ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories,” is a standard that was first published in the year 1999 by ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission), as a replacement for the ISO Guide 25 published till then. The aim of creating ISO/IEC 17025 is to establish an international standard specifically for laboratory quality management systems. The initial issue of ISO/ISE 17025 combined the ISO 9001:94 standards and laboratory-specific language from the ISO Guide 25 to form a lab quality management system requirement. Since then, ISO/IEC 17025 has been adopted globally (by more than 50,000 labs) as the accreditation benchmark for laboratories to be deemed technically competent. The standard has been revised twice since 1999 – first in 2005 and again in 2017. The revisions were intended to keep up with the industrial advancements while incorporating technology into standards, whilst complying with ISO 9001:2015.
Studies have observed that in most cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited with ISO/IEC 17025. The article details the significance of ISO/IEC 17025 accreditation for laboratories, benefits for instrument or asset owners who wish to calibrate from accredited labs, and how this standard differs from the ANSI/NCSL Z540 and ISO 9001 Standards.
The goal of creating the ISO/IEC 17025 Standard is to provide confidence in laboratory results, demonstrating that they are competent and that they deliver valid and unbiased data with a minimal margin of error. The following are the objectives of the standard:
The following eight principles are regarded as the primary drivers behind all the requirements stated in ISO/IEC 17025:
Following are certain benefits for labs accredited with ISO/IEC 17025 standards:
The accreditation process consists of a number of stages, including document review, process audits, and accreditation results provided by third-party accreditation bodies. The following are brief descriptions of each step:
Step 1: Start Your Research/Preparation: Research and learn about the accreditation process. ISO/IEC 17025 general training will detail the different standards. Training on the scope of accreditation and other criteria such as general, structural, resource, and process requirements and more specific ones like product quality assurance requirements will help understand the accreditation processes.
Step 2: Gap Analysis and Preparing Accreditation Checklist: Preparing a gap analysis checklist can help identify what the lab is currently equipped with, recognize the areas for improvement, and determine the time for achieving an ISO 17025 accreditation.
Step 3: Drafting an Accreditation Project Plan: Prepare a framework for approaching accreditation bodies by consulting the checklist outlined in step 2. Make a workflow and timetable for the steps involved with applying for and maintaining accreditation.
Step 4: Documentation: In this step, processes, methods, and lab procedures should be documented as per QMS (Quality Management System) standards. Proper documentation includes, but are not limited to, the following:
Step 5: Internal Audit for QMS Conformity: An internal audit will ensure that the lab follows established procedures after implementing the quality management system. Based on the non-conformities and the internal audit report, an action plan may be developed. This will help the lab in correcting any problems before beginning accreditation testing.
Step 6: The audit from an Accreditation Body: An accrediting organization will conduct the final examination of the laboratory. They may interview some company or lab workers, examine certificates and records, inspect documents and samples, and check equipment.
External auditors generally seek for statements, proven methods, records, and written policies to ensure that the lab’s technical competence is valid. If any non-conformities are identified, appropriate actions must be taken, and these measures will be documented in the report for further evaluation.
After addressing the non-conformities, a lead assessor verifies them. When there are no longer any concerns, the accreditation body will prepare and give the accreditation certificate to the lab. The certificate will show that the laboratory or organization is competent in offering specific calibration or testing services.
Although both ISO 9001:2015 and ISO 17025:2017 are QMS (Quality Management Systems) applicable to any industry, their scope and application areas are significantly different. ISO 17025 applies for calibration and testing laboratories, whereas ISO 9001 can be applied to any organization as a standard for quality.
A specific set of QMS standards must be met for an organization to obtain ISO 17025:2017 certification, which are comparable to those required by ISO 9001:2015. The following are the minimum requirements according to on the standard (ISO 17025:2017), also valid for ISO 9001:
Implementing an ISO/IEC 17025 standard allows you to choose between two options based on the accreditation program:
Option A: If an organization haa not yet implemented ISO 9001, it must include them as part of the ISO 17025 QMS Scope.
Option B: If the organization has an ISO 9001 certification (prior to planning ISO 17025 accreditation), these conformities can be re-submitted during the ISO 17025 accreditation, eliminating re-work.
Implementing ISO 9001:2015 may be helpful (add-on) for laboratories, but it is not required to comply with ISO 17025:2017.
ANSI/NCSL Z540.3-2006 details the “Requirements for the Calibration of Measuring Test Equipment” instead of ISO/IEC 17025:2017, which describes “General Requirements for The Competence of Testing and Calibration Laboratories.” Although both standards deal with how a Calibration or Testing Laboratory should function, Z540-1 is distinct from 17025 since it is limited to calibration laboratories.
ISO/IEC 17025:2017 is the most widely used certification standard as it effectively addresses all of ANSI/NSCL Z540.3’s requirements, except Z540.3 Section 5.3 (b). Section 5.3 (b) explains, “Where calibrations provide for verification that measurement quantities are within specified tolerances, the probability that incorrect acceptance decisions (false accept) will result from calibration tests shall not exceed 2% and shall be documented. Where it is not practicable to estimate this probability, the test uncertainty ratio shall be equal to or greater than 4:1.
NOTE: Achieving these requirements may involve adjustment and management of calibration system parameters such as: measurement reliability, calibration intervals, measurement uncertainty, calibration tolerances, and/or guard bands.”
ISO 17025 differs from Z540 when it comes to traceability. ISO 17025 demands that the calibration chain be unbroken and that measurements be traced back to a national standard and requires traceability to SI units. This implies that traceability is maintained via laboratory standards and includes an uninterrupted sequence of calibrations. Traceability must be demonstrated by the use of lab personnel and proof of traceability, according to ISO/IEC 17025. Traceability must also be capable of being traced back to a national standard
17025 is more stringent than Z540-1 in terms of measurement uncertainty. All calibrations performed under 17025 are required to be subjected to comprehensive uncertainty analysis. Traceability cannot be achieved, according to ISO 17025, without knowing the correct uncertainty ratio.
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