What is an ISO 17025 Accreditation?
In 1999, the International Organization for Standardization (ISO) developed and issued ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories. Also known as the ISO 17025 accreditation, this ISO standard must be met by labs in order to be deemed “technically competent”. Without the accreditation, regulatory authorities and suppliers might not accept calibration or test results from a testing or calibration lab.
The ISO/IEC 17025 accreditation is an international standard requirement for testing and calibration laboratories. It enables labs to demonstrate their competence in producing valid and reliable results and build trust among their customers worldwide.
The first competence standard issued in 1979, ISO 9000, lacked the emphasis on procedure verification. It was later modified as the ISO/IEC 17025 quality management system and included more specific requirements for labs generating testing and calibration results.
This management system model is useful for any organization that performs testing, sampling or calibration, and wants reliable results. The ISO 17025 accreditation meets the needs of all types of laboratories (whether owned and operated by government, industry, or any other organization), universities, research centers, government institutions, regulators, inspection bodies, product certification organizations, and other conformity assessment bodies.
This article is a brief introduction to the benefits of the ISO/IEC 17025 accreditation and the steps you need to follow to get your lab accredited by a well-recognized certification body.
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Benefits of an ISO 17025 Accreditation
- Cost and time savings: The accreditation saves an ample amount of time and operational capital by avoiding retesting products. It also eliminates the requirement for individual supplier audits by a third party.
- Reduced waste: Laboratory accreditation is a sustainable approach for labs to demonstrate technical competence, instilling trust among their customers. The standardization of the tests and calibrations prevent any repetitions of the procedures or wastage of materials.
- Improved accuracy: The standard validates test and calibration methods and ensures accurate results.
- International recognition: 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.
- Technical competency: Lab accreditation means measurement traceability and calibrations meet the highest standards. It establishes the technical competency of lab staff to provide correct and valid results.
- Increased lab efficiency: The ISO 17025 accreditation is a great way for testing laboratories to enhance operational efficiency and productivity. It evaluates staff procedures, methods, and lab equipment, ensuring you can produce accurate results in your lab. Maintaining high-quality results and reducing measurement uncertainties and errors is critical to a testing or calibration lab’s success.
Image: An illustration of ISO/IEC accreditation benefits.
How to Get an ISO 17025 Accreditation
The process of accreditation involves multiple steps including document review, process audits, and accreditation results that are provided by third-party accreditation bodies. All these steps are briefly explained below:
1. Start Your Research/Preparation
First things first: Start your research and learn about 17025. Take general training on ISO/IEC 17025 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 yourself at all levels of organizations.
2. 17025 Gap Analysis and Checklist
Outline the areas of improvement in your laboratory management system to meet the management and technical requirements of ISO 17025 accreditation. A gap analysis checklist will help identify what your lab already has, areas to improve, and how much time you need to complete the accreditation process.
3. Create Your 17025 Implementation Project Plan
Prepare a framework for approaching accreditation bodies by referring to the checklist created in the earlier step. Plan a workflow and timeline of the steps that you will follow while applying for accreditation and beyond.
In this step, you’ll need to document all the processes, methods, and procedures of your lab. Proper documentation includes, but are not limited to, the following:
- Quality Manual
- Functional Procedures
- Work Instructions
- Quality Records
- System Procedures and Formats
5. Audit QMS Performance
You have improved your quality management system and curated all documentation, but now your lab needs to know if all is working well. For this, your 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 assist your lab in correcting any issues before beginning the accreditation assessments.
6. Final Audit from an Accreditation Body
The final assessment of labs will be performed by an accrediting body. They may interview some employees of your company 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, you will be asked to correct them.
After correcting the non-conformities, a lead assessor will verify them. The accreditation body will then prepare and transfer the accreditation certificate to your lab when there are no longer any issues. The certificate will demonstrate the technical competency of your organization or lab in providing particular calibration or testing services.
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Accreditation Bodies and Certificates
Today, there are several accreditation bodies around the world. To recognize each other’s accreditation, the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement (ILAC MRA) evaluates each accreditation body against the ISO/CASCO standard. All the ILAC MRA signatory accreditation bodies are all globally recognized.
Moreover, like ISO/IEC 17025 standards, the accreditation bodies also provide some other related certificates including ANSI/NCSL Z540, ANSI/NCSL Z540.1-1994, ISO 9000, ISO 9001, ISO/IEC 17025:1999, ISO 15189, ISO/IEC 17025:2017, and ISO/IEC 17025:2005.
Some U.S. accreditation bodies under the umbrella of ILAC are:
- The ANSI-ASQ National Accreditation Board (ANAB)
- The American Association for Laboratory Accreditation (A2LA)
- Perry Johnson Laboratory Accreditation (PJLA)
- International Accreditation Service, Inc. (IAS)
- National Voluntary Laboratory Accreditation Program (NVLAP or NIST)
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ISO 17025 is an internationally recognized quality assurance accreditation for calibrations and testing laboratories of all shapes and sizes. The accreditation focuses on the laboratory management system of the organization or lab and, once all requirements are met, confirms the lab’s technical competence in performing tests and calibration procedures.
Furthermore, the accreditation certificate helps labs improve their reputation at the international level, increasing customer confidence, and trust in their technical procedures.
You can accelerate the accreditation process by outfitting your lab with high-quality equipment. Or, you may be required to procure new equipment to meet the ISO/IEC 17025 standard.
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