iso 134852016 fda qsr internal audit checklist

Understanding the Applicability of ISO 13485:2016 Requirements

ISO 13485:2016, a quality management standard for medical devices, provides guidelines for organizations to ensure they consistently meet customer and regulatory requirements. While some clauses in the standard may not be applicable to every organization or type of medical device, it is essential to understand which requirements are relevant and how to implement them effectively.

According to ISO 13485:2016, if a requirement in Clauses 6, 7, or 8 does not apply due to an organization's activities or the nature of its medical devices, it may be excluded from the quality management system. However, the organization must ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

In cases where regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion. Additionally, organizations are responsible for ensuring that processes required by ISO 13485:2016 that are applicable but not performed in-house are monitored, maintained, and controlled through agreements with external parties.

It is also important to note that requirements specified in ISO 13485:2016 apply equally to associated services provided by an organization. The standard is applicable to organizations of all sizes and types, unless explicitly stated otherwise. Furthermore, ISO 13485:2016 can be used by suppliers or external parties that provide product-related services to organizations.

In summary, understanding the applicability of ISO 13485:2016 requirements is crucial for organizations to ensure they meet customer and regulatory demands. By implementing effective quality management systems, organizations can consistently deliver high-quality medical devices and related services that meet customer and regulatory expectations.

Iso 134852016 fda qsr internal audit checklist