ISO 13485: 2003 Medical Devices
ISO
13485:2003 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 ISO 13485:2003 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. All
requirements of ISO 13485:2003 are specific to organizations providing medical
devices, regardless of the type or size of the organization.
ISO 15189: 2007 Medical Laboratories
ISO
15189:2007 specifies requirements for quality and competence particular to
medical laboratories. ISO
15189:2007 is for use by medical laboratories in developing their quality
management systems and assessing their own competence, and for use by
accreditation bodies in confirming or recognising the competence of medical
laboratories.
Code
|
ISO 13485: 2003 & ISO 15189: 2007 Medical
|
Duration
|
MMS-01
|
Understanding of ISO 13485: 2003
|
1 Day
|
MMS-02
|
Internal Audit of ISO 13485: 2003
|
2 Days
|
MMS-03
|
Understanding of ISO 15189: 2007
|
1 Day
|
MMS-04
|
Internal Audit of ISO 15189: 2007
|
2 Days
|
