How do I document the "Context of the Organization"?


Answer from the qms experts:

The "Context of the Organization" is a requirement new to the ISO 9001:2015 version - and comes, in part, from the adoption of the so-called "Annex SL" format of ISO management systems standards. No specific information is required by the International Standard to be retained by an organization in support of considering the factors which influence how it determines its context. It is also unclear, from reading the standard, how often this consideration is to be done, other than that it's "relevant to the strategic direction and ability to achieve the intended quality management system result(s)" - which includes customer satisfaction. Since it's fairly typical for an organization to have a business plan which covers one to three years, it might follow that the consideration of the organizational context could be performed at least annually.

There's an appropriate time for documenting the background to determine the organization's Context, which is when performing a review of the management system, as required by ISO 9001:2015, clause 9.3. As a requirement of the "Performance Evaluation" section of ISO 9001, the Management Review is (in part) conducted to ensure the quality management system is aligned with the strategic direction of the organization. While the review frequency isn't mandated by the ISO 9001 standard, it would follow that a 30,000 ft. view would be appropriate to support strategic planning.

Documenting the consideration of an organization's context can be successfully recorded in the "retained documentation" associated with the 9.3 Management Review requirements.