ISO 9001:2015 QMS - Understanding the organization and its context

ISO 9001:2015 QMS
Understanding the organization and its context

Clause 4.1 of ISO 9001:2015 QMS standard deals with the requirements related to the understanding the organization and its context. According to the requirements of the standard, following needs to carry out:

(i) Determine: Internal and external issues (positive and negative factors or conditions) relevant to organization's purpose, strategic direction and that can affect organizational ability to achieve intended results.
(ii) Monitor and review: Information about the determined external and internal issues (positive and negative factors/conditions)

Clarification:
(i) There are many issues that can make easier the understanding the external context of the organization. Such issues may arise from legal, technological, competitive, cultural, social and economic environments and that can be global, national, regional or local.
(ii) There are many issues that can make easier the understanding the internal context of the organization. Such issues may relate to the organization's value, culture, knowledge and performance.

We see that the requirements of ISO 9001:2015 QMS standard starts with asking for determination of all issues that can enhance or interrupt achievement of the quality management system outcomes. The organizational issues may be internal and/or external that may be well defined, substantially subjective or not so well defined. We need to understand them. A subjective issue may be internal issue within and among groups/people in an organization. It is required for the organization to monitor and review all those issues that can affect achievement of defined goals. With monitoring and reviewing internal and external issues, an organization is better prepared to make improvements and thus leads to a success path. The management of the organization should identify persons, who are well-versed with the organization and its processes and who understand the standard's requirements very well,. These persons should be encouraged to create a suitable, adequate and effective quality management system by monitoring and reviewing internal and external issues. The persons in the organization should make their best efforts to understand related issues and process details, so that they may contribute to achievement of the defined goals.

Step-by-step process:
(i) Make a team of identified persons.
(ii) The team should be asked to think and identify all positive/negative factors and conditions that are relevant and that can affect achievement of organizational goals.
(iii) The team should make a list of all such issues with necessary details.
(iv) Assign responsibility to monitor and review such issues to different persons or groups in the organization, so that effective decisions can be taken for the improvement.

Questions
(i) What are the requirements for understanding organization and its context in ISO 9001:2015?
(ii) Why should an organization determine internal and external issues?
(iii) What can be internal issues that can affect organizational ability to achieve intended results?
(iv) What can be external issues that can affec organizational ability to achieve intended results?
(v) What may be the step-by-step process for understanding the organization and its context.

(Written for the Forthcoming Book - Implementing ISO 9001:2015 Quality Management System - A Reference Guide - Dr. Divya Singhal and Keshav Ram Singhal. Suggestions and comments invited.)


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