ISO/IEC 17025:2017 - General Requirements for the Competence of Testing and Calibration Laboratories
Understanding ISO/IEC 17025:2017
ISO/IEC 17025:2017 is the globally recognized standard that defines the essential requirements for the competence of testing and calibration laboratories. This accreditation ensures that laboratories adhere to strict quality management and technical standards, proving their ability to deliver accurate, reliable, and consistent results.
ISO/IEC 17025:2017 is applicable to all organizations performing laboratory activities, regardless of the number of personnel. With a focus on technical competence, impartiality, and continuous improvement, ISO 17025 supports laboratories in offering high-quality testing and calibration services that meet both regulatory and customer expectations.
What is Accreditation?
Accreditation is a voluntary, third-party evaluation process that ensures a laboratory’s quality management system meets the required standards for technical competence and reliability. As part of the accreditation process, a laboratory undergoes regular reviews and assessments to verify its compliance with ISO/IEC 17025 standards.
Laboratory accreditation is granted only by an official Accreditation Body (AB), which conducts a thorough evaluation of the lab’s operations, procedures, and practices. Achieving ISO/IEC 17025 accreditation demonstrates that a laboratory can consistently deliver accurate, reliable, and high-quality testing and calibration services, in line with both industry regulations and customer expectations.
Benefits of ISO/IEC 17025 Accreditation
ISO/IEC 17025 accreditation offers numerous advantages for laboratories, ensuring credibility and boosting global recognition. Here are the key benefits:
Improved Accuracy
ISO/IEC 17025-accredited labs follow validated testing and calibration methods, ensuring precise and reliable results. This globally recognized standard builds trust among customers and stakeholders by demonstrating a commitment to quality and accuracy.
Cost Reduction
ISO/IEC 17025 promotes sustainability by standardizing tests and calibrations, reducing repetitive procedures and minimizing material wastage. This standard helps laboratories cut operational costs by enforcing strict guidelines and ensuring effective result monitoring.
International Recognition
ISO/IEC 17025 is globally recognized, making it easier for your lab’s results to be accepted worldwide. This boosts your reputation, gives you a competitive edge, and opens up opportunities in international markets.
Increased Laboratory Efficiency
By focusing on improving staff procedures, equipment, and workflows, ISO/IEC 17025 helps labs operate more efficiently. The accreditation process reduces errors, improves consistency, and ensures long-term productivity.
Professional ISO/IEC 17025 Consultant in Malaysia
At SQC, we offer comprehensive ISO/IEC 17025:2017 consulting services to guide your laboratory through every step of the certification process. Our expert consultants ensure your laboratory complies with ISO/IEC 17025 standards, helping you improve operational efficiency and achieve long-term success. Our structured approach includes:
Initial Consultation and Assessment
We conduct an in-depth consultation to understand your laboratory’s specific requirements, operational practices, and goals for ISO/IEC 17025:2017 certification. This helps us to identify gaps and define a tailored plan that aligns with both your laboratory’s needs and the ISO standard.
Planning and Customization
We perform a thorough analysis of your laboratory’s goals, current practices, and desired outcomes with ISO/IEC 17025. This allows us to identify your specific needs and expectations for laboratory accreditation.
Gap Analysis and Policy Development
Our consultants conduct a thorough gap analysis, comparing existing processes with ISO/IEC 17025 requirements. We then assist in creating a customized documentation framework, revising policies, and aligning procedures to bridge identified gaps.
Training and Implementation
Working alongside your team, we support the rollout of new processes identified in the gap analysis. We provide training on key ISO/IEC 17025:2017 concepts such as method validation, equipment calibration, and ensuring technical competence across all laboratory personnel. We also help you implement an internal audit process to monitor compliance and effectiveness.
Pre-Certification and Audit Support
Before the official certification audit, we conduct a pre-assessment audit to evaluate your laboratory’s readiness. If any issues or non-conformities are identified, we work with you to implement corrective actions to address them. We also assist you in selecting an accredited certification body and provide guidance throughout the certification audit process to ensure a smooth and successful outcome.
Continuous Support and Improvement
After achieving ISO/IEC 17025 certification, we continue working with your laboratory to promote a culture of continuous improvement. We conduct regular reviews to maintain compliance and ensure your management systems adapt to evolving industry standards.
FAQs on ISO/IEC 17025:2017
What is ISO/IEC 17025:2017?
ISO/IEC 17025:2017 is an international standard that specifies the requirements for the competence of testing and calibration laboratories. It ensures that laboratories produce accurate and reliable results, demonstrating their ability to meet both technical and quality requirements in testing and calibration.
Why is ISO/IEC 17025 important for my laboratory?
ISO/IEC 17025 ensures that your laboratory meets international standards for accuracy, reliability, and competence in testing and calibration activities. Achieving certification can improve your laboratory’s credibility, enhance customer confidence, increase business opportunities, and help reduce operational risks. It also supports compliance with regulatory and industry standards.
What are the requirements for ISO/IEC 17025 certification?
To achieve ISO/IEC 17025 accreditation, laboratories must meet several requirements, including General Requirements, Structural Requirements, Resource Requirements, Process Requirements, and Management System Requirements. These ensure a systematic approach to delivering reliable and consistent testing or calibration results. Get in touch with our consultants to find out more.
How long does it take to achieve ISO/IEC 17025 certification?
The time required to achieve ISO/IEC 17025 certification typically ranges from 6 months to 18 months, depending on the size of the laboratory, the complexity of its operations, and the level of preparedness. Our consultants can provide a tailored timeline for your specific situation.
Can I apply for ISO/IEC 17025 certification without a consultant?
While it is possible to pursue ISO/IEC 17025 certification independently, many laboratories find it beneficial to work with a consultant. Consultants provide specialized knowledge, helping streamline the process, ensure compliance with the standard, and minimize the risk of non-conformities. They can save valuable time and resources.
What support does SQC provide throughout the certification process?
SQC offers end-to-end consultancy services in Malaysia, guiding you through every step of the ISO/IEC 17025:2017 certification process. Our services include gap analysis, documentation development, training, implementation support, internal audits, and pre-certification audit preparation. We ensure that your laboratory is well-prepared and confident for the certification audit.
Can ISO/IEC 17025 be integrated with other ISO standards?
Yes, ISO/IEC 17025 can be integrated with other ISO management standards, most commonly ISO 9001 – Quality Management Systems. This approach allows laboratories to demonstrate both their technical competence in testing and calibration (via ISO 17025) and their commitment to quality management (via ISO 9001), enhancing trust with clients and improving overall operational efficiency.
What is the cost of ISO/IEC 17025 certification in Malaysia?
The cost of ISO/IEC 17025 certification in Malaysia varies based on several factors, including the size and complexity of the laboratory, the scope of activities, and the certification body fees. Consulting fees may also vary depending on the level of support needed, generally ranging around several thousand Ringgit Malaysia. Contact us to find out more.
Achieve Precision and Reliability with ISO/IEC 17025:2017 Certification
Ensure your laboratory is fully compliant with international standards for testing and calibration accuracy. At SQC, we provide expert guidance to help you meet the ISO/IEC 17025:2017 requirements, improving your lab’s performance and reliability. Enhance your lab’s credibility and ensure accuracy with our tailored certification services.
Ready to take your lab to the next level? Contact us today for a consultation!