The seven requirement clauses in plain language
- Clause 4, Context. Identify the internal and external issues that affect your business, who your interested parties are, and use that to define the scope of your quality management system and its processes.
- Clause 5, Leadership. Top management must own the QMS: set a quality policy, assign roles and responsibilities, and keep customer focus visible. This cannot be delegated to a quality manager alone.
- Clause 6, Planning. Address risks and opportunities, set measurable quality objectives, and plan changes deliberately instead of letting them happen.
- Clause 7, Support. Provide the resources, competence, awareness, communication, and documented information the system needs to run.
- Clause 8, Operation. The largest clause: control how you plan and deliver products and services, from understanding customer requirements through design, purchasing, production, release, and handling nonconforming outputs.
- Clause 9, Performance evaluation. Monitor customer satisfaction, analyze data, run internal audits, and hold management reviews.
- Clause 10, Improvement. React properly to nonconformities with corrective action and continually improve the system.
What ISO 9001 does not require
Common myths, corrected: the 2015 edition does not require a quality manual, does not require a management representative job title, does not mandate specific software, and does not prescribe how you must structure your documentation. It requires certain documented information (see the dedicated question on required documents) and leaves the format to you.
The thread that ties it together
Auditors are trained to follow the Plan-Do-Check-Act cycle through your system: objectives and risks (Plan) should connect to operational controls (Do), which generate monitoring data and audit results (Check), which feed corrective actions and management review decisions (Act). If an auditor can trace that loop with real records, the system works. Where the loop breaks is exactly where findings appear.