Use ISO 13485 2003:
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To establish a quality management system that is oriented towards the design, development, production, and installation of medical devices and related services.
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To demonstrate your ability to supply medical devices and related services that meet customer expectations and comply with regulatory requirements.
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To evaluate how well your organization is able to meet customer expectations and comply with regulatory requirements.
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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 that complies with the ISO 13485 standard, you also need to comply with all relevant product and service oriented technical standards and regulations.
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INTRODUCTION TO ISO13485
