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MKC EN ISO 9001  - Quality management systems - Requirements

This standard specifies the requirements for a quality management system when an organization:

a) should demonstrate its ability to consistently provide products and services that satisfy customers and applicable legal and regulatory requirements, and

b) aims to improve customer satisfaction through effective system application, including processes to improve the system and ensure compliance with customer and applicable legal and regulatory requirements.

All requirements of MKC ISO 9001 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

The adoption of a quality management system is a strategic decision of an organization that can help improve its overall performance and provide a solid foundation for continuous development initiatives.

The potential benefits for an organization from implementing a quality management system based on this international standard are:

a) ability to consistently provide products and services that meet requirements of the user and applicable legal and regulatory requirements;

b) encouraging the possibility of increasing user satisfaction;

c) addressing risks and opportunities related to their context and goals; d) the ability to demonstrate compliance with the specific requirements of the quality management system

This international standard can be used by internal and external parties.

The quality management system requirements specified in this International Standard are complementary to the product and service requirements.

This international standard promotes a process approach that incorporates the Plan-Do-Check-Act-PDCA cycle and risk-based thinking.

What is Plan-Do-Check-Act (PDCA) Cycle? | Kanbanize

The process approach allows the organization to plan its processes and their interactions.

The PDCA cycle enables an organization to ensure that its processes are adequately resourced and adequately managed, and that opportunities for improvement are identified and acted upon.

Risk-based thinking allows the organization to determine the factors that could affect its process and its quality management system to deviate from planned results, to establish preventive management so that negative effects are minimized and maximized. opportunities when they arise. (see point A.4).

Consistently meeting requirements and addressing future needs and expectations presents a challenge for the organization in an increasingly dynamic and complex environment. To meet this goal, the organization might find it necessary to adopt various forms of improvement, in addition to correction and continuous improvement, such as sudden change, innovation, and reorganization.

Principles of quality management

This International Standard is based on the principles of quality management that are described in the ISO 9000 standard. The descriptions include a statement of each principle, an explanation of why that principle is important to the organization, some examples of products that are related to that principle, and examples of typical activities. to improve the operation of the organization when applying the principle.

Principles of quality management are:

focus on the user;

leadership; hiring people;

process approach,


making decisions based on facts;

management of mutual relations.

Other standards involved in quality management

MKC EN ISO 9004 - Management for the continuous success of the organization - Quality management approach

MKC ISO 10001 - Customer satisfaction - Guidelines for the management of organizations

MKC ISO 10002 - Customer satisfaction - Guidelines for handling complaints in organizations

MKC ISO 10003 - Customer satisfaction - Guidelines for resolving external disputes between organizations

MKC ISO 10004 - Customer satisfaction -- Guidelines for monitoring and measurement

MKC ISO 31000 - Risk management - Guidelines

MKC EN IEC 31010 - Risk management -- Risk assessment techniques

and many other standards adopted by  ИСРСМ ТК 9  - Quality management, environmental management and risk management