Mar 18, 2018

How to identify internal issues and external issues and Interested Parties for ISO 9001:2015

Traditionally, most organizations look at things like their market, their customers and their internal processes, while some will include looking at their environmental impact. Very few organizations actually look at their workforce, their community and the cultural and social aspects of the company. The 2015 version of the ISO 9001 standard pushes companies to include all these elements when planning the scope of the QMS.

External and Internal Issues

When the phrase Context of the Organization is used, context means a combination of external and internal factors that have a direct impact on the organization and its ability to continue providing products and services to its customers. Internal factors includes things like the organization’s culture, structure, governance, technology, strategic decisions and vision for the future. External factors encompassed the whole environment in which the organization operates: social, cultural, legal, political, regulatory, statutory, economical, etc., at all levels including local, state, country and even international.

The definition in the standard uses the words “external and internal issues,” clearly indicating that the company can’t simply focus on only its customers and owners. The standard also defines that the issues must be relevant to the company’s strategic direction and purpose, and that these issues could affect its ability to achieve the QMS’ intended results. So the size of the parking lot will not be part of the context. The first challenge is to determine the boundaries, which is why there is a requirement to determine the scope of the system.

As we have to determine issues that are relevant to the organization’s purpose, we first need to determine what that purpose is. The purpose will have various levels. The first, obvious purpose of the any organization is to create existing services or products. As strategic direction is also included in the requirements, one strategic direction could be to expand the range of products or services. This is the second level of the purpose. The last level comes from the requirement that all issues that could affect the organization’s ability to achieve the QMS’ intended results should be identified. The QMS has been implemented to allow an organization to create services or products effectively and efficiently to the requirements of both the company and its customers. Using all these phrases together will enable you to create the boundaries that are crucial to the next steps.

Once the external and internal issues have been identified, the organization must monitor and review these.  This task would be impossible to do without the boundaries mentioned in the analysis above. Operationally, this means that top management must identify what should be monitored, how this will be done, and how often it should be reviewed. Reviews are often only done annually, or even less often, i.e. only every five years when a strategic review is done. For organizations in fast-changing environments however, reviews might have to be done more frequently. When the context is examined, critical information about this will be revealed.

The notes in the standard give some guidelines on how to understand context. Although the context of an organization always exists already, it is not always acknowledged explicitly. This standard forces an organization to scrutinize the context, set proper boundaries, and then to monitor and review the context. Through this, the standard acknowledges that “one size does not fit all”.

Interested parties

Interested parties have always existed, the same as context did. We now need to take them into account based on the boundaries defined by the context.

There are many interested parties, including shareholders and owners, government bodies, employees, business associations, customers, suppliers, debt holders and the communities where people or facilities are located. The context can be used to determine how wide you need to go.

Once the interested parties have been identified, we need to define their “needs and expectations.”


Needs depend on the interested party. Some examples are debt holders needing to believe that the organization will pay its debts on time and in full, and suppliers needing to know that the organization will continue to use them, will pay on time, and will deal with them honestly and fairly.


For employees, a need to get paid, but they will also expect honesty and fairness. Some might expect promotions, while others may expect their work to be enjoyable or challenging. Expectations will vary widely, even within a homogeneous group such as suppliers. Some are expectations can be difficult to measure. Customers do for example not expect to discover that the product they bought was produced using slave labor, nor will they expect to find out that their clothing has cancer-causing chemicals in them. Expectations will vary substantially and will also change over time.

To summarize: an organization’s leadership must determine what the context of the organization is and who the interested parties are based on that context. They then need to define the strategic direction and scope of their QMS. The final step is to make sure that the quality policy and objectives are aligned with the context and the strategic direction.

The leadership can ensure that their QMS is effective and efficient at delivering what the interested parties need and expect by determining the organization’s context and interested parties.

ISO 9001 quality management systems (QMS) are implemented using Effivity software in Heidelberg (Germany), while ISO 14001 & OHSAS 18001 Health Safety Management Systems (HSE) are implemented with Effivity in Dhaka (Bangladesh).

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