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ISO 9001 is a set of standards that ensures the quality of products and services, general. ISO 3485 Certification is similar to ISO 9001 Certification in the sense of ensuring quality, however, its scope is limited to all those industries that are involved in the manufacture, distribution, or retail of medical devices.
Read this entire article to know about the similarities and differences between ISO 9001 and ISO 13485 Standards
SIMILARITIES BETWEEN ISO 9001 AND ISO 13485
- Both help in achieving the organization’s quality management system
- Both focus significantly on risk assessment and mitigation.
- Understanding the customer’s expectation to deliver quality products.
- Both ISO 9001 Certification and ISO 13485 Certification use the Plan-Do-Check-Act cycle.
- Both ISO 9001 and ISO 13485 focus on the competencies of employees and infrastructure for quality.
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