ISO 9001 - Quality management system or QMS is an international standard that contains requirements for a quality management system in a business organization that the organization must fulfil in order to harmonize its operations with internationally recognized norms. The quality system is a management system, which leads to the achievement of set goals in terms of the quality of business and service provision. This system consists of the organizational structure, the responsibility of the subject in the organization, the processes and resources needed to manage the system. This standard is part of the most famous series of ISO 9000 standards, which in addition to it contains several standards, some of which are:

ISO 9000 - Fundamentals and vocabulary: presents the concept of management systems as well as the terminology used;

ISO 9004 - Management with the aim of achieving sustained success of the organization - Approach through quality management.

ISO 19011 – Guidelines for management systems auditing

The quality management system according to the ISO 9001 standard is based on both the process approach (PDCA cycle) and seven quality management principles, namely:

● Principle 1: Customer focus,

● Principle 2: Leadership,

● Principle 3: Engagement of people,

● Principle 4: Process approach,

● Principle 5: Improvement,

● Principle 7: Relationship management

These principles can be used by management as a framework to guide the organization towards performance improvement. The principles are derived from the collective experience and knowledge of experts around the world who participate in the work of Technical Committee ISO/TC 176 (Quality Management and Quality Assurance), which is responsible for developing and maintaining the ISO 9000 family of standards.

ISO 9001 is suitable for all organizations that want to improve the way they manage, regardless of the size or activity of the organization. In addition, ISO 9001 is compatible with other management system standards such as ISO 45001 Occupational Health and Safety Management System and ISO 14001 Environmental Management Systems. They share many principles, as well as similar structure through Annex SL, so it is common practice to combine standards in implementation and certification.

The standard has evolved through versions (by publishing years):

ISO 9001:1987 - Part of the ISO 9000 series of standards, "Model for quality assurance in design, development, production, installation, and servicing". The emphasis is on compliance with procedures rather than the management process itself.

ISO 9001:1994 – emphasis on quality assurance through preventive actions, instead of only final checks, as well as compliance with procedures.

ISO 9001:2000 - a turn in the treatment of quality by putting process management in the foreground, as well as involving senior managers in order to integrate quality into the business system

ISO 9001:2008 – the version that brought clarification of the existing requirements from version 9001:2000 and changes with the intention of improving consistency with the ISO 14001 standard

The latest version of the standard is 9001:2015. Improvements compared to the previous version are:

• Greater emphasis on leadership engagement
• Helps display organizational risks and opportunities in a structured way
• Use of simplified language and general structure and terminology, particularly useful for organizations using multiple management systems
• More effective display of supply chain management
• Easier for service and knowledge-based organizations

The purpose of this standard is to increase the efficiency of the organization through the application of a process approach. Its advantage is providing links between individual processes, sectors and their interaction. By defining the input and output elements of all processes and defining the required resources, a starting point for planning is created, as well as feedback on customer satisfaction. This model increases clients' trust in the product/service and leads to a better positioning in the market.

Some of the advantages of properly implemented ISO 9001 standard for an organization:

• A more efficient way of working so that all processes are adapted and understandable to everyone in the organization and business, which increases efficiency and productivity and reduces internal costs
• Meets legal and regulatory requirements
• Enables expansion into new markets, clients and sectors that require a certificate before starting work
• Identifies and presents risks related to the organization