ISO 9001 Requirements

ISO 9001 key areas

The ISO 9001 standard requires your organisation address seven key areas – also known as clauses – in order to achieve continual improvement within your Quality Management System:

  1. Context of the organisation
  2. Leadership
  3. Planning
  4. Support
  5. Operation
  6. Performance evaluation
  7. Improvement

Supported by the quality management principles these requirements help your business to successfully implement an effective Quality Management System.

Context of the organisation

Clause 4 of the ISO 9001:2015 Standard is where you set out the purpose and strategic direction of your business in terms of quality. It covers the following points:

  • Determining the factors, both internal and external to your business, that 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
Human hand holding pen and checklist, selective focus


The ISO 9001 standard recognises that an effective Quality Management System depends on the commitment of your organisation’s senior management. It therefore requires, through clause 5, that your leadership team 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.
Man presenting to people sitting at a table


An effective Quality Management System is one that operates on risk-based thinking, putting in place measures to address both risks and opportunities alike. As part of clause 6 therefore, companies must:

  • Document potential risks including their severity and chance of occurrence
  • Plan to prevent or reduce undesired effects
  • Integrate plans to enhance desirable effects
Business People Planning Strategy Analysis Office Concept


The ISO 9001 standard requires, through clause 7, that your organisation provides adequate resources to operate an effective Quality Management System. This includes providing resources for:

  • Robust infrastructure
  • Efficient working environments
  • Effective HR Management
Man presenting to room of people sitting on chairs


The Operation section within ISO 9001:2015, also known as clause 8, describes the work your company must do to develop and deliver goods or services to your customers.

Your processes 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 records.
Woman in lab writing on a chart

Performance evaluation

Clause 9 of the ISO 9001:2015 standard requires your organisation to measure and analyse your processes, recording the results in order 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.
Two men looking at large screen with image of a price graph


The final clause in the ISO 9001:2015 standard stresses the importance of continual improvement within a business.

Measures should be put in place to:

  • Improve services and products for the betterment of the business
  • Better match customer needs and therefore improve customer satisfaction
  • Identify instances of processes not achieving their goals and update them accordingly
Lady with flip board presenting to people sat at a desk

Frequently asked questions

What are the requirements of ISO 9001:2015?

What are the requirements of ISO 9001:2008?

Get your free personalised quote

  • Product of Interest

  • Company Information

  • Contact Details

  • Product of Interest

  • Company Information

  • Contact Details

  • Product of Interest

  • Company Information

  • Contact Details


QMS International use cookies to provide you with a better site experience, enable features and to help us understand how our website is being used.

By continuing, you consent to the use of cookies in accordance with our Cookie Policy

Allow All Cookies

Allow Strictly Necessary Cookies Only