Significance of 17025 Accreditation

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.

 

ISO/IEC 17025 – Objectives and Principles:

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:

  1. Provide a framework upon which accreditation bodies may assess laboratory competence.
  2. Establish broad standards for demonstrating lab compliance in order to do specific tests or calibrations.
  3. Assist in the development and implementation of a laboratory’s quality management system.

 

The following eight principles are regarded as the primary drivers behind all the requirements stated in ISO/IEC 17025:

  1. Capacity: The notion that a laboratory should have the necessary resources (people with the required abilities and knowledge, an environment with the appropriate equipment and facilities, quality control, and procedures) to perform a calibration task and produce competent results.
  2. Exercise of Responsibility: The notion that employees in an organization have the authority to conduct specific activities within the overall scope of work and that the organization can be held accountable for outcomes.
  3. Scientific Method: The work performed by the organization is based on accepted scientific methods, often consensus-based, and any deviations from standard scientific procedures should be confirmed in a manner that is acceptable to experts in the field.
  4. The objectivity of Results:
  1. The organization’s outcomes are primarily based on measurable or derived data.
  2. The term “subjective” should be used to indicate that test results are only created by people who have been determined qualified to do so and that such conclusions are recognized as subjective (by the standard), or that experts in the field of testing acknowledge the result is subjective.
  1. Impartiality of Conduct: This means that the research of individuals executing tests is guided by obtaining competent outcomes through the application of accepted scientific techniques. All other influences are considered secondary and must not take precedence.
  2. Measurement Traceability:
  1. The results should be derived from a defined measurement system, established by recognized known quantities (Ex: SI system) or other well-characterized instruments or quantities within the laboratory’s scope of work.
  2. The concept that the chain of comparison of measurement between these accepted, known quantities or intrinsic devices or components, and the Measuring device delivering the objective result, is unchanged and continuous for the whole measurement chain, including uncertainty.
  1. Test Repeatability: The belief that the test that yielded the stated results will repeat those same findings, with tolerable variances during subsequent testing and within the limits of employing the same techniques, apparatus, and personnel utilized in a previous test.
  2. Transparency of Process: The concept that the procedures in place within the laboratory producing the desired results are open to internal and external review, allowing factors that may harm the laboratory’s quest for scientific method-based results to be quickly recognized and mitigated.

 

ISO/IEC 17025 Lab Accreditation – Benefits:

Following are certain benefits for labs accredited with ISO/IEC 17025 standards:

  1. Improves lab reputation: The ISO 17025 is an internationally accepted standard for lab accreditation and is highly regarded by scientific communities. Therefore, accreditation allows organizations to enhance Lab’s credibility and demonstrates the dependability of their testing, measurement, and calibration to clients, rivals, and stakeholders alike. In addition to being a formal recognition of laboratories, it also demonstrates the laboratory’s dedication to a robust and well-defined quality system.
  2. Compliance with Standards: All laboratories, regardless of size or headcount, may obtain ISO 17025 accreditation. As a result, obtaining it is an excellent way for all businesses to comply with regulatory and legislative standards. It demonstrates compliance with safety criteria, which satisfies authorities, consumers, and clients since it shows adherence to safety policies.
  3. Demonstrates continuous excellence: The difficulty of obtaining ISO 17025 accreditation is not in dispute, yet it’s well worth the effort. It’s something to aim for and maintain. Laboratories must continue to excel and maintain data quality to meet this standard. In this way, clients, stakeholders, and workers may rest assured that the data generated in the laboratory is accurate and reliable, further demonstrating the firm’s excellence and expertise.
  4. Scaling laboratory business: You’ll boost client pipeline with a stronger brand image, assured compliance, and rules to ensure better organizational performance. Clients can be certain that the procedure is trustworthy and done correctly. The ISO 17025’s worldwide reputation also gives it an edge over the competition and the opportunity to compete internationally.
  5. Optimal use of resources: While the accreditation may appear to be a costly process, it is more than offset by the time and cost-saving advantages. These labs can eliminate end-product retests, and ensure that independent auditors are no longer required to conduct supplier audits.
  6. Enhanced efficiency: Following the rules of the standard is also a great method to improve operational efficiency and productivity. You can guarantee that your laboratory’s process generates the most precise results in the most efficient way by using your ability to constantly evaluate personnel procedures, methods, and equipment.
  7. Standard Procedures and Documentation: ISO 17025:2017 requires that all procedures, changes implemented, and mistakes or discrepancies be recorded in order to avoid future problems, which improves stability within the laboratory and enhances the result outcomes. When employees follow the required documentation, they are more accountable.

 

ISO/IEC 17025 Accreditation – Procedure:

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:

  1. Quality Manual
  2. Functional Procedures
  3. Work Instructions
  4. Quality Records
  5. System Procedures and Formats

 

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.

 

ISO 9001 Vs ISO/IEC 17025 Standards:

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:

  1. Improvement
  2. Management reviews
  3. Management system documents control
  4. Documentation of management system
  5. Corrective actions
  6. Handling risks and opportunities
  7. Records control
  8. Internal audits

 

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.

 

ISO/IEC 17025:2017 vs. ANSI/NCSL Z540 Standards:

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.

 

e2b calibration offers industry-leading ISO-certified calibration services. Our labs are ISO/IEC 17025 accredited and operated by a team of qualified calibration experts. Our verifiable services are unmatched in the industry. We are registered with ANAB. We are also ANSI/NCSL Z540-1-1994 certified. We have the NIST Traceable Wide scope of ISO/IEC 17025 accreditation. Contact e2b calibration for all your equipment calibration needs.

 

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