What are the Key Changes between the 2005 and 2017 Versions of the ISO/IEC 17025 Standard?

Quality Management System 2018-06-01

The ISO/IEC 17025 standard specifies the requirements for the competence of testing and calibration
laboratories. The requirements of the 2017 version of the ISO/IEC 17025 standard are applicable to all
organizations performing testing, calibration, and/or sampling.

The newest standard provides an update in:

- terminology;

- process approach, whereby the standard is aligned with other recent standards such as: ISO 9001;

- scope;

- the usage of recent and updated IT technology; and

- the concept of risk-based thinking.

The 2005 version of ISO/IEC 17025 vs. the 2017 version of ISO/IEC 17025

To begin with, the 2005 version of ISO/IEC 17025 included the following:

- Scope

- Normative references

- Terms and definitions

- Management requirements

- Technical requirements

Meanwhile, the 2017 version of ISO/IEC 17025 includes the following:

- Scope

- Normative references

- Terms and definitions

- General requirements

- Structural requirements

- Resource requirements

- Process requirements

- Management system requirements

When comparing the scope of ISO/IEC 17025:2005 version with the scope of ISO/IEC 17025:2017
version, it is noted that the 2017 version of the ISO/IEC 17025 standard specifies the general
requirements for the competence, impartiality, and consistent operation of laboratories.

Additionally, in the normative reference section of ISO/IEC 17025:2017, ISO/IEC Guide 99 is listed as a
reference which provides the basic and general concepts, and associated terms. ISO/IEC 17000 is also
listed as a reference, which specifies the vocabulary and the general principles for conformity
assessment.

The terminology has been updated as well, which means that the ISO/IEC 17025:2017 standard covers
the newest ISO/IEC terminology and the changes that have been included in the International
Vocabulary of Metrology (VIM). Under the section terms and definitions of the ISO/IEC 17025:2017
standard, the term “laboratory” has been added. This term refers to the bodies that perform one or
more of the following activities such as testing, calibration, and/or sampling, associated with subsequent
testing or calibration.

It is important to mention that the newest standard focuses more on information technology, mainly in
the use of systems, the provision of electronic test results, and the provision of electronic records.

Main requirements of the 2017 version of ISO/IEC 17025

General requirements: This clause includes impartiality and confidentiality, whereby the laboratory
activities are to take into account impartiality and safeguard the confidentiality of all the information
obtained during the execution of laboratory activities.

Structural requirements: This clause represents the legal entity that defines and documents the range of
laboratory activities. Additionally, it identifies the management, the laboratory activities, the
organization and management structure, the responsibility, authority and interrelationships of all
personnel.
Resource requirements: This clause highlights the importance of the provision of the resources such as
the personnel, facilities and environmental conditions, equipment, metrological traceability, and the
externally provided products and services used to support the operation of the laboratory.

Process requirements: In this clause, it is mentioned that the process requirements are deployed as
follows:

- Review of requests, tenders, and contracts;

- Selection, verification, and validation of methods;

- Sampling;

- Handling of test or calibration items;

- Technical records;

- Evaluation of measurement uncertainty;

- Assuring the validity of results;

- Reporting of results;

- Complaints;

- Nonconforming work;

- Control of data – information management.

The clauses presented above are included in the following scheme which represents the operational
processes of a laboratory.

Management system requirements: This clause states that the laboratory has two options to choose
when implementing a management system, Option A or Option B.

Option A: This option lists the main requirements for implementing a Laboratory Management System.
This means that the Laboratory can implement directly a management system based on the
requirements of ISO/IEC 17025. In addition, the laboratory can choose to incorporate the requirements
of ISO 9001 that are relevant for performing laboratory activities.

Option B: When a laboratory chooses to implement a management system through Option B, they have
to operate in accordance with the requirements of ISO 9001, in a way that fulfills requirements 4 to 7 of
the ISO/IEC 17025 standard.

However, as it is stated in ISO/IEC 17025, both options are intended to achieve the same result in the
performance of the management system and compliance with clauses 4 to 7.

Another change in the 2017 version of the ISO/IEC 17025 standard is the modification of the Annexes.

ISO/IEC 17025:2005 version included the following Annexes:

- Annex A (informative) Nominal cross-reference to ISO 9001:2000

- Annex B (informative) Guidelines for establishing applications for specific fields

Meanwhile, ISO/IEC 17025:2017 version includes the following Annexes:

- Annex A (informative) Metrological traceability

- Annex B (informative) Management system options

About the author

Albina Osmani is a Senior Course Development Manager at PECB. She is in charge of developing and
maintaining training courses related to QMS. If you have any questions, please do not hesitate to
contact her at: qms@pecb.com.