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Kwalitycert was founded with a mission to help organizations to transform their businesses and empower business professionals using ISO as a tool. We always have relied on our global experience, employees, partners and associates in delivering concrete pragmatic solutions to clients that are holistic and sustainable.

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What are the differences between ISO 17025 and ISO 13485?

ISO healthcare

ISO 17025 stands for TESTING AND CALIBRATION LABORATORIES. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade hence, ISO 17025 accreditation is not equivalent to ISO 13485 certification.

 ISO 13485 stands for MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS, helps in complying with a specific quality system. ISO 17025 certified through accreditation board but ISO 13485 by certification body. Process steps involved in 17025 & ISO 13485,   

ISO 17025 – TESTING AND CALIBRATION 
LABORATORIES 
ISO 13485- MEDICAL DEVICES — QUALITY 
MANAGEMENT SYSTEMS 
Reviewing requests, tenders & contracts Context of the organization 
Method suitability Leadership 
Sampling   Quality objectives 
Handling items   Management system documentation 
Records   Control of management system documents
Measurement uncertainty  Control of records 
Result validity   Actions to address risks and opportunities
Result reporting  Improvement & Corrective actions
Complaints and nonconforming work   Internal audits & Management reviews 
Internal audits & Management reviews 

Health is wealth so nobody is going to compromise with health and hygenic products. How a customer thinks that your product is safe and hygene, its purely depends on ISO certification they see that your product or company is certified through ISO or not. For any ISO standard contact Kwalitycert experts. To know more about ISO 13485 certification in Nigeria, Kenya, Jordan, Lebanon, Saudi arabia, Oman, and India please feel free to contact us.

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