Quality
ISO 9001:2015 — Quality management systems
The reference standard for quality management: keep your customers satisfied over time through controlled processes.
At a glance
- Type
- International standard, certifiable
- Publisher
- ISO
- Edition
- 2015 (+ Amendment 1:2024)
- Certification
- Accredited certification body, 3-year cycle
65 requirements tracked · 67 shared controls
What is ISO 9001?
ISO 9001 sets out the requirements of a quality management system (QMS) that consistently delivers products and services meeting customer and regulatory requirements and increases customer satisfaction. It is the most widely used management standard in the world.
It relies on the process approach, risk-based thinking and the PDCA cycle (plan, do, check, act). Its structure (clauses 4 to 10) is shared with the other management system standards: an ISO 27001 ISMS and an ISO 9001 QMS can share management review, internal audits, document control and nonconformity handling.
Key requirements
- 1
Context, interested parties and processes
Understand the organisation’s environment and the expectations of interested parties, and describe the QMS processes and their interactions.
- 2
Leadership and quality policy
Top management gets involved, sets the quality policy and objectives and puts the customer first.
- 3
Risks and opportunities
Identify what could prevent the intended results, or improve them, and plan actions.
- 4
Resources, competence and documented information
Have the people, infrastructure and knowledge needed, and control documents.
- 5
Operation and control of external providers
Plan operational activities, control design, production and externally provided products or services.
- 6
Monitoring, customer satisfaction and internal audit
Measure process performance and customer satisfaction, audit the QMS and hold management reviews.
- 7
Nonconformities and improvement
Control nonconforming outputs, take corrective actions and improve continually.
Summary written by OK-GRC. The texts of ISO standards are protected by copyright and are not reproduced.
How OK-GRC helps
- ISO 9001 requirements linked to 67 common controls, including 21 dedicated quality controls
- Quality manual, quality policy, external providers and customer satisfaction procedures as bilingual templates
- Register of risks and opportunities in the same tool as security risks
- Internal audit programme, findings, root cause analysis (5 whys, Ishikawa) and corrective actions
- Management review prepared automatically (indicators, audits, complaints, actions)
- A dedicated “Quality manager” role with suitable rights
Related frameworks
With ISO 27001 controls in place, your ISO 9001 starting score is about 48 to 53%.
The controls you put in place for ISO 9001 also count for:
- ISO 27001Same common structure: 54 to 56 of the 65 ISO 9001 requirements benefit from an existing ISMS.
- ISO 22301Business continuity extends the control of processes and suppliers.
- ISO 42001ISO/IEC 42001 applies the same management system logic to AI.
- ISO/IEC 17025Testing and calibration laboratories: your QMS is the foundation of ISO/IEC 17025 Option B and already covers, at least partly, 23 to 24 of the 25 requirements of its clause 8.
Frequently asked questions about ISO 9001
Can ISO 9001 and ISO 27001 be audited together?
Yes. Many certification bodies offer combined audits for integrated management systems. The shared requirements (management review, internal audit, document control, corrective actions) are then prepared only once.
Do we need a quality manual?
The 2015 edition no longer requires one, but a manual remains a convenient way to present the QMS, its scope and processes. OK-GRC provides a template to adapt.
Informational content up to date as of October 2026; it does not constitute legal advice. Always check the official texts in force.
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