ISO 9001 Quality Management Standard

What is ISO 9001?

ISO 9001 is the most widely recognised quality management system standard in the world. It demonstrates your organisation’s commitment to supplying a product or service that consistently meets your customers’ requirements.

UKAS accredited ISO 9001 certification is frequently a condition of being a supplier to large companies, Local Government departments or Government funded bodies (e.g. NHS, MOD).

The emphasis of ISO 9001:2008 is on maintaining well defined operating processes and striving to continually improve what you do – to the benefit of your customers, your staff and your organisation. It does not require you to change any of your operating processes but simply ensure that they are consistent and controlled.

A good Quality Management System is built around the business and not around the standard. It should be easy to maintain and set up so you can focus on your business needs and not on ISO 9001.

The ISO 9001 process provides a robust framework for improving every organisation’s quality system by adopting eight quality management principles:

  1. Customer focus
  2. Leadership
  3. Involvement of people
  4. Documented processes
  5. Integrated systems
  6. Continuous improvement
  7. A factual approach to decision making
  8. Mutually beneficial supplier relationships

Who can benefit from ISO 9001?

ISO 9001 is for all industries and sectors. It combines good business practice – generally, for your industry and specific to your business.

You can introduce ISO 9001 into any size or type of organisation. It is very common for medium to large companies to have ISO 9001 certification, even expected if they supply other large companies. Smaller companies are able to use their ISO 9001 credentials to compete on a level with bigger enterprises.

Your organisation can benefit if you currently feel your performance could be better in the following areas:

  • Accessing new markets or customer types
  • Improving your customer satisfaction
  • Increasing the effectiveness of your employees
  • Improving your control of your operations

How can ISO 9001 help you grow your business?

Here are three key ways that ISO 9001 can help:

  1. ISO 9001 enables you to increase your sales by expanding your customer base and meeting the conditions of specific sales contracts
    More often than ever procurement professionals use ISO certification as a means of simplifying the qualification process. Asking for ISO 9001 as a prerequisite of supplying is an easy way for many large organisations to differentiate between competing companies. Equas clients have found they have acquired significant new business that they would not have won without ISO 9001.
  2. It can enable you to reduce your costs through realising more efficient ways of working
    ISO 9001 provides a platform for better organisation and improves your responsiveness to customers. Because Quality Management puts your customers’ requirements at the centre of your business it ensures your team focus on the right activities. Satisfied customers lead to repeat business and good word of mouth leads to more referrals.
  3. Moving your business away from dependence on individuals towards a process-based approach
    As businesses grow, there is a greater to need to develop systems and processes so that all relevant employees can repeat and maintain best practice. Growing companies are, too often, reliant on key individuals. This dependence limits what you can achieve and can stifle growth.
    Investors welcome ISO 9001 as proof that a business can succeed with or without key individuals. Because investors will pay more for an ISO 9001 business, you will get a higher value when you are ready to sell.

What is the process for achieving ISO 9001 certification?

  1. Firstly, you need to make a decision on whether to use a UKAS accredited or non-UKAS accredited certification body. You need to ensure you are satisfying your current and potential customers’ requirements for UKAS certification. (Click here for more information about UKAS)
  2. Decide which of your products, services and locations you want to include in the scope of the certification.
  3. Decide when you want to achieve certification by and plan to maintain the momentum of the project. For one standard, we recommend three to four months as a comfortable period to complete the necessary work.
  4. Identify and allocate the resources required to complete the project by your target certification date. Where necessary, engage the support of an external consultancy firm.
  5. Decide how you will operate and maintain your management system documents and records e.g. pc, local server or specialist quality management system software (click here for more information about Activ Online Management System).
  6. Commence the Project
    • Ensure you have buy-in from key colleagues
    • Carry out a Gap Analysis of your current system against the certification requirements
    • Plan the project including resources and timescales
    • Appoint a Certification Body
  7. Project Implementation
    • Project Manage to ensure key milestones and deadlines are met
    • Map your operating processes to get a high level overview
    • Create appropriate documents to control your operating processes (e.g. purchasing, order processing, employee training)
    • Train your employees in the policies, procedures and control measures that are relevant to them
    • Carry out an Internal Audit and close out any significant actions identified
    • Complete your first Management Review meeting
  8. Undergo a certification audit by a UKAS-accredited certification body. This audit will be split into two visits. The first visit will review your system documentation (referred to as a Stage 1 audit). The second visit will audit your records, interview employees and assess whether you have effectively implemented your system (referred to as a Stage 2 audit).

What factors will affect your return on investment?

The return you make on your investment in implementing and maintaining an ISO 9001 certified Quality Management System will depend on a number of factors:

  • What new business you win or retain from customers who require you to have ISO 9001 certification.
  • How well you exploit your ISO 9001 certification in your marketing and PR materials.
  • The emphasis you place on identifying and implementing improvements that enhance your current service or product offerings.
  • The time taken to achieve certification. The longer it takes you to achieve certification the longer it will be before you realise any benefits. It’s often the case that organisations that take a long time to achieve certification have to undertake a certain amount of rework during the project due to personnel changes or changes in operating processes.
  • How inefficient and inconsistent your operations were before you started on the certification process.
  • How well you maintain your Quality Management System after you’ve achieved certification.

What are the implications of ISO 9001:2015?

The ISO 9001 standard is currently being reviewed and a new version of the standard is scheduled for release in September 2015.

If you are certified before the new version comes into force, you will be able to retain your ISO 9001:2008 certification for up to 3 years from the date on which you first achieve certification.

A draft version of the new standard has been published and based on the draft we expect the following key changes from the current version.

  • Greater evidence required that your Quality Management System is based on clear and well-defined processes
  • Greater involvement from the senior management and Directors
  • Requirement to conduct a high level risk assessment to identify areas where you can improve outcomes for your customers and stakeholders and reduce the likelihood of you not responding appropriately to events in your external market
  • Greater control over work outsourced to third parties
  • Tighter requirements on Quality Objectives and the monitoring and measurement of them

Please contact us if you would like advice and support on how to amend your current Quality Management System to comply with the requirements of ISO 9001:2015.

How can ISO in a Box™ help you?

We can help you achieve ISO 9001 certification whatever your industry sector. If you need to meet the requirements of other standards alongside, we specialise in building integrated systems.

Find your local ISO Consultant.

Contact us now to find out how to achieve ISO 9001, discuss your requirements or to obtain a fixed-price quotation with guaranteed certification.

What are the costs and timescales to achieve ISO 9001 certification?

If you would like an immediate email quotation then please provide some information about your organisation: