REQUIREMENTS OF ISO 9001

THE MAIN CLAUSES OF ISO 9001

Clause 1 - Scope 

This describes the scope of the ISO 9001 standard. It doesn’t outline any actual requirements.

Clause 2 - Normative References

This clause identifies other standards and documents that relate, to and are referenced, within ISO 9001.

Clause 3 - Terms and Definitions

This explains certain key words and phrases that are used throughout the standard. It helps you understand some of the jargon.

Clause 4 - Context of the Organisation

Here us where you build a picture of the business environment in which you operate. You need to understand this before you can start to build your system.

• Determine the relevant external and internal factors that affect your organisation

• A SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis may prove useful

• You should identify everyone with an interest in your business such as staff, suppliers, clients - known as stakeholder

Clause 5 - Leadership and Commitment

A QMS won’t work without commitment from top management. This is key to the success of your system and auditors will look for evidence of this.

• Top management must be directly involved and take overall responsibility - they cannot delegate

• They should develop a Quality Policy setting out the overall intention

• Roles and responsibilities must be clear

Clause 6 - Planning

Risk-based thinking is a key principle of ISO 9001. This is all about ensuring that you get the expected results and there are no nasty surprises. Only with proper planning will you be ‘right first time’.

• You must establish your quality objectives

• Identify and document risks

• Develop processes to prevent, reduce and eliminate unwanted events

• Plan to make the most of any opportunities that arise
   

Clause 7 - Support

You need to make sure that the system is adequately resourced.

• Employees must be aware of the QMS and their role within it

• People must be competent in their roles

• You must have effective communications

Clause 8 - Operation

This is where your system comes to life. This clause is about the day-to-day activities that produce the products and services to deliver to your customers.

• Make sure what you do will result in the desired outcomes

• Processes need to be planned, implemented and controlled

• You probably need some written procedures

• Outsourced processes must be controlled & communication with customers is vital

Clause 9 - Performance evaluation

The only way to tell if your QMS is working and you are raising quality standards is to measure what you do.

• Determine what needs to be monitored, how to monitor and when

• You must include compliance and customer satisfaction

• You must carry out internal audits

• The results must be measured, analysed and evaluated

• Top management must review the system and performance

​Clause 10 - Improvement

You must put things right when they go wrong. This is ‘corrective action’ which leads to continual improvement. This underpins the concept of a QMS.

• Identify nonconformities and take corrective action

• Address future needs and expectations

• Work to improve customer satisfaction