ISO 9001:2015 Compliance Software

All 32 clauses from 4.1 (Context of the organization) through 10.3 (Continual improvement). Every clause is fully active with CRUD, filtering, and analytics. See the full table above.

No. Svend replaces both standalone QMS software (Qualio, MasterControl, ETQ — typically $500-2,000+/mo) and standalone statistical software (Minitab, JMP — $110-700/mo). NCR tracking, internal audits, training records, management review, document control, supplier management, quality economics, SPC, DOE, and 200+ statistical analyses are all in one platform. No duplicate data entry, no manual export between tools.

Full nonconformance management per clause 10.2. NCRs follow a 5-state workflow: open → investigation → CAPA → verification → closed. When corrective action is needed, a linked CAPA follows a 6-state lifecycle: draft → containment → investigation → corrective action → verification → closed. Each transition is validated — you cannot skip steps or close without verification. Log NCRs with severity classification (minor, major, critical) and ISO clause reference. Conduct root cause analysis using 5 Whys or fishbone diagrams — Synara AI reviews your analysis and flags blame framing, circular logic, or premature stops. NCRs auto-create statistical studies for data-driven investigation. Full audit trail — every status transition and every field edit logged with timestamp, user, old value, and new value.

Yes, per clause 9.2. Create audit programs with lead auditors, department scoping, and ISO clause mapping. Record findings as observations, minor nonconformities, major nonconformities, or opportunities for improvement. Findings auto-cascade into NCRs — when an auditor records a nonconformity, the system creates a linked NCR automatically with severity and clause reference carried over. Each finding generates corrective actions tracked to closure with verification. Every field edit on audit records is logged with timestamp, user, old value, and new value.

Yes, per clause 7.2. Define competence requirements by role, track employee training records with completion dates and expiry dates, monitor compliance rates per ISO clause, and receive alerts before certifications expire. Edit employee details and training records inline with full field-level change history. One-click recertification resets completion and expiry dates for recurring training without losing the original record. The training matrix integrates with the learning module for course delivery and assessment.

Per clause 7.5. Controlled document register with document numbers, categories, version tracking, and approval workflows. Schedule reviews, track revisions with change summaries, and maintain a full audit trail — every field edit and status transition logged with timestamp, user, old value, and new value. Obsolete versions are automatically archived. Supports quality manuals, SOPs, work instructions, and forms.

Yes. Supplier register with approval status, quality ratings, evaluation scheduling, and product/service records. Track approved supplier lists, schedule periodic re-evaluations, and link supplier performance data to incoming inspection NCRs. Every field edit and status transition logged with full change history. Integrates with the NCR tracker for externally provided product nonconformances.

QMS features are included in Team ($99/mo) and Enterprise ($299/mo) plans. Both include a 14-day free trial — no charge until day 15. Cancel anytime during the trial and you won't be billed. No additional per-module charge. For context, standalone QMS software typically costs $500-2,000+/mo and still requires separate statistical tools. Svend includes both. Purchasing power pricing is available for Southeast Asia, India, Latin America, Africa, and other emerging markets.

Quality economics connects quality events to financial impact through four analyses: Taguchi loss function (quantifies the cost of deviation from target — not just out-of-spec), Cost of Quality using the Prevention-Appraisal-Failure model (shows where your quality spend actually goes), Bayesian SPC decisions (statistically optimal stop/adjust/continue recommendations), and lot sentencing with operating characteristic curves (accept/reject/inspect decisions that balance producer and consumer risk). These are built into the platform — not a separate module or add-on.

Most QMS tools are standalone — they track compliance workflows but don't connect to the statistical tools you use for actual analysis. In Svend, the modules form a closed feedback loop: audit findings auto-create NCRs, NCRs auto-create statistical studies for root cause investigation, study results route back as QMS actions (create an NCR, schedule an audit, update a training requirement). Every QMS event feeds into the Bayesian evidence system as quantified evidence. There is no manual data transfer between tools because there are no separate tools.

Standalone QMS platforms cover compliance workflows — NCR tracking, document control, audits. But they don't include statistical analysis, so you still need Minitab or JMP for SPC, capability studies, DOE, and hypothesis testing. That means two separate subscriptions, no integration, and manual data transfer. Svend combines both in one platform with closed-loop integration between QMS and statistical modules, plus quality economics that neither standalone QMS nor standalone statistical software offers. Team plan starts at $99/mo.

Yes. Every status transition and every field edit across all QMS records — NCRs, audits, documents, suppliers, and training records — is logged with timestamp, user, old value, and new value. NCR workflows enforce validated state transitions (you cannot skip containment or close without verification). Document approval workflows track every revision with change summaries. Your external auditor can trace exactly who changed what field, when, and what it was before — not just status transitions but every individual field modification.