Understanding Context of the Organization | ISO 9001 Element 4.1 | Lean ISO 9001

This video discusses the application of Lean to the Understanding the Context of the Organization in ISO 9001 2015 standard element 4.1. You will discover how to respond to these requirements in a Lean manner. For understanding the organization and its context, the ISO 9001 standard requires the organization to determine external and internal issues relevant to its purpose and its strategic direction. Let's look at some typical examples of internal issues:

• Employee turnover, as it increases training time
• Expected retirement of key personnel, as it may present loss of knowledge
• Availability of qualified workforce, as it affects delivery schedule
• Aging equipment, as it impacts production schedule
• Poor customer satisfaction negatively affects customer retention
• IT security to prevent hijacking of the data
• And others

External issues may include:
• Supply chain interruption
• Loss of key providers
• Competitive pressures
• Changed regulations
• Changes in trade union rules
• Natural disasters
• And others

It is essential in Understanding the Context of the Organization that the standard requires the businesses to monitor and review information about these issues. There are three notes in this element 4.1 that are beneficial to consider
• NOTE 1 Issues can include positive and negative factors or conditions
• NOTE 2 Issues may arise from the legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local.

If you need to start or revise your issues lists, consider saving time and money using our Context Matrix Template. Check the link below to this free download. The following videos will explore how this Context Matrix may help us monitor and review these internal and external issues. This will help in Understanding the Context of the Organization, as required by the ISO 9001 standard.

Link to the Context Matrix download

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