Requirements of ISO 9001
The ISO 9001 Quality Management Systems standard is the most popular of all ISO standards. More than one million organisations around the world have adopted it. Businesses choose to implement ISO 9001 because it makes a positive impact and it’s also quite simple to put in place and keep running.
Here’s a handy guide to the requirements of ISO 9001.
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An introduction to ISO 9001
There are a few things you can do to familiarise yourself with the basics of ISO 9001:
Watch our 4 minute video What is ISO 9001? An Introduction to Quality Management Systems
Download our free Guide to the Requirements of ISO 9001 which puts the main clauses in plain English.
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