Trial

COMPARISON OF

ISO 9001:2000 AND

ISO 13485:2003

ISO 9001:2000

ISO 13485:2003

0 Introduction

0.1 General

The adoption of a quality management

system should be a strategic decision of an

organization. The design and implementation

of an organization’s quality management

system is influenced by varying needs,

particular objectives, the products provided,

the processes employed, and the size and

structure of the organization. It is not the

intent of this International Standard to imply

uniformity in the structure of quality

management systems or uniformity of

documentation.

0 Introduction

0.1 General

This

International

Standard

specifies

requirements for a quality management

system that can be used by an organization

for the design and development, production

installation, and servicing of medical devices,

and the design, development, and provision

of related services.

The

quality

management

system

requirements specified in this International

Standard

are

complementary

to

requirements for products.

Information

marked “NOTE” is for guidance in

understanding or clarifying the associated

requirement.

It

is

emphasized

that

the

quality

management system requirements specified

in

this

International

Standard

are

complementary to technical requirements for

products.

This International Standard can be used by

internal and external parties, including

certification

bodies,

to

assess

the

organization’s ability to meet customer,

regulatory, and the organization’s own

requirements.

The quality management principles stated in

ISO 9000 and ISO 9004 have been taken

into consideration during the development of

this International Standard.

0.2 Process approach

This International Standard promotes the

adoption of a process approach when

developing, implementing, and improving the

effectiveness of a quality management

system, to enhance customer satisfaction by

meeting customer requirements....