ISO 17025 is the internationally recognized standard that specifies the general requirements for the competence of testing and calibration laboratories. It ensures that laboratories produce valid and reliable results, enhancing confidence in their work both nationally and internationally. The standard is structured around two key components: management requirements and technical requirements. Among these, process requirements form the core of the technical section, defining how laboratories must perform testing and calibration activities effectively and consistently.
For organizations seeking ISO 17025 Certification in Bangalore, understanding the process requirements is essential. These requirements ensure the integrity, accuracy, and reliability of laboratory results—core aspects for maintaining compliance and customer trust.
What Are Process Requirements in ISO 17025?
Process requirements refer to the operational aspects that a laboratory must establish and control to ensure the validity and consistency of its test and calibration results. These requirements define the workflow—from receiving the sample to reporting the final result—and encompass everything that affects the quality of laboratory operations.
ISO 17025:2017 outlines several clauses under process requirements (Clause 7), which include:
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Review of requests, tenders, and contracts
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Selection, verification, and validation of methods
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Sampling procedures
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Handling of test and calibration items
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Technical records
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Evaluation of measurement uncertainty
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Ensuring the validity of results
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Reporting of results
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Complaints and nonconforming work
Each of these plays a vital role in ensuring that a laboratory’s processes meet the standard’s quality and technical competence expectations.
Example of a Process Requirement: Method Validation
A prominent example of a process requirement under ISO 17025 is method validation. Laboratories must use appropriate methods and procedures for testing and calibration to ensure the reliability and accuracy of their results. When a standard method is unavailable or modified, the laboratory must validate the non-standard method to prove that it is fit for its intended purpose.
Key aspects of method validation include:
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Accuracy and Precision – Demonstrating that the method produces results close to the true value and can do so consistently.
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Linearity – Confirming that the method provides results that are directly proportional to the concentration of the analyte within a specific range.
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Limit of Detection and Quantitation – Determining the smallest concentration that can be reliably detected or quantified.
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Selectivity – Ensuring the method can differentiate between the analyte of interest and other components.
Validation data must be documented and retained as part of the laboratory’s technical records, as this evidence proves the reliability and reproducibility of test methods.
Other Important Process Requirements under ISO 17025
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Review of Requests, Tenders, and Contracts
Before accepting a new testing or calibration assignment, laboratories must review customer requirements to ensure they have the competence, resources, and methods to meet expectations. This step prevents misunderstandings and ensures accuracy from the start. -
Handling of Test and Calibration Items
Proper handling, transportation, storage, and retention of samples are critical to prevent contamination, degradation, or loss. Laboratories must establish clear procedures for labeling, tracking, and securing all samples throughout the testing process. -
Ensuring the Validity of Results
Laboratories must monitor the validity of their results by using control charts, replicate testing, or inter-laboratory comparisons. This continuous verification ensures the consistency and credibility of reported results. -
Reporting of Results
Reports must be clear, accurate, and include all necessary details such as measurement uncertainty, methods used, and deviations if any. Transparency in reporting builds trust and ensures compliance with ISO 17025. -
Handling Nonconforming Work
If a deviation or error occurs, laboratories must have procedures to identify, document, and correct nonconforming work promptly. They must also evaluate the impact of such incidents on previous results and notify customers when required.
Why Process Requirements Matter
The process requirements of ISO 17025 are essential because they directly impact the credibility and accuracy of laboratory outputs. Compliance ensures:
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Consistency in testing and calibration methods.
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Confidence in results among clients and regulatory bodies.
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Reduced risk of errors, nonconformities, and disputes.
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International recognition, as ISO 17025 is accepted worldwide.
By implementing these process controls, laboratories demonstrate a strong commitment to quality, competence, and reliability.
Achieving ISO 17025 Certification in Bangalore
For laboratories in Bangalore, achieving ISO 17025 certification involves developing a comprehensive quality management system that meets both management and process requirements. Partnering with expert ISO 17025 Consultants in Bangalore can simplify this journey. These professionals guide laboratories in documentation, internal audits, training, and preparing for external assessments.
B2Bcert, a leading ISO consulting firm, offers end-to-end ISO 17025 Services in Bangalore. Their experts help laboratories design compliant systems, validate methods, and maintain robust quality practices aligned with international standards.
By obtaining ISO 17025 Certification, laboratories in Bangalore can enhance their operational efficiency, improve customer satisfaction, and gain a competitive advantage in both national and global markets.
Conclusion
An example of a process requirement under ISO 17025 is method validation, which ensures testing and calibration methods are accurate, reliable, and suitable for their intended purpose. Alongside other process controls—such as handling samples, reporting results, and ensuring validity—these requirements form the foundation of laboratory competence and trustworthiness.
For organizations seeking ISO 17025 Certification in Bangalore, understanding and implementing these process requirements is crucial. With the right guidance from experienced ISO 17025 Consultants in Bangalore and comprehensive ISO 17025 Services in Bangalore, laboratories can confidently meet global standards and deliver consistently reliable results.