ISO 17025:2017 is an international standard that specifies the general requirements for the competence of testing and calibration laboratories. In India, ISO/IEC 17025 certification refers to the accreditation of testing and calibration laboratories based on this standard. ISO/IEC 17025 certification ensures that a laboratory operates according to internationally recognized testing and calibration standards. It covers various aspects, including quality management system requirements, technical competence, personnel competency, equipment calibration, testing methods, and traceability of measurements.
In India, ISO/IEC 17025:2017 certification is managed by accreditation bodies such as the National Accreditation Board for Testing and Calibration Laboratories (NABL). Laboratories seeking certification must undergo a rigorous accreditation process to demonstrate compliance with the standard’s requirements.
The ISO/IEC 17025:2017 implementation process would involve several steps. Here, we have shown you the outline of the implementation process:
Initiation:
The first step for the ISO 17025: 2017 implementation process is to identify the need and benefits of ISO/IEC 17025 accreditation. Obtaining ISO 17025 certification will enhance the credibility and trustworthiness of your laboratory’s testing and calibration services. It provides complete assurance to your clients, internal and external stakeholders, and regulatory authorities that the laboratory consistently delivers accurate and reliable results. Once you decide to go ahead with the accreditation process, the next step is to appoint an expert consultant, a management representative, or a team of experienced personnel to oversee the implementation process.
Gap Analysis:
While planning ISO 17025 accreditation, whether you plan to undertake the process yourself or use the services of an expert consultant, it is essential that you identify and evaluate the gap that needs to be bridged to get your testing and calibration laboratory from where it is now to the standard of compliance needed to secure ISO 17025 accreditation. Evaluate current laboratory practices against ISO/IEC 17025 requirements and identify the areas of improvement. This is a thorough evaluation exercise. At Zyirn, our consultants with more than two decades of experience help clients with gap analysis to identify non-conformities and provide solutions to comply with the standards.
Resource Allocation:
The ISO 17025 accreditation process needs proper resource allocation. You must allocate necessary resources such as personnel, budget, and infrastructure, for the implementation process.
Documentation:
Documentation serves as a backbone of quality management systems for demonstrating compliance with the ISO 17025 requirements. It encompasses a wide range of documents such as Quality Manual, Procedures (such as sample handling, equipment calibration, SOPs etc), Work Instructions (such as safety manuals, sample preparation, data recording), and Record-keeping systems (test reports, calibration certificates, equipment maintenance logs, training records, and audit findings) required by ISO/IEC 17025. Proper documentation is of utmost importance to demonstrate the accuracy, reliability, and traceability of processes and data to comply with ISO 17025 standards. This is not one-time work but a continuous process.
Training and Awareness:
It is imperative to understand the importance of personnel competence in performing calibration and testing services. This is one of the key requirements for complying with the ISO 17025 standards. All the relevant documentation related to personnel training records, qualifications, competence assessments, responsibility, and task logs must be documented. This ensures, that all the laboratory personnel are well-trained and competent in their respective roles. At Zyirn, we provide training and awareness programs to our clients regarding ISO/IEC 17025 requirements, roles, and responsibilities. Contact us today to accelerate your team performance and achieve laboratory excellence.
Process Alignment:
Align all the laboratory processes with ISO/IEC 17025 requirements, focusing on accuracy, reliability, and traceability.
Internal Audits:
A critical aspect for ISO 17025 implementation is conducting internal audits to assess compliance with ISO/IEC 17025 standards. It’s important to perform regular assessments of the laboratory’s quality management systems to identify non-conformities and areas for improvement. At Zyirn, our expert consultants help you with in-depth rigorous internal audits to help you comply with the standards, while you can concentrate on other business aspects.
Management Review:
It is important to conduct regular management review meetings to evaluate the effectiveness of the Laboratory Quality Management System (QMS). Make decisions for continual improvement wherever necessary.
Corrective Actions:
Implementing corrective actions to address identified non-conformities and improve processes is an important aspect of compliance. This is a continuous process with a risk-based approach to identify, determine, evaluate, monitor, record, and address the non-conformities to adhere to ISO 17025 standards.
Preparation for Certification Audit:
Preparing for an external audit is the final and important step for your laboratory. An external audit by an accreditation body checks the efficiency and compliance of your laboratory QMS. The auditors check whether your documentation meets all requirements of ISO 17025 standards, whether all the procedures and processes are followed correctly, and whether all your staff and personnel are qualified, trained, and know their role in QMS. The result of the external audit will grant your certification to maintain compliance standards or your laboratory needs some corrective actions before becoming accredited. Being audited is time-consuming, costly, and requires meticulous efforts. At Zyirn, we will help you get ready for a successful external audit. Our consultants will ensure your lab meets the compliance standards to showcase your quality management systems.
Certification Audit:
You must demonstrate compliance with ISO/IEC 17025 requirements during the certification audit. At Zyirn, we are committed to providing our expert services with internal and external audit, documentation, and personnel training anytime and supporting the preparedness for your lab audit anywhere in the world with our advisory consulting and guidance. We help you with the closure of non-conformities and readiness for the external certification audit by the accreditation body.
Certification:
You will receive ISO/IEC 17025 accreditation certificate upon successful completion of the certification audit.
Post-Certification Support:
Post-certification, you must maintain compliance with ISO/IEC 17025 standards through ongoing monitoring, internal audits, and management reviews. Continuously improve the quality management systems (QMS) to enhance your laboratory performance.
This outline provides an overview of the ISO/IEC 17025:2017 implementation process. Each step may involve multiple sub-steps and activities, depending on the specific requirements of the laboratory and the complexity of its operations.
At Zyirn, we help our clients with the documentation, internal audit, and overall preparedness for the ISO170:2017 certification audit. Our expert consultants at Zyirn are here to help you at every stage of ISO 17025 implementation and certification. Do connect with us at [email protected] for any requirements you may have for the ISO 17025 implementation process.