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EUROLAB and the new ISO/IEC 17025:

Creating impact, networking for capacity building and promoting accreditation added-value.

A. S. Ribeiro 1,2,3, L. Martin 3 ,D. Nieuwenhuis 3

1National Laboratory for Civil Engineering, 2RELACRE, Portuguese Association of Accredited Laboratories, 3EUROLAB aisbl

E-mail: asribeiro@lnec.pt, laura.martin@eurolab.org, drewin.nieuwenhuis@eurolab.org

EUROLAB new website: www.eurolab.org

2 SCIENTIFIC INSTRUMENTATION CENTRE

Metrological Quality Unit

E-mail: lfmartins@lnec.pt; asribeiro@lnec.pt

Introduction & ISO/IEC 17025 and the role of accreditation today

ISO/IEC 17025:2017 new approach

EUROLAB supports laboratories in the transition process

Looking ahead and final remarks

References

Accreditation, as part of the Quality Infrastructure, is recognized as a key activity to assure technical

competence and integrity of organizations that provide conformity assessment services (namely, testing,

examination, inspection, calibration, validation, verification and certification).

According to UNIDO, a Quality Infrastructure is a system contributing to governmental policy objectives in areas including industrial development,

trade competitiveness in global markets, efficient use of natural and human resources, food safety, health, the environment and climate change.

❑ Quality Infrastructure Building Trust for Trade. United Nations Industrial Development

Organization (UNIDO). Vienna, Austria.

❑ Accreditation: A briefing for Governments and Regulators. EA. Paris, France.

❑ The Economics of Accreditation. M. Frenz, R. Lambert. UKAS, March 2013. London, UK

❑White Paper: Revision of Standard ISO/IEC 17025: 2005. Nov. 2014. EUROLAB aisbl, Brussels,

Belgium.

ISO/IEC 17025:2005 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling.

It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.

ISO CASCO Toolbox is a set of conformity assessment standards that together establish a framework to conformity assessment

activities, covering the practices of Testing, Inspection and Certification bodies (TIC industry) to facilitate trade on a basis of the

mutual recognition of conformity assessment results.

The publication of ISO/IEC 17025:2017 introduced a new vision of the

laboratories and conformity assessment bodies management in relation to

the implementation of Management Systems.

ISO/IEC 17025:2017 Requirements

4. General Requirements

5. Structural Requirements

6. Resource Requirements

7. Process Requirements

8. Management System Requirements

4.1 Impartiality

4.2 Confidenciality

6.1 General

6.2 Personnel

6.3 Facilities and environmental

conditions

6.4 Equipment

6.5 Metrological traceability

7.1 Review of request, tenders

and contracts

7.3 Sampling

7.5 Techical records

7.7 Assuring the validity of

results

7.9 Complaints

7.2 Selection, verification and

validation of methods

7.4 Handling of test or

calibration items

7.6 Evaluation of measurement

uncertainty

7.8 Reporting of results

7.10 Non conforming

work

7.11 Control of data – Information management

8.1 Options

8.2 Management

system documentation

(Option A)

8.3 Control of management

system documents (Option A)

8.4 Control of records

(Option A)

8.5 Actions to address risks

and oportunities (Option A)

8.6 Improvement

(Option A)

8.7 Corretive action

(Option A)

8.8 Internal audits

(Option A)

8.9 Management

reviews (Option A)

6.6 Externally provided

products and services

In the new structure, aligned with ISO 9000 Series, a new set of requirements were established, having

in mind new thinking, namely, regarding the flexibility of new organizations, the digital transition and the

risk approach. The main changes are:

❑ Focus on impartiality

❑ Risk-based thinking

❑ Sampling activities

❑ Process based approach

❑ Decision rules in conformity assessment

❑ Uncertainty applied to testing & sampling

❑Wider interpretation of equipment & rules

❑ Digitalization & information technologies

❑ Requests, Tenders & Contracts

❑ Scope of activities

❑ Flexibility in system documentation

❑Metrological traceability

EUROLAB aisbl has been involved in the transition process of ISO/IEC 17025:2017 since its

beginning, voicing laboratories, providing knowledge transfer and capacity building. The major

actions to mention are:

❑ Publication of White Paper: Revision of Standard ISO/IEC 17025:2005.

❑ Participation in ISO/CASCO meetings of WG 44 for the revision of the ISO/IEC 17025: 2005.

❑ Publication, in early 2018, of the revised 21 cookbooks, to support laboratories to promote the

accreditation transition.

❑ Cooperation at ILAC Laboratory Committee to develop the 1st International Survey “on

Harmonization and Consistency of Accreditation”.

❑ Cooperation in the development of ILAC guides and exemples for training of Assessors.

❑ Agarwal, R., Bajada, C., Green, R. and Lo, E (2017). Economic Value of NATA Accreditation to Australia, Univ. of Technology Sydney.

❑ 2017 International Survey on Harmonization and Consistency of Accreditation A global view of Laboratories and Conformity

Assessment Bodies concerns, expectations and challenges. ILAC Laboratory Committee. April 2018.

❑ F. Gaub (2019).Global trends to 2030. Challenges and Choices for Europe. ESPAS – European Strategy and Policy Analysis System.

European Union. Brussels, Belgium.

Data integrity

Cybersecurity

Communication

Cloud computing Data management

Cross border eCommerce

5G

GDPR

Access & information

IoT (Internet of Things) AI – Artificial Intelligence

Open data

Lab of the future

Digital transitionIntellectual Property

EUROLAB aisbl is aware of the challenges ahead, with major changes related to

trends & catalysts [ESPAS Report] that are shaping the future.

Trends identified are freedom and democracy impact, shift of global power, Economy

turning East and connectivity is the new geopolitics.

Catalysts of the transition are the increase of trade, food and water resources

management, grow of conflict and violence, technology AI vs. Human Intelligence.

In the future, conformity assessment will be required to provide support to technological changes, e.g. in energy,

communication, environment and climate changes, infrastructures, AI, IoT, Agri-Food, Water and many others.

Testing & Measurement will be needed to provide safety and to assure quality of life.