What is ISO 9001 and why is it important?

Aaron Hoare Date published: Jul 04, 24

ISO 9001 is an international standard specifying requirements for a quality management system (QMS). The standard obliges organizations to prioritize superior quality practices and establish a dependable QMS to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements.

ISO 9001 is applicable to any organization, regardless of size or industry, that seeks to enhance its quality management processes and ensure customer satisfaction. Effectively, if you operate in a context where meeting customer expectations and regulatory compliance are crucial, ISO 9001 is likely relevant. This encompasses businesses from manufacturing to service providers and all those seeking a framework for continual improvement.

ISO 9001 is due to be revised at some point in 2026. Once the revision is published, we will update all our ISO 9001 resources to reflect any new changes to the standard. For now, this article refers to ISO 9001:2015.

Who is ISO 9001 for?

ISO 9001 is relevant to a vast array of organizations across different sectors. Examples include organizations in industries such as automotive, aerospace, healthcare and education, all of which benefit from the structured QMS approach mandated by ISO 9001. The standard emphasizes risk-based thinking and incorporates a process approach, enabling organizations to identify opportunities for improvement and minimize risks, regardless of their specific industry.

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ISO 9001 serves as the foundational cornerstone for numerous industry-specific standards, operating as a parent framework that informs and enhances more specialized quality management systems. For instance, ISO/IEC 17025, which outlines criteria for the competence of testing and calibration laboratories, derives its fundamental QMS principles from ISO 9001.

Similarly, ISO 15189, specific to medical laboratories' quality and competence, and ISO 13485, tailored to the regulatory requirements of medical device manufacturing, both build upon the structural and procedural foundation established by ISO 9001. Other pertinent examples include ISO/TS 16949, which is for automotive industry suppliers, and ISO 22000 aimed at ensuring food safety management.

By establishing a robust and versatile QMS framework, ISO 9001 provides these specialized standards with the foundational elements required to address industry-specific needs while ensuring a consistent approach to quality management. However, in short, if your industry/organizational setting is one that has its own, more specific ISO standard, you should ideally look for certification to that standard rather than ISO 9001. That said, ISO 9001 would still offer some reassurance of the quality of your practices even if you are working in a setting where a more specific ISO would be better suited.

ISO 9001 is of paramount importance for any organization looking to bolster its quality assurance efforts because it is globally recognized. Certification facilitates demonstrating the reliability of processes and the quality of outcomes. It also involves requirements for internal audits and management reviews, underscoring an organization's commitment to continual improvement and customer satisfaction.

The adoption of ISO 9001 can significantly enhance the perception of your organization as credible and trustworthy to both current and potential customers or business partners. Additionally, many governmental organizations and large corporations often require ISO 9001 certification as a prerequisite for doing business or for crucial funding.

Is ISO 9001 a requirement for any organizations?

While ISO 9001 is not mandatory, it is highly recommended globally. Particularly when the implications of poor quality can be severe, the question might better be asked: can you afford not to be certified? Whether your organization’s outputs impact product safety, customer satisfaction or regulatory compliance, ISO 9001 serves as a robust framework ensuring reliability and quality.

Certification to ISO 9001 also enhances cooperation between organizations with similar scopes and fosters greater acceptance across different regions. By adhering to a globally recognized standard, organizations can facilitate international trade, as the acceptance of quality assurance standards eases transactions and collaborations across borders. For example, a food distributor in one country that is ISO 9001 certified will have greater assurance of the quality practices of its produce supplier from another country if they themselves are also ISO 9001 accredited.

Another significant benefit is improved data sharing and consistency, leading to a more substantial collective data set, which in turn can drive industry innovation and informed decision-making.

What are the benefits of ISO 9001 accreditation?

Those mentioned above are not the only benefits of ISO 9001 certification. Below are additional advantages to obtaining certification:

• Assurance of quality practices and outcomes recognized worldwide

• Meeting the increasing demand for consistent data

• Enhancing both domestic and international reputation

• Satisfying prerequisites for tender applications

• Improving your chances of being a preferred partner for clients

• Gaining a competitive edge over non-certified organizations

• Aligning with the standards of certified competitors

• Reducing costs through more efficient practices and fewer errors

• Saving time via automation of numerous tasks

• Proactively managing risks, preventing negative impacts

• Creating a unified source of truth through centralized document management

• Establishing a foundation for continual improvement, driving positive results across key performance indicators

Utilizing reliable and efficient quality management software can fundamentally improve compliance with ISO 9001 and foster ongoing enhancements. From managing training and development to organizing audits effectively, the right QMS reduces the time and effort required for essential quality management tasks, allowing organizations to focus on quality improvements based on actionable insights. Ideagen’s quality solutions simplify achieving these aspirations.

How to attain ISO 9001 accreditation

If you have confidence in your quality management system, you can apply to a relevant accreditation body within your country. Many of these bodies offer an online application process. For example, in the UK, the United Kingdom Accreditation Service (UKAS) is a primary accreditation body and lists entities authorized to certify to ISO 9001. In the US, the ANSI National Accreditation Board (ANAB) provides a directory of recognized certification bodies. Globally, other significant entities include the International Accreditation Service (IAS), with national-level accreditation bodies such as COFRAC in France and DANAK in Denmark.

Once you apply, a pre-assessment is typically conducted. During this stage, the accrediting body will pinpoint any major issues that need to be resolved prior to the official audit. This preliminary review, often termed an "audit gap analysis," helps you identify areas where your quality management system may require significant adjustments or updates. Implementing a reliable quality management software can facilitate this process.

Following the resolution of these issues, you will undergo an audit against the criteria laid out in ISO 9001. Achieving certification generally takes between 3 to 6 months, although this timeline can vary based on the state of your existing quality management system, the quantity of deficiencies identified, and the workload of your selected accreditation body. Nonetheless, 3 to 6 months is a typical timeframe for most organizations to attain certification.

How to maintain ISO 9001 accreditation

We'll explain this process based on how you maintain ISO 9001 certification through a UKAS certified body, but the process is very similar across accreditation bodies worldwide. After achieving certification, you will enter a "surveillance" period, during which the accreditor will conduct annual reviews to ensure continued compliance with ISO 9001 standards. These surveillance audits focus on specific areas of your quality management system to identify any significant non-conformities.

Every 3 to 4 years, the accrediting body will perform a comprehensive re-assessment audit. This is how the assessment cycle will look. While the surveillance and re-assessment process might vary slightly depending on the accreditation body, it typically follows a similar pattern: periodic surveillance audits accompanied by a full re-assessment at a predetermined interval, usually every 3 or 4 years.

The most effective way to ensure continuous compliance with ISO 9001 requirements is to utilize efficient quality management software. Such software aids in fostering a pervasive culture of quality throughout your organization, making the maintenance of ISO 9001 compliance more straightforward and systematic.

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