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, 7.7, 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	Quotes carry priced line items, an approval step, and a recorded accept-or-decline decision before they convert to work; contracts and rate cards hold the agreed terms. Sample intake captures client, project, and requested tests. Judging whether the laboratory has the capacity and competence to take the work on remains a laboratory decision.	Available (capacity decision: customer)
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)	QC batches with control components, Levey-Jennings control charts per method and analyte against a computed mean and standard deviation, and automatic Westgard evaluation (1-3s, 2-2s, R-4s, 4-1s, 10x) that raises an out-of-control finding on the most recent point. Out-of-spec results are flagged on entry and routed through configurable review and approval. Interlaboratory comparison and proficiency testing remain a laboratory activity.	Available (proficiency testing: customer)
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	Clients raise queries against a specific sample through the customer portal, so the message thread and the audit-trailed record behind it sit together when a complaint arrives. Maintaining the complaints register and running the process remain a laboratory activity.	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) and encryption at rest at the infrastructure level via the managed database provider.	Available

Clause 6 — Resource requirements

Clause	Requirement	How Aliquora supports it	Status
6.2	Personnel (competence, authorization)	Per-analyst training records tied to a specific test or method, carrying in-training, trained, or revoked status and an expiry date, with optional quizzes and recorded attempts. An organization policy can warn on, or block outright, result entry by an analyst who is not currently qualified for that test. Role-based access separately controls who may create samples, enter results, sign, approve, or administer. Awarding competence in the first place remains a laboratory decision.	Available (competence decision: customer)
6.4	Equipment	An equipment register with calibration and maintenance intervals, last-performed and next-due dates, and a logged event history that resets the schedule. Due and overdue items raise alerts, and an organization policy can warn on, or block, use of out-of-calibration equipment. Instrument result import ties instrument output back to the sample. External calibration certificates and their traceability remain a laboratory responsibility.	Available (certificates: customer)
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	Investigations open against out-of-spec or deviating results, each carrying numbered CAPA items typed corrective or preventive, assigned to an owner with a due date, and tracked through completion. Overdue CAPA items are swept daily and raised. Opening, closing, and every status change is audit-trailed. Determining root cause and judging effectiveness remain the laboratory's decisions.	Available (root-cause judgement: customer)
8.8 / 8.9	Internal audits and management reviews	A built-in compliance audit runs an ISO/IEC 17025 control set against your live data on demand and on a schedule, producing findings you can acknowledge and export alongside the raw audit logs. Planning the audit programme and running management review remain laboratory activities.	Partial

Shared responsibility

Accreditation depends on both the software and how your laboratory operates it. Aliquora supplies the data-control, record, and reporting capabilities above, and it holds the records behind several clauses the laboratory owns the judgement for: training and competency records, the equipment calibration and maintenance register, and the investigation and CAPA trail. What stays with the laboratory is the judgement itself — impartiality and confidentiality, awarding competence, method validation evidence, measurement-uncertainty budgets, metrological traceability, participation in proficiency testing, the internal-audit programme, management review, and the decision to seek and maintain accreditation. We are glad to support an assessor's review of any capability listed here.