SIG RQMS-CMP-003·REV 02·Live
Map your standard.
Assessors don't audit adjectives — they audit clauses. Here is exactly where each requirement of your standard lives inside RainerQMS, clause by clause, module by module.
ISO/IEC 17025:2017
The home standard. RainerQMS was designed around 17025's management and technical requirements — not adapted to them after the fact.
| Clause | Requirement | Where it lives in RainerQMS |
|---|---|---|
| § 4.1 | Impartiality | Impartiality risk register with scoring, owners and review dates |
| § 6.2 | Personnel | Training & competency records, authorizations, e-signed completions |
| § 6.4 | Equipment | Instrument register, calibration & maintenance scheduling, uncertainty |
| § 6.5 | Metrological traceability | Reference standards on every calibration record, certificates attached |
| § 7.7 | Ensuring validity of results | PT/ILC rounds with automatic z-scores and En numbers |
| § 7.9 | Complaints | Complaints module: intake → investigation → response → closure |
| § 7.10 | Nonconforming work | Quality events with severity classification and disposition |
| § 8.3 | Control of documents | Document lifecycle, versioning, e-signed approval, periodic review |
| § 8.4 | Control of records | Immutable, append-only audit trail across every module |
| § 8.5 | Risks and opportunities | 5×5 risk register across operational and regulatory categories |
| § 8.7 | Corrective actions | CAPA with root cause, action items and effectiveness checks |
| § 8.8 | Internal audits | Audit programs, clause-mapped checklists, findings to closure |
| § 8.9 | Management reviews | Reviews with compiled inputs, minutes and tracked actions |
ISO 15189:2022
For clinical microbiology, chemistry and pathology labs. The 2022 revision leans hard into risk-based thinking — which is exactly how RainerQMS is wired.
| Clause | Requirement | Where it lives in RainerQMS |
|---|---|---|
| § 4.1 | Impartiality | Impartiality risk register, reviewed on schedule |
| § 6.2 | Personnel | Competency matrix, authorizations, recurring training with expiry |
| § 6.4–6.5 | Equipment & calibration | Instrument lifecycle, calibration records, traceability |
| § 7.3.7 | Ensuring validity (IQC / EQA) | PT/EQA rounds with automatic scoring and CAPA escalation |
| § 7.5 | Nonconforming work | Quality events with severity, investigation and disposition |
| § 7.7 | Complaints | Complaints module mapped end to end |
| § 8.2–8.3 | QMS documentation & control | Controlled documents with lifecycle and distribution |
| § 8.4 | Control of records | Append-only audit trail with actor, action and timestamp |
| § 8.5 | Risk & opportunities | Risk register with mitigation tracking |
| § 8.7 | Nonconformities & corrective action | CAPA with effectiveness verification |
| § 8.8 | Evaluations / internal audit | Audit management with clause-mapped checklists |
| § 8.9 | Management review | Compiled-input reviews with tracked outcomes |
FDA 21 CFR Part 11
Electronic records and signatures are native to RainerQMS, not an add-on. Signatures carry name, date-time and meaning, and are cryptographically linked to the record they sign.
| Section | Control | Where it lives in RainerQMS |
|---|---|---|
| § 11.10(d) | System access limited to authorized individuals | Role-based access control, MFA, account lockout |
| § 11.10(e) | Secure, computer-generated audit trails | Append-only audit trail with actor, action and timestamp |
| § 11.10(g) | Authority checks | Per-action permissions — only authorized roles can sign or approve |
| § 11.10(i) | Education, training and experience | Training module with e-signed completion records |
| § 11.50 | Signature manifestations | Printed name, date-time and meaning shown on every signature |
| § 11.70 | Signature / record linking | Signature bound to a SHA-256 hash of the signed record |
| § 11.100 | Unique signatures | Signatures tied to unique, individual user identities |
| § 11.200 | Signature components & controls | Identity re-verification at the moment of signing |
| § 11.300 | Password controls | Password policy, expiry controls, MFA (TOTP) |
GLP & GMP
For QC labs operating inside GxP environments: the workflows regulators expect, with ALCOA+ data integrity underneath.
| Expectation | Where it lives in RainerQMS |
|---|---|
| Deviation management | Quality events with severity classification and investigation |
| CAPA | Six-state CAPA lifecycle with effectiveness verification |
| Change control | Multi-stage change workflow with impact assessments and e-signatures |
| Training & qualification | Role-based curricula, completions, expiry and overdue tracking |
| Equipment qualification & calibration | Lifecycle records, calibration history, PM schedules |
| Data integrity (ALCOA+) | Attributable, contemporaneous, original records; append-only trail |
| Documented procedures | Controlled documents with lifecycle and periodic review |
ISO 9001:2015
Running 9001 alongside your lab accreditation? The same records satisfy both — no parallel bookkeeping.
| Clause | Requirement | Where it lives in RainerQMS |
|---|---|---|
| § 6.1 | Actions to address risks | Risk register with scoring and mitigation plans |
| § 7.2 | Competence | Training assignments, scores, e-signed completion |
| § 7.5 | Documented information | Document control with lifecycle and versioning |
| § 9.2 | Internal audit | Audit programs, checklists, findings |
| § 9.3 | Management review | Reviews with compiled inputs and tracked actions |
| § 10.2 | Nonconformity & corrective action | Quality events + CAPA, linked end to end |
Ready for your accreditation body.
Whether your assessor arrives from A2LA, ANAB, UKAS or NABL, the drill is the same: show the system, show the records, show the closure. RainerQMS supports the assessment workflow — findings in, responses out, evidence attached — so the visit is a walkthrough, not an excavation.
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Bring your checklist.
We'll bring the records.
Book a demo mapped to your standard — we'll walk your own clauses, one by one.