ISO 9001 Requirements

The ISO 9001 standard requires your organisation to address five key areas to achieve continual

  1. Quality Management System;
  2. Management Responsibility;
  3. Resource Management;
  4. Product Realisation;
  5. Measurement, Analysis and Improvement.

The following explains the ISO 9001 requirements for each of these areas in a bit more detail.

1) Quality Management System

The Quality Management System sets out the processes your business must follow to achieve the ISO 9001 quality standard and to meet your customers’ needs. It covers the following points:

  • Improving customer focus
  • Strengthening leadership
  • Involving employees
  • Establishing robust processes
  • Driving continual improvement
  • Embedding evidence-based decision making
  • Managing customer relationships.

2) Management Responsibility

The ISO 9001 standard recognises that an effective Quality Management System depends on the commitment of your organisation’s senior management. It therefore requires your leadership team to take responsibility for:

  • Creating the Quality Management System
  • Establishing the quality policies and objectives
  • Communicating these policies and objectives to employees responsible for the quality of the company’s products and services
  • Managing the annual reviews.

3) Resource Management

The ISO 9001 standard requires your organisation to provide adequate resources to operate an effective Quality Management System. This includes providing resources for:

  • Robust infrastructure
  • Efficient working environments
  • Effective HR Management.

4) Product Realisation

Product Realisation describes the work your company must do to develop and deliver goods or services to your customers. Your Product Realisation process will set out:

  • The requirements and quality objectives of your products or services
  • The process guides, documents and resources your employees need to create products or services successfully
  • The monitoring, inspection or testing your company needs to ensure the quality of your products or services
  • The rules governing the creation and storage of your Product Realisation records.

5) Measurement, Analysis and Improvement

ISO 9001 requires your organisation to measure, analyse and improve its processes to:

  • Demonstrate it conforms to the requirements of the ISO 9001 standard
  • Ensure it applies all aspects of its Quality Management System
  • Support continual improvement in quality management across the organisation.

Find out more about the ISO 9001 audit, costs, and training.