The standard that accredits the technical competence of your laboratory. Without ENAC accreditation, your reports carry no weight before regulators, industrial clients or public authorities.
ISO/IEC 17025:2017 — published by ISO and IEC and adopted in Spain as UNE-EN ISO/IEC 17025:2018 — is the international standard that sets out the requirements for technical competence and impartiality in testing and calibration laboratories. In Spain, the body that grants accreditation under this standard is ENAC (Entidad Nacional de Acreditación), the national accreditation body designated by the Government under Regulation (EC) No 765/2008. A report signed by an ENAC-accredited laboratory under ISO/IEC 17025 enjoys international recognition through the MLA agreements of EA (European co-operation for Accreditation) and ILAC, meaning that a client in Germany, France or Mexico will accept your results without repeating the test.
The 2017 edition introduced a significant conceptual shift compared to the previous 2005 version: it moved beyond a procedural requirements model and adopted a risk-based approach aligned with the ISO High-Level Structure (HLS). This means the laboratory must identify the risks and opportunities affecting its impartiality and the validity of its results, not merely maintain calibration records. Requirements are grouped into three blocks: general requirements (impartiality and confidentiality), structural requirements (organisation, laboratory responsibilities) and technical requirements divided into resource requirements, process requirements and management system requirements. Method validation and verification, internal quality control of data (control charts, reference materials, proficiency testing) and the estimation and expression of measurement uncertainty in accordance with the GUM Guide are the most demanding technical pillars.
At Summum Calidad we support laboratories across a wide range of sectors: water and environmental laboratories, construction materials laboratories, clinical and veterinary analysis laboratories, dimensional and electrical metrology laboratories, and agri-food laboratories. Our team carries out the gap analysis against the standard, designs the document management system tailored to the specific accreditation scope (matrices, methods, parameters), implements the metrological traceability plan for equipment and manages the evaluation process with ENAC through to the award of the certificate. We are consultants, not accreditors: accreditation is granted by ENAC following its independent assessment.
We assess the laboratory's current situation against each requirement of ISO/IEC 17025:2017. We review existing documentation, declared equipment and uncertainties, internal quality control and proficiency testing records. The output is a prioritised gap report with the estimated effort required to close each gap.
We draft the laboratory quality manual, the technical testing or calibration procedures and the supporting procedures (equipment management, traceability, uncertainty, non-conformances, complaints, internal audit). We support the validation or verification of methods according to normative criteria and prepare uncertainty budgets in accordance with GUM.
We support technical staff in applying the system: equipment control, calibration plans, control charts, participation in proficiency testing (interlaboratory comparisons). We conduct a full internal audit to detect deviations before the ENAC evaluation and prepare the management review report.
We prepare the laboratory for the ENAC evaluation visit: mock evaluation, closure of non-conformances from the prior diagnosis and documented response to the assessor's findings. Once accreditation has been granted, we help you maintain the system and manage renewal and scope extension cycles.
The operational detail: what we deliver as part of the work and what we keep alive afterwards.
Quality manual and technical procedures
Complete documentation of the laboratory management system: manual, technical testing/calibration instructions, supporting procedures and record forms.
Measurement uncertainty budget
Calculation and expression of expanded uncertainty U (k = 2) for each parameter within the accreditation scope, following the GUM Guide and EURACHEM/CITAC guidelines.
Metrological traceability plan
Equipment inventory, calibration records, traceability chain to CEM or BIPM, calibration frequencies and acceptance criteria for calibration certificates.
Method validation and verification
Validation protocol (linearity, repeatability, reproducibility, detection limit, recovery) or verification of standardised methods to demonstrate declared performance.
Proficiency testing and internal quality control plan
Selection of proficiency testing schemes (EA/ILAC-accredited providers), control charts (Shewhart, EWMA), use of certified reference materials and z-score monitoring.
ENAC evaluation mock assessment
Internal evaluation following the same protocol used by ENAC assessors: document review, interviews with technical staff and observation of live tests or calibrations.
An accredited laboratory needs more than a quality system: it needs traceability software (LIMS) from Summum Sistemas and, if it provides services to public authorities, the ENS compliance that we also manage from Summum Calidad.
Integration of laboratory data, LIMS and metrological traceability platforms with management dashboards.
View service → calidadCompliance with the National Security Framework (ENS) for laboratories providing services to public authorities or handling classified data.
View service → calidadISO 9001 as an umbrella management system when the laboratory is a unit within a larger organisation seeking corporate certification.
View service →ISO 9001 is a generic quality management system applicable to any organisation; it demonstrates that processes are controlled and oriented towards continuous improvement, but it does not validate the laboratory's technical competence. ISO/IEC 17025 goes much further: it requires demonstrating that the laboratory produces technically valid results through method validation, estimation of measurement uncertainty, metrological traceability of equipment and regular participation in proficiency testing. Many laboratories hold both, but 17025 is the only one that allows reports to be issued with validity before third parties and regulators.
In Spain, accreditation under ISO/IEC 17025 is granted by ENAC (Entidad Nacional de Acreditación), the official national accreditation body designated by the Government under Regulation (EC) No 765/2008. ENAC is a signatory member of the Multilateral Agreement (MLA) of EA (European co-operation for Accreditation) and of ILAC (International Laboratory Accreditation Cooperation), so certificates issued by ENAC-accredited laboratories are recognised internationally. Summum Calidad guides the implementation process, but accreditation is always granted by ENAC following its independent evaluation.
The typical process takes between 12 and 18 months from the start of the consultancy project to the award of the ENAC certificate. The duration depends on factors such as the number of methods and parameters forming the accreditation scope, the starting state of the laboratory's documentation and equipment, and ENAC's scheduling of the evaluation. Laboratories with solid prior documentation and experienced technical staff can complete the process at the lower end of that range. Summum Calidad sets a milestone plan from the first gap analysis.
Measurement uncertainty is the parameter that quantifies the reasonable range within which the true value of the measured quantity may lie. ISO/IEC 17025:2017 requires testing and calibration laboratories to estimate, express and declare uncertainty in their reports whenever it is relevant to the validity of the result. The calculation follows the GUM (Guide to the Expression of Uncertainty in Measurement) methodology from the BIPM. A report without declared uncertainty, when the client or regulator requires it, does not comply with the standard.
Yes. The size of the laboratory is not an exclusion criterion: ENAC accredits both large-company laboratories and small independent ones. What matters is demonstrating technical competence for the requested accreditation scope. In small laboratories, resources are leaner and the same person often takes on several responsibilities, which the standard permits as long as impartiality is guaranteed. Summum Calidad has worked with single-person laboratories and with multi-department laboratories; the document system is sized to the real laboratory, not a theoretical model.