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The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements.
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Numerous certification bodies exist, which audit organisations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as "ISO 9000" certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2015 (ISO 9001:2008 expired around September 2018).
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The services that Bluefield offer cover the life cycle of equipment, from equipment planning and optimisation to operation and reliability improvement. Bluefield stands alone in its ability to provide this breadth of service whilst staying focused on mining equipment. This enables us to deliver specialist advice and the best value for our clients.
ISO 9001 is the world's most widely recognized Quality Management System (QMS). It belongs to the ISO 9000 family of quality management system standards (along with ISO 9004), and helps organizations to meet the expectations and needs of their customers, amongst other benefits.
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ISO 9001:2015 is an international standard related to quality management, applicable to any organization from all types of business sectors and activities. ISO 9001:2015 provides a framework to respond to changing quality requirements in balance with society, economics and environment.
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