Context Of The Organization

The ISO 9001:2015, ISO 14001:2015 & ISO 45001:2018 standards requires quality management systems, environment management system and occupational health & safety management systems to be strategically aligned with the strategic direction, business objectives and intent. This has resulted in a very unique and important requirement called “context of the organisation” being added to the standard.

Before you begin work on ISO 9001, ISO 14001, ISO 45001 or the QMS, EMS, OHSMS compliances, the standard specifies that you should understand your business environment. You should understand what internal and external issues affect or may affect your organisation. Identify which stakeholders or interested parties will be affected, have the potential to be affected or perceive themselves to be affected. Each of the internal and external issues, along with various interested parties, if not addressed effectively, will pose a risk and will impact how the organisation achieves its intended output and strategic objectives.

The QMS, EMS & OHSMS standards also talks about scope definition based on the context, interested parties, products and services, etc. Any requirements of the ISO 9001:2015 standard that cannot be applied due to the nature of operations of the organisation can be identified and documented under scope.

The Context of the Organisation module of Effivity ensures you meet all these requirements in an effective, efficient and simple manner. The steps below demonstrate the capabilities of this module and show how to comply with the requirements relevant to the context of organisation clause.

  1. Define the context of the organisation by establishing the aim of the organisation, nature of the business and benefits of the business and establish strengths and weaknesses of, threats to and opportunities for your business.
  2. Define the different external issues that could arise due to competition, legal framework, culture and economy, etc. and how those issues affect your organisation. In addition, list the risks and opportunities associated with each external issue.
  3. Define the different internal issues, such as lack of competence, low productivity and differing values. Identify how these issues affect your organisation. Also, identify the risks and opportunities associated with each internal issue. These risks and opportunities can be analyzed in the Risk and Opportunity module of the software.
  4. Define the stakeholders and interested parties (an individual, a group of people, an organisation) and identify their needs and expectations. Define how they affect your organisation when their needs and expectations are not effectively addressed, and list risks associated with stakeholders and interested parties while keeping an eye on any possible opportunity for growth.
  5. Risks associated and captured along with internal issues, external issues and interested parties are available in the Risk and Opportunity module where you can identify, plan and take action to manage the risks.
  6. Define the boundaries of your QMS. This is the scope for which your organisation will be implemented and certified. As the standard is generic, it may happen that not all requirements will be applicable to your organisation. In this case, you can identify requirements that don't apply if the company’s capability to meet customer requirements and satisfaction is not impacted negatively.
  7. Justify requirements for clauses that don’t apply.
  8. Flow charts, procedures and forms relating to the context of the organisation can be captured in the Documented Information module.

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The comprehensive capabilities of this module enable all the requirements of the context of the organisation clause to be addressed in a quick and simplified manner while ensuring 100% compliance with the ISO 9001:2015, ISO 14001:2015 EMS standard and ISO 45001:2018 OHSMS standard. Contact us at for further information, or visit ISOCertification/Register.htm to subscribe to our award winning and one of a kind ISO 9001, ISO 14001, ISO 45001 compliance software to manage your organizational context with the most popular ISO software.

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