ISO 9001:2015 revision explained: 'Context of the organisation'

The ISO 9001:2015 revision included some dramatic changes to the standard. One of the major changes was the introduction of the context of the organization in ISO 9001. Of course, the clause around the context of the organization may change and evolve with the predicted 2026 revision to ISO 9001. When that update is confirmed, we will update our ISO 9001 resources to reflect any key changes. But for now, in this article, we discuss the major change that occurred to ISO 9001 in 2015 that introduced this new clause of ISO 9001: “context of the organization.”

Why context is so important meaning ISO 9001 introduced context of the organization

Implementing a quality management system (QMS) is a strategic decision influenced by the context of the organization. "Context of the organization" is a new clause of ISO 9001, requiring organizations to consider both the internal and external issues that can impact their strategic objectives and how they plan their QMS.

Your organization should focus particularly on factors and conditions that can affect your products, services, investments and interested parties. Context becomes an important consideration and helps to ensure that your QMS is designed and adapted for your organization rather than taking a “one size fits all” approach.

This is why the context of the organization in ISO 9001 asks you to really consider the organization’s context, the needs and expectations of interested parties and an appropriate scope of the quality management system as a foundation point before structuring your ISO 9001 compliant QMS around these considerations.

Determining the context (step by step)

While there is no prescribed method of determining the context of your organization in relation to ISO 9001, you should take this simple and pragmatic four-step approach:

• Identify the internal issues that can affect your organization’s products, services, investments and interested parties
• Identify the external issues that can affect your organization’s products, services, investments and interested parties
• Identify who are the interested parties and what are their requirements
• Regularly review and monitor those internal issues, external issues and interested parties you have identified

With these four steps in mind, let’s dig a bit deeper into each step so you can best establish the context of your organization for ISO 9001.

Identifying internal issues

Your organization’s internal context is the environment in which you aim to achieve your objectives. Internal context can include your approach to governance, your contractual relationships with customers and your interested parties. Internal considerations really are the foundational pillar for establishing your ISO 9001 context of the organization.  

Internal issues can include your:

• Regulatory requirements, e.g. mandated local regulatory obligations
• Strategies to conform to your policies and achieve your objectives
• Relationship with your staff and stakeholders, including partners and suppliers
• Resources and knowledge (e.g. capital, people, processes and technologies)
• Risk appetite
• Assets
• Product or service
• Standards, guidelines and models adopted by the organization
• Information systems

 

Identifying external issues

To understand your external context, consider issues that arise from your social, technological, environmental, ethical, political, legal and economic environment. This next step is just as key to establishing the context of the organization, because it naturally impacts internal factors.

External issues may include:

• Government regulations and changes in the law
• Economic shifts in your market
• Your competition
• Events that may affect your corporate image
• Changes in technology

Identifying interested parties

Identifying any and all interested parties is essential for establishing the ISO 9001 context of the organization. Your interested parties include customers, partners, employees and suppliers. When developing your QMS, you only need to consider interested parties that can affect your:

• Ability to consistently provide a product or service that meets your customers' needs and any statutory requirements and regulations
• Continuous improvement processes and plans
• Ability to enhance customer satisfaction through effectively applying your system
• Your process for ensuring you conform to your customers' requirements and any statutes or regulations that apply

Regular reviews and monitoring

Finally, you must regularly review and monitor those internal or external issues you have identified as part of your establishment of the context of the organization in ISO 9001. Once you understand your internal context, management can carry out a political, economic, social and technological (PEST) analysis, for example. By doing this, you can determine which factors will affect how you operate.

While you have no control over external issues, you can adapt to them or put in place preparedness measures. PEST factors can be classified as “risks” and “opportunities” in a strengths, weaknesses, opportunities and threats (SWOT) analysis, or other alternative methods.

Next steps to establish your ISO 9001 context of the organization

Now that you have a better grasp on the ISO 9001 context of the organization clause, it’s time to consider whether you have a quality management system in place that will support your ISO 9001 compliance goals. This will involve setting objectives, refining processes and rigorous documentation.

By far the easiest way to establish the ISO 9001 context of the organization and to maintain a compliant QMS is to invest in the right software. Ideagen offers quality management software solutions that are trusted worldwide to make the task of ISO 9001 compliance simple