There are significant similarities between the two standards, including:
• The standard’s role in helping organizations achieve a quality management system
• Risk mitigation and assessment is a significant focus in both standards
• A focus on the realization of quality products through understanding the customer
• Both 9001 and 13485 use Deming cycles (Plan-Do-Check-Act)
• 13485 and 9001 emphasize employee competency and infrastructure for quality
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ISO 9001:2015 Certified Quality Management System
ISO 9001 is the international standard which provides specifications for a quality management system which can be applied at any organization regardless of industry, product or service, or company size. |
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ISO 13485:2016 Certified Medical Devices Quality Management Systems ISO 13485 is a comprehensive management system specifically for the manufacture of medical devices. It places a more significant focus on regulatory compliance and offers less flexibility in the organizational process. Preview our letter for ISO 13485:2016 Certificate here |
