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Brochure: The IAF Initiative for Accredited Certification to ISO 13485 - Medical Devices
ISO 13485 accredited certification within a national regulatory framework
Granting healthcare practitioners access to medical devices that are made in another country is critical to all healthcare systems. Indeed, most countries import more medical devices than they export. Each country must sensibly regulate access to medical devices in order to protect their citizens from unsafe devices.
Regulators are increasingly realizing the benefit of recognizing the quality management system standard ISO 13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes. This international standard provides the basis for medical device regulations to be harmonized around the world.
Just as doctors and patients benefit from receiving medical devices made outside their country, medical device industries throughout the world benefit from being able to provide them. In 2011, there were 6.5 billion people in the world living in 192 countries. Many of these countries do not have harmonized medical device regulations to protect their citizens, yet the need to protect their citizens is great. As each nation develops its own national medical device regulations, the likely increased demand for national factory audits would become impossible to bear for a manufacturer. This would not merely result in a barrier to trade for the supplier, but also a barrier to care for the importing country. Many countries import more than 90% of their healthcare technologies. By utilizing the international standard ISO 13485, with cooperation of IAF member accreditation bodies, the medical device industry can be provided with one ISO 13485 certificate that can be accepted everywhere, while also meeting the importing countries demand for safe and effective medical devices.
Use of this initiative very much depends upon awareness among the global regulatory community. In particular, organizations such as the Global Harmonization Task Force (GHTF), Pan American Health Organization (PAHO), Asian Harmonization Working Party (AHWP) and Association of Southeast Asian Nations (ASEAN) are very important to the harmonization of medical device regulations. However, even with the endorsement of such organizations, it is equally important that individual regulatory authorities are aware of the requirements and structure of this initiative.
ISO 13485 is intended to address medical device regulatory requirements for a quality management system. Although ISO 13485 is based on the Quality Management Systems standard ISO 9001, it focuses less on business performance and more on risk management. ISO 13485 ensures that medical device manufacturers consistently produce medical devices that meet regulatory requirements and are designed and manufactured to be safe for their intended use.
Many international regulators have directly or indirectly endorsed use of ISO 13485 as the model for meeting their own regulatory requirements for medical device manufacturing. Many countries have developed their medical device regulations using ISO 13485 or the criteria within it, and other countries are now using or beginning to use this same standard in their medical device regulations.
Medical device regulators, certification bodies and members of GHTF have worked together to provide a common framework for regulating medical devices. GHTF Study Group 3 has created several documents that provide helpful guidance on the application and interpretation of ISO 13485. GHTF Study Group 4 provides guidance on the methodologies and requirements for the audit of quality systems against ISO 13485.
The IAF initiative enables consistent and credible ISO 13485 certification. Without the harmonization provided by IAF, there remains the potential for variations of credibility among issued ISO 13485 certificates.
The IAF documents were created to be used for developing and improving medical device regulations around the world, while preventing unnecessary barriers to care at the national level.
A summary of the relationships between key stakeholders is shown in the following diagram: