In today’s dynamic business environment, where technologies and innovations are developing rapidly, maintaining a high level of quality is an important factor in the success of any organization, regardless of its size. Quality helps build trust and long-term relationships with customers and other interested parties.
Quality management is a process through which an organization plans, controls and improves its products, services and processes in order to meet defined quality requirements. This process may cover the entire life cycle of a product or service – from development and delivery to after-sales service.
 
A Quality Management System (QMS) is a set of policies, processes, responsibilities and resources through which an organization manages the quality of its products and services and improves its performance.
The primary purpose of a QMS is to support the organization in consistently providing products and services that meet customer requirements and applicable statutory and regulatory requirements, while improving processes and enhancing customer satisfaction.  
Standards in the Field of Quality Management
Quality management systems can be developed in accordance with different international standards, depending on the organization’s activities, sector and applicable requirements.
ISO 9001 Quality management systems – Requirements specifies requirements for a quality management system and is applicable to organizations of all types and sizes, regardless of their activities.
ISO 13485 Medical devices — Quality management systems — Requirements for regulatory purposes specifies requirements for quality management systems for organizations involved in the design, production, installation and servicing of medical devices and related services, with an emphasis on applicable regulatory requirements.
IATF 16949 Quality management system requirements for automotive production and relevant service parts organizations specifies specific requirements for quality management systems for organizations in the automotive industry and its supply chain.
Other standards and guidance documents are also used in the development, implementation, maintenance and improvement of quality management systems, including ISO 9000 Quality management — Fundamentals and vocabulary, ISO 9004 Quality management — Fundamentals and vocabulary, ISO 10013 Quality management systems — Guidance for documented information and ISO 19011 Guidelines for auditing management systems.
 
What Should You Do if You Want to Implement a Quality Management System?
To develop and implement a quality management system, an organization should determine the applicable requirements based on its activities, processes, objectives and the specific requirements of the relevant standard.
An organization may develop and implement the system using its own resources or engage an external consultant.
CONSEJO supports organizations in the development, implementation and improvement of quality management systems. Consulting services may include an assessment of the current state, determination of applicable requirements, development of the necessary documented information, implementation support, training for management and employees, internal audits, and preparation for a certification audit.
 
Benefits of Implementing a Quality Management System
Implementing a quality management system can support an organization in:

• improving process management and traceability;
• clearly defining responsibilities, objectives and performance indicators;
• consistently providing products and services that meet applicable requirements;
• enhancing customer satisfaction;
• improving interaction between processes and functions within the organization;
• making better use of information in decision-making;
• enhancing the competence and awareness of people within the organization;
• identifying opportunities for improvement;
• continually improving the system and its processes;
• demonstrating the organization’s ability to meet applicable requirements.

Where a quality management system is subject to certification, the certificate can provide independent demonstration of conformity with the requirements of the relevant standard and may be a requirement or an advantage in certain contractual relationships, procedures or markets.
 
Related Standards
ISO 9001 – Quality management systems – Requirements
ISO 13009 – Tourism and related services – Requirements and recommendations for beach operation
ISO 13485 – Medical devices – Quality management systems – Requirements for regulatory purposes
ISO 31000 – Risk management – Guidelines
ISO 37001 – Anti-bribery management systems
IATF 16949 – Quality management system requirements for automotive production and relevant service parts organizations