ISO 9000 is a set of international standards designed to help businesses meet the needs of customers while meeting regulatory and statutory requirements.
Many companies see the introduction of a quality management system as a major step forward in controlling and improving their key processes. Other companies simply react to customer demand which assumes they already have suitable systems in place - regardless of whether or not that's the case.
Looking at how you currently do things - and identifying opportunities to improve - is a great way to start introducing quality management. You will also need to decide whether you want to be formally certified for meeting the ISO 9001 standard.
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 before investing.
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 will be activities which directly affect customer satisfaction.
- You will 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
- ISO 9001 ensures your system will maintain quality at a consistent level. You decide what defines the quality level to meet customer requirements and satisfaction.
- A quality system meeting ISO 9001 will cover the full range of activities that affect the customer. It will also include measures to ensure the quality system runs smoothly.
- A quality system based on ISO 9001 can be separately assessed to prove it meets the standard (see Certification).
ISO 9001 focuses on how your quality system should be managed
- It is based on eight quality management principles which you must follow to achieve the standard.
- It requires that you document your systems.
- It demands a commitment to continual improvement.
- It requires full engagement from senior managers.
ISO 9001 is a flexible and logical way to achieve a recognised standard system
- The requirements of ISO 9001 may be tougher than those of a basic 'in-house' quality system. For example, it's common for in-house systems to bypass internal audit procedures.
- Achieving ISO 9001 certification demonstrates that you are serious about quality.
- Many larger companies, in particular, are reassured by suppliers who have a quality system certified to ISO 9001. This may be especially important if you want key supplier status.
Be aware of the costs involved
- Designing and introducing the system.
- Using the system. A poorly-designed system can be expensive and bureaucratic (see A healthy system).
- Certification and 'surveillance' visits.
Costs should be more than offset by the benefits the system will bring
- Costs can run into several thousand pounds. See Costs and resources.
- Some companies whose customers do not demand ISO 9001 choose to postpone certification. Others feel that the outside audit is a worthwhile exercise.
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
- They should be accredited by the United Kingdom Accreditation Service (UKAS).
- Certification by a non-UKAS accredited body is likely to lead to credibility problems with your customers.
Arrange a visit from the certification body's auditors
- They will seek objective evidence that you are complying with the ISO 9001 standard.
- UKAS prohibits auditors from acting as consultants. They will not tell you how to meet the standard but can offer advice.
The auditors will tell you of any shortcomings in your system
- If you satisfy the standard, the auditors recommend the award of certification.
- You can also be certified if the auditors only identify a small number of 'minor' problems. You will be required to correct these problems within a specified timeframe.
- If the auditors find more serious 'major' problems, you will be required to correct them and possibly undergo a re-audit before certification is achieved.
Once you are certified, you can display the certification body's logo
- If the body is UKAS-accredited, you can usually also display the UKAS 'tick and crown' symbol on your website and marketing material (consult UKAS about exceptions to this rule before doing so).
All certification bodies are required to revisit registered companies
- These surveillance visits normally take place annually at agreed dates to make certain you still meet the requirements of the standard.
- You will be given time to deal with any minor or major problems identified before any action is taken to withdraw your certificate.
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.
The ISO 9000:2015 series
The ISO 9000:2015 series of standards has replaced the ISO 9000:2008 series
- It's designed to apply to all types of business and focuses on delivering customer satisfaction.
- There's a greater emphasis on performance and managing risk rather than detailed requirements.
- The standard also aims to be easy to integrate with other management systems.
ISO 9000:2015 consists of a number of standards
- ISO 9000:2015 covers the fundamental ideas of quality management and contains a glossary of terms used across the ISO 9000 standards.
- ISO 9001:2015 is the new, unified standard, setting out the requirements against which you can be certified.
- ISO 9004:2009 looks at how you can make your quality management system more effective.
- ISO 19011:2011 provides guidance on quality management system audits.
The full series of ISO 9000 publications includes guidance on the standards
- Find guidance on ISO 9000 from the International Organization for Standardization (ISO).
- Read about ISO 9001 for smaller businesses from the British Standards Institution (BSI).
- Buy copies of standards from the ISO store or the BSI shop.
- Find a certification body accredited by UKAS.
- Find training for management system auditors from the International Register of Certificated Auditors.
- Contact your local Enterprise Agency or Local Enterprise Partnership for information on quality management grants and support.
"ISO 9001 is the world's most popular management systems standard. Accredited certification to ISO 9001 is an excellent method of improving customer confidence, enhancing brand image and gaining access to markets where certification is a condition to supply." - NQA
"ISO 9001 outlines simple principles that require a lot of hard work, but lead to a better understanding of how your organisation processes work. Most UKAS-approved certified bodies offer low-cost schemes for certification." - CQI