This is where the organisation sets out the purpose and strategic direction of the business in relation to quality. Clause 4 covers the following points:

• Determining the factors, both internal and external to your organisation, that could affect the quality of your services.
• Identifying the stakeholders in your business such as staff, suppliers and other interested parties.
• Understanding your customers and their needs.

An effective Quality Management System does depend very heavily on your organisation’s commitment from senior management. It therefore requires in Clause 5 that the leadership take responsibility for:

• Developing the Quality Management System.
• Establishing the quality policies and objectives for the organisation.
• Communicating these policies and objectives to all employees.
• Managing the annual reviews.

A highly effective Quality Management System requires the organisation to operate risk-based thinking, putting in place measures to address both opportunities and risks. Therefore, under Clause 6, organisations must:

• Document potential risks including their severity and chance of occurrence.
• Plan to prevent or reduce undesired effects.
• Integrate plans to enhance desirable effects.

Clause 7 states that your organisation provides adequate resources to operate an effective Quality Management System, including providing resources for:

• Robust infrastructure
• Effective HR processes / management
• Efficient working environments

Clause 8 in the ISO 9001:2015 standard describes the work your organisation must do to develop and deliver good or services to your clients.
Your procedures are required to 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 records.

Clause 9 of the ISO 9001:2015 standard requires your organisation to incorporate both measurement and analysis of your processes, and record the results so that:

You can demonstrate it conforms to the requirements of the ISO 9001 standard
You can ensure it applies all aspects of its Quality Management System

The final cause, and foundation for the ISO 9001:2015 standard stresses the importance of continual improvement within the organisation.

Therefore, measures are required to be put in place that:

• Improve services and products for the improvement of the organisation.
• Better match customer needs and therefore improve customer satisfaction.
• Identify instances of business processes not achieving their goals and update them accordingly.