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ISO 13485 is not a product standard, but a process standard. A quality system that complies with the ISO 13485 standard is insufficient; you must also comply with all relevant product and service oriented technical standards and regulations. ▪ To establish a Quality Management System (QMS) that is oriented towards the design, development, production, and installation of medical devices and related services. ▪ To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements. ▪ To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements. ▪ To become certified or registered.
ISO 13485 is not a product standard. It’s a process standard. Therefore, it’s not enough to establish a Quality Management System (QMS) that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.
ISO 13485 Vs ISO 9001 ISO 13485 is based on the ISO 9001 Quality Management standard. Both standards are organized in the same way and use basically the same numbering system. In addition, most of the ISO 13485 requirements are taken directly from ISO 9001 without modification.
However, some ISO 9001 requirements were modified and others were excluded. Of course, ISO 13485 also includes a special set of requirements specifically related to the supply of medical devices and related services. In general, ISO 13485 is made up of two kinds of requirements: old ISO 9001 requirements and new requirements that are specifically related to medical devices and associated services.
ISO 13485 excludes ISO 9001 requirements related to continual improvement and customer satisfaction. Continual improvement is excluded because most medical device regulations require organizations to maintain their Quality Management Systems, not to improve them. And customer satisfaction is excluded because committee members thought it was too subjective.
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ISO 13485 Medical Device QMS |
