ISO DIS 13485

Description / Abstract: General

This International Standard specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle including the design and development, production, storage and distribution, installation, or servicing of a medical device and the design, development or provision of associated activities (e.g. technical support). The quality management system of the organization demonstrates the ability to consistently meet customer and applicable regulatory requirements. It may also be used by suppliers or external parties that provide goods and quality management system related services to such organizations.

The main objective of this International Standard is to facilitate global alignment of appropriate regulatory requirements for quality management systems applicable to organizations providing medical devices. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001:2008 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 9001:2008 unless their quality management system conforms to all the requirements of ISO 9001:2008.

Application

All requirements of this International Standard are specific to organizations regardless of their type or size.

Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by this International Standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable 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 regulatory requirements 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 this International Standard reflect exclusion of design and development controls.

If any requirement(s) in Clauses 6, 7 or 8 of this International Standard is (are) not applicable due to the activities undertaken by the organization or the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system. For the clauses that are determined to be not applicable, the organization documents justification as described section 4.2.2.

In this International standard the following terms or phases are used in the context described below:

Whena requirement is qualified by the phrase ‘as appropriate', it is deemed to be ‘appropriate' unless the organization can justify otherwise. A requirement is considered ‘appropriate' if it is necessary for:

othe product to meet requirements;

o the organization to carry out corrective action; or

o the organization to manage risks.

• When a requirement is required to be ‘documented', it is also required to be established, implemented and maintained.

• When the term ‘risk' is used, the application of the term is within the scope of this International standard and pertains to:

o the safety or performance requirements or

o meeting applicable regulatory requirements.

• When the term ‘product' is used, it can also mean ‘service'. Product applies to outputs that are intended for, or required by, a customer, or any intended output resulting from a product realization process.

• When the term ‘regulatory requirements' is used, it encompasses statutory, regulatory and legal requirements. The application of the term ‘regulatory requirements' is limited to requirements for the quality management system and the safety or performance of the medical device.

• Information marked "NOTE" is for guidance in understanding or clarifying the associated requirement.