What Is ISO 9001? The Ultimate Guide to the Standard

ISO 9001 is an internationally recognised quality management system. It helps organisations deliver high-quality products and services in accordance with industry regulations and customer expectations.

This guide covers key areas of the ISO 9001 standard. We’ll explain what exactly ISO 9001 is, list its wide-ranging benefits and take you through the certification process. You’ll also learn how to choose the right certification body for your organisation.

Read on for the ultimate guide to ISO 9001 – perfect for any business aiming for ISO 9001 certification to streamline operations and boost customer satisfaction. Set your organisation apart in today’s competitive marketplace.

Established by the International Organisation for Standardization (ISO), ISO 9001 is the globally respected standard for quality management. As a recognised mark of quality, it is an attractive certification for organisations worldwide.

This ISO standard helps organisations implement transparent, repeatable processes to maintain a quality service for their customers. ISO 9001’s main aim is to help organisations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service.

ISO 9001 can be adopted by any organisation, regardless of size, sector or industry. The standard is based on eight quality management principles that guide businesses towards improved performance. These are:

• Customer focus
• Leadership
• People Involvement
• Process Approach
• Systematic approach to management
• Continual Improvement
• Factual Approach to decision making
• Mutually beneficial supplier relations

A Quality Management System (QMS) is a set of business processes that help ensure your business delivers consistently high standards. Together with the relevant documentation, a QMS defines your commitment to creating products and services in accordance with pre-defined standards. A QMS is vital for businesses.

It helps them coordinate and guide their daily activities and operations so they comply with customer and regulatory requirements. It also helps improve an organisation’s effectiveness on a continuous basis.

A QMS can help you improve processes when something goes wrong, outlining what your team needs to do to find out what went wrong and what to do to ensure it doesn’t happen again.

The key elements of a QMS include:

• Quality planning – designing processes that will help meet objectives
• Quality assurance – ensuring processes are being followed
• Quality control – checking output to ensure consistency and fixing issues
• Quality improvement – constantly improving all processes

With enhanced quality in products and services, your business can see increased customer confidence and have a competitive edge in the marketplace.

Why choose ISO 9001? There are plenty of benefits for your organisation – here are just a few:

1. Improved customer satisfaction and retention: ISO 9001 helps businesses understand and align their processes to customer needs. By increasing product or service quality, customer satisfaction levels rise, promoting customer loyalty and repeat business.
2. Improved business processes and efficiency: This standard endorses a process approach. It helps businesses organise internal processes and reduce inefficiencies. This leads to less waste and more productivity, saving you money and boosting profits.
3. Increased reputation: ISO 9001 certification enhances a company’s credibility, demonstrating a commitment to quality. This increases trust among customers, partners and stakeholders, elevating its reputation in the market.
4. Access to new business: ISO 9001 certification is proof that you have a globally recognised QMS in place, which reassures potential customers that you can consistently deliver high-quality results. In some markets and industries, an ISO 9001 certification is a mandatory requirement for accessing tenders and becoming part of a wider supply chain. Achieving this certification can open doors to new business opportunities that competitors can’t access.
5. Risk management: ISO 9001 helps organisations to identify and control operational risks, improving predictability and the reliability of business outcomes. This proactive approach to risk helps businesses anticipate and address issues that could negatively impact their performance early on.
6. Consistency in delivering products and services: The standard advocates a consistent approach to processes, which leads to predictability in the quality of products and services delivered, which then leads to customer satisfaction.
7. Engagement of employees: Implementing ISO 9001 involves employees in improving processes. This can help increase their engagement and motivation, creating a more positive work environment and leading to enhanced productivity. Top management is required to take an active role as part of this process.

British Assessment Bureau’s research shows that ISO 9001 can exceed customer expectations.  When asked for their motivation for implementing the standard, 43% of clients said it was to win more business. Having achieved certification, 62% said ISO 9001 had successfully led them to winning work. When we asked our customers how ISO 9001 had helped them:

• 76% reported improved internal processes and efficiency
• 62% qualified for, or won new business
• 24% could tender for more new business
• 13% retained contracts with existing clients

Businesses that deliver great results every time can be more likely to delight their customers. Make sure your organisation is set up to deliver those results. Read more about the benefits of ISO 9001.

ISO 9001 is a standard that highlights the importance of meeting customer requirements which leads to high-quality products and services. It advocates a process approach, viewing processes as interconnected. This helps organisations pinpoint potential errors and prevent them, resulting in better quality outcomes.

3 ways ISO 9001 certification improves quality

1. Continual improvement: ISO 9001 is built around the concept of continual improvement. It empowers organisations to routinely analyse their processes and make necessary adjustments, driving ongoing improvements in product quality, operational efficiency and customer satisfaction.
2. Establishes regulatory compliance: ISO 9001 is an industry-recognised certification that emphasises a process approach, making it easier to comply with any mandatory quality regulations.
3. Evidence-based decision making: ISO 9001 advocates making decisions based on data and evidence, which leads to better-quality outcomes as decisions are grounded in reality, not assumptions.

ISO 9001 certification is not mandatory or a legal requirement. It’s a voluntary step an organisation can choose to take based on its business needs and objectives. However, getting certified can boost an organisation’s credibility and customer confidence, providing a competitive edge over businesses that aren’t ISO 9001-certified.

While the certification itself isn’t legally required, the processes it promotes can help organisations meet various regulatory and statutory requirements, reducing risk. For example, clients in certain markets and industries (such as aerospace and medical device manufacturing) may require an ISO 9001 certification from contractors, making it a practical necessity.

Take our ISO 9001 Readiness Quiz to assess whether you’re ready to begin your certification journey.

ISO 9001:2015 is the most current version of the ISO 9001 standard, replacing ISO 9001:2008. This table compares the two versions:

Achieving ISO 9001 certification requires a thorough understanding of the standard, its principles, and how it applies to your organisation’s processes and operations.  It’s essential to familiarise yourself with the ISO 9001 requirements and interpret them within the context of your business. The following steps are key to certification: 

• Secure top management commitment and support – this is critical for certification success. Leaders play a decisive role in driving the ISO 9001 implementation process, aligning quality objectives with business strategy and committing the necessary resources.
• Develop an implementation plan outlining clear objectives, timelines and responsibilities. This strategic roadmap enables your organisation to manage the certification process effectively.
• Establish training programmes for employees, ensuring they understand their role in the QMS. Staff should be aware of quality objectives, their personal responsibilities and how their actions can influence outcomes.
• Once the QMS has been implemented, conduct regular internal audits and management reviews and make quick, effective adjustments to ensure the system’s effectiveness.

When your QMS is considered effective, you can invite an accredited certification body to perform a certification audit. Once this is successfully completed, your organisation will be awarded the ISO 9001 certification. You will need to prove your QMS actions to your auditor with several documents, including:

• Your quality policy
• Scope of the QMS
• Quality objectives and how you plan to meet them
• Management review results
• Internal audit programs and results
• Competence records
• The procedure for control of externally provided processes, products and services.

You may require many other documents in addition to these – find out more details about the required documents for ISO 9001. The ISO 9001 certification process will highlight areas where your documentation needs improvement, so don’t worry if you don’t have everything in place before you begin. Consider working with a qualified ISO 9001 consultant to navigate the process if required.

Download our ISO 9001 Checklist

If you are currently engaged in the process of implementing a Quality Management System (QMS) with the aim of obtaining ISO 9001 certification, this checklist serves as a valuable tool to evaluate your adherence and pinpoint areas that may need further attention.

The ISO 9001 certification process involves two assessments. The first examines your existing processes to find any areas that need improving. The second examines those areas to ensure that you’ve made the required improvements and that you can demonstrate how your QMS is used.

Stage 1 assessment

The first assessment is also known as the Stage 1 assessment. Your auditor will review your documentation and processes before identifying any gaps between what you have and what you need to achieve your ISO 9001 certification.

How long the assessment will take depends on the size of your organisation and the industry you’re in. We’ll tell you in advance how long we expect your assessment to take.

Once the Stage 1 assessment is complete, we’ll send you an overview of areas identified by your auditor that require improvement before your ISO 9001 certification can be issued. We refer to these areas of improvement as ‘non-conformities’ and there are two types.

• Major non-conformities need to be rectified immediately.
• Minor non-conformities can be reviewed at the next assessment.

Stage 2 assessment

Your auditor will use the second assessment to examine the non-conformities they found in the Stage 1 assessment and your responses to them. Your auditor will also ensure your processes work in practice as part of the Stage 2 assessment.

To do this, they’ll meet with your managers and staff. They’ll want to see internal audits and management reviews, too. This helps your auditor ensure that everyone knows the processes and, more importantly, how to follow them. Assuming that there are no major issues, your auditor will recommend you for certification.

If our auditor identified any further non-conformities, these will be included in their report – you’ll need to resolve these before your certification can be issued. Our compliance department will then review your auditor’s recommendation. This step is a vital requirement of our UKAS accreditation.

Assuming our team finds no areas of concern, they will confirm that your QMS meets the required standard. Congratulations; you just achieved ISO 9001 certification!

The time it takes to achieve ISO 9001 certification can vary depending on your organisation’s size and complexity and its existing management processes. On average, small to medium-sized businesses might take 3 to 6 months, while larger organisations might need up to 12-18 months. 

The Stage 1 assessment, which involves understanding the requirements of ISO 9001 and conducting a gap analysis, can take a few weeks to a month. The bulk of the time is typically spent implementing the QMS across the organisation, which can span several months. Next, internal audits and management reviews are conducted, and any identified issues are addressed. This could take another few weeks to a month.

The Stage 1 and Stage 2 certification audits then follow, which require a significant amount of time to conduct the audits and address any non-conformities identified.

Once the Stage 2 audit is passed, the organisation is recommended for certification, which can take a few weeks to be issued. While the certification process requires a significant time investment, the benefits of ISO 9001 certification make the commitment worth it.

ISO 9001 Key Requirements Checklist

Discover what you need for ISO 9001 with our free key requirements checklist.

Download Now

Your ISO 9001 certificate lasts three years. To maintain your certification, you’ll undergo an assessment once a year. The annual assessments are a repeat of the Stage 2 assessment and are necessary for keeping your ISO 9001 certification. They ensure your QMS is still operating to a high standard after any improvements.

You’ll recertify your QMS every three years. This demonstrates to your customers, both existing and new, that your QMS continues to operate to the standards of ISO 9001 and that your certification is being regularly reviewed and maintained. If an organisation fails to meet audit requirements at any point, it could risk losing its certification.

It’s important to remember that an ISO 9001 certification is not a one-time event – it is a long-term commitment to quality management and improvement. You can find out more about the three-year ISO certification cycle here.

How much your ISO 9001 certification costs depends on several factors. That’s why, when determining your quote for certification, we use an industry-standard approach that takes into account:

• Staff numbers
• Industry
• Complexity and risk
• Number of sites

An auditor might only need a few days to assess a smaller organisation, but a bigger business with a number of different sites will need longer. One way we can reduce the time and cost of certification is through a process of ‘sampling’.

Our auditor can visit a single site (assuming it is representative of the processes followed by other sites). Rather than visit each site for your annual assessments and recertification, our auditor will visit different sites as a cost and time-cutting measure. Despite associated costs, an ISO 9001 certification is a worthwhile investment.

Achieving this certification can lead to long-term financial benefits, improved customer satisfaction and loyalty, increased operational efficiency, market expansion and risk mitigation. Not achieving certification could lead to lost business if ISO 9001 certification is a common standard in your industry or required by some clients.

If you want to know more about the investment required for ISO 9001 certification, we’ve put together a guide to budgeting for your ISO certification.

When you achieve ISO 9001 certification through a recognised certification body, you have proven that an independent third party has verified that you meet all requirements of the standard. This is a powerful message to new and existing clients. Not all certification bodies are equal -reputation and experience matter.

Choose a body with a solid track record in providing ISO 9001 certifications, particularly within your industry. A certification body that understands your local market and relevant legal and market requirements can add significant value. It’s crucial that your chosen certification body offers a transparent certification process and is willing to explain this in detail. Ongoing support is an asset in ensuring your QMS’s continued success.

This might include help understanding audit findings or guidance on maintaining certification. A certification body must be impartial and objective, steering clear of any conflicts of interest that could compromise the certification process. While cost shouldn’t be the sole deciding factor, the fee structure should be transparent. Make sure you understand all related costs before making a decision.

Pay particular attention to ongoing fees. Some organisations charge annual ‘management’ or ‘administration’ fees, while others don’t. An annual re-audit is mandatory, but some certification bodies may insist on visiting (and charging) you more than once a year.

Certification bodies, such as British Assessment Bureau, carrying out certification to ISO management standards will follow ISO 17021, which specifies requirements for bodies providing audit and certification of management systems. This means we cannot write documentation for you or provide consultancy in conjunction with certification in order to remain objective and impartial.

What we can do is provide ISO training, which can be a useful exercise before committing to implementing a standard. Remember, your choice of certification body plays a crucial role in your organisation’s success in achieving and maintaining ISO 9001 certification. It’s a decision that requires careful consideration to ensure a successful certification journey.

As experts in the industry, you can trust us to take you through the process in a professional and encouraging manner so you can focus on achieving your ISO 9001 certificate as soon as possible.

UKAS-accredited, superior certification

We are one of the few certification providers that enjoy UKAS accreditation – which makes the difference between an ISO 9001 certificate that will win you new business and a piece of paper that fails to impress your potential new clients. You can be sure that an ISO 9001 certificate from British Assessment Bureau will put you ahead of the competition. Learn more about how UKAS accreditation makes your ISO 9001 certificate stand out.

Expertise on tap

It can be challenging to determine where your business needs to improve in order to achieve your ISO 9001 certificate. When our auditors conduct their assessment, they’ll identify gaps and areas of improvement that would stand in your way. Even better, they’ll provide you with a comprehensive report with recommendations that you can start working on immediately.

Customer satisfaction

You can tell that we put our customers first because of the reviews we receive from them. In fact, 97% of our customers have left us reviews of 4 or 5 stars on Feefo.

Flexible payment options

We offer the option to spread your payments over monthly instalments so you can pay for your ISO 9001 certification in the way that makes the most sense for your business.

We asked our clients to outline why they chose ISO 9001 and how it has helped them.

• “We felt it was important for Explore to achieve this standard, not only to give us credibility in the marketplace but to act as a tool to ensure the processes and procedures we thought were right for business were actually doing their job. Having ISO 9001 acts as an important first step to opening doors with potential customers, especially with larger tier 1 contractors.” – Explore Transport, British Assessment Bureau client
• “ISO 9001 certification adds a significant level of credibility to how our company is perceived.” – Aura Q, British Assessment Bureau client
• “We sought ISO certification to improve the quality and consistency of the services we offer to the people we serve.” – Stephen Hawkins, Age Concern Hounslow
• “Implementing ISO certification has improved our internal processes and awareness of how we operate.” – Peter Keast, ADA Network
• “The value that our clients hold of ISO is really quite huge – in all of our tenders, there is now a requirement for ISO certification, and some quite specifically ask for ISO 9001. Although we previously had quality systems in place, there were processes that were often ‘lost’ and we maybe weren’t as organised as we could be. ISO 9001, in particular, has allowed us to really develop our existing processes, and as a result, we are much more organised and ready for our planned growth.” – Lawrence Hargreaves, Nicoll Curtin

Achieving ISO 9001 certification can do great things for your organisation. You can significantly enhance your organisation’s reputation, increase operational efficiency and boost customer satisfaction.

As a trusted partner, British Assessment Bureau provides experience and expertise, assisting businesses across the majority of industries in achieving ISO 9001 certification.

Our approach to ISO 9001 certification is designed to make the process as smooth as possible. We partner with you to understand your unique business needs and tailor our services accordingly, ensuring a rewarding certification journey.

Ready to take the next step towards ISO 9001 certification and unlock these benefits for your organisation? Get started today.