Context of the organization is one of the new concepts that everyone who is implementing ISO 9001:2015 will face. Questions from many quality professionals include “What is context and how do I apply it at my company?” and “Why do I need to care about context of the organization?”
Context of the organization ISO 90012015 is a critical component of an ISO 9001:2015 Transition. According to the Merriam Webster Dictionary (yes, it still exists!) the word “context” has the following meaning:
noun con·text \ˈkän-ˌtekst\
the words that are used with a certain word or phrase and that help to explain its meaning; the situation in which something happens; the group of conditions that exist where and when something happens
Full Definition of CONTEXT
1: the parts of a discourse that surround a word or passage and can throw light on its meaning
2: the interrelated conditions in which something exists or occurs
This is a significant difference between the ISO 9001:2008 and ISO 9001:2015. It pretty much changes the concept and application of chapter 4. The context of the organization as described in the ISO 9001:2015 requires you to define influences of various elements on the organization and how they reflect on the QMS; the company’s culture, objectives and goals, complexity of products, flow of processes of and information, size of the organization, markets, defines customers etc. It is also a means to detect risks and opportunities regarding the business context.
ISO 9001:2015 indicates that the context of the organization is critical in order to shape “the boundaries and scope of the QMS”. Following is an excerpt:
4 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional or local.
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge and performance of the organization.
So every organization needs to define its internal and external factors that effect its “view” on how the scope is applied to important quality management features such as risk-based thinking. The context of the organization requires the organization to evaluate itself and its context. The output of this context evaluation will be 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. It is also recommended that this “Context of the Organization” be formalized and a review be included in every Management Review Meeting.
A new procedure should be prepared to ensure that the context of the organization is reviewed regularly and in a formal manner. CVG Strategy’s Exemplar Global Certified ISO 9001:2015 Lead Auditors are very knowledgeable about ISO 9001:2015 and are ready to help you and your organization with the transition.