Sep 13, 2017

How to address context of the organization requirement of ISO 9001:2015 standard ?

The context of the organization is a new requirement in 2015 version of ISO 9001 QMS standard.

Many organizations are struggling to understand and effectively address this requirement.

At Effivity we make QMS compliance simple and suggest the following to our users.

  1. Identify your vision and mission. If you don’t have that defined, pen down where you want to reach in future and how you will go there.
  2. Identify your business environment, your competition, and customers’ needs/preference. You can use SWOT analysis and PESTEL analysis.
  3. Identify all the challenges/issues/problems you face internally in your organization which impacts your business/product or service quality/customer satisfaction/business continuity and profitability. Ask a question to yourself, how this will affect my business and is there any related risk. While you identify issues, ensure you consider positive issues as well which might open up an opportunity for your organization.
  4. Repeat the same exercise to identify external challenges/problems and issues.
  5. Identify all the stakeholders / interested parties you are associated with. These can be your customers, suppliers, employees, surrounding community, investors, bankers, government authorities, regulatory bodies etc. Put yourself in their shoes and think what could be their needs and expectations from your organization. Ask one more question – what will be the impact on your organization if these needs and expectations are not fulfilled and what kind of risk may exist.

Effivity offers a module named “Context of the organization”. Using this module you can automate all of the above processes and make it user-friendly while meeting 100% ISO 9001:2015 standard requirement and aligning your QMS with the strategic direction of the business.

Get your free Effivity account at www.Effivity.com


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