San Diego ISO 17025 Medical Device Certification

ISO 17025 Certification for Medical Device Industry: Ensuring Quality and Compliance

When it comes to medical device manufacturing and calibration, maintaing quality and compliance are the most important factors to provide safety and satisfactions. Equipment manufacturer's need to stick to strict regulations and standards to produce reliable products. The most common standard that needs to be achieved for these organizaiton is ISO 17025 Certification, which outlines the requirements fo rproper lab testing, research, and calibration. GL Technologies works with biopharmaceutical and medical device organizations throughout San Diego to help implement quality management systems to obtain ISO 17025 certification and meet industry demands. Our team of technicians will come to your facility and perform testing, calibrations, and corrections as needed, while helping to implement processes and quality management systems to meet the certification demands.

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The Benefits of ISO 17025 Certification

ISO 17025 Certification provides numerous benefits for organizations in the medical device industry. Some of these benefits include:

Organization Credibility

By achieving ISO 17025 Certification shows your laboratory's commitment to quality and reliability in its testing and calibration processses. Having the ISO certification gives your lab credibility that your research methods stick to strict quality management processes and overall technical competence. ISO certification also opens up the doors for collaboration and partnerships with other credited labs as a trusted company.

Improved Quality Management System

The certification improves quality management systems (QMS), leading to improved laboratory operational efficiency while reducing laboratory errors. ISO 17025 helps organizations to stay competitive in a demanding and competitive regulated market, showcasing the commitment to delivering the best testing and calibration industry requirements.

Demonstrate Technical Competence

Because of the rigorous standards that need to be maintained to achieve ISO 17025 certification, it shows your organization's commitment to your testing and research procedures. The certification will show personnel competency, calibration and testing methods, equipment calibration, and quality assurance. It provides an extra layer of security that the laboratory operates at the highest level of technical proficiency.

Meet Compliance Regulations

Compliant regulations play an important for biopharmaceutical and medical related industries to show that your organization is providing correct and accurate results in testing, and is committed to patient safety, ISO 17025 certification shows this. It maintains your adherence to the validity of laboratory results and helps organizations stay in line with the changing industry standards.

ISO 17025 Certification Process

The ISO 17025 Certification process involves several steps, including:

Pre-Assessment

During the "pre-assessment" phase, organizations that are seeking certification will undergo an evaluation to determine its readiness for the "formal assessment". It involves a detailed review of management system documentation, procedures, and practices against the requirements that are outlined in ISO 17025. The goal of the pre-assessment is to identify any gaps that need to be addresed before moving forward and gives organizations an opportunity to evaluate its preparedness, make improvements, and meet compliance standards. When the pre-assessment is thorough, organizations will increase teh chance of a successful ISO 17025 certification process.

Formal Assessment

During the "formal assessment" phase, the team at GL Technologies will thoroughly evaluate the laboratory's QMS (quality management system), technical competency, and how it sticks to the requirements outlined in ISO 17025. This process will involve a document review, on-site inspections, and interviews with laboratory personnel. The goal is evaluate the laboratory's ability to produce accurate and reliable results while maintaining data integrity.

Corrective Action

When the root cause or identification of non-conformites are found, correct action will take place followed by the implementation of measures to prevent reoccurence. The process involves steps that include documenting non-conformity, analyize the cause of these issues, developing corrective measures, and verifying the effectiveness of these measures. By implementing corrective actions, organizations will earn or maintain compliance with ISO 17025 requirements.

Certification

After the quality management system is in place, an accredited certification company, like GL Technologies, will conduct an on-site assessment to evalute the lab's copmliance with the ISO 17025 standards. We provide a thorough review of the documentation, observation of research activities, and testing. If the laboratory is able to demonstrate and meet the ISO 17025 requirements, it will be awarded certification which will show the company's competence, reliability, and commitment to accurate results for clients.