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

Home Page	Our Libraries	A to Z Index	Our Customers
How to Order	Our Products	Our License	Our Guarantee
PRAXIOM RESEARCH GROUP LIMITED First Edmonton Place, 14th Floor, 10665 Jasper Avenue Edmonton AB Canada T5J 3S9 - 780-461-4514 - orders@praxiom.com
Updated on May 16, 2016. On the Web since May 25, 1997.

Title 45 is 109 pages long. It is detailed, accurate, and complete, and uses language that is clear, precise, and easy to understand. We guarantee it. It will be delivered to you as an email attachment.
Order Our Title 45	Check Prices	Check PDF Sample