6 Steps of Getting an ISO/IEC 17025 Accreditation and its Benefits

ISO/IEC 17025 is a global standard that specifies the general requirements for laboratories to perform competently, impartially, and consistently. The International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC) collaborated on the publishing of the standard. It identifies the activities that must be included in laboratory operations to encourage trust in the laboratory's ability to produce valid and consistently reliable testing, calibration, and sampling results. ISO/IEC 17025:2017 is the most recent revision.

Accreditation is a formal recognition by an Accreditation Body that a laboratory is effective in fulfilling the requirements of ISO 17025 standard to perform tests within its accredited scope. The standard and accreditation are used by laboratories that are independently owned and operated as well as those that are part of larger organizations, regardless of industry or size, that are involved in sampling or measurement activities. This includes both regulated government and public sectors and unregulated sectors. ISO/IEC 17025, along with ISO 9001, serves as the foundation for ISO 15189, which specifies requirements for competence and quality, as well as medical laboratory accreditation. ISO/IEC 17025 Consultant will make the accreditation process easy. Accreditation implies several actions, including document review, process audits, and accreditation results provided by third-party accreditation bodies. All these steps are encapsulated below:

• Start Your Research/Preparation: The accreditation process starts with the research and learning about 17025. Take ISO/IEC 17025 awareness training and discover what the individual requirements are. Learn about the scope of accreditation and different requirements, including general, structural, resource, and process requirements, to prepare by hand at all levels of organizations.
• 17025 Gap Analysis and Checklist: Make a summary of the areas of improvement in the laboratory management system to meet the management and technical requirements of ISO 17025 accreditation. Also, a gap analysis checklist will help identify what the lab already has, an area to improve, and how much time need to complete the accreditation procedure.
• Create the ISO/IEC 17025 Implementation Project Plan: Prepare a framework for approaching accreditation bodies by referring to the checklist created in the earlier step. Design a system and timeline of the steps that the organization will follow while applying for accreditation and elsewhere.
• Documentation: In this step, the organization will need to document all the processes, methods, and procedures of the lab. Appropriate documentation includes:
• Quality Manual
• Functional Procedures
• Work Instructions
• Quality Records
•  System Procedures and Formats
• Audit QMS Performance: The organization has enhanced the quality management system and curated all documentation, Now the lab needs to know if all is working well. For that, the lab will need to conduct internal audits to learn about any non-conformities based on the internal audit report and build an action plan. This will support the lab in modifying any issues before beginning the accreditation assessments.
• Final Audit from an Accreditation Body: The final assessment of labs will be performed by an accrediting body. They may interview some employees of the organization or lab, inspect documents and records, observe selected calibrations or tests, and examine equipment. They look for statements, documented procedures, records, and written policies to check your lab’s technical competency. If any non-conformities are found, the organization will be asked to correct them. After modifying the non-conformities, a lead assessor will authenticate them. The accreditation body will then prepare and transfer the accreditation certificate to the lab when there are no longer any issues. The certificate will demonstrate the technical capability of the organization or lab in providing calibration or testing services.

Benefits of an ISO 17025 Accreditation 

• The ISO 17025 accreditation saves enough time and operational capital by avoiding retesting products.
• Laboratory accreditation is a sustainable approach for labs to demonstrate technical competence, instilling trust among their customers.
• The standard validates test and calibration methods and ensures accurate results.
• The globally recognized accreditation certificate validates the performance of your lab for your customers and stakeholders, thus giving you an edge over your competitors and boosting your reputation at the international level.
• Lab accreditation means measurement traceability and calibrations meet the highest standards, it provides correct and valid results. 
• The ISO 17025 accreditation is the best for testing laboratories to develop operational efficiency and productivity. Sustaining high-quality results and reducing measurement uncertainties and mistakes are dangerous for a testing or calibration lab’s success.

Source: https://punyam.wordpress.com/2022/07/20/6-steps-of-getting-an-iso-iec-17025-accreditation-and-its-benefits/