Context of the Organization, ISO 9001:2015

As per ISO 9001:2015, the definition of Context of the Organization is “business environment“, “combination of internal and external factors and conditions that can affect an organisation’s approach to its products, services and investments and interested Parties”.

To fully understand your organisation and its purpose, it is necessary to determine your external and internal issues which may affect your organisation’s ability to meet its intended strategic objectives. Each of the internal issues and external issues along with various interested parties if not addressed effectively, will pose a risk and will have an impact on how an organisation achieves its intended output and strategic objectives.


The implementation of QMS should be the strategic decision of the organisation and is influenced by the context of the organisation and the changes in that context. The organisation must consider issues related to values, culture knowledge and performance of the organisation for the understanding of internal issues.

The organization must consider issues related to arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional or local for the understanding of external context. An organisation’s internal context is the internal environment within which the
organisation seeks to achieve its sustainability goals. Ultimately, quality is given as a result of a product or service that satisfies all key stakeholders requirements.

Your organisation will, therefore, be required to identify all relevant interested parties and their relevant requirements. The context of the organisation requires the organisation to evaluate itself and its context. The output of this context evaluation will be a determination of the scope of its quality management system, and this output should be included in the QMS “documented information” for evidence of a review.

These processes must include monitoring and measure processes to ensure all interested party requirements are identified and understood and all activities undertaken by your organisation are
meeting these requirements.

At TQCAS, we will help you in identifying parties that can affect you or your organisation, which will in return assist you in maintaining your stakeholder’s confidence in your organisation.

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Context of the Organization, ISO 9001:2015 – Transcend Quality Conformity Assessment Services Pvt. Ltd.