When Recognition Matters

WHAT ARE THE KEY CHANGES

BETWEEN THE 2005 AND 2017
VERSIONS OF THE ISO/IEC 17025
STANDARD?

www.pecb.com
//////////////////////////////////////////////////////////////////////////////////////////////////////

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

2 WHAT ARE THE KEY CHANGES BETWEEN THE 2005 AND 2017 VERSIONS OF THE ISO/IEC 17025 STANDARD? MAY 2018
//////////////////////////////////////////////////////////////////////////////////////////////////////

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.

Handling of tes or calibration items 7.4

Preparation of
Item Sampling Calibration / test execution Release of item Item
item

7.3

7.5
7.10
Technical records
Nonconforming
Resource Management
work
Control of data
/ Infromation
management
7.11

Request Report of
results
Selection verification
Revies of request, Evaluation of
Ensuring the validity Reporting of
tenders and measurement
Validation of of results results
contracts uncertainty
method

7.1 7.2 7.7 7.6 7.8

7.9 Complaints

MAY 2018 WHAT ARE THE KEY CHANGES BETWEEN THE 2005 AND 2017 VERSIONS OF THE ISO/IEC 17025 STANDARD? 3
//////////////////////////////////////////////////////////////////////////////////////////////////////

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.

4 WHAT ARE THE KEY CHANGES BETWEEN THE 2005 AND 2017 VERSIONS OF THE ISO/IEC 17025 STANDARD? MAY 2018