ISO 13485 2016 Translated into Plain English

PART	TITLE 45 TABLE OF CONTENTS	PAGE
1	Introduction	3
2	Definitions	16
3	Overview	36
4 4.1 4.2	Systemic Requirements Organizational Requirements Documentation Requirements	39 39 44
5 5.1 5.2 5.3 5.4 5.5 5.6	Management Requirements Commitment Requirements External Requirements Policy Requirements Planning Requirements Managerial Requirements Review Requirements	50 50 50 50 51 53 54
6 6.1 6.2 6.3 6.4	Resource Requirements Allocation Requirements Personnel Requirements Infrastructure Requirements Environmental Requirements	57 57 57 58 59
7 7.1 7.2 7.3 7.4 7.5 7.6	Realization Requirements Planning Requirements Customer Requirements Development Requirements Purchasing Requirements Production Requirements Measurement Requirements	62 62 63 66 75 77 88
8 8.1 8.2 8.3 8.4 8.5	Remedial Requirements Planning Requirements Research Requirements Product Requirements Analytical Requirements Improvement Requirements	91 91 93 99 102 103

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Updated on April 18, 2021. On the Web since May 25, 1997.

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