article

Transitioning to ISO/IEC 17025:2017

Posted: 4 September 2020 | | No comments yet

Dr Murat Cokakli outlines the impact that transitioning to this new standard will have on laboratories and operators in the food supply chain.

Transitioning to ISO/IEC 17025:2017

Laboratories were originally given until 30 November 2020 to transition to ISO/IEC 17025:2017. ILAC, in agreement with ISO, has since extended that transition period until 1 June 2021 due to COVID-19. Many laboratories had, however, already completed the process and this gives us insight into the impact of ISO/IEC 17025:2017 on accredited laboratories and their customers in the food supply chain.

Accreditation to ISO/IEC 17025, the globally recognised standard for laboratory competence in testing and calibration, is indispensable for food testing laboratories, especially those that act as a hub for the provision of safety and quality evidence in supply chains.

The transition to ISO/IEC 17025:2017 introduced several changes to the activities and management systems employed by food testing laboratories. At the same time, food laboratory customers have also been affected by the new standard’s practices. It is therefore important to consider both groups – laboratory and customer – when evaluating the impact of the transition.

Previous iterations of ISO/IEC 17025 essentially revolved around prescriptive requirements, but the 2017 version differs because it imposes a process-based model that focuses on results, thereby giving greater flexibility to the laboratory in its operations. Examples of this results orientated approach include the absence of terms such as ‘quality manual’ and ‘quality manager’, the lack of a requirement to conduct annual internal audits and management reviews (instead these are performed at planned intervals), the introduction of risk-based thinking and assessments for all laboratory activities, and finally, there are options for management system requirements.

From a technical perspective, the incorporation of decision rules for conformity assessment, giving opinions and interpretations in the results, the contribution of sampling on measurement uncertainty, and ensuring result validity, are all new topics that have considerably changed the laboratory environment. Table 1 summarises the main changes in the new ISO/IEC 17025 standard and outlines its impact on food laboratories and their customers.

Technical issues

ISO/IEC 17025:2017 has clearer definitions for method validation and verification. All the standard methods must be verified to show that the laboratory meets the performance requirements. If laboratory developed or non‑standardised methods are to be used, they must firstly be validated via the consideration of relevant characteristics such as robustness. In addition, any deviation from the test methodology, which may influence the result, must be reported.

The new standard also includes a clearer definition of the requirements for establishing the validity of test results. Although it gives greater flexibility to these requirements, based on risk-analysis, the laboratory should have a strategy for how to confirm and monitor the validity of these test results. Examples of these changes include the use of quality control samples/materials, functional checks, alternative instrumentation, use of control charts, and/or the review of reported results. Each laboratory should adapt the way it validates its measuring criteria to meet its own specific circumstances, preferably with the incorporation of risk analysis.

The goal for customers is the determination of compliance with certain specifications. Therefore an important change for both food laboratories and their customers has been the implementation of decision rules; defined as a “rule that describes how measurement uncertainty is accounted for when stating conformity with a specified requirement”.

Food laboratories have been required to develop procedures on decision rules. These rules are then linked to the evaluation of measurement uncertainty when conformity assessment is to be included in the report. Furthermore, the level of risk must be assessed when stating conformity to a specification based on statistical assumptions (eg, false acceptance, false rejection) and it must be documented. In the new version of the standard, estimating the uncertainty associated with the decision rule is still important, but laboratories now have to identify critical influencing factors. These must be kept under control to avoid having to evaluate the measurement uncertainty for each result.

Humans are a core component of laboratories and their technical expertise can have a direct influence on the quality of test results. ISO/IEC 17025:2017 has increased the importance of monitoring the technical competence of staff. Technical personnel must undertake proficiency testing (PT), quality control studies, all with an understanding of the relevant reference materials (RM) and with all necessary examinations being applied and recorded. Reference materials and proficiency tests are used for personnel monitoring, method validation/verification or quality control, but references to ISO 17034 and ISO 17043 have been included to emphasise the importance of RM and PT providers respectively. Similarly, all purchased products and services from external providers (including subcontracting) should be selected, assessed and monitored based on a fit‑for-purpose perspective.

Management system

The new standard also includes the use of both conventional and electronic data. If an electronic record or management system is used, the standard states it must be validated, with potential risks assessed. It must also allow tracking, whereby what has been changed and who is responsible is clear and traceable.
A guiding principle of the new standard is that all actions should address risk and opportunity. It also replaces the concept of preventive actions with the requirement that corrective action planning should be linked to risk and opportunity, determined by updating. When developing and implementing an action plan, a guiding principle must be the minimisation of risk and the maximisation of opportunity. Nonconformities are assessed using established levels of risks.

Table 1 – Impact of 2017 version of ISO/IEC 17025 on food laboratories and their customers

Main changes in the 2017 version of ISO/IEC 17025

Direct impact on*

Clause

Topic (new issues)

Laboratory

Customer

3.6.

Sampling, associated with subsequent testing and calibration (as a lab activity)

XX

XX

4.1., 4.2.

Impartiality, confidentiality (specified in the scope of the standard)

XX

XXX

6.2.

Personnel (monitoring competence)

XXX

 

6.4., 6.6.

Equipment, externally provided products and services (assessment and monitoring)

XX

 

6.5.

Metrological traceability (establishing, maintaining)

X

 

7.1.1.

Review of requests, tenders, and contracts (customer approval)

XX

XX

7.2.

Selection, verification and validation of methods

XXX

XX

7.3.

Sampling (as a lab activity in addition to testing and calibration)

XX

XX

7.4.

Handling of tests or calibration items (disclaimers and customer approval)

X

X

7.5.

Technical records (traceability, use of electronic records)

XX

 

7.6.

Evaluation of measurement uncertainty (identification of influencing factors)

XX

X

7.7.

Ensuring the validity of results (quality control, proficiency tests, intermediate checks, etc.)

XXX

 

7.8.

Reporting of results (incorporation of decision rules)

XXX

XXX

7.9.

Complaints (procedure availability, communication to customer, complaint handling)

XXX

XXX

7.10.

Nonconforming work (impact analysis, risk evaluation, actions)

XX

X

7.11.

Control of data and information management (use of validated and protected systems)

XX

XX

8.2.-8.4.

Management system (documentation and control)

XX

 

8.5.

Actions to address risks and opportunities (new topic)

XXX

 

8.6.

Improvement (customer feedback, laboratory activities)

XX

XX

8.7.

Corrective actions (link to updating risks and opportunities)

XX

 

8.8., 8.9.

Internal audits, management reviews (monitoring, effectiveness check, risk assessment)

XXX

XX

* Impact of each topic was assessed by direct relatedness to the laboratory and/or customer depending on the degree of change in relevant requirements and/or effect of change (1: minimal change and impact, 3: most changes and impact)

Laboratory-customer relations

When looking at the relationship between laboratory and customer, ISO/IEC 17025:2017 clarifies several situations. Before the laboratory receives a test sample, all relevant information regarding the sample, scope, test methods, limitations of the method (including limit of detection/quantification), and the terms and conditions of service should be provided and agreed upon.

If a conformity statement is needed in the report, the basis on which this is decided (legislation, laboratory, trade criteria, etc.) should be communicated to and accepted by the customer. Any subcontracting work must also be approved and, if any of the information supplied by the customer may affect the validity of the results, a disclaimer must be put into the report.

Customers should also be aware that laboratory complaint procedures are available upon request. It is critical that laboratories always fully investigate all complaints, with individuals not involved in the activities in question carrying out the investigation and review. Whenever possible, the outcome of the investigation should be reported to the customer.

Unlike in the previous version of the standard, sampling is now identified as a laboratory activity, but procedures must be defined and the contribution of measurement uncertainty calculated, if sampling is to be included in the test results.

Laboratory management and personnel (including external personnel) must be committed to impartiality. They must also ensure all information relating to customers, including that which is obtained or created during laboratory activities, remains confidential.

The customer must be informed in writing if any information is to be shared with third parties for legal and other reasons. Additionally, laboratories must identify risks to its impartiality and demonstrate how it has eliminated or minimised these risks.

Summary

The 2017 version of ISO/IEC 17025 puts a greater emphasis on the implementation of concepts and process. More flexibility is given to the laboratory to help achieve its goals, but quality and the reliability of test results remain the primary aim in its technical requirements. The new standard’s management system can be easily integrated with ISO 9001, with the identification of risks and opportunities as a core topic.
For operators in the food sector, completion of the transition to ISO/IEC 17025:2017 is an assurance that the laboratory can reliably and securely meet the needs of the supply chain.

About the author

Dr Murat Cokakli works on the Global Food Technical Support Team at SGS, a world leader in inspection, verification, testing and certification. Murat has more than 10 years of experience in food testing laboratories, in addition to his previous research and training experience in Medical School. He holds a PhD in molecular biology and has a strong microbiology background. He works intensively on harmonisation of laboratory activities mainly related to method development and validation, quality control, laboratory design, technical procedures and advancement.

Send this to a friend