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Growing Public Healthcare Support by IAF and the New ISO 13485:2016


Every patient in the world deserves safe and effective care when they go to the doctor. Taking care of seven billion patients is a shared responsibility among tens of thousands of medical device manufacturers worldwide. Everything from gene-altering devices used to cure cancer to root canal fillings; they all play a critical role in our well-being and sometimes our survival.

Since 1996, Medical Device Regulators and industry have been working with and refining the quality system standard ISO 13485. The purpose of each refinement is to improve healthcare worldwide. Twenty years later, more countries have adopted this standard for regulatory purposes. There is even a “Playbook” created by medical device regulators that advocates use of 13485 when developing a regulatory system.

ISO 13485:2016 was redesigned to further target more specific risks related to medical devices, such as medical device use errors, concerns with software and more attention to the supply chain. In fact, the newer version has been expanded so that the entire supply chain is included. IAF MD9:2017 was restyled to accommodate the expanded scope. It is no wonder more regulatory authorities are asking for ISO 13485 certificates than ever before.

The IAF has been working with Medical Device Regulators through the Asian Harmonization Working Party, which requested IAF help address certain risks posed by distributors of medical devices. Most countries import 90%-98% of their devices, many of which enter the market through distributors. The AHWP, which now includes 30 nations from Africa, Asia, Latin America and the Middle East, wrote guidance that allows use of ISO 13485 to regulate Good Distribution Practices concerning medical devices. Singapore has more than 800 medical device distributors, which can now use an IAF backed ISO 13485 certificate to help the authorities monitor that part of the supply chain.

In turn, Medical Device Distributors can be granted as much as a 50% decrease in audit durations, since the activities for design and manufacturing are carried out elsewhere. The IAF has expanded the scope for accredited ISO 13485 certification. Parts and Suppliers can now find more value in supporting the healthcare chain using this same certification. There are new scopes for accreditation in IAF MD9:2017 Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485) for suppliers of “Parts and Services”, just for that purpose (see Table A1.7).

Quality Systems play a critical role in supporting patient care. International trade and international healthcare are intractably linked. The IAF Multilateral Recognition Arrangement sub-scope for ISO 13485 is becoming increasingly relevant, as credible ISO 13485 certificates are seen as critical to assisting regulators with healthcare protection. The IAF MLA allows regulators to distinguish certificates obtained through competent, onsite quality system audits from certificates purchased using online audits. Indeed, our lives do depend on quality system ISO 13485, now more than ever.