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Nov 22 2021 · ISO/IEC 17025:2017 Section 7 10” Nonconforming Work” & Section 8 6 “Improvement” • This webinar is being recorded • All PJLA webinar recordings and slides are available for download from the Past Webinars section of our website –https://www pjlabs com/training/pjla-webinars • All attendees are muted However feel free to

The new ISO/IEC 17025:2017

The new ISO/IEC 17025:2017

1 | Page

The new ISO/IEC 17025:2017

By Dr. George Anastasopoulos

Director, Conformity assessment, IAS

Email: ganastasopoulos@iasonline.org

Introduction - Background information

ISO/IEC 17025

was first issued in 1999 by the International Organization for Standardization (ISO) and the International Electro-technical Commission (IEC). It is the single most important standard for

calibration and testing laboratories around the world, with more than 50.000 laboratories accredited,

globally.

At the International Laboratory Accredita

tion Cooperation (ILAC) General Assembly in October 2013 the Laboratory Committee (which is composed of stakeholder representatives of accredited testing and calibration) recommended that ILAC request that ISO/CASCO establish a new work item to comprehensively revise ISO/IEC 17025:2005. CASCO is the ISO committee that works on issues relating to conformity assessment. CASCO develops policy and publishes standards related to conformity assessment; it does not perform conformity assessment activities. CASCO's standards development activities are carried out by working groups made up of experts put forward by the ISO member bodies. The experts are individuals who possess specific knowledge relating to the activities to be undertaken by the working group.

The 6th

ISO/CASCO WG 44 meeting was held on July 10-12, 2017 in ISO Central Secretariat, Geneva. The deliverable of this meeting was the FDIS version of the new ISO/IEC 17025 version. The document is expected to proceed to publication, planned for end November/December 2017. Please note that throughout this article the term "the standard" refers to the new ISO/IEC 17025:2017.

About the New Standard

The format of the new standard has been significantly changed to be more in line with new ISO formatting guidelines. The basic format is similar to other new standards such as ISO/IEC 17020 and

ISO/IEC 17065.

The new standard is now structured as follows:

1. Scope

2. Normative references

3. Terms and definitions

4. General requirements

5. Structural requirements

The new ISO/IEC 17025:2017

2 | Page

6. Resource requirements

7. Process requirements

8. Management requirements

Annex A - Metrological Traceability (Informative)

Annex B - Management System (Informative)

Bibliography

General Information

According to International Accreditation Forum (IAF) and the International Laboratory Accreditation

Cooperation (ILAC), accreditation is defined as

"the independent evaluation of conformity assessment bodies against recognized standards to ensure their imp artiality and competence." This standard was developed with the objective of promoting confidence in the operation of laboratories and contains requirements for laboratories to enable them to demonstrate that they operate in a competent and impartial way and that they are able to provide valid results.

During its development phase it has been tried to align the standard with the principles of ISO 9001,

although this was not always practically possible. Still it is a fair statement to make that the laboratories

complying with the standard will also, in general, comply with the principles of ISO 9001. The standard can be used for accreditation purposes, for self-assessment of the laboratories and for second party assessments by laboratory customers, regulatory authorities, organizations and schemes using peer-assessment. Its requirements are applicable to any organization that performs the activities of testing and/or

calibration and/or sampling associated with subsequent testing or calibration. Therefore, accreditation

to the new standard can be also achieved by organizations offering sampling associated with

subsequent testing or calibration. When the standard uses the term "laboratory" is referring to any of

the 3 options mentioned above (testing, calibration, and sampling).

The potential of performing only sampling activities is a new element in the standard. If, for example, a

laboratory is performing tests and takes samples by its own capacity, it should meet all requirements

related to both: sampling a nd testing. On the other hand, if any organization performs only sampling and then the samples are forwarded to a laboratory for testing, then this organization should comply with new standard requirements regarding sampling and its management system should ensure that the sampling activity doesn't affect negatively on test results.

Requirements for sampling organizations are

similar to testing and calibration laboratories: personnel shall be competent, equipment has to be maintained and calibrated, sampling procedure has to be validated, quality of sampling has to be assured etc. Confirmation of competence of organization to provide sampling can be provided through accreditation against the new ISO/IEC 17025.

Guide 99 ISO/IEC,

International vocabulary of metrology - basic and general concepts and associated

terms (VIM), is referenced in the standard as a normative reference. The definitions also given in ISO/IEC

The new ISO/IEC 17025:2017

3 | Page

17000 are applicable. In addition, the standard provides the detailed definitions of the terms

impartiality, complaint, interlaboratory comparison, intralaboratory comparison, proficiency testing,

laboratory, decision rule.

Main Requirements

The Standard introduces

its main requirements throughout the clauses 4 to 8.

Clause 4 - General requirements

Impartiality and Confidentiality requirements are discussed in clause 4. The risk-based thinking is

evident throughout the standard. It should be noted that the new standard expects from the laboratory

to plan and implement actions to address risks and opportunities. Although addressing risks and opportunities is laboratory's responsibility, the standard sets specific requirements. The first requirement of such risks and opportunities that is needed to be addressed is mentioned in clause 4, where the labora tory is required to identify and eliminate or minimize risks related to impartiality, on an on-going basis.quotesdbs_dbs7.pdfusesText_5
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