Introduction

ISO/IEC 17025:2017 is an internationally recognized standard that provides the general requirements for the general competency for all types of laboratories, including testing and calibration labs. Published by the International Organizations for Standardization (ISO) and the International Electrotechnical Commission (IEC), ISO 17025 is one of the most important standards utilized by labs that carry out calibration, testing or sampling activities across the world. ISO 17025 accredited labs have demonstrated that they are technically proficient and are able to produce precise and accurate test and calibration data.

The latest revision of ISO/IEC 17025 takes into account the changes in the laboratory environment, work practices and lab technologies. ISO/IEC 17025:2017 includes a revised scope that covers all laboratory activities, a new structure, incorporates the process approach and risk-based thinking and has a stronger focus on the use of electronic records and reports. It also takes into consideration ISO 9001:2015. Laboratories already accredited to ISO/IEC 17025:2005 will need to transition to the new ISO/IEC 17025:2017 version by December 1, 2020. Click here to learn how our ISO 17025 management system experts can help make the transition seamless.

Who is ISO 17025 Accreditation For?

ISO 17025 is beneficial for labs of any size in any industry that wants to deliver trusted and reliable results. This includes laboratories that are owned or operated by the government, universities, research centers, product certification organizations or other industry organizations that perform testing, calibration or sampling.

What are the Benefits of ISO/IEC 17025 Accreditation?

Laboratories that comply with ISO 17025 requirements and achieve accreditation experience a range of benefits, including:

• Enhance the reliability of lab and test results

• Increase customer confidence

• Improve ability to consistently produce valid results

• Demonstrate technical competency

• Improve lab operations, reduce risks and waste

• Generate wider national and international acceptance of lab and test results

• Meet customer requirements for ISO 17025 accreditation

High-Level Overview of ISO 17025 Requirements

ISO/IEC 17025:2017  is divided into 5 main clauses that describe the general requirements for competent, impartial, and consistent laboratory operations.

Clause 4: General Requirements

This clause defines the requirements for impartiality and confidentiality. Impartiality refers to the presence of objectivity, or the freedom from conflicts of interest. Labs should not allow commercial, financial, or other pressures to compromise their results. Confidentially requires laboratories to keep all customer information obtained or created during lab activities private.

Clause 5: Structural Requirements

This clause encompasses the requirements for defining the organizational structure. ISO 17025 accredited laboratories must be a legal entity, or part of a legal entity that is responsible for its testing, calibration or sampling activities. The laboratory will need to define the management responsible for the operations and the responsibility of laboratory personnel. Laboratories will need to define and document their range of activities and are required to document their procedures in order to ensure consistent activities and the validity of results.

Clause 6: Resource Requirements

The 6 subclauses in Clause 6 describe the requirements for the resources necessary to manage and perform laboratory activities. Laboratories internal and external personnel, such as contractors, must be competent and work within the laboratory management system. The competence requirements and job functions shall be documented, and management shall communicate the duties, responsibilities and authorities to personnel. Labs will need to ensure the facilities and environmental conditions are suitable and do not negatively affect the validity of results. The requirements for the conditions will need to be documented, monitored, controlled and recorded. Labs will need to have access to the equipment required for the performance of laboratory activities and establish a documented calibration program. ISO 17025 accredited laboratories must establish, maintain and provide objective evidence of metrological traceability of their measurement results using a documented unbroken chain of calibrations. ISO 17025 provides the requirements for externally provided products and services.

Clause 7: Process Requirements

Clause 7 of ISO 17025 includes 11 subclasses that define the requirements for the following:

• Review of Requests, Tenders and Contracts
• Selection, Verification and Validation of Methods
• Sampling
• Handling of Test and Calibration Items
• Technical Records
• Evaluation of Measurement Uncertainty
• Ensuring the Validity of Results
• Reporting of Results
• Complaints
• Nonconforming Work
• Control of Data and Information Management

Clause 8: Management Systems Requirements

Laboratories must establish, document, implement and maintain a management system that is capable of supporting and demonstrating a commitment to ISO 17025 requirements. Labs can meet requirements by implementing either Option A or B. Option A lists the minimum requirements for the implementation of a laboratory management system, which includes ISO 9001 requirements relevant to the scope of laboratory activities. Option B is for labs that already have an established and maintained ISO 9001:2015 management system. If implementing Option B, the requirements of Clauses 4 – 7 of ISO 17025, documentation requirements and management review requirements will still need to be fulfilled.

Author

Victoria Ontiveros | Marketing Coordinator 

Victoria focuses on creating quality educational content that provides value to current and potential clients. By collaborating with members of leadership and sales, she is able to develop informative articles that answer common questions and connect with current trends.

Victoria earned her Bachelor of Science in Sociology with an emphasis in communications from Texas A&M University.