ISO 13485 2016 in Plain English - Table of Contents

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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OTHER ISO 13485 2016 PAGES

Introduction to ISO 13485 2016

Outline of ISO 13485 2016 Standard

Overview of ISO 13485 2016 Standard

ISO 13485 2016 versus ISO 13485 2003

Plain English ISO 13485 2016 Definitions

ISO 13485 2016 Translated into Plain English

ISO 13485 2016 Quality Management Checklist

ISO 13485 2016 Quality Management Gap Analysis

ISO 13485 2016 Quality Management Audit Program

Skills and Knowledge Internal Auditors Should Have


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