Sample identity and custody
Retain the identifiers, source, dates and context needed to distinguish the sample and follow it through the process.
Accredited laboratory software guide
LIMS software for SANAS-accredited laboratory workflows.
How a Laboratory Information Management System can support traceability, equipment-data imports, authorised review, reporting and ISO/IEC 17025-aligned laboratory controls without misrepresenting software as accredited.
Direct answer
A LIMS can support a SANAS-accredited laboratory, but the software itself is not SANAS accredited.
SANAS accreditation applies to a laboratory or other conformity assessment body and the activities listed in its accredited scope. A LIMS supports the records, traceability and controlled workflow used by the laboratory.
The laboratory remains responsible for its competence, approved methods, personnel, equipment, quality system, validation and reporting. Software should preserve those controls and make their evidence easier to retain and review.
SANAS and ISO/IEC 17025
Accreditation is broader than the information system.
The laboratory’s capability depends on its complete technical and management system. The LIMS should support that system without being mistaken for it.
01
Competence
Laboratory personnel, methods, equipment and technical decisions remain central to valid results.
02
Impartiality and consistency
Processes must be applied consistently and protected from inappropriate influence or uncontrolled change.
03
Defined scope
Accreditation applies to the activities listed in the laboratory’s approved scope, not every possible test or software feature.
04
Traceable records
Samples, tests, source data, review, changes and reports should remain identifiable and retrievable.
05
Validated systems
The laboratory should verify that configured software behaves correctly for the approved workflow it supports.
06
Continual control
Permissions, master data, methods, reports and system changes require ongoing governance after go-live.
Operational evidence
dMS LIMS is used in a client laboratory operating under SANAS accreditation.
The client is not named in this public overview, but the operational use demonstrates that dMS can be configured around demanding laboratory controls rather than remaining a theoretical feature list.
- Samples, tests and result context remain connected.
- Equipment datasets can be imported through configured mappings.
- Specifications and result status are controlled against the appropriate test.
- Authorised users review and report laboratory information.
- Certificate of Analysis output is produced from controlled data.
This is an implementation claim, not a claim that SANAS accredits or endorses the dMS software product.
Operational useImplemented in an accredited environment
Real sample, result, review and reporting workflows are supported in day-to-day laboratory use.
Software statusConfigured and controlled
The laboratory validates the implementation and governs changes according to its own quality system.
Accreditation statusHeld by the client laboratory for its defined scope
Accreditation should always be verified against the laboratory’s current SANAS certificate and scope.
LIMS controls
What should the system preserve in an accredited laboratory environment?
The correct configuration depends on the laboratory, but these controls are common areas for implementation and validation.
Tests, methods and specifications
Apply the correct result structure, units, limits and controlled definitions for the relevant laboratory activity.
Instrument-data imports
Map and verify exported datasets so that imported values reach the correct samples, tests and fields without uncontrolled recapture.
Permissions and review
Separate capture, review, authorisation and administration responsibilities according to the laboratory’s approved workflow.
History and change evidence
Retain sufficient evidence to understand the source, status and authorised changes affecting laboratory information.
Reports and COA
Produce reports and Certificates of Analysis from authorised sample, test, specification and result information.
Implementation and validation
Configure the LIMS around the approved laboratory process, then verify it deliberately.
Accredited laboratory implementation is not a generic software installation. It requires controlled decisions by the laboratory and the implementation team.
Map the approved workflow
Identify samples, methods, test definitions, equipment sources, roles, review stages and authorised outputs.
Configure controlled structures
Build master data, permissions, imports, specifications, reports and COA formats around the approved process.
Verify data behaviour
Test representative manual and imported results, limits, calculations, status logic and output.
Approve and train
Obtain responsible laboratory approval and train each user according to their authorised role.
Control change
Review future changes to methods, imports, master data, permissions and reports before operational use.
SANAS LIMS FAQ
Common questions about software in accredited laboratory environments.
Clear distinctions matter because accreditation, implementation and software capability are related but not interchangeable.
Is dMS LIMS SANAS approved?
No software product is presented here as SANAS approved or accredited. SANAS accreditation applies to the laboratory or other conformity assessment body and the activities listed in its accredited scope. dMS LIMS is in operational use at a client laboratory operating under SANAS accreditation and supports the controlled workflows used by that laboratory.
Can a LIMS guarantee SANAS accreditation?
No. Accreditation depends on the laboratory’s competence, methods, personnel, equipment, quality system, records and implementation. A LIMS can support those controls but cannot guarantee accreditation.
Does ISO/IEC 17025 require a specific LIMS product?
ISO/IEC 17025 does not prescribe the use of a named LIMS product. A laboratory may use controlled systems suited to its work. Where a LIMS is used, the laboratory should validate and control the configured system so that it supports approved methods, traceability, review and reporting.
Can dMS import results from laboratory instruments?
Yes. Configured import profiles can map exported instrument or equipment datasets into the appropriate samples, tests and result fields, subject to verification against the actual export structure.
Can dMS produce Certificates of Analysis?
Yes. The LIMS can produce controlled Certificate of Analysis output from authorised sample, test, specification and result information.
Who validates a LIMS implementation for an accredited laboratory?
The client laboratory remains responsible for validating the configured implementation against its approved procedures, methods, data-integrity controls, permissions, reports and accredited scope.
Practical implementation
Discuss the laboratory workflow, evidence and validation requirement.
Review the sample structures, equipment exports, methods, specifications, permissions, reports and Certificates of Analysis that the implementation must control.