ISO/IEC 17025:2017 Alignment Guide

Scope & how to read this guide

ISO/IEC 17025:2017 specifies general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. Accreditation to the standard is held by the laboratory, assessed by an accreditation body — it is never held by a software product. Aliquora provides technical capabilities that support the records, reporting, and data-control aspects of the standard.

The tables below map Aliquora's capabilities to the standard's clauses, with the same honest status legend used across our compliance documents:

Clause 7 — Process requirements (technical)

The technical clauses are where a LIMS contributes most. Clauses 7.5, 7.8, 7.10, and 7.11 are the core fit.

Clause	Requirement	How Aliquora supports it	Status
7.1	Review of requests, tenders and contracts	Sample intake captures client, project, and requested tests; capacity and contract review remain a laboratory process.	Partial
7.2	Selection, verification and validation of methods	A configurable test/method catalog records method name, units, and reference/spec limits; an optional method-library add-on provides pre-built methods. Method verification/validation evidence is owned by the lab.	Available (validation evidence: customer)
7.4	Handling of test items	Sample receiving, storage-location assignment, grid positions, status, and chain-of-custody from log-in through reporting.	Available
7.5	Technical records	Each result, observation, analyst, and timestamp is captured as a structured record with an append-only audit trail, so original observations and the staff responsible are recoverable. Amendments are tracked; verified results require a re-authenticated, reason-documented administrator unlock.	Available
7.6	Evaluation of measurement uncertainty	Numeric outputs and formula-driven calculations are supported; the uncertainty budget and its evaluation are defined by the laboratory.	Customer
7.7	Ensuring the validity of results (QC)	Automatic out-of-spec flagging on entry plus configurable review/approval workflows; control-chart and QC-trend monitoring is a laboratory practice supported by exportable data.	Partial
7.8	Reporting of results	Configurable report/COA templates produce reports that identify the laboratory, the item, methods, results against specification, and reviewer/approver sign-off. Templates support orientation, paper size, and per-material-type layouts.	Available
7.9	Complaints	An organizational process; audit-trailed records support investigation.	Customer
7.10	Nonconforming work	Automatic out-of-spec flagging on result entry highlights nonconforming results so they can be held, reviewed, and dispositioned before reporting.	Available
7.11	Control of data and information management	Authenticated, role-based access; server-side authority checks; organization-level data isolation; append-only audit trail; system access limited to authorized users. Encryption in transit (TLS); encryption at rest is planned.	Available (rest encryption planned)

Clause 6 — Resource requirements

Clause	Requirement	How Aliquora supports it	Status
6.2	Personnel (competence, authorization)	Role-based access controls who may create samples, enter results, sign, approve, or administer; competence records and authorization decisions are a laboratory responsibility.	Partial
6.4	Equipment	Instrument result import (CSV/file mapping and assisted extraction) ties instrument output to samples; calibration and maintenance records are a laboratory responsibility.	Partial
6.5	Metrological traceability	Methods and reference data are recorded with results; establishing and demonstrating metrological traceability remains a laboratory activity.	Customer

Clause 8 — Management system requirements (Option A)

Clause	Requirement	How Aliquora supports it	Status
8.2	Management system documentation (policies, objectives)	Aliquora stores controlled records and configuration; authoring and approving your quality manual and policies remains a laboratory activity.	Customer
8.3	Control of management system documents	A document-control module manages versions, review state, and access to controlled documents within the lab.	Available
8.4	Control of records	Records are stored as structured data with an append-only, time-stamped audit trail; signed/verified records are protected from edits; CSV/PDF export supports retention. Retention scheduling is a customer responsibility.	Available (scheduling planned)
8.5	Actions to address risks and opportunities	Automatic out-of-spec detection and review workflows surface risks to data quality; the lab's risk process and documentation remain its own.	Customer
8.7	Corrective actions	Retest requests and audit-trailed result changes support investigation; a formal CAPA register is a laboratory process.	Partial
8.8 / 8.9	Internal audits and management reviews	Exportable audit logs and reporting feed internal-audit and management-review evidence; running the reviews is a laboratory activity.	Customer

Shared responsibility

Accreditation depends on both the software and how your laboratory operates it. Aliquora supplies the data-control, record, and reporting capabilities above. The laboratory remains responsible for impartiality and confidentiality, personnel competence and authorization, method validation evidence, measurement-uncertainty budgets, equipment calibration and maintenance, metrological traceability, internal audits, management review, and the decision to seek and maintain accreditation. We are glad to support an assessor's review of any capability listed here.