Why you need ISO 9001 and ISO 13485 Certification

Both ISO 9001 and ISO 13485 are similar in a sense that they both provide a set of standards to ensure the quality of products and services. However, whereas ISO 9001 certification can be applied to any industry irrespective of its sector, ISO 13485 certification is industry- specific and can only be applied to those organizations that are involved in manufacture, distribution, or retail of medical devices.
Let us find out the similarities and differences between these two standards.
SIMILARITIES BETWEEN ISO 9001 AND ISO 13485
The primary goal of both the standards is the implementation of Quality Management System in an organization.
Risk assessment, its prevention as well as mitigation is their primary focus.
Delivery of quality products by understanding customer’s expectations.
Both ISO 9001 and ISO 13485 utilize management strategies such as Plan-Do-Check-Act cycle.
These standards focus on the competency of employees as well as processes to ensure quality.
Sis Certifications is specialized in providing ISO Certification in saudi arabia. We provide these certifications under accreditation board IOAS, IAS and IAF.

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