ISO 17025

ISO/IEC 17025 — Testing and calibration laboratories

ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality, and consistent operation of laboratories. It covers testing and calibration performed as part of or as a service to quality systems based on product or process requirements, together with the management of those operations.

It is applicable where such services are mandatory, such as for trade and certification purposes, and optional for laboratories using them within their own internal quality assurance processes. This International Standard does not cover the inspection.

ISO/IEC 17025:2017 is applicable to all laboratories, irrespective of the extent of testing performed; whether testing is performed for external customers or by the laboratory itself; and whether they perform testing on materials, products, components, assemblies, or complete structural units under simulated process conditions (e.g., using destructive testing techniques).

Purpose of ISO 17025

ISO 17025 was established with the goal of promoting confidence in laboratory operations. It sets requirements for laboratories to demonstrate that they are capable of producing reliable results and that they operate properly. Laboratories that comply with this ISO 17025 will also conform to ISO 9001 principles.

What labs are expected to do?

ISO 17025 requires that a laboratory develop and implement solutions to address risks and opportunities. Addressing both risks and possibilities provides a foundation for improving the effectiveness of the management system, obtaining higher outcomes, and preventing negative consequences. The responsibility for determining which risks and possibilities need to be addressed rests with the laboratory.

ISO 17025 will help laboratories work together more successfully and exchange information and experience, as well as harmonize standards and procedures. Conformity to ISO 17025 makes it easier for laboratories from different countries to compare results.

Structure of ISO 17025

ISO 17025:2017 is divided into four main parts:

Part 1 General requirements

Part 2 Competence requirements 

Part 3 Laboratory-management system 

Part 4 Assessment of conformance, and monitoring of continued conformity

ISO/IEC 17025 is intended to be used in conjunction with other relevant standards in the field. This international standard is not, in itself, intended to cover all the relevant requirements for the operation of a laboratory. Other standards may need to be referred to when specific needs are identified.

ISO 17025 is not intended for use in any country where the laboratory system operates in isolation from other national systems, which could make its use inappropriate.

The structure of ISO 17025:2017 was designed to be flexible, allowing its use in conjunction with other requirements.

ISO 17025:2017 does not include requirements for the competence of individual analysts or other individuals involved in testing and calibration operations covered by this document. It is up to each laboratory to determine who needs to be competent, based upon the specific needs of the laboratory.

Improve confidence in testing

ISO 17025 is intended to help laboratories maintain technical competence and produce accurate results. This International Standard promotes confidence in the laboratory, its data, and the services it provides by ensuring compliance with relevant requirements on an ongoing basis.

What are competencies?

Competence is defined as “the ability of individuals to achieve required or expected end results, with the help of available resources, in a manner consistent with prevailing ethical and safety standards through the application of knowledge, skills, and attitudes”.

ISO 17025:2017 specifically requires that each laboratory should determine and document requirements for individual technical competence and for organizational competence. The scope of this requirement is limited to “technical” competencies because it is assumed that organizations will determine and document the requirements for their own “organizational” competence.

These requirements may be documented as part of a structured or unstructured program.

• ISO 17025:2017 states that the laboratory must define and maintain a qualification system to ensure that personnel performing tests, calibration, preparation of standard materials, the release of test reports, and so on have the knowledge, skills, and attitudes to do their jobs.
• The standard does not require tests for specific competencies of individual analysts or other individuals involved in testing operations covered by this document. It is up to each laboratory to determine which person shall be qualified.
• A limit may be set on the number of personnel who are not required to meet the laboratory’s competency requirements. The reason for this limit may be that people who are not qualified do not routinely work in an area where incorrect decisions could result in damage to equipment or could lead to invalid test results, invalid calibration data, invalid certification of standard materials, and so on.
• The laboratory must ensure, through documented procedures, that all personnel is adequately trained and competent before being allowed to carry out assigned tasks.
• Training shall be provided at the time of the initial assignment or prior to using new equipment or techniques. Training may also be conducted during routine tasks in order to ensure that competence is maintained throughout the year.
• A person who does not have the appropriate qualifications or is not competent to perform assigned work may be delegated routine activity only if that person is under the direct supervision of a qualified and competent person.
• If training records are not kept, it will be difficult to ensure that person maintains their competency. The standard requires documentation of the initial qualification according to the requirements set out by the laboratory.
• The standard requires documentation of the initial qualification according to the requirements set out by the laboratory. 
• Testing and calibration must always be carried out by or under the supervision of qualified personnel. The test result shall not be released until it has been confirmed that the person who performed the test was competent.
• ISO 17025:2017 does not require written tests, but the laboratory must ensure that personnel is qualified to perform specific activities.
• Documenting procedures is an integral part of overall competence management. It ensures that the documented procedures are available for inspection and it allows a laboratory to compare its own practices with those in ISO 17025:2017.

When should competency be checked?

Whenever a change in working conditions or changes in the area of responsibilities take place.

What needs to be documented?

• All activities, including competency management system(s), qualification system(s) developed and maintained by each laboratory shall be documented in a systematic and orderly manner in order to ensure consistency and control of operations. 
• The standard says nothing about the format of these records and states that they may be in the form of written documents, database records, or qualification schemes. It is up to each laboratory to decide on which system it uses to document its procedures for ensuring qualified personnel and its training programs.
• ISO 17025:2017 does not require documentation on written tests, but requiring more than one test may be an indication that the laboratory does not have adequate documentation on its training programs.
• The competency of individuals may be checked by documented assessment of their knowledge, skills, or attitudes. The results shall be recorded and made available to those concerned with laboratory activities.
• The competency of all personnel is to be assessed at least once a year, but the laboratory may decide on more frequent assessments if it considers that this is necessary.
• Inspections or evaluations of a laboratory’s compliance to ISO 17025:2017 shall include an assessment of how personnel are managed, trained, and kept competent.
• The standard requires record-keeping but does not require written tests or procedures for checking competence. The laboratory must ensure that the training program and its documentation meet requirements set out by the standard.

Contact us : For more information about the standard, ISO 17025 Certification to not hesitate to contact us through mail: enquiry@iascertification.com or whatsapp: +6531591803