The Ultimate Guide to ISO 9001

What Does ISO 9001 Mean?

Quality management should be a top priority for organisations large and small. Without it, your business could face a number of consequences such as reduced sales, falling behind competitors and poor customer loyalty. If your products and services are of high quality, you could be more likely to attract higher-quality clients.

Whether your organisation wants to improve its reputation or reach its full potential, ISO 9001 can help.

Learn more about ISO 9001 and its meaning with our ultimate guide.

What is ISO 9001 and what does ISO 9001 mean?

ISO 9001 is an internationally recognised quality management system for quality management, created by the International Organization for Standardization (ISO).

The latest iteration, ISO 9001:2015, provides a framework for organisations to systematically manage and improve the quality of their operations, products and services in line with industry regulations and customer expectations.

ISO 9001 can guide organisations to quality management success by highlighting the importance of strong leadership, documented processes and evidence-based decision-making in meeting customer needs and industry regulations.

What is a Quality Management System (QMS)?

A Quality Management System (QMS) comprises a set of business processes and principles designed to help your organisation deliver consistently high-quality products and services.

Considered a vital tool by organisations of all sizes, a QMS helps businesses coordinate and guide operational activities and strategies. It helps organisations to comply with relevant industry regulations and become more efficient over time.

A QMS demonstrates your organisation’s commitment to quality and regulatory compliance. It helps identify areas of weakness, allowing the opportunity to fix them and implement measures to prevent recurrence.

The key elements of a QMS include:

• Quality planning – Building processes and policies that can help meet quality objectives

• Quality control – Checking all output to ensure quality consistency and addressing issues quickly

• Quality assurance – Ensuring adherence to internal and external quality processes

• Quality improvement – Highlighting the importance of continual improvement in quality management

Download our guide to the key requirements for ISO 9001.

The 8 principles of ISO 9001

ISO 9001 is based on eight core principles which provide organisations with a comprehensive framework for business operations:

1. Customer-focused organisation – Understanding and meeting customer needs is crucial

2. Leadership – Senior management establishes the organisation’s alignment and direction

3. Involvement of people – Engaging employees at all levels leads to greater efficiency

4. Process approach – Effectively managing interrelated processes increases system effectiveness

5. System approach to management – Interdependent processes should be managed as a single system

6. Continual improvement – Ongoing improvement should be a consistent goal

7. Evidence-based decision-making – Decisions should be data-driven

8. Mutually beneficial supplier relations – Interdependencies with suppliers and other interested parties can create value

Learn more details about the principles of 9001.

What are the benefits of ISO 9001?

By implementing a Quality Management System in line with ISO 9001, organisations can enjoy a wide range of benefits:

1. Increased business efficiency – ISO 9001 demands a systematic process approach, with organisations streamlining internal processes to reduce waste and costs, while maximising resource use and productivity.

2. Improved customer satisfaction – An ISO 9001 QMS helps organisations align their products and services with customer needs, increasing satisfaction and retention, which can boost sales.

3. Enhanced reputation – ISO 9001 certification can act as a badge, signifying to customers, stakeholders and partners that your organisation prides itself on delivering quality output.

4. Stronger risk management – ISO 9001 protects and improves quality levels by helping organisations take a proactive approach. This means businesses can identify and control operational risks before they have a negative impact.

5. Win new markets and business – In some highly regulated industries and markets ISO certification is mandatory to work with other companies or apply for tenders. ISO 9001 is also a globally recognised standard, which could make expanding your operations easier.

6. Consistent high-quality levels – Because of its process-driven approach, ISO 9001 can make it easier for organisations to maintain a consistently high level of quality and improve upon it, ultimately leading to higher customer satisfaction.

7. More engaged employees – Implementing effective quality management processes requires top management to get input from employees. This can increase their productivity and engagement by promoting a more positive, inclusive working environment.

How does ISO 9001 signify your commitment to quality?

Customers value high-quality products, services and customer service. They are more likely to return to organisations that consistently deliver high quality than to those whose quality levels are unpredictable or low – meaning ISO 9001 can significantly benefit your business.

ISO 9001 advocates for an interconnected process approach to ensuring quality. This helps organisations pinpoint and prevent potential errors, which can result in better quality outcomes.

ISO 9001:2015 vs ISO 9001:2008

You may sometimes see ISO 9001 referred to as ISO 9001:2015. This refers to the latest revision of the standard, which was revised in 2015. The previous version of ISO 9001 was ISO 9001:2008.

ISO standards are revised to ensure they remain relevant with evolving industries and compliant with current regulations.

Here are the key differences between the 2015 and 2008 iterations of ISO 9001:

Is ISO 9001 certification mandatory?

Being ISO 9001 certified is not a mandatory or legal requirement for Irish organisations.

However, some industries – such as medical device manufacturing and aerospace engineering – require businesses to achieve ISO certification to be eligible for contracts.

Your ISO certification status could depend on which industry your organisation is in, the markets you want to target and how much you want to stand out from your competitors.

Read our pharmaceutical risk management strategy checklist.

How to become ISO 9001-certified

Becoming ISO 9001-certified requires an organisation to dedicate significant time and resources to the process.

The first step is to thoroughly understand the ISO 9001 standard, its requirements and the current state of your pre-existing Quality Management System. You will then need to analyse how the standard requirements can be interpreted within the context of your organisation.

Besides gaining a thorough understanding of the ISO 9001 standard, other key steps include:

• Securing commitment and support from top management – This is essential for certification success. It would be their responsibility to align quality objectives with business strategy and commit the necessary resources.

• Developing a robust QMS implementation plan – This should have clear objectives, responsibilities and timelines. It should be treated like a roadmap allowing your organisation to systematically and effectively achieve certification.

• Establishing comprehensive training programmes for employees – This can help workers understand their roles and responsibilities within the QMS, as well as the overall quality objectives.

• Conducting regular internal audits and management reviews – This step should be taken to monitor the QMS’s effectiveness and identify areas that need adjustments.

Once your QMS proves effective, you can invite a certified body to undertake an audit and begin the formal certification process.

The process of getting ISO 9001-certified

Becoming ISO 9001-certified is a two-step process involving Stage 1 and Stage 2 assessments. The first stage assesses your existing QMS and highlights areas of noncompliance and improvement. The second stage verifies that your organisation has made the appropriate changes and that you can demonstrate how your QMS is used.

An auditor will conduct both assessments and highlight major nonconformities (which must be addressed immediately) and minor nonconformities (which can be addressed during the Stage 2 assessment).

If your QMS meets the standards, your auditor will recommend you for certification.

Download our free ISO 9001 checklist.

How long does ISO 9001 certification take?

The certification timeline can vary depending on your organisation’s size and complexity and existing management processes.

For example, an average timeframe might be 3-6 months for SMEs and 12-18 months for larger organisations.

How long does ISO 9001 certification remain valid?

Your initial ISO 9001 certification is valid for three years from the certification date.

Quality management is a long-term investment, and your organisation must undergo annual assessments to maintain certification. If your organisation fails to meet audit requirements at any point, it risks losing its certification.

How much does ISO 9001 certification cost?

ISO 9001 certification costs differ depending on a number of factors, including your industry, staff numbers and the number of sites you have. It also depends on the complexity and potential risks associated with your organisation’s processes and activities.

As a cost-cutting measure, auditors could visit a single site for the initial certification but audit another site rather than visiting each separately (assuming that the same standard-compliant processes are implemented across all sites).

Despite the associated costs with becoming certified, the return on investment makes achieving ISO 9001 certification an appealing business opportunity.

How to choose an ISO certification body

Choosing the right ISO certification body for your organisation is essential for achieving certification.

Using a recognised certification body demonstrates that an independent third party has verified your compliance with all ISO 9001 requirements, highlighting your commitment to quality management. This can be appealing to both existing and new customers.

Not all certification bodies are created equal, so doing thorough research is essential. Look for an accredited certification body that has a transparent certification process, provides support, is objective and impartial, and fully understands your organisation’s goals.

How Amtivo can help you

Undergoing the ISO 9001 certification process can be a lengthy, complex journey depending on the state of your pre-existing QMS – and that means ISO 9001 requires planning, focus and implementation.

Amtivo can help to alleviate some of the stress and make your certification journey smooth. Our expert team is based in Dublin, Ireland – and we can help you identify your organisation’s goals and work towards them.

Our INAB accreditation guarantees that your ISO certificate will be accepted and respected worldwide, making it easier to expand and secure clients in new markets.

You can also access our free ISO 9001 introductory training course.

Get started on your ISO 9001 journey – get a quote from us today.