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Who Needs the ISO 17025 Accreditation, What are its Requirements and Why?

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Compliancehelp Consulting, LLC
Who Needs the ISO 17025 Accreditation, What are its Requirements and Why?

This article aims at explaining the key facts about ISO 17025 accreditation i.e., the organizations to which it is applicable, the core requirements of achieving it, and why they should achieve it. 


ISO 17025 is an essential accreditation that helps to prove the technical capabilities and quality management commitment of the testing and calibration laboratories. Therefore, this accreditation demonstrates the high competency of a laboratory to provide accurate and reliable results of their testing and observations. It also gives evidence that a lab is fully meeting the compliance requirements as well as expectations of the clients i.e., businesses, governmental organizations, and individuals whose products they calibrate. Achieving the ISO 17025 accreditation is a premium achievement required by testing and calibration laboratories today to survive in the competitive market. This article explains further about the accreditation to provide a simple guide to laboratories for achieving it. 


Organizations that Need to Get the ISO 17025 Accreditation


ISO 17025 is the accreditation entirely meant for organizations that perform testing and calibration functions. It applies to the laboratories or labs that are privately-owned or are public-sector undertakings. They include research laboratories of various industries, universities involved in various research studies, regulators, governmental bodies, product certification agencies, inspection authorities, and different conformity assessment bodies. Any organizations or centers that collect samples of products or materials, do testing and calibrate them are eligible to get this ISO accreditation. 


Specifications of the ISO 17025 Accreditation 


The ISO 17025 accreditation is meant to ensure the technical abilities of a testing and calibration laboratory and the validity of analytical results produced by it. Therefore, it underlines two key sets of requirements. One set emphasizes improving the quality of work procedures carried out in the lab and hence includes technical requirements. Another set specifies the key administrative requirements that should be fulfilled to make sure the intended purposes and objectives of the laboratory are achieved. 


Technical Requirements


• Qualifications and skills required by the technical staff

• Key procedures to be followed for improving the quality of testing equipment, analytical tools, facilities and work environment conditions

• Specific criteria for choosing appropriate testing and calibration methods 

• Procedures used for sampling, handling the items to be tested ,and measuring their traceability

• The methods required for ensuring the quality and generating accurate results or reports of the testing and observations


Administrative Requirements


• Valid information about the laboratory including its legal status, ownership and how they process and handle the confidential information

• Requirements for implementing the Quality Management System (QMS)

• Key methods deployed for documentation control of the laboratory work procedures 

• Handling, responding, or addressing customers complaints, queries, and feedback

• Key protocols to be followed for outsourcing any services 

• Practices for continual improvement of the QMS and other management systems which include internal audits, record of performance metrics, senior management reviews and corrective/preventive actions


What Ways ISO 17025 is Rewarding to the Laboratory


ISO 17025 accreditation is not just a formal requirement for the laboratories, but it is more of a rewarding experience that gives a boost to their credibility and helps them acquire more clients. 


• Gives recognition to the lab at the national and international level

• It guarantees that the laboratory’s operations are technically efficient and able to provide valid results

• Enables the laboratory to collaborate with other reputed organizations, even in international markets

• Establishes the quality of the results obtained by the laboratory which inspires confidence in customers

• Guarantees the ability of the laboratory to protect their relationship with the customers like maintaining adequate communication, preserving their confidentiality, understanding their new emerging needs, etc. 

• Fosters methodologies for continuous improvement of the testing and other processes along with preventive management to help the laboratory deliver quality results consistently


Key Takeaway


ISO 17025 is widely known and adopted by a vast number of laboratories, big or small, small independent labs or large corporate counterparts. This accreditation acts as the best benchmark of quality assurance which gives them the status of a well-authorized testing lab. The ISO 17025 accreditation does not just give evidence of the technical capabilities of a lab but also its conformance to the legal and industrial regulations. Therefore, achieving it would help a laboratory to gain prominence in the market which would subsequently attract new clients and opportunities. 

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