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ISO 17025:2017 Validations and Accreditation Readiness

Independent documentation review, method validation packages, and audit preparation for forensic laboratories.

Conforval provides two complementary services for laboratories seeking ISO/IEC 17025:2017 accreditation or the extension of an existing accredited scope.

The first is a structured, independent review of your laboratory documentation — identifying gaps, inconsistencies, and non-conformities before your accreditation body does. The second is a full method validation service, delivering complete validation packages to the standard required by SWGDAM, ENFSI, and ISO 17025. Both services can be engaged independently or as a combined programme.

Service A

Accreditation Readiness Review

An independent audit of your documentation — before the official one.

The Accreditation Readiness Review is a structured, expert-led examination of a laboratory's quality management documentation, standard operating procedures, validation reports, and records — assessed against the requirements of ISO/IEC 17025:2017 and, where applicable, SWGDAM or ENFSI guidelines.

The review identifies findings at three severity levels:

Critical

A finding that would constitute a non-conformity likely to result in accreditation refusal or a major corrective action request from the accreditation body.

Major

A significant gap or inconsistency that requires correction before submission, though unlikely to result in immediate refusal if accompanied by a credible corrective action plan.

Minor

An observation that represents best-practice improvement and may be noted by the assessor, but does not threaten accreditation outcome.

Each finding is documented in a structured findings report with a reference to the applicable clause, a plain-language description of the gap, and a recommended corrective action. A corrective action log is provided in an editable format, ready for use during the correction cycle.

Review tiers

Choose the level of review you need

Three engagement tiers covering everything from a rapid focused check to a full-cycle, corrective-action-supported review.

Express Review

5–7 days
Scope

A targeted review of a defined document set — typically one to three validation reports or a single SOP cluster — against the relevant ISO 17025 and method-specific requirements. Suitable for laboratories that have completed most preparation and require a focused, rapid check on a specific area before submission.

Deliverable

Annotated document set with inline comments; summary findings table (Critical / Major / Minor); recommended corrections.

Standard Review

10–15 days
Scope

A comprehensive review of the laboratory's core quality management documentation — quality manual, all relevant SOPs, validation reports within the accreditation scope, and the laboratory's existing corrective action history. Covers all applicable clauses of ISO/IEC 17025:2017 Sections 4–8.

Deliverable

Full annotated document set; clause-mapped findings report; corrective action log (editable); executive summary for laboratory management and accreditation body correspondence.

Comprehensive Review

4–6 weeks
Scope

All elements of the Standard Review, plus a remote interview session with the quality manager and technical staff, review of uncertainty budgets and measurement traceability records, and a corrective action support phase. A re-review of corrected documents is included within the engagement period.

Deliverable

All Standard Review deliverables; interview summary notes; uncertainty budget assessment memo; written corrective action guidance per Critical/Major finding; re-review sign-off record.

Onboarding

What to prepare for a review

To initiate any tier of review, provide the following:

  • A complete list of methods within the intended accreditation scope, including kit names, platform identifiers, and applicable sample types
  • All relevant validation reports (draft or final)
  • The quality manual and any SOPs directly referenced by the validation reports
  • Uncertainty of measurement documentation, where available
  • Any previous assessor reports or non-conformity records, if applicable

A secure document transfer protocol is provided on engagement. All submitted documents are treated as strictly confidential and not retained beyond the agreed engagement period.

Service B

Method Validation Services

Complete validation packages to SWGDAM, ENFSI, and ISO 17025 standards.

For laboratories that require validation work to be conducted from the ground up — or that need existing validation data to be structured, supplemented, and documented to accreditation standard — Conforval provides full method validation services across the forensic DNA workflow.

Validated method categories

  • ✓Presumptive and confirmatory testing (blood, saliva, semen; colorimetric and immunochromatographic assays)
  • ✓DNA extraction (manual and automated platforms — PrepFiler, PrepFiler BTA, Maxwell RSC)
  • ✓DNA quantification (real-time PCR; PowerQuant, Quantifiler Trio, and equivalents)
  • ✓STR profiling (GlobalFiler, PowerPlex Fusion, and national-scope equivalents)
  • ✓Probabilistic genotyping software validation (STRmix, ArmedXpert, and equivalents)

Each validation package includes

  • ✓Experimental design documentation
  • ✓Raw data and statistical analysis
  • ✓Acceptance criteria justification
  • ✓Uncertainty of measurement budget
  • ✓Validation report formatted to ISO 17025 and SWGDAM reporting conventions
Why us

Why independent review matters

Internal quality checks are a necessary part of any QMS, but they carry an inherent limitation: the team that wrote the documentation is the least well-positioned to identify its own gaps. An independent reviewer — working from the perspective of an assessor, with no prior exposure to the laboratory's methods or institutional assumptions — consistently identifies material findings that internal review cycles have missed.

Conforval reviewers have direct experience with the assessment process from the perspective of both the laboratory and the technical assessor. This dual perspective is the defining advantage of an external readiness review.

Related service

Combine with the Forensic Science Academy

Laboratories undertaking accreditation preparation may benefit from combining validation and documentation review with structured education. The Academy's Tier 4 — ISO 17025 QMS Guidance for Accreditation — is cross-linked directly with this service line.

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Discuss your accreditation timeline

Whether you are preparing for initial accreditation, a scope extension, or a re-assessment following non-conformities, we would be glad to discuss the most appropriate level of support.

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