In the business world, customer satisfaction is one of the main focuses, if not the main goal to achieve for the success and growth of organizations. This premise is comprehensive to any kind of activity, including laboratorial. In an era when trust, quality, competence, impartiality, traceability and transparency are decisive factors for organisations providing testing, sampling and calibration services, they need to demonstrate that they comply with these values and have the ability to deliver reliable results. This way, there can be a more assertive decision making by those who benefit from these services. The implementation of management systems has proven to be a key strategy to ensure the competence of laboratories to generate valid and reliable results.
The genesis of ISO/IEC 17025 begins with ISO guide 25, which underwent several updates until it became ISO/IEC 17025, published in 1999 and adopted internationally in 2000. Currently called ISO/IEC 17025:2017, the standard was updated by ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) in 2017 to better serve the laboratories that use it.
This standard aims to harmonise laboratory activities at international level and is divided into five main sections:
Process requirements, and;
Management system requirements.
Who is the standard aimed at?
Exclusively developed for testing, sampling and calibration laboratories, ISO/IEC 17025:2017 specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all entities carrying out laboratory activities, whether public or private, regardless of size, that wish to demonstrate credible results. Laboratories accredited by this standard provide valuable support to Companies, Industries, Universities, Research and Research Centres, Economic, Sectoral and Regulatory Inspection Entities, Product Certification Bodies, as well as other conformity assessment bodies.
As an example, companies which intend to certify their products, whether food products, construction products or others, must test them in accredited laboratories in order to show the independence, impartiality and trust of the results presented, so that the Certification Bodies can later make their decisions.
The same applies to companies that intend to export products, for example food products, since it is generally required that they demonstrate, through laboratory results issued by accredited laboratories, that the products are within the limits required by the destination country. This eliminates commercial barriers, which translates into gains in competitiveness, financial, time and confidence in the products and in the exporting country.
What are the benefits of ISO/IEC 17025 for laboratories?
The implementation of the Standard, without limitation, guarantees the following benefits for Organisations:
It allows laboratories to demonstrate that they operate competently, increasing customer confidence;
Facilitates co-operation between laboratories, eliminating technical trade barriers at national and international levels;
Promotes an approach to address the risks associated with the activity;
Improves information security;
Contributes to the technical competence of the collaborators;
Avoids or minimises the need to repeat tests/calibrations;
Improves process control, identification, traceability and storage;
Contributes to the quality assurance of the results issued;
Brings greater competitiveness over the competition, and;
Improves compliance with legal requirements.
The accreditation activity consists in the evaluation and recognition of the technical competence of entities to carry out specific conformity assessment activities (e.g. tests, calibrations, certifications and inspections). It essentially serves to gain and convey confidence in the performance of certain technical activities by confirming the existence of a minimum level of technical competence, accepted internationally through Mutual Recognition Agreements.
It is important to clarify that implementation of ISO/IEC 17025 is voluntary, unless legally required in specific sectors such as health or environment, and that accreditation is not a requirement under the standard. Organisations will continue to benefit from implementing the standard even without achieving accreditation. However, it is recommended that organisations are accredited, as this is often a condition required by customers and is increasingly an explicit requirement for new business opportunities. Overall, laboratories wishing to be accredited should define the scope so that it includes methods they perform routinely and those where commercial or legal issues make accreditation more advantageous.
Success factors for having ISO/IEC 17025 implemented in your organisation
Recognising that the process of implementing the standard is challenging, organisations need to ensure a number of aspects are in place for its success. Namely, ensure top management involvement through the provision of adequate financial, human and technological infrastructure and resources; ensure the existence of a competent team with technical expertise, including in management systems; and consider hiring external experts (consultancy) in order to optimise the implementation process and/or ensure adequate training of people.