ISO/IEC 17025 accreditation requires a quality management system — but not a LIMS. Affinity QMS sits above your LIMS and handles the quality management layer that A2LA, ANAB, and PJLA actually evaluate: documentation, CAPAs, training, audit readiness, and method validation records. Built for contract labs and in-house testing operations.
ISO 17025 quality management software · Laboratory QMS · A2LA accreditation software · Testing lab quality system · From $499/mo
ISO/IEC 17025:2017 has two main requirement domains: management requirements and technical requirements. Affinity QMS addresses the management layer — the policies, procedures, records, and corrective action systems that your accreditation body evaluates during assessment.
Management System Requirements
Clause 8 covers your quality management system documentation: quality manual, document control, management review, internal audits, corrective actions, and risk-based thinking. Every Clause 8 requirement maps directly to an Affinity QMS module — no manual cross-referencing or custom configuration required.
Process Requirements (Technical Records)
Clause 7 covers method validation, measurement uncertainty, equipment calibration, handling of test items, and reporting of results. Affinity QMS maintains the quality management records that support your technical operations — traceability from method qualification to individual test results, without replacing your LIMS.
Nonconformities and Corrective Actions (Clause 8.7)
ISO 17025 Clause 8.7 requires that nonconformities — whether identified through internal audit, proficiency testing, or customer complaint — trigger a documented corrective action with root cause analysis and effectiveness verification. Affinity QMS CAPA module handles this workflow end-to-end, with accreditation body assessment in mind.
Clauses 8.8 and 8.9 — Audits and Management Review
ISO 17025 requires a planned internal audit program and periodic management review. Affinity QMS schedules, executes, and records both — with findings linked to CAPAs and management review outputs documented for your next accreditation assessment. Your assessor will see a functioning audit program, not a planned one.
| ISO 17025:2017 Clause | Requirement | Affinity QMS Module |
|---|---|---|
| Clause 8.2 | Management System Documentation | Document Control |
| Clause 8.4 | Control of Records | Document Control / QMS Core |
| Clause 8.7 | Corrective Actions | CAPA Management |
| Clause 8.8 | Internal Audits | Audit Management |
| Clause 8.9 | Management Reviews | Audit Management / QMS Core |
| Clause 6.2 | Personnel Competency & Training | Training Management |
| Clause 6.6 | Externally Provided Products & Services | Supplier Management |
Your LIMS handles test results. Affinity QMS handles the quality management system that your accreditation body assesses — the documentation, training, CAPAs, audits, and supplier records that sit above your technical operations.
Accreditation Audit Preparation — Organizing Technical Records, Method Validations, and Proficiency Testing Results
A2LA and ANAB assessors arrive expecting to find a functioning quality system — not a collection of documents assembled in the weeks before the assessment. Most labs spend 3–6 months preparing for each accreditation cycle because their records are scattered across shared drives, email archives, and paper binders. Affinity QMS maintains your management system records in a continuously organized, assessor-ready state so accreditation preparation is a review, not a reconstruction.
Method Validation Documentation — Traceability from Measurement Uncertainty to Method Qualification
ISO 17025 requires labs to validate test methods and document measurement uncertainty for every test in their scope of accreditation. The documentation trail — from method development through validation, uncertainty estimation, and analyst qualification — needs to link back to the specific tests in your accredited scope. Without a system designed for this, method validation records are disconnected from the accreditation evidence your assessor needs to see.
Inter-Lab Proficiency Tracking — Monitoring PT Results and Triggering Corrective Action When Z-Scores Exceed Limits
ISO 17025 requires laboratories to participate in proficiency testing programs and take corrective action when results fall outside acceptable limits (typically |z-score| > 2). Managing PT round results, z-score calculations, trend analysis, and corrective action triggers across multiple PT programs and multiple analytes — without a documented system — is how labs lose accreditation between assessments.
Affinity QMS is accreditation-body agnostic. The same quality management system supports A2LA, ANAB, PJLA, and any ILAC MRA signatory assessment — with no reconfiguration required.
Unlike laboratory LIMS systems, Affinity QMS handles the quality management layer that sits above your LIMS.
A LIMS (Laboratory Information Management System) manages samples, test results, and instrument data. It is not a quality management system. ISO 17025 accreditation requires both — and the QMS layer is what your accreditation body actually evaluates during assessment. The documentation, CAPAs, training records, internal audits, and management reviews that demonstrate your laboratory's commitment to quality are outside the scope of most LIMS platforms. Affinity QMS fills that gap — sitting above your LIMS, managing the quality system infrastructure that A2LA and ANAB assess, without replacing the laboratory data management tool your analysts already use. One platform completes your ISO 17025 quality system. No integration project required.
See how Affinity QMS gives testing and calibration laboratories a continuously assessor-ready quality management system — the QMS layer that sits above your LIMS and satisfies ISO/IEC 17025:2017 clause by clause.