Detailed Standard Description


ISO 13485

Medical Devices - Quality Management Systems - Requirements For Regulatory Purposes
Release Date:
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).

Application All requirements of this International Standard 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 (see 7.3), 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 this International Standard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3].

If any requirement(s) in Clause 7 of this International Standard is(are) not applicable due to 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 [see 4.2.2 a)].

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 [see 4.1 a)].

In this International Standard the terms "if appropriate"¯ and "where appropriate"¯ are used several times. When a requirement is qualified by either of these phrases, it is deemed to be "appropriate"¯ unless the organization can document a justification otherwise. A requirement is considered appropriate¯ if it is necessary in order for the product to meet specified requirements, and/or the organization to carry out corrective action.

Standard FAQ


What is a controlled document?

A controlled is a document that must be controlled as to its revision level and distribution.

Do you think that organizations, which implement an ISO Quality Management System, do it for the benefits that compliance brings, or is it only for certification?

In my experience, I have found that a number of companies & organizations go for ISO certification only because they have to or it is a customer requirement to do business. For medical device manufacturers in the US, FDA GMPs, harmonized with ISO, are mandatory. Top Managements usually look primarily at their bottom lines and see ISO as an expense, not a benefit. They may hire a QA or Engineering Manager to be responsible for ISO enforcement, documentation, and compliance - but primarily to keep the companies out of trouble with customers, government, and regulatory auditors. Only token management support is provided and when they're caught in a non-conformance situation or with a deficient product, they expect the assigned compliance person to get them out of trouble.