ISO/IEC 13485

ISO18001OHSMS 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 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 are specific to organizations providing medical devices, regardless of the type or size of the organization. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity with ISO 13485 reflect exclusion of design and development controls.

ISO 13485 Management Systems of Medical Devices.
Its primary objective is to facilitate harmonized medical device regulatory requirements. The standard contains specific requirements for manufacture, installation and servicing and calls for:
Medical Device
A manufactured product is defined as a medical device if it is used to: Medical devices can include:
Instruments, Appliances, Implants, Machines, Software, Materials, Calibrators, Apparatuses, In vitro reagents, Related articles.
Manufactured products that achieve results by pharmacological, immunological, or metabolic means are not medical devices. However, the results achieved by medical devices may be assisted by these means.

The benefits of certification Who can apply for ISO 13485
ISO 13485 contains requirements that are essential for any organization operating at any tier in the medical device and pharmaceutical supply chain. It is especially relevant to manufacturers that wish to demonstrate applicable regulatory requirements, and by organizations whose services support medical device manufacturers.

Registration Process
The process of registration follows three simple steps: Initial Certification Audit
The assessment process for achieving certification consists of a two stage Initial Certification Audit as follows:

Stage 1 - the purpose of this visit is to confirm the readiness of the organisation for full assessment. The assessor will: Stage 2 - The purpose of this visit is to confirm that the quality management system fully conforms to the requirements of ISO 13485 in practice. The assessor will: