ISO 13485 is an international standard that establishes the requirements for a comprehensive quality management system (QMS) for the design and manufacture of medical devices. This international standard can be used by an organization for the design and development, production, installation, and servicing of medical devices as well as the design, development, and provision of related services.
This standard, officially known as ISO 13485:2003 Medical devices — Quality management systems — Requirements for regulatory purposes was first published in 1996 by the International Organization for Standardization (ISO). Because the medical device manufacturing sector is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied, ISO 13485 aims to support manufacturers in designing QMS that establish and maintain the effectiveness of their processes.
ISO 13485 is a stand-alone standard based on ISO 9001; however, it excludes some of the requirements of ISO 9001 that are not appropriate, and it includes some particular requirements for medical devices. Some of the differences are:
- ISO 13485 standard’s primary objective is to facilitate harmonized medical device regulatory requirements for QMS.
- ISO 13485 does not require organizations to demonstrate continual improvement, it only requires organization to demonstrate that the QMS is effectively implemented and maintained.
- Requirements regarding customer satisfaction are absent from the medical device standard.
ISO 13485 also helps organizations meet QMS requirements from the European Union Directives, such as 93/42/EEC, 90/385/EEC and 98/79/EEC.
All requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization. All organizations that wish a higher level of confidence in the ability to consistently achieve and maintain compliance with regulatory requirements can adopt ISO 13485.
This standard can help organizations minimize surprises and failures which might adversely affect patient safety and damage an organization’s reputation. Organizations can also benefit by:
- Reducing operational costs by highlighting process deficiencies and improving efficiency.
- Increasing customer satisfaction by consistently delivering quality products and systematically addressing complaints.
- Proving commitment to quality through an internationally recognized standard.
- Adding transparency to the way complaints, surveillance, or product recalls are handled.
- Gaining access to markets that recognize or require the certification including Canada and Europe.
This standard supersedes earlier documents such as EN 46001 and EN 46002 both published in 1997 as well as ISO 13485 and ISO 13488 that were published in 1996. As mentioned above, ISO 13485 is based on ISO 9001 but it does not include all its requirements; consequently organizations whose QMS conform to this standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
Most global medical device market regulators require manufacturers to implement a QMS as part of their product registration effort. In most countries, ISO 13485 certification is the preferred or required method of meeting QMS requirements.