ISO 9001:2015
ISO 9001:2015 Quality Management
ISO 9001:2015 applies to any type of organization, regardless of size, structure, products or services offered.
The implementation and certification of the quality management system in accordance with the ISO 9001:2015 standard demonstrates the organization's ability to consistently provide products and/or services that satisfy the customer's requirements and legal requirements, respectively the organization's commitment to increasing customer satisfaction, taking into account the risks and the opportunities associated with the context of the organization and with the objectives set by it, in order to develop the business in the long term and to achieve the desired sustainable development.
ISO 9001:2015 specifies the requirements for a quality management system with the aim of understanding the context in which the respective organization operates and determining the risks as a basis for planning. The identification of risks and opportunities, but especially the adoption of measures to treat the risks, determines the increase in the performance of the organization and the prevention of unwanted effects.
ISO 9001:2015 is based on the seven principles of quality management described in ISO 9000:2015:
Customer orientation;
Leadership;
Staff commitment;
Procedural approach;
Improvement;
Evidence-based decision-making;
Stakeholder Relationship Management.
Plan-Do-Check-Act
SO 9001:2015, structured according to the PDCA Cycle ("Plan-Do-Check-Act"), promotes the adoption of the process-based approach for the effective documentation, implementation and improvement of the quality management system. The procedural approach involves the systematic definition and management of all the processes in the organization and the interactions between the processes in order to fulfill the organization's objectives in accordance with the policy in the field of quality.
ISO 9001:2015 also promotes the adoption of risk-based thinking, which allows the reduction of normative requirements and their replacement with performance-based requirements, a greater flexibility of requirements regarding processes, documented information and organizational responsibilities. One of the key purposes of a quality management system based on risk-based thinking is to act as a prevention tool.
Organizations can choose to develop a more extensive risk approach than is provided for in ISO 9001:2015 and for this purpose they can use the ISO 31000:2018 standard "Risk management. Guidelines".
The ISO 9001:2015 standard was adopted for the following reasons:
- adapting to changes in the business environment (the need to achieve the desired goal of sustainable development, globalization, regionalization, customer requirements and needs, the information revolution);
- greater applicability for service provider organizations;
- integration with other standards for management systems (environment, information security, etc.);
- adoption of Annex SL (High Level Structure) and its terminology;
- the introduction of new concepts related to quality and management;
- the use of the revised quality principles.
The ISO 9001:2015 standard has brought important changes compared to the previous edition, its structure and adopted terminology being in accordance with Annex SL of the ISO Directives - High-level structure, identical basic text, common terms and basic definitions - developed by JTCG ( Joint Technical Coordination Group), annex which:
- aligns the format, text, terms and definitions used by all management system standards including the IWA (International Workshop Agreement) documents;
- allows the addition of specific requirements for each standard.