Quality Management System – ISO 9001

A quality management system (QMS) is defined as a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. A QMS helps coordinate and direct an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.

Benefits of quality management systems

Implementing a quality management system affects every aspect of an organization’s performance. Benefits of a documented quality management system include:

Meeting the customer’s requirements, which helps to instill confidence in the organization, in turn leading to more customers, more sales, and more repeat business.

Meeting the organization’s requirements, which ensures compliance with regulations and provision of products and services in the most cost- and resource-efficient manner, creating room for expansion, growth, and profit

These benefits offer additional advantages, including:

• Defining, improving, and controlling processes
• Reducing waste
• Preventing mistakes
• Lowering costs
• Facilitating and identifying training opportunities
• Engaging staff
• Setting organization-wide direction
• Communicating a readiness to produce consistent results

What does ISO 9001:2015 cover?

ISO 9001 is based on the plan-do-check-act methodology and provides a process-oriented approach to documenting and reviewing the structure, responsibilities, and procedures required to achieve effective quality management in an organisation.

• Requirements for a QMS, including documented information, planning and determining process interactions
• Responsibilities of management
• Management of resources, including human resources and an organisation’s work environment
• Product realisation, including the steps from design to delivery
• Measurement, analysis, and improvement of the QMS through activities like internal audits and corrective and preventive action

Changes introduced in the 2015 ISO 9001 revision are intended to ensure that ISO 9001 continues to adapt to the changing environments. Some key updates in ISO 9001:2015 include:

• The introduction of new terminology
• Restructuring some information
• An emphasis on risk-based thinking to enhance the application of the process approach
• Improved applicability for services
• Increased leadership requirements