ISO 9001 Requirements

Q: What are the requirements of ISO 9001:2015?

The ISO 9001:2015 standard requires your organisation to address seven key areas to achieve continual improvement. Clauses 0-3 are not included here as they are not mandatory ISO 9001 requirements. Context of the organisation Leadership Planning Support Operation Performance evaluation Improvement

Q: What are the requirements of ISO 9001:2008?

The ISO 9001:2008 standard required your organisation to address five key areas to achieve continual improvement: Quality Management System Management Responsibility Resource Management Product Realisation Measurement, Analysis and Improvement

Q: Do you need a formal quality manual to comply with ISO 9001?

Not anymore. ISO 9001:2015 no longer requires a formal quality manual, however, it’s still important to maintain documentation and it can benefit your organisation. Learn more about whether ISO 9001 requires a quality manual in our blog.

Q: Which clause covers documentation?

Clause 7 (Support) outlines your responsibility to provide resources for the QMS, including maintaining documented information that describes your processes, meeting customer requirements, and making sure continual improvement happens.

Q: What is continual improvement?

Continual improvement is a fundamental principle of ISO 9001. It’s the ongoing effort to identify and implement changes that make your Quality Management System (QMS) more effective.

Q: What happens if my business doesn’t yet meet ISO 9001 requirements?

Not to worry! That’s what we’re here for. Following a gap analysis, we’ll be able to help you identify areas within your procedures and processes that need improvement and support your business well on its way to compliance.

ISO 9001 clauses

The ISO 9001 Standard requires your organisation to address 10 ISO 9001 clauses. These are in place to help achieve continual improvement within your Quality Management System (QMS):

Clauses 0 – 3: Introduction, Scope, References, Terms and Definitions
Clause 4: Context of the organisation
Clause 5: Leadership
Clause 6: Planning
Clause 7: Support
Clause 8: Operation
Clause 9: Performance evaluation
Clause 10: Improvement

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

GET ISO 9001 CERTIFICATION

Introduction, Scope, References, Terms and Definitions

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.

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

Leadership

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.

Man presenting to people sitting at a table

Planning

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

Business People Planning Strategy Analysis Office Concept

Support

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

Man presenting to room of people sitting on chairs

Operation

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.

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

Improvement

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

Lady with flip board presenting to people sat at a desk

How Citation ISO Certification can help you meet ISO 9001 requirements

Our ISO consultants can help you prepare for ISO 9001 so that your business is ready to meet the current ISO 9001:2015 requirements. For more information, why not take a look at our guide to ISO 9001 in the workplace?

Defining the scope of your QMS

Our support will help you determine the areas, people and locations where you’d like to implement ISO 9001

Roles and responsibilities

In order to meet the ISO 9001 requirements, you’ll need a dedicated team who will be observing the pathway to certification. This helps to ensure you have all the right people in the right places!

Gap analysis

This is a crucial step for ensuring that you’re on the right track for following ISO 9001 guidelines. A gap analysis helps to identify areas where your business is meeting the requirements, and where it isn’t, providing an overview of where needs improvement so we can help you target these areas.

Document control system

We’ll support your business in highlighting its ISO 9001 processes, procedures and work instructions. This is another essential area where your organisation must set out a system to control and manage your ISO 9001 documents.

Employee training

ISO 9001 training is vital in making your staff aware of the operational changes. This fosters a sense of collective responsibility for all in the workforce and supports the continuity of areas that already reach the ISO 9001 requirements and the effort towards the areas that are not there yet.

Corrective actions

Finally, in order to meet the ISO 9001:2015 requirements, corrective actions need to be made to address non-conformities in your organisation. These actions are made to identify, resolve, and prevent non-conformities.