ISO 9001 Requirements

ISO 9001 clauses 0 to 3 of the ISO 9001:2015 Standard, provide foundational elements that set the stage for the rest of the ISO 9001 requirements. They’re not mandatory for implementation, but having a good understanding of them can really support your organisation in using the standard effectively. Here’s a breakdown:

• Introduction (Clause 0): This clause provides an overview of the Standard, its purpose, and the benefits of implementing a QMS. Not only that, it also introduces some key concepts, like the process approach, the Plan-Do-Check-Act (PDCA) cycle, and risk-based thinking.
• Scope (Clause 1): This clause defines the scope of the ISO 9001 Standard, outlining what it covers and what it doesn’t.
• References (Clause 2): This section lists any normative references, which are external documents that ISO 9001 refers to for additional information.
• Terms and Definitions (Clause 3): Clause 3 defines key terms used throughout the Standard to ensure clear and consistent understanding.

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

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

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 the ISO 9001 Clauses, clause 6 states 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

Clause 7 of the ISO 9001 Clauses says 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

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 ISO 9001 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.

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.

The final of the ISO 9001 Clauses stresses the importance of continual improvement within a business.

Clause 10 states 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