What is and what is not ISO 9001

Since you are here, you probably know already that ISO 9001 is one of the most popular standards in the world - if not the most popular. Its purpose is to define the requirements that organizations should meet to establish an effective quality management system (QMS). This article discusses what ISO 9001 is, but also a few misconceptions about this standard.

First, what is ISO 9001…

It is an international standard, first published in 1987 under the name Quality systems – Model for quality assurance in design/ development, production, installation and servicing. However, ISO 9001 was not the first ever standard for quality assurance. Actually, it was based on BS 5750 a British quality assurance standard developed by the British Standards Institution (BSI) in the late 1970s. BS 5750 itself was influenced by MIL-Q-9858, a U.S. military quality standard from 1959.

Since 1987 ISO 9001 was revised four times, in 1994, in 2000, in 2008 and 2015.  A new edition of ISO 9001 is expected in 2026.

Over its history ISO 9001 undergone a major shift from quality assurance to quality management. This change was introduced by the 2000 edition of the standard. The current edition of ISO 9001 (2015) is based on several key concepts like process approach, risk-based thinking, continual improvement, customer focus or top management leadership and involvement.

A quality management system according to ISO 9001 can be implemented by any organization, regardless of size, structure or industry. The standard is not limited to manufacturing and can be used in service industries, healthcare, education and many other sectors.  Non-governmental organizations, governmental agencies, religious organizations or education institutions have implemented quality management systems according to ISO 9001. A famous sport institution, the football club Manchester United, achieved in 1997 ISO 9001 certification.

What ISO 9001 is not

Despite its respectable history and widespread adoption, ISO 9001 is still often misunderstood and there many misconceptions about this standard. Let’s clarify some of them.

ISO 9001 is not a product standard

An ISO 9001 certification for the manufacturing enterprise is a not a confirmation for the quality or conformity of its product. This is exactly the reason why organizations are not allowed to include mentions or reference to their ISO 9001 certification on the packaging of the product that is visible to the customer. 

A person cannot be ISO 9001 certified

The ISO 9001 certification is QMS certification and a QMS can only be implemented in an organization, not by an individual. As a result, a person can’t be ISO 9001 certified. Professionals can be certified as ISO 9001 practitioners or auditors, as evidence of their competence.

ISO 9001 is not a legal requirement

ISO 9001 is a voluntary standard. It may be referenced to by contracts, the QMS certification may be among the criteria for public procurement, but ISO 9001 implementation is not a legal obligation.

ISO 9001 Is not just for large companies

Many small family business implement ISO 9001 successfully. This standard is not only for large corporation, it can be applied by any organization regardless of size.

Getting an ISO 9001 certification doesn't mean no more audits

On the contrary! After obtaining an ISO 9001 certification the organization must undergo regular internal and external audits to maintain its certification. Second-party audits (conducted by organizations to their suppliers) may or may not be discontinued once the supplier becomes certified to ISO 9001

Conclusion

ISO 9001 is a useful tool which, if applied correctly, can help organizations improve various aspects of their operations. However, ISO 9001 is not a magic solution that guarantees success. By gaining a good understanding of what ISO 9001 is and what is not, a company can make informed decisions about implementing a quality management and maybe pursuing a certification.

For a detailed presentation of the requirements in ISO 9001 you may want to check out online course available here.

If you are interested in becoming certified as ISO 9001 practitioner or auditor you can find more information about our certification programs here.