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 hygienic products. How a customer thinks that your product is safe and hygiene, its purely depends on ISO certification they see that your product or company is certified through ISO or not. For any ISO standard contact Qualitcert experts. To know more about ISO 13485 certification in Nigeria, Kenya, Jordan, Lebanon, Saudi Arabia, Oman, and India please feel free to contact us.