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ISO 17025 for Laboratory equipment

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Guest user Created:   Jan 31, 2020 Last commented:   Jan 31, 2020

ISO 17025 for Laboratory equipment

It is actually the ISO 17025 standard that deals with laboratory equipment specifically and is that separate to the ISO 13485 ?"

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ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 17025 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Tracey Evans Jan 31, 2020

Both ISO 17025 and ISO 13485 standards have the same objectives when it comes to equipment - to ensure that monitoring and measuring equipment is fit for purpose through the control of identification, maintenance, calibration, and metrological traceability. The standards are separate however, as the overall purpose and scopes are different. ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories addresses a number of requirements, including requirements for equipment used by testing and calibration laboratories so that competency can be demonstrated to deliver reliable results.

ISO 13485 Medical devices - Quality management system, Requirements for regulatory purposes addresses a number of requirements, including requirements for equipment where an organization providing medical devices or related services needs to demonstrate its ability to consistently meet applicable regulatory and customer requirements. The overlap between the standards come about because of common activities - the need for testing and calibration of medical device equipment. ISO 13485 is therefore also applicable for external providers of products and services to medical-device organizations, including calibration and maintenance services. It is therefore recommended that ISO 17025 laboratories that provide services or products to medical device organizations have a thorough understanding of ISO 13485 in order to meet necessary customer and regulatory requirements. Likewise, an ISO 13485 organization requiring testing or calibration services, or performing those activities themselves inhouse, should have thorough knowledge of ISO 17025.   

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Jan 31, 2020

Jan 31, 2020

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