Guide · ISO 9001
What ISO 9001 Is and How a Quality Management System Works
A clear guide to the international reference standard for quality management systems: what it asks for, how it is organised and what it brings to an organisation.
What it is
International standard for Quality Management Systems (QMS)
Who it's for
Any organisation, of any size or sector
Objective
Customer satisfaction and continual improvement
What ISO 9001 Is
ISO 9001 is the international standard for Quality Management Systems (QMS). It aims to get the organisation working continually towards customer satisfaction by meeting customer requirements.
It does not define what a product or service should look like, but rather how management should be organised so that results are consistent and improve over time.
Objectives of the Standard
- Support the conformity of products and services and increase customer satisfaction.
- Be consistent with the organisation's business strategy.
- Base management on processes, evidence-based decision-making and continual improvement.
Who It Applies To
It applies to any organisation, public or private, regardless of its size or activity.
It is common among companies working for clients that demand quality assurances, that take part in tenders, or that want to bring order to their internal processes.
Key Concepts
- Process approach
- Managing activities as interrelated processes that transform inputs into outputs.
- Risk-based thinking
- Identifying what could affect results and planning actions to address it.
- Customer satisfaction
- Understanding customer needs and measuring how far they are being met.
- Documented information
- The documentation and records the system needs to operate and to demonstrate that it does.
- Continual improvement
- Reviewing results and taking action to improve the performance of the system.
Structure of the Standard
ISO 9001 follows the common structure shared by ISO management system standards. Its requirements are organised into the following clauses:
- 4. Context
- Understanding the organisation, its interested parties and defining the scope of the system.
- 5. Leadership
- Top management commitment, policy, and roles and responsibilities.
- 6. Planning
- Risks and opportunities, objectives and how to achieve them.
- 7. Support
- Resources, competence, awareness, communication and documented information.
- 8. Operation
- Planning and control of the processes specific to the standard.
- 9. Performance evaluation
- Monitoring and measurement, internal audit and management review.
- 10. Improvement
- Nonconformities, corrective actions and continual improvement.
Benefits
- Greater customer satisfaction.
- Better integration of processes.
- More informed decision-making.
- Greater credibility with clients and suppliers.
What a Company Should Bear in Mind
- The scope of the system: which processes, sites and activities it covers.
- The involvement of top management: the standard assigns it specific responsibilities.
- Keeping documentation proportionate to the size of the company.
- Maintenance: once implemented, the system needs to be reviewed and audited periodically.
The certificate is issued by an independent certification body following an audit of the system; a consultancy helps implement and prepare it.
Relationship with Other Management Systems
Because ISO management system standards share a common structure, it is common to integrate them into a single system.
Common Questions about ISO 9001
Is ISO 9001 mandatory?
No. It is a voluntary standard. Even so, many clients and public administrations request or value it in purchasing and tender processes.
Is ISO 9001 only for manufacturing companies?
No. It applies equally to service companies, retail, public administration or any other activity.
How does it relate to other ISO standards?
It shares a common structure with standards such as ISO 14001 and ISO 45001, which makes it easier to implement them in an integrated way.