Context & Scope (Clause 4)
Interested parties, internal and external issues, QMS scope, and the processes that make up the system.
pTrackly keeps QMS processes, owners, nonconformities, corrective actions, internal audits, and management reviews in one workspace auditors can follow.
The most widely adopted management standard
Public tenders and procurement teams often require it, especially for outsourcing, manufacturing, and IT services.
ISO 9001:2026 is now the current edition
It replaced ISO 9001:2015 in September 2026. Existing certificates stay valid through a transition of about three years.
Agree QMS scope, sites, and products. Import existing procedures, records, and quality data.
Process map, quality policy, document control, and NC/CAPA workflow, with records from daily work.
Run internal audits and management review, close findings, and confirm certification readiness.
The certification body runs stage 1 and stage 2 audits; surveillance audits follow.
Clauses 4 to 10, mapped to owners, records, and evidence.
Interested parties, internal and external issues, QMS scope, and the processes that make up the system.
Top management sets quality policy and objectives, assigns roles, and stays accountable for QMS effectiveness.
Plan actions on risks to conformity and set measurable quality objectives with owners and deadlines.
Resources, competence, awareness, and controlled documents: versioned, approved, and available where work happens.
Customer requirements, design, external suppliers, production, release, and control of nonconforming outputs.
Customer satisfaction, process performance, internal audits, management review, and corrective action.
Every process gets an owner, risks, and KPIs, so the map stays a working tool, not a stale slide.
Complaints, defects, and findings become NCs with root cause, corrective action, due dates, and an effectiveness check.
Plan the audit programme, log findings by clause, and generate management review inputs from live data.
Document control, internal audits, and management reviews run once and map to every standard.