ISO 13485 is a quality management standard for medical devices and defines quality management requirements in the following five sections:

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Systemic requirements

Management requirements

Resource requirements

Realization requirements

Remedial requirements

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The purpose of this quality management standard is to help both medical device suppliers and service providers to meet customer and regulatory requirements. According to ISO 13485: 2016, any medical device supplier or service provider can achieve these objectives if it establishes a quality management system (QMS) which ensures continual improvement of the suitability, adequacy, and effectiveness of its system. ISO 13485: 2016 is based on the ISO 9001: 2008 standard. Both standards are organized in the same way with a similar numbering system. Many of the ISO 13485 requirements are taken directly from ISO 9001 without modification but some ISO 9001 requirements were modified and others were excluded. ISO 13485: 2016 also includes an extensive set of requirements specifically related to medical devices.

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In general, the new ISO 13485 standard is more flexible than the old. In the past, organizations could only exclude section 7 requirements. Now, organizations may exclude any requirement in sections 6, 7, or 8 if they can justify doing so, due to the nature of their activities or products and if it does not undermine regulatory compliance. The new standard also says that organizations may exclude “design and development controls” iregulations permit and may refer to these regulations to justify their decisions.

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ISO 13485: 2016 applies to all medical device suppliers and medical device service providers. It applies to organizations that participate in one or more stages of the product life-cycle, including but not limited to organizations that design, develop, produce, store, distribute, install, or service medical devices and to organizations that design, develop, or provide related medical device support service activities. Also including external suppliers that provide products or services to these organizations. These external suppliers may choose to comply with the standard or be contractually obligated to do so. Regulatory bodies often expect organizations to define the roles they play in the medical device supply chain. You may be expected to specify whether you're a manufacturer, an importer, a distributor, a representative, a developer, or a designer of medical devices. Because of this, ISO 13485: 2016 expects you to identify the roles you play, the regulatory requirements that apply in your case, and to build these requirements into your organization's QMS.