ISO 9001:2015 Quality management systems – Requirements (ISO 9001) is the international standard that specifies the requirements of a QMS (quality management system). A QMS enables organisations of all types and sizes to drive operational efficiency by ensuring the consistent quality of their products and services.
ISO 9001 is the only quality management standard against which organisations can achieve independently audited certification to demonstrate that they are following its best practice. More than 1 million organisations in over 170 countries are currently certified to the Standard.
ISO 9001 establishes process-driven methods of producing and delivering products and services with consistent results. The Standard comprises 11 clauses: 0 is the introduction, 1–3 provide context for the Standard and 4–10 specify the requirements for a QMS.
These requirements are:
Understanding the environment in which the organisation operates and defining the scope of the QMS.
Processes covering the entire lifecycle of products and services, from planning and control to evaluating whether products and services meet the quality requirements.
The need for top management to lead the QMS project, create a quality policy, and assign roles, responsibilities and authorities relating to quality management.
Monitoring, measurement, analysis and evaluation; internal audits; and management reviews.
Risks and opportunities, and their effect on quality objectives.
Continual improvement of the management system by addressing nonconformities.
The importance of supporting the QMS by providing the necessary resources and organisational structures, and creating appropriate documentation.
These requirements are based on the seven QMPs (quality management principles) described in ISO 9000:
QMP 1 – Customer focus
QMP 2 – Leadership
QMP 3 – Engagement of people
QMP 4 – Process approach
QMP 5 – Improvement
QMP 6 – Evidence-based decision making
QMP 7 – Relationship management
Business success depends on balancing investment and returns.
Develop poor-quality goods and services and no one will buy them; create high-quality products and services and you risk pricing yourself out of the market when attempting to recoup your costs.
With an effective QMS, your products and services will meet established quality levels every time, giving you greater control over production costs and increasing customer satisfaction.
Implementing a QMS will help your organisation:
ISO 9001 is the only quality management standard against which organisations can achieve independently audited certification.
Certification is not compulsory – you may decide that you benefit enough by implementing the Standard’s best practice.
However, certification is a good way of enhancing your organisation’s credibility by demonstrating that you follow processes to ensure your products and services meet quality criteria.
Each ISO 9001-compliant QMS is specific to the organisation that implements it. ISO 9001 implementation projects vary in time and cost depending on numerous factors, including:
As with QMS implementation costs, the duration of an ISO 9001 project varies depending on the organisation.
Generally, larger organisations can expect to reach certification in 8–12 months and smaller companies can achieve it faster – often in as little as 2 months.
Follow these steps to certify to ISO 9001:
Assuming the results of the pre-certification audit are positive, you should then be ready for certification.
ISO 9001 follows the Annex SL structure common to many ISO management system standards.
This sets out ten high-level section headings, identical core text for sub-clauses and requirements, and a number of common terms and core definitions.
This means ISO management system standards are compatible, making it easier to implement management systems that conform to multiple standards, such as ISO 14001 (environmental management systems), ISO 27001 (information security management systems) and ISO 25001 (occupational health and safety management systems).
Educate your employees on the importance of quality management with our ISO 9001 Staff Awareness E-Learning Course.