Customer Support: 131 242

i2i Intertek.com
  • Shopping Cart
    There are no items in your cart
We noticed you’re not on the correct regional site. Switch to our AMERICAS site for the best experience.
Go to AMERICAS site
Dismiss alert
Celebrate World Standards Day. Save 10% with code WSD2026 until 31 Oct. Save now
Please enter a keyword to search
Advanced search
Home
Publishers
ISO
ISO 13485 - PRACTICAL GUIDE : 2016

ISO 13485 - PRACTICAL GUIDE : 2016

Current

Current

The latest, up-to-date edition.

Add to Watchlist

ISO 13485:2016 - MEDICAL DEVICES - A PRACTICAL GUIDE

Available format(s)

Hardcopy , PDF 1 User , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

English

Published date

01-01-2016

Publisher

International Organization for Standardization

Add to Watchlist
Preview
$213.40
Including GST where applicable
Summarise this standard

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Quality management system
5 Management responsibility
6 Resource management
7 Product realization
8 Measurement, analysis and improvement
Annex A - Guidance for small organizations
Bibliography

This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide This International Standard specifies requirements for a quality management and applicable regulatory requirements.

Committee
ISO/TC 210
DocumentType
Guide
ISBN
978-92-67-10774-5
Pages
0
PublisherName
International Organization for Standardization
Status
Current

Standards Relationship
SA HB 13485:2020 Identical
NSAI-ISO Guide to ISO 13485:2016 Identical

Frequently Asked Questions

ISO 13485 - PRACTICAL GUIDE sets quality management system requirements for organisations involved in the lifecycle of medical devices. It is an international standard published by International Organization for Standardization (ISO).

ISO 13485 - PRACTICAL GUIDE is used by medical device manufacturers and supply-chain organisations demonstrating consistent quality and regulatory controls. It is an international standard published by International Organization for Standardization (ISO).

ISO 13485 - PRACTICAL GUIDE is International Organization for Standardization (ISO)'s standard for medical device quality management systems, while ISO 9001 covers quality management systems (International). ISO 13485 - PRACTICAL GUIDE sets quality management system requirements for organisations involved in the lifecycle of medical devices. ISO 9001 sets requirements for establishing, operating and continually improving a quality management system.

ISO 13485 - PRACTICAL GUIDE is an international standard published by International Organization for Standardization (ISO), and is applied internationally rather than in a single country.

ISO 13485 - PRACTICAL GUIDE sets quality management system requirements for organisations involved in the lifecycle of medical devices. In practice it is applied by medical device manufacturers and supply-chain organisations demonstrating consistent quality and regulatory controls.
$213.40
Including GST where applicable
AUD
CAD
CHF
CNY
DKK
EUR
GBP
HKD
IDR
INR
JPY
KRW
MXN
NOK
NZD
SEK
SGD
USD
ZAR
Hardcopy - English
PDF 1 User - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
01
02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
31
32
33
34
35
36
37
38
39
40
41
42
43
44
45
46
47
48
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
69
70
71
72
73
74
75
76
77
78
79
80
81
82
83
84
85
86
87
88
89
90
91
92
93
94
95
96
97
98
99
100