Addressing the Context of an Organization

Tuesday, 15 September 2015
ASR Editor
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Central to maintaining a business is an understanding of the organization, its context as well as the needs and expectations of interested parties. Context could be expressed in an organization's existing vision, mission, policy or objectives.

The organizational context applies for both the ISO 9001:2015 and the ISO 14001:2015 standards.

Determining relevant internal and external issues is followed by the monitoring of those issues to achieve the intended results of the organization's business system. See ISO 9000:2015 or the ISO 14001:2015 for reference.

There is value in taking a look at your "Context of the Organization" and find opportunities for improvement.

4.1 requires an organization to determine internal and external issues that are relevant to its purpose and its strategic direction.

Examples of a relevant internal issue that impacts strategic direction might be old manufacturing equipment or lack of qualified and competent technicians.

Examples of relevant external issues might include rapid changing customer requirements, globalization, or not fully understanding customer needs. These issues could be included in a vision or mission statement followed by the development of quality objectives.

4.2 requires organizations to determine the needs/requirements of interested parties that are relevant to the QMS. Examples might be customer requirements, regulatory requirements, or quality standards. Some of these needs could be included in a mission or vision statement.

4.3 asks for the Scope of the Organization. This statement is really no different than what has been previously required. However, exclusions to the scope must not impact the ability or responsibility to provide products and services to enhance customer satisfaction.

4.4 addresses the QMS and its processes. Again, no different than what ISO 9001:2008 required. Organizations will continue to determine inputs and outputs to their processes, as well as evaluate and implement necessary changes to their system. This could be covered by expanding existing process maps.

4.4.2 a) requires the maintaining of documented (procedures/work instructions) information as well as retaining the documented information. While 2015 does not require a quality manual, there will be a need to document many items. An existing quality manual could be modified or a new manual developed to house a mission and vision statement, a quality policy, quality objectives, risk management flow chart, process maps and other documents that might be in the standard and important to your firm.

In summary....context of an organization is really all the parts, pieces, relationships, environment, and more that make up a business including employees, customers, suppliers, equipment and buildings, regulations, the marketplace, and quality management system to name a few. The end objective is for organizations to fully understand all the issues that are relevant to their strategic direction.

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