Purpose and objectives

The ISO/IEC 17025:2017 standard specifies the general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. Its primary objective is to ensure that laboratories produce valid and reliable results, which is critical for maintaining quality in testing and calibration processes. By establishing a framework for quality management and risk-based thinking, the standard fosters a culture of continuous improvement, helping laboratories enhance their operational efficiency and service delivery.

Scope: who must comply

ISO/IEC 17025:2017 applies to all organizations that perform testing, calibration, or both, regardless of their size or the nature of their operations. This includes:

• Testing Laboratories: Facilities that perform tests on samples, such as environmental, chemical, or mechanical testing.
• Calibration Laboratories: Organizations that provide calibration services for measuring instruments, ensuring their accuracy and reliability.
• Industry Sectors: Laboratories across various sectors, including healthcare, manufacturing, and environmental services, must comply to demonstrate their competence and reliability to clients and regulatory bodies.

The standard is vital for organizations looking to achieve accreditation from recognized bodies, ensuring that they meet the necessary quality and operational benchmarks.

How SN EN ISO/IEC 17025:2018 relates to other standards

ISO/IEC 17025:2017 does not exist in isolation. It relates closely to several other important standards:

• ISO 9001: This standard focuses on quality management systems and is often complementary to ISO/IEC 17025, providing a broader quality framework.
• ISO 15189: This standard is specific to medical laboratories and details the quality and competence requirements for medical testing.
• ISO/IEC 17020: It pertains to the requirements for the operation of various types of bodies performing inspection, enhancing the standards' focus on impartiality and consistency.

Revision history and current status

The publication body of ISO/IEC 17025 is the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). The current revision of the standard was released in 2017, transitioning from the previous version, ISO/IEC 17025:2005. Key changes in this revision include:

• Emphasis on risk-based thinking and management, promoting a proactive approach to quality and operational risks.
• Enhanced focus on the competence of personnel and the need for continuous improvement processes.
• Updated requirements for document control and record-keeping to align with modern technological advancements.

By adhering to these revised requirements, laboratories can ensure they remain compliant with ISO/IEC 17025:2017 and continue to provide high-quality testing and calibration services.