAP) Audit Model.
FDA website. https://www.fda.gov/media/88272/download.
20. ISO 19011: 2018 Guidelines for Auditing Management
Systems. ISO website. https://www.iso.org/standard/70017.
html.
21. Op cit 10.
22. Regulation (EU) 2017/745 of the European Parliament and
of the Council of 5 April 2017 on medical devices, amend-
ing Directive 2001/83/EC, Regulation (EC) No. 178/2002
and Regulation (EC) No. 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC (EU MDR). EUR-
Lex website. http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX%3A32017R0745.
23. Pure Food and Drug Act. Encyclopedia.com. https://www.
encyclopedia.com/history/united-states-and-canada/us-history/
food-and-drug-act-1906.
24. The 1938 Food, Drug, and Cosmetic Act. FDA
website. https://www.fda.gov/about-fda/
histories-product-regulation/1938-food-drug-and-cosmetic-act.
32
º quality objectives not measurable or inconsistent
with quality policy (5.4)
º document changes and approvals or reviews not
clear in revised documents (4.2)
º internal auditors not independent from areas being
audited (8.2)
º customer property requirements not fulfilled even
though the organization retains customer property,
such as intellectual property, patient records,
designs and drawings onsite (7.5)
Conclusion
Overall, setting up a robust quality management system
requires following compliant processes per ISO stan-
dards/regulations, adhering to continuous improvement
principles, engaging appropriate stakeholders and over-
sight from senior management. Organizations that plan
and execute strategies per the approach described above
have been successful in implementing a QMS.
Note: This chapter is from Harde A. Setting up a
Quality Management System. In Takes PA and Nozawa
S, eds. Global Medical Device Regulatory Strategy, 2nd
ed. Rockville, MD: Regulatory Affairs Professionals
Society 2020:59-92.
References
1. “What is Auditing?” American Society of Quality (ASQ) web-
site. https://asq.org/quality-resources/auditing.
2. ISO 9000:2015 Quality Management Systems:
Fundamentals and Vocabulary. International Organization
for Standardization (ISO) website. https://www.iso.org/obp/
ui/#iso:std:iso:9000:ed-4:v1:en.
3. ISO 9001 Quality Management Systems Requirements. ISO
website. https://www.iso.org/standard/62085.html.
4. ISO 13485 Medical Devices: Quality Management Systems:
Requirements for Regulatory Purposes. ISO website. https://www.
iso.org/standard/59752.html.
5. 21 CFR 820 Medical Devices: Quality System Regulation
(QSR). FDA website. https://www.accessdata.fda.gov/scripts/
cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=820&showFR=1.
6. British Standards Institution’s (BSI) BS 5750 series of standards.
7. Compare ISO 13485 and FDA QSR 21 CFR 820.
Relationship Between FDA QSR 21 CFR 820 and ISO
13485:2016. https://13485store.com/medical-device-standards/
compare-fda-qsr-21cfr820-and-iso-13485/.
8. Op cit 2.
9. Plan-Do-Check-Act (PDCA). ASQ website. https://asq.org/
quality-resources/pdca-cycle.
10. EU Medical Devices Directive (93/42/EEC, MDD). EUR-
Lex website. https://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX:31993L0042.
11. Active Implantable Medical Devices Directive (90/385/EEC,
AIMDD). EUR-Lex website. https://eur-lex.europa.eu/
legal-content/EN/TXT/?uri=CELEX:31990L0385.
12. In Vitro Diagnostics Directive (98/79/EC, IVDD). EUR-
Lex website. https://eur-lex.europa.eu/legal-content/EN/
ALL/?uri=CELEX%3A31998L0079.
13. ISO/TR 14969:2004 Medical Devices: Quality Management
Systems: Guidance on the Application of ISO 13485: 2003.
ISO website. https://www.iso.org/standard/33752.html.
14. ISO 14001:2015 Environmental Management Systems:
Requirements With Guidance for use. ISO website. https://
www.iso.org/standard/60857.html.
15. Op cit 4.
16. Japanese MHLW Ministerial Ordinance 169. Revision of
Japanese Medical Device QMS Requirements. PMDA website.
https://www.pmda.go.jp/english/review-services/regulatory-
info/0004.html.
17. Op cit 4.
18. ISO/IEC 17021-1:2015 Conformity Assessment: Requirements for
Bodies Providing Audit and Certification of Management Systems
Part 1: Requirements. ISO website. https://www.iso.org/obp/
ui/#iso:std:iso-iec:17021:-1:ed-1:v1:en.
19. Medical Device Single Audit Program (MDSAP) Audit Model.
FDA website. https://www.fda.gov/media/88272/download.
20. ISO 19011: 2018 Guidelines for Auditing Management
Systems. ISO website. https://www.iso.org/standard/70017.
html.
21. Op cit 10.
22. Regulation (EU) 2017/745 of the European Parliament and
of the Council of 5 April 2017 on medical devices, amend-
ing Directive 2001/83/EC, Regulation (EC) No. 178/2002
and Regulation (EC) No. 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC (EU MDR). EUR-
Lex website. http://eur-lex.europa.eu/legal-content/EN/
TXT/?uri=CELEX%3A32017R0745.
23. Pure Food and Drug Act. Encyclopedia.com. https://www.
encyclopedia.com/history/united-states-and-canada/us-history/
food-and-drug-act-1906.
24. The 1938 Food, Drug, and Cosmetic Act. FDA
website. https://www.fda.gov/about-fda/
histories-product-regulation/1938-food-drug-and-cosmetic-act.