ISO 9001:2015 Quality management systems — Requirements (ISO 9001) was initially published by the International Organization for Standardization (ISO) in 1987 and has been revised four times since then, to take into account evolving economies, technological advances, and societal changes. The current version was published in September of 2015 to update and complement its predecessor, ISO 9001:2008. Today, iso 9001 certification is the world’s most recognised Quality Management System (QMS) Standard, with more than 1 million organisations across the globe having adopted it. ISO 9001 is defined as the international standard that sets out the criteria for a QMS. Organisations, all over the world, use ISO 9001 to ensure consistency in the quality of the products and services they offer to consumers while meeting all regulatory requirements. It also helps improve customer satisfaction and streamline business operations. ISO 9001 is the most coveted certification of the ISO 9000 family of quality management systems and the only standard in the series that can be certified to.
What are the requirements of ISO 9001?
ISO 9001 is composed of ten clauses, 8 of which are requirements. The first three clauses (Scope, References, and Terms and definitions) are informational in nature. The 8 requirements are as follows: Context of the organisation, Leadership, Planning, Support, Operation, Performance evaluation, and Improvement. In a previous article (please insert link to article titled ISO 9001 Quality Management System Requirements) we had covered all the requirements in great detail. In this article, we will reveal what requirements are at the essence of QMS certification. Although all clauses are equally important, these two are fundamental in terms of laying down a solid foundation to ensure an effective implementation of the ISO 9001:2015 standard.
Before continuing the study, we suggest that you read the article iso 27001 certification process for more information on the types of ISO certifications. The two clauses are as follows:
Scope of ISO 9001
The first clause, Scope, consists of a statement describing with precision the activities of the applicant organisation, the products/services it delivers to its clients, the facilities and locations where those products/services are delivered, as well as any regulatory requirements it is bound by. Essentially, the scope defines exactly what your organisation does.
The current version of the ISO 9001 standard provides guidance and further explanation on how to effectively define the scope of your QMS. These explanations provide a framework that helps standardise how organisations define the scope of their QMS. Although it is advised to keep your scope clear and concise, it is of greater importance to ensure the specifics of your scope are fully documented in your QMS in such a way that if any external party were to read it, they would easily get a clear understanding of the nature of your operations.
Defining the scope of the QMS
Defining the scope of the QMS has been a requirement of the ISO 9001 standard since its inception. Nevertheless, it has evolved and increased in importance with every version of the standard. Today, it represents a fundamental component of the quality manual, as it specifies how far the QMS extends throughout the organisation’s operations, describing and justifying any exclusions from the standard requirements. The importance of this clause cannot be overstated, as it is through the scope that is defined what your QMS covers within your organisation.
Context of the organisation
The Context of the organisation clause is relatively new, as it was only introduced with the 4th and latest instalment of the 9001 standard. It was added to take into account the considerable changes that took place in the operating environments of organisations over the last decade or so. In such a relatively short period of time, we have witnessed immense progress in technology, with social media becoming pervasive parts of our daily lives and we have seen our environment deteriorate faster than ever before, leading to new laws and regulations being introduced. There have also been significant changes in the political, economic, social, and financial spheres. These are what the ISO 9001 standard considers as the external factors that can have an impact on an organisation, its products and services, investments and interested parties. On the other hand, we have also witnessed drastic changes affecting the internal environments of organisations in terms of processes, systems, people, and knowledge. This is what the standard refers to as internal factors. The combination of the external and internal factors is what constitutes, for the standard, the context of an organisation.
This clause and the Scope clause complement each other and are both fundamental to the ISO 9001 implementation process. Without a proper understanding of what an organisation does and the environment in which it operates, an organisation cannot plan its QMS effectively. Without properly considering the various factors that can affect their business operations, organisations cannot create a strategic plan to address them.
Therefore, it can be said that the Scope and Context of the organisation clauses are at the core of any sound QMS implementation because they ensure that the QMS is designed and adapted specifically for your organisation, rather than adopting a standardised approach that does not take into consideration who you are as an organisation.