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Update: Die FDA erwagt derzeit (Stand 2018), die ISO 13485:2016 anstatt des 21 CFR part 820 als Nachweis eines QM-Systems anzuerkennen. FDA 21 CFR Part 820, also known as the Quality System Regulation (QSR), is a document that outlines Current Good Manufacturing Practice (CGMP) regulations.21 CFR Part 820 (Quality System Regulation). Internet: gmp-compliance.org/files/guidemgr/CFR-2020-title21-vol8-part820.pdf. Origin/Publisher:. Title 21 - Food and Drugs Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) Subchapter H - MEDICAL DEVICES (QSR - 21 CFR 820). 4 Quality Management System. 4.1 General Requirements. 4.1.1 The organization shall document a quality management. 21 CFR Part 820 - QUALITY SYSTEM REGULATION · Subpart A - General Provisions (§§ 820.1 - 820.5) · Subpart B - Quality System Requirements (§§ 820.20 - 820.25) TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES SUBCHAPTER H - MEDICAL DEVICES