A Detailed Overview of the ISO 9001 Certification

Kate Onissiphorou

by Kate Onissiphorou

21st September 2022

The ISO 9001 certification is the most common and comprehensive internationally-recognised certification for quality management systems. It applies to both private and public/government organisations providing products and services for either profit or not-for-profit.

ISO 9001 is a badge of honour for organisations that are vying for international recognition. It provides a high level of assurance that an organisation has the capacity and quality management system to be globally competitive.

What is ISO 9001?

3D illustration of a rubber stamp with the text ISO 9001

More specifically, ISO 9001:2015, which is the most recent version of ISO 9001, is a set of guidelines for organisations to include in their quality management systems. It’s formulated and agreed upon by various national standards bodies that constitute ISO. 

Although ISO 9001 is not legally binding in itself, it has equivalent local statutory requirements. Hence, it’s still followed based on local needs and regulations.

An organisation should adhere to the ISO 9001 standards if it either:

  • Wants to gain a competitive edge and recognition in the global market by showing its products and services can meet high international quality standards; and/or
  • Wants to further improve customer service and client satisfaction by going above and beyond the minimum standards in a particular country.

It’s worth noting that the ISO 9001 requirements are generally applicable to any organisational entity, be it private or public. Plus, they don’t consider the size of the organisation or the products and services it provides. As a result, any organisation that complies with the management system quality standards can receive ISO 9001 certification.

The importance of the ISO 9001 quality management system

Having an ISO 9001-certified quality management system means an organisation can demonstrate it complies with internationally-accepted standards. This is a mark of quality and competence, which translates into a good reputation and international credibility. 

Organisations must undergo meticulous inspections and assessments before they’re awarded ISO 9001 certification. During the ISO 9001 certification process, an organisation can identify threats and take action to combat and prevent them. It also has the opportunity to evaluate its systems and change them if necessary. Certification can therefore significantly improve an organisation’s operations while minimising any internal and external threats.

Having an ISO 9001 certified quality management system is important to an organisation’s stakeholders. These stakeholders might include customers or clients, employees, investors, partners, suppliers, and the general public. It also gives the global community a better understanding of an organisation’s particular specialism.

Learn more about how ISO certification can benefit your business here.

What is required for ISO 9001 certification?

Although ISO 9001 certification isn’t legally binding, ISO standards are recognised by various countries and territories as a credible certification for quality standards. Some certification requirements within the organisation are mandatory, while others are non-mandatory.

Examples of mandatory requirements 

Here are some examples of the mandatory requirements an organisation must meet to secure ISO 9001 certification:

  • Monitoring and measuring equipment calibration records ReAgent employee checking equipment
  • Records on training, skills, experience, and qualifications
  • Records relating to design and development outputs review
  • Records on design and development inputs
  • Records on design and development controls
  • Design and development output records
  • Design and development changes records

Examples of non-mandatory requirements

Here are some examples of non-mandatory procedures that are often included: 

  • Determining the context of the organisation and any interested parties
  • Addressing risks and opportunities
  • Competence, training, and awareness
  • Equipment maintenance and measuring 
  • Document and record control
  • Design and development
  • Production and service provision

Example of ISO quality management systems

ISO provides downloadable documents and templates for specific standards. The ISO 9001 standards for quality management systems (QMS) are more generic and comprehensive compared to other standards. 

For example, the first and most important ISO QMS standard is the calibration step, in which the capacity of an organisation is evaluated and compared to international standards. This is a long and tedious process that involves auditing the infrastructure, operations, and roles within the organisation.

What are the principles of ISO 9001?

ISO 9001 certification is guided by seven core principles of quality management systems. The principles can be summarised as follows:

  • Engagement of people – an organisation should empower its people 
  • Customer focus – this emphasises the importance of meeting and exceeding customer expectations ReAgent employees working in the factory
  • Leadership – the unifying agent that directs the organisation in achieving QMS goals
  • Process approach – this relates to the consistency and standardisation of the management system and its impact on reliability and predictability
  • Improvement – there should be an emphasis on making the organisation better in every aspect of management
  • Evidence-based decision making – organisations should take a scientific and data-driven approach that ensures an accurate response
  • Relationship management – this involves both the internal and external stakeholders of an organisation, such as investors.

The difference between ISO 9001 and ISO 13485

The main difference between ISO 9001 and ISO 13485 is that ISO 9001 tends to be more generic and is focused on the quality management systems outlined above. It applies to all types of organisations, regardless of their size or the type of products or services they provide. 

ISO 13485, on the other hand, specifically relates to the management systems involved in the manufacture of medical devices.

ReAgent’s ISO certifications

ReAgent currently holds four ISO accreditations: ISO 9001 for quality management, the ISO 14001 environmental certification, ISO 13485 for quality management systems relating to medical devices, and ISO 45001 for occupational health and safety.

If you’d like any further information about our ISO certifications, please feel free to contact our friendly team.


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