WHAT IS THE DIFFERENCE BETWEEN ISO 17025 COMPLIANT & ACCREDITED?

WHAT IS THE DIFFERENCE BETWEEN ISO 17025 COMPLIANT & ACCREDITED?

Not sure what the difference is between ISO 17025 accreditation and ISO 17025 compliance? That question is asked by many quality, tooling, or maintenance managers. The short answer is that accreditation is legally verified, while compliance is not. This is important to determine for meeting quality guidelines or regulations. Establishing accreditation is also useful when choosing or evaluating a laboratory.

What is ISO 17025?

ISO/IEC 17025 is a competence standard for calibration and testing laboratories issued by the International Organization for Standardization and the International Electrotechnical Commission. The original ISO 9000 standard issued in 1979 did not emphasize procedure verification. The ISO/IEC 17025 standard was issued in 1999 to provide more specific requirements for laboratory testing competence. ISO 17025 requirements cover testing and calibration performed using standard methods, nonstandard methods, and custom developed methods. The standard applies to all laboratories regardless of scope coverage.

ISO/IEC 17025 Accreditation

ISO/IEC 17025 accreditation is formal recognition given by an accrediting body that a laboratory has displayed calibration testing competence. Accreditation is voluntary, there are no requirements that a laboratory must obtain or maintain ISO/IEC 17025 accreditation to perform calibration testing. The ISO/IEC 17025 accreditation is accepted internationally as proof of conformance to the standards requirements. The accreditation process includes document review, process audit, and accreditation result. An audit is performed annually by the accrediting body.

ISO 17025 accreditation process e2b cal

Scope Determination

A laboratory’s Scope of Calibration is determined by the accreditation process. The scope lists the calibration or test capability that has been verified by the accrediting body. Each instrument category listed on the scope includes the testing method, detection limit, and reference standard. The Scope of Calibration and the Accreditation are the same document. The accreditation information is often listed on the first page, with the scope following.

e2b calibration ISO 17025 accreditation scope

What is ISO 17025 Compliant?

While researching calibration laboratories, you may come across an organization that is ISO 17025 compliant. ISO compliance communicates that a laboratory follows the standard, but has not passed or completed an audit with an accrediting body. This can be confusing because there is no simple way to verify that a lab is compliant to the ISO/IEC 17025 standard unless the accreditation process has been completed. Imagine someone getting pulled over and telling a police officer that they are driver’s license compliant, this is the same principle.

Why Choose an Accredited Calibration Laboratory vs an ISO 17025 Compliant Laboratory

Organizations often choose an accredited laboratory over an ISO 17025 compliant laboratory to mitigate risk, increase confidence, and meet quality requirements. The International Organization of Standards created 17025 as a recognizable global standard of quality and conformance. Laboratories that pass all necessary audits are awarded the accreditation, which communicates proven effectiveness of testing efforts and verification of the quality management system. The risk of process variance, inappropriate testing conditions, and poor documentation are substantially reduced when working with an accredited laboratory.

Proof of Conformance

The confirmation of performance by an accrediting body simplifies the conformance verification process for most organizations. The majority of companies find that verifying quality by checking accreditation status is much easier than conducting their own audits. Even if an organization were to research internal controls and processes, they may not know what to look for in regards to conformance.

Conformance Factors:

      • Technical competence of laboratory staff
      • Effectiveness and conformance of test methods
      • Suitability of testing environment and sampling
      • Maintenance of test equipment
      • Verification of test and calibration data quality
      • Traceability of measurements and calibration methods to recognized standards

Quality Requirements & Guidelines

Internal, customer, or regulatory guidelines are becoming firmer with time. Requirements will often dictate the use of a third party, ISO 17025 accredited calibration laboratory. Many times this is to decrease risk throughout a supply chain.

When choosing a calibration laboratory, don’t mistake ISO 17025 compliance with accreditation. Although the terms sound similar, they are not the same. Review any quality guidelines to check if there is a requirement to use an ISO/IEC accredited laboratory. To ensure that a laboratory can meet quality requirements, review the Scope of Accreditation.

About e2b calibration

Located in Northeast Ohio, e2b calibration is an ISO/IEC 17025 accredited calibration and repair laboratory. A full scope of services (traceable to NIST) are available for most calibration, test, and measurement instruments. Service is available onsite or at our environmentally controlled laboratory.

Our staff includes highly-trained metrology experts, quality control and laboratory management, and a full support department for accounting, software, and customer account management. Our goal is to provide customers with an easy, convenient way to manage calibration and repair.

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