© ISO 2003 — All rights reserved
29 ISO 9001:2000
ISO 13485:2003
Risk management is a key requirement in many activities and requirements associated with quality management
systems for medical device organizations.
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization
a needs to demonstrate its ability to consistently provide product that meets customer and applic-
able regulatory requirements, and b aims to enhance customer satisfaction through
the effective application of the system, including processes for continual improvement of the
system and the assurance of conformity to customer and applicable regulatory require-
ments.
NOTE In this International Standard, the term
“product” applies only to the product intended for, or required by, a customer.
1 Scope
1.1 General
This International Standard specifies requirements for a quality management system where an organization
needs to demonstrate its ability to provide medical devices and related services that consistently meet
customer requirements and regulatory requirements applicable to medical devices and related services.
The primary objective of this International Standard is to facilitate harmonized medical device regulatory
requirements for quality management systems. As a result, it includes some particular requirements for
medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as
regulatory requirements. Because of these exclusions, organizations whose quality management
systems conform to this International Standard cannot claim conformity to ISO 9001 unless their
quality management systems conform to all the requirements of ISO
9001 see Annex B.
Reason for differences: This subclause uses and explains terms that are appropriate for the medical device sector. In
addition, the terms “customer satisfaction” and “continual improvement” are eliminated as they are not relevant in a
standard whose objective is to facilitate the harmonization of medical device regulations for quality management
systems around the world.
Paragraph 2 is intended to clarify that the intent of
ISO 13485 is to facilitate the harmonization of regulatory quality management system requirements around the
world, to point out that this intent requires the addition of some requirements not found in ISO 9001 and the deletion
of some requirements that are found in ISO 9001, and to clarify the fact that adherence to ISO 13485 cannot result in
the claim of adherence to ISO 9001.
The term “and related services” has been added twice to modify the term “medical devices” because “medical
device” does not include “services” in its definition. This is in contrast to ISO 9001, where the term “product” does
include “services” as part of its definition.
30
© ISO 2003 — All rights reserved
ISO 9001:2000 ISO 13485:2003
1.2 Application
