ISO 9000 and Medical Devices

2015 marks not only an update of ISO 9001 for Quality Management Systems, but also a revision of ISO 9000: Quality Management Systems – Fundamentals and Vocabulary. This lays the foundation for the changes to ISO 9001 by providing definitions of the terms needed to understand and properly implement the new version of ISO 9001. This is important because standards in the ISO 9000 series are meant to be used in a variety of industries, throughout which some terms might not have the same meaning across-the-board. For example, ISO 9001 and 9000 define the word risk as the effect of any kind of uncertainty, a meaning that would not necessarily be the same in all different organizations that use the standard. ISO 9000 is incredibly important because it needs to be used in unison with ISO 9001.
Stethoscope regulated by ISO 9001
ISO 9001 is a broad document and needs to be adapted slightly to be used for an organization’s purposes. In some cases, adaptation of 9001 can become fully standardized. An example of this is BS EN ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes. BS EN ISO 13485 is an international standard for organizations that are required to provide medical devices that must consistently meet customer and regulatory requirements. This is intended to apply to all organizations that meet this criterion, regardless of size.

This standard draws upon the 2008 version of ISO 9001, adding to it the unique guidelines needed for medical devices, while excluding some that do not apply. It also borrows some concepts from ISO 9000, specifically the supply chain, consisting of the supplier, organization, and customer, which it uses to describe the journey of medical supply products from creation to consumer use. Embodying the guidelines of ISO 9001, BS EN ISO 13485 lists general requirements of a compliant organization, including: identifying the processes needed for quality management, determining the sequence of these processes, determining the methods needed to control these processes, ensuring the availability of the resources needed to execute, analyzing these processes, and implementing actions necessary to achieve effectiveness in planned results.

The guidelines added to BS EN ISO 13485 are inclusive only to quality management for medical devices and should not be applied to organizations in other industries. For example, BS EN ISO 13485 takes the idea of controlling production and service provisions, but adapts it by discussing topics such as contamination control and preserving the sterility of medical devices. It also details techniques needed to measure medical devices, which need to be precise to properly fulfill their purpose.

Annex B of BS EN ISO 13485 describes the changes and adaptations between the document and ISO 9001. All sub-clauses originating in ISO 9001 are found with brackets [] around them to demonstrate the quoting of past ideas. In addition to describing these changes, BS EN ISO 13485 goes even further to assist the standard reader by indicating why the changes have been made. For example, BS EN ISO 13485 excludes mention of text referencing ISO 9004, since it has no relation to that standard.

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