Essential guide to ISO 9000

A quality management system provides improved control of key processes

• All employees follow agreed processes for carrying out key activities, reducing the risk of costly mistakes.

A quality system provides a sound basis for improving quality and customer satisfaction

• The system describes existing key operations. The system can be adjusted to account for essential changes, such as new technologies, new customers and new ideas.
• The system provides a way of collecting and acting on suggestions for improvement. This improves the chances of broader quality management initiatives being successful and continuous.

A quality system lets you manage growth more effectively

• The system makes it easier to integrate new employees and activities.
• Having a system makes it easier to stay in control.

Many customers demand that each of their suppliers has a quality system

• They want to make sure the quality of your product or service meets their needs.
• Many larger customers will require the system to be ISO 9001 certified.

Setting up a quality system usually involves recording current methods of performing key tasks.

Start by looking at your current practices in key areas

• These tend to be 'mission critical' activities, where errors will cause serious problems. Typically, they are activities which directly affect customer satisfaction.
• You also want to focus on any areas that are causing concern.
• Concentrating on key areas brings the fastest improvements in effectiveness. The system can be rolled out later to other areas.

Plan your approach

• Think about the resources you will need.
• Analyse your current business processes by discussing them with the employees involved.
• Agree a format for recording information. This will include a description of any processes and any related instructions.
• Document the processes in the agreed format.
• Authorise the processes. Usually, a specified senior manager will be responsible for authorisation.

Do what is necessary to put the processes in place

• Distribute details of the processes to the employees involved.
• Train employees so they are competent at their job.

Check the new processes are working

Problems may occur due to one or a combination of the following:

• errors in the earlier writing stage process
• employees working in a different way from that agreed
• changes in circumstances since the original processes were agreed

Act to correct the problems

Finding and fixing problems shows the system is being used positively. Correct problems by:

• reviewing results from the checking process
• preparing (and authorising) revised processes
• making sure employees are trained to follow the revised processes

In this way, existing practices build to become an effective quality system

• The authorised processes set out the agreed best working method, but can be updated when necessary.

ISO 9001 (or 'BS EN ISO 9001') is the internationally-agreed standard for effective quality systems

Certification involves an independent assessment of your quality system to confirm that it meets the requirements of ISO 9001.

You need to design, document and set up your own quality system

• The system will need to cover all the requirements of the ISO 9001 standard.
• You may need outside help.
• Your quality system cannot be audited until you have generated documentary evidence to show you are meeting the standard.
• Many certification bodies will not conduct a formal assessment until the system has been operating for at least three months.

Find a certification body with relevant experience in your sector

The largest cost of ISO 9001 is the involvement of company employees

• Reducing this cost by minimising employee involvement is a false economy. The 'ownership' created by involving employees in designing the quality system increases the likelihood of them accepting it.

The next largest cost will be for designing and developing the system

• This needs to be led by someone with experience in this particular field.
• You may have someone within your own organisation who has carried out this role - perhaps with a former employer.
• Your local business support organisation may offer free or subsidised advice and training, and will be able to provide names of approved consultants.

Any grants for this tend to be directed through local business support organisations

• Different areas have different grants, which depend on local conditions.
• A typical grant may cover up to 50 per cent of the cost of an approved consultant.

Certification fees are around £1,000 for the smallest companies

• Overall costs depend upon company size and the number of locations involved.
• Ask certification bodies for quotes for initial audits and surveillance visits. Many will give an all-inclusive price, including surveillance visits for three years.
• Ask your certification body if it offers special rates for smaller companies. Typically, this will depend on how long the assessment is likely to take, based on the type of activity, number of staff employed, your industry and number of operating sites.

The standard requires that companies have trained internal auditors

• These internal auditors can carry out audits on the system.
• An internal audit can provide an effective way of monitoring the system and identifying areas for improvement.

Most companies will eventually achieve certification if they wish to. But in doing so, they often build systems that are far too complicated for their own needs.

Avoid creating too much paperwork

• Consider using working documents as a way to keep records.
• Challenge every new form that is suggested. Can an existing form be changed instead?
• Keep the number of controlled copies of system documents to a sensible minimum. ISO 9001 does not demand that everyone has a copy of everything.
• Use your IT system to minimise the need for paper copies. Give employees access to key documents through your internal network or on reputable cloud storage platforms.

Ensure internal audits are carried out regularly

• Use these reports to monitor the system and drive improvements.
• Continually question whether you are running the system or the system is running you.

Introduce a balanced method for dealing with changes to the system

• The method must be formal enough to maintain management control.
• The method must be informal enough to encourage employees to put ideas forward. If not, employees will lose respect for the system and may introduce changes informally instead.

Take every opportunity to compare your system with those of other companies

• Compare yourself with suppliers, sister companies and customers, for example.
• Use supplier assessment audits.
• Use customer questionnaires.
• Ask questions on social media with relevant hashtags.
• Create an online forum or blog for discussion.