What is ISO 9001 Certified? Meaning & Regulations

The International Organization for Standardization (ISO) first published their ISO 9000 family of quality management systems in 1987.

What is ISO 9000?

At the core of ISO 9000 are seven quality management principles. ISO 9001 sets out a series of requirements that any organisations that wishes to met the quality standards must fulfil.

ISO Certified Meaning

If an organisation is ISO 9001 certified, it means they’ve satisfied the criteria to embed the seven quality management principles across their operations.

The seven quality management principles are as follows:

  • Customer Focus – The organisation understands current and future customer needs. They meet customer requirements while striving to exceed customer expectations.
  • Leadership – Directors and managers define the organisation’s goals and work to create unity of purpose. The organisation creates and maintains a culture in which people can work towards achieving the organisation’s objectives.
  • Engagement – Across the organisation and at all levels, people make full use of their abilities to help the organisation achieve its goals.
  • Process Approach – The organisation manages activities and related resources as a process.
  • Improvement – One of the organisation’s ongoing objectives should be to strive towards overall performance improvement.
  • Relationship management – The organisation treats all external providers, including suppliers and contractors, as interdependent. They work towards establishing a mutually beneficial relationship.

How to Become ISO 9001 Certified

The ISO does not itself certify organisations. Instead, they rely on independent certification bodies to audit organisations based on the seven quality management principles. These certification bodies also have the power to issue ISO 9001 compliance certificates.

During the certification process, the auditor will scrutinise the organisation’s various sites, functions, products, processes, and services. Following the audit, they’ll present the organisation’s directors with a list of areas for improvement. The auditor will only issue a certificate if the organisation can present a satisfactory improvement plan.

There are no degrees of ISO 9001 certification. Organisations are either certified, or they’re not. ISO 9001 certification does not last forever. The certification body will conduct a fresh audit every three years or so.

You can read a detailed explanation of what it means to be ISO 9001 certified in this resource from the ISO.

Who Needs ISO 9001 Certification?

Many seem to think that ISO 9001 certification is only for manufacturing businesses. But ISO designed the standard so that any organisation can use it, regardless of their size or sector. This includes service providers such as schools, universities and hospitals.

So what might it look like in practice for a service provider to achieve ISO 9001 certification?

As we specialise in improving certain standards in healthcare settings, let’s explore what it might mean for a healthcare provider to become ISO 9001 certified.

ISO 9001 for Healthcare

In a healthcare setting such as a hospital, an ISO 9001 auditor might consider the following:

  • The hospital works to ensure its patient’s needs are met and exceeded. But it’s also focused on meeting the needs of regulatory bodies, and any other interested parties.
  • The leadership can define the hospital’s purpose and objectives, enabling hospital managers to clearly outline responsibilities and define roles in order to help the hospital achieve its objectives.
  • The hospital can define the risks associated with its service provision, equipment, infrastructure and clinical resources, and can demonstrate its ability to manage these risks.

If you’re aiming for ISO 9001 certification in your healthcare organisation, we can help you get there.

Air Quality & Exposure Levels for ISO 9001

We offer workplace air quality monitoring consultations, with which you can monitor your staff’s exposure to any potentially harmful substances in your hospital. This will help you understand your risk levels, so you can devise an air quality solution that works for you.

This will help you demonstrate that you’re aware of the inherent risks in your organisation, and that you take a proactive approach to managing these risks. It will also help you demonstrate your commitment to ongoing improvement – another key ISO quality management principal.

We also stock an extensive range of specialist air purification systems for healthcare settings. These will enable you to significantly improve the air quality in your organisation, which will help you secure your ISO 9001 certification for the long-term. Head here to browse our range of hospital air purifiers.