Basics of ISO/IEC 17025: What does it look like?

Posted by Charles Wilson on October 26th, 2019

The International Standard of ISO/IEC 17025 that demonstrates the general requirements for the competent, impartial, and consistent operation of laboratories. ISO 17025 specifies the activities that must be included in laboratory operations to promote confidence in its ability to produce valid and consistently reliable testing, calibration, and sampling results. ISO/IEC 17025:2017 is the current, revised standard that was published with cooperation between the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC).

ISO/IEC 17025 includes identification of the technical competence of laboratories. Accreditation is a formal declaration by an Accreditation Body, after assessment and confirmation, that a laboratory is effective in meeting the requirements of ISO 17025 to perform tests according to its accredited scope.

The standard and accreditation of ISO 17025 are used by independently owned and operated laboratories, as well as those are part of larger organizations, irrespective of the industry and size, which are involved in sampling or measurement activities. This includes regulated government and public sectors, as well as non-regulated sectors.

The ISO/IEC 17025:2017 standard splits into 5 main sections that contain the requirements for laboratory accreditation:

Section 4.General Requirements: 

The General requirements section covers two requirements which are impartial and confidential, that are vital for maintaining the trust and confidence that the users of tests and calibrations place in the laboratories they have used. Impartiality involves that the laboratory will not allow commercial, financial, or other pressures to compromise the quality of results. Internal issues, personal relationships, or other conflicts of interest are addressed and resolved. Confidentially requires the laboratory to keep all results and information private.

Section 5.Structural Requirements: 

This Structural requirements section defines the basic organizational components of a laboratory, its range of activities, and its commitment to an effective management system. It determines that an accredited laboratory must be a legal entity or part of a legal entity, which is responsible for its testing and calibration activities. Section 5 sets management is responsible for in an accredited laboratory and their responsibilities to customers, regulatory authorities, and organizations that provide recognition.

Section 6.Resource Requirements: 

There are six clauses in resource requirements that address the requirement for the laboratory to have available the personnel, facilities, equipment, systems, and support services necessary to perform its laboratory activities.

Section 7.Process Requirements: 

The Process requirement section covers 11 core processes to improve efficiency. The section begins with the Review of Requests, Tenders and Contracts. The Selection, Verification and Validation of Methods are one of the most technical and most important parts of the ISO 17025 standard. Sampling, the handling of test items, and technical record keeping are covered here. Ensuring the validity of results is the quality monitoring and control function in the laboratory. Several tools for monitoring are listed, and the requirements for proficiency testing are explained.

Section 8.Management Systems Requirements: 

In the Management system requirements there are to options such as options A & B, Option B applies if the laboratory is part of a larger organization. Here, the management system requirements specified in clauses 8.2 to 8.9 are covered by the existing QMS, as long as laboratory activities are included and the laboratory is capable of demonstrating its fulfilment of ISO 17025 clauses 4 to 7. If the laboratory’s Quality Management System is independent of any other management system, Option A applies and the laboratory must comply with Section 8’s requirements.

This section covers eight activities, including QMS documentation such as policies and objectives, control of documentation and records, addressing risks and opportunities, improvement, and corrective action. Also in the ISO 17025 certification the basic requirements of ISO 17025 documents are ISO 17025 manual, iso quality procedure, SOP and quality system implementation.