Quality Management Software ISO 9001 Quality Management System Software

ISO 9001 QMS SOFTWARE

ISO 9001 quality management system software that runs the work behind certification

Q: What is ISO 9001 quality management system software?

It is software that helps teams document, run, and prove the workflows required for an ISO 9001 QMS, including procedures, audits, CAPA, evidence, and management review.

Q: Can Process Street help with ISO 9001 certification?

Yes. Teams use Process Street to centralize procedures, assign recurring quality work, capture audit evidence, and maintain records. Lion Containers used Process Street while achieving ISO 9001, ISO 45001, and ISO 14001 certifications.

Q: How is this different from the ISO 9001 guide?

The ISO 9001 guide explains the standard and implementation path. This page is for buyers evaluating software to make ISO 9001 work happen repeatedly.

Q: When should I choose Process Street instead of a specialist eQMS?

Choose Process Street when workflow execution, approvals, document governance, and evidence capture matter more than deep lab, device, or validated manufacturing modules.

Q: What workflows should an ISO 9001 QMS run first?

Start with document approval, training acknowledgement, internal audits, nonconformance intake, CAPA, supplier checks, management review, and recurring evidence requests.

Process Street helps quality teams turn ISO 9001 requirements into assigned workflows for document control, internal audits, CAPA, management review, and evidence. Use it when your QMS needs proof that work happened, not another binder, spreadsheet, or shared drive.

Get started Contact sales

Quality manager reviewing labeled ISO 9001 workflow cards for documents, audits, CAPA, and management review.

Trusted by more than 3000 companies

WHAT IT CONTROLS

ISO 9001 work needs owners, records, and repeatable follow-through

A QMS should make each requirement executable. The broader quality management software guide is useful for market comparison, while this page focuses on ISO 9001 execution: controlled procedures, recurring checks, approvals, evidence, and corrective action records that stand up during certification and surveillance audits. That distinction matters when the buyer already knows the standard and now needs software to run the work.

Where Process Street fits ISO 9001 QMS work

Ops

Ops runs ISO 9001 workflows for document review, training acknowledgement, internal audits, management review, nonconformance, and CAPA. Each run has owners, due dates, required fields, approvals, attachments, and a history of what happened.

Learn more about Ops

Docs

Docs gives quality teams a governed home for policies, SOPs, work instructions, forms, and quality records. Review cycles and approvals keep controlled documents aligned with the workflows people actually run.

Learn more about Docs

Cora

Cora helps turn existing procedures, audit notes, and quality requirements into workflows, then supports ongoing review so quality work keeps improving instead of drifting between audits.

Learn more about Cora

What to look for in ISO 9001 QMS software

Document control

Route SOPs, forms, and work instructions through review, approval, publication, acknowledgement, and scheduled review, so teams use the current version.

Internal audit workflows

Assign audit tasks, capture evidence, track findings, and preserve a record for the ISO 9001 audit trail without rebuilding files later.

CAPA and nonconformance control

Log issues, assign owners, verify root cause, approve corrective actions, and confirm closure with evidence before the next audit cycle.

Management review cadence

Run recurring review workflows for objectives, risks, performance data, action items, leadership signoff, and follow-up accountability.

Evidence capture

Attach photos, files, measurements, approvals, comments, and decisions inside the workflow, tied to the person and date.

Buyer fit

Use Process Street when ISO 9001 work needs to move across people and teams, not only sit inside a specialist eQMS database.

Get started Contact sales

Related solutions

More from the Quality Management Software hub

Document Control Software For Manufacturing Quality

Keep current SOPs, work instructions, specifications, and quality forms moving through review, approval, release, acknowledgement, and change follow-up. Process Street connects each controlled document to named owners, due dates, evidence, and an audit-ready history.

Learn more

In Process Quality Control Software

Process Street turns in-process checks into assigned workflows with required measurements, pass or fail rules, evidence, and approvals. Use it when operators must catch a deviation before the next production step begins.

Learn more

Quality Audit Management Software For Manufacturing

Process Street turns plant, supplier, process, and product audits into assigned workflows with evidence, findings, approvals, and corrective actions. Use it when every audit step must be completed consistently and proved without rebuilding records from spreadsheets, email, or shared drives.

Learn more

Backed by happy clients

With Process Street we've been able to bring documentation to life… allowing us to adapt processes quickly, improve governance and achieve consistent results