Requirements of ISO/IEC 17025 for Testing Laboratories

Requirements of ISO/IEC 17025

According to the International Organization for Standardization (ISO), the ISO/IEC 17025:2017 requirements apply to all organizations conducting laboratory activities, regardless of the company size.

The standard identifies the general requirements for impartiality, competence, and consistent laboratory operations.

Due to this, QSE Academy has created a 3-part article to explain everything you need to know about the new ISO/IEC 17025:2017.

For the first part, we’ve simplified all the information about the background and main requirements.

Background Information about ISO/IEC 17025

ISO and the International Electrotechnical Commission (IEC) first issued the ISO/IEC 17025 in 1999.

The standard is the most essential standard for calibration and testing laboratories across the world. There are more than 50,000 international laboratories that are accredited.

At the International Laboratory Accreditation Cooperation (ILAC) General Assembly on October 2013, the Laboratory Committee suggested for ILAC to appeal that ISO/CASCO create a fresh work item to expansively revise ISO/IEC 17025:2005.

Note that the Laboratory Committee is comprised of stakeholder representatives of accredited testing and calibration.

Meanwhile, CASCO, which is an ISO committee, works on conformity assessment matters.

It develops policy and publishes standards associated with conformity assessment. However, CASCO does not execute conformity assessment activities.

Furthermore, working groups perform the standards development activities of CASCO. ISO member bodies put forward experts to create working groups.

Those experts have explicit knowledge about activities to be carried out by the working group.

During the 6th ISO/CASCO WG 44 meeting in ISO Central Secretariat, Geneva in July 2017, the FDIS version of the new ISO/IEC 17025 version was delivered.

Format of the New ISO/IEC 17025:2017 Standard

To establish harmony with the new ISO formatting guidelines, the format of the new ISO/IEC 17025:2017 standard has been considerably modified.

The basic format is akin to ISO/IEC 17065 and ISO/IEC 17020.

The new standard is now structured as follows:

Scope
Normative references
Terms and definitions
General requirements
Structural requirements
Resource requirements
Process requirements
Management requirements

Annex A – Metrological Traceability (Informative)
Annex B – Management System (Informative)
Bibliography

General Information About the New ISO/IEC 17025:2017 Standard

nal Accreditation Forum (IAF) defines accreditation as “the independent evaluation of conformity assessment bodies against recognized standards to ensure their impartiality and competence.”

The new ISO/IEC 17025:2017 standard was developed to:

Drive confidence in laboratory operations;
Provide requirements for laboratories;
Enable laboratories to show they perform competently and impartially;
Ensure laboratories are capable of providing valid results.

Likewise, ISO/IEC 17025:2017 can be used for:

Self-assessment of the laboratories;
Accreditation purposes;
Second party assessments by organizations, regulatory or statutory authorities, laboratory customers, and schemes using peer-assessment

The standard gives detailed definitions of the terms laboratory, decision rule, impartiality, proficiency testing, complaint, interlaboratory comparison, and interlaboratory comparison.

Besides, the standard’s requirements apply to any organization that executes the activities of testing and/or calibration and/or sampling. This could be associated with subsequent testing or calibration.

Hence, a laboratory can secure ISO/IEC 17025:2017 accreditation by offering to sample associated with subsequent testing or calibration.

However, conducting only sampling activities is a new element in the ISO/IEC 17025:2017.

For instance, if your organization is performing tests by taking samples on your capacity, you should fulfill both sampling and testing requirements.

But if you forward samples to a laboratory for testing, then you should comply with the requirements of the new standard.

This is to guarantee that the sampling activity won’t impact negatively the test results.

Here are the requirements for sampling organizations:

Competent personnel;
Maintained and calibrated equipment;
Validation of sampling procedure;
Assurance of quality of the sampling.

Note that the standard’s development phase tried to align with the ISO 9001 principles. Somehow, laboratories complying with this standard also conform to ISO 9001 principles.

Main Requirements of ISO/IEC 17025:2017

The main requirements of the new ISO/IEC 17025:2017 standard can be found throughout clauses 4 to 8.

Clause 4 – General Requirements of ISO/IEC 17025:2017

Clause 4 explains the requirements involving impartiality and confidentiality.

Since risk-based thinking is evident throughout ISO/IEC 17025:2017, the new standard expects laboratories to plan and implement actions to address risks and opportunities.

The standard has created this set of requirements:

A laboratory should detect and remove or minimize risks associated with impartiality, on an on-going basis.
A laboratory should notify customers in advance, of the details it plans to release in public.
A laboratory should discuss how to manage the release of classified data required by law or authorized by contractual arrangements.
The confidential requirement extends to laboratory personnel such as individuals acting on the laboratory’s behalf, contractors, personnel of external bodies, and committee members.
The confidential requirement extends to cases wherein data is recovered from regulators or complainants.

Clause 5 – Structural Requirements of ISO/IEC 17025:2017

Clause 5 defines main requirements such as:

A laboratory’s legal status;
Identification of management;
Organization and management structure;
Range of laboratory activities;
Availability of personnel responsible for the implementation;
Availability of personnel in maintaining the integrity of the management system;
Documentation of procedures

ISO/IEC 17025:2017 requires a laboratory to only claim conformity with this document for this range of laboratory activities. This omits externally provided laboratory activities on an ongoing basis.

Therefore, a laboratory expected to be accredited should specify in the scope of accreditation only testing/calibration/sampling activities.

In the 2005 version of ISO/IEC 17025, the standard permitted subcontract tests and calibrations if a laboratory was not in a position to perform them.

However, the new standard states that a laboratory can be accredited only for those laboratory activities, for which it is competent.

Thus, subcontracting is allowable for circumstances such as sickness of personnel, an overload of work, maintenance of equipment, and the like.

We’ve only covered the basics of the new ISO/IEC 17025:2017, along with some of its general requirements.

We still have two more articles that can explain everything you must know about the standard.

But should you require assistance after reading this post, our team of ISO experts can help you comply with the new ISO/IEC 17025:2017. You may also look into our toolkits for you to start implementing the standard.

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Main Requirements of ISO/IEC 17025 : 2017 – Part 1