ISO 9001:2015 QMS standard requires determining external and internal issues that are relevant to the organization's purpose and the organization's strategic direction and that affect the organization's ability to achieve the intended results of the QMS. I have posted an article 'Understanding the organization and its context' at this blog that provide an understanding on the standard's requirements and the suggested method to determine external and internal issues.
In this connection, note given at the end of the requirements of clause 4.1 is relevant. We should understand three basic points - (i) Issues may be positive and/or negative factors/conditions. (ii) External issues may arise from external environment that can be from legal, technological, competitive, market, cultural, social and economic environments. (iii) Internal issues are issues that an organization's people face in the organization due to internal environment. These are the issues related to values, culture, knowledge and performance of the organization.
Some external issues may relate to:
- Government regulations that affect the organization's performance,
- Changes in law that has an impact on the organization,
- Economic shifts in the organization's markets,
- Competition the organization is facing,
- Events (such as business fairs, customers meet etc) that may improve or affect corporate image of the organization,
- Changes in technology (yet not adopted by the organization),
- What others (external interested parties) require from the organization, such as bankers requires timely submission of statement related to hypothecated goods, customer requires timely delivery of the product/service etc.
Some internal issues may relate to:
- Accountability of the people working in the department/ organization - whether defined or not, whether defined adequately or not,
- Coordination with different groups/people/departments in the organization,
- Performance,
- Monitoring of activities,
- Allocation of individual tasks/responsibilities/job specifications,
- Formal reporting relationships,
- Grouping of people/department/processes,
- Communication,
- Delegation of authorities,
- Availability of the procedure for the activity performance, measurement, monitoring, evaluating,
- Product/service offerings,
- Organizational structure (needs changes),
- Policies,
- Assets (such as facilities, property, equipment, technology etc.),
- Capabilities of people,
- Information system within the organization,
- Relationship of people within the organization,
- Organization's culture,
- Standards/industry guidelines/business model adopted by the organization and its awareness among people within the organization,
- Habits of people, such as late coming, leaving early, taking frequent leave from work etc.
Internal context may be anything within the organization that may influence the way in which the organization manages its internal issues.
Best wishes,
Keshav Ram Singhal
For details on the Training Handbook on 'ISO 9001:2015 QMS Awareness', please CLICK HERE.
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