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ISO 13485:2016 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 and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.
All ISO standards are reviewed every five years to establish if a revision is required in order to keep it current and relevant for the marketplace. ISO 13485:2016 is designed to respond to the latest quality management system practices, including changes in technology and regulatory requirements and expectations. The new version has a greater emphasis on risk management and risk-based decision making, as well as changes related to the increased regulatory requirements for organizations in the supply chain.
ISO 13485 certification provides a framework for manufacturers to meet the applicable regulatory requirements. This can provide assurance that medical device products are safe and effective, while also providing global recognition as an approved manufacturer of medical devices. The certification also helps to ensure that manufacturers can remain in compliance with international standards without having to invest extra resources into understanding different regulations in different countries.
Having a quality management system in place helps to improve efficiency and productivity by streamlining various processes related to the manufacture, distribution, installation and servicing of medical devices. This includes the implementation of processes that help reduce waste, errors, costs and time while improving customer satisfaction. Additionally, since the ISO 13485 standard mandates product traceability requirements from beginning to end—including throughout the design process—it can help reduce product recalls due to noncompliance or other issues.
When you earn ISO 13485 certification, it shows potential customers that your company is committed to excellence in quality management practices and producing safe products that meet their needs. Additionally, it enhances your brand reputation within the industry since potential business partners will know you follow strict guidelines when manufacturing medical devices. The improved brand recognition can lead to more sales opportunities as well as increased customer loyalty over time.
Another major benefit of earning ISO 13485 certification is reduced risk of recalls due to failure to meet safety or other requirements set by regulators. This can help protect both customers and organizations from costly legal penalties and reputational damage caused by product recalls or other issues related to non-compliance with local regulations. Furthermore, it will help organizations build trust among their customers by demonstrating their commitment to delivering safe and effective products.
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