Quality management system
Quality Management System – is a comprehensive approach to managing an organization aimed at achieving a high level of quality in products or services, satisfying customer needs, and complying with standards and regulatory requirements. The foundation of a quality system is always the company’s activities – this may include production, distribution of products, or providing services.
Тhe main components of a QMS:
Company Quality Policy: This defines the goals and directions of the organization in the field of product or service quality, aimed at improvement, reducing non-conforming products, and company development.
Quality Planning: Developing quality goals and processes aimed at ensuring the quality of products or services.
Production of Products/Provision of Services: Organizing and conducting the actual production of goods or provision of services according to approved procedures, work instructions, and aimed at achieving quality goals.
Quality Control: Implementing a quality control system for products or services in the form of outgoing control, conducting tests, inspections, completing compliance checklists, etc., which help prevent defects and ensure adherence to quality requirements. An effective tool for this is conducting internal audits for compliance with internal requirements and standards, regulations, and laws.
Quality Improvement: Continuous improvement of products/services, processes, and management systems to achieve greater efficiency and meet customer needs. Customer surveys, handling and addressing complaints.
Standards for quality management systems can assist in implementing a QMS. The most popular standards are:
ISO 9001: This is an international standard that sets requirements for quality management systems of organizations in all sectors. ISO 9001 provides a framework for effective management of organizational processes considering customer and regulatory requirements. It is a universal standard for any field.
ISO 13485: This standard specializes in quality management systems for medical devices and related services or industries. It sets requirements for quality management systems specific to the production of medical devices and services.
ISO 22000: This standard defines requirements for food safety management systems. ISO 22000 helps organizations establish risk management systems, ensure food safety, and comply with regulatory requirements.
These standards help organizations establish and maintain effective quality management systems. They enable achieving high product or service quality, meeting customer needs, and adhering to standards and regulatory requirements.
A useful tool for implementing a QMS is the PDCA Cycle or Plan-Do-Check-Act, which means – plan-do-check-act. This cycle was developed by Edward Deming and is a methodology for managing and continuously improving processes.
This cycle consists of four stages:
Plan: At this stage, goals and objectives are defined, as well as strategies, methods, and processes developed to achieve these goals.
Do: At this stage, planned actions are implemented. This includes carrying out processes according to the developed plan.
Check: After implementing actions, their effectiveness is assessed. This may include analyzing results, comparing with initial indicators, and identifying deviations from expectations.
Act: At this stage, measures are taken to improve the process based on the results obtained. This may include implementing corrective actions, refining the plan, or making changes to the process itself.