By/ Ahmed Hasham
Lead auditor QMS, EMS, OHSAS
Context of organization is a new requirement in ISO 9001:2015 maintaining the organization must consider both the internal and external issues that can impact its strategic objectives.
Clause 4 of ISO 9001:2015 Context of the organization requires the organization to evaluate itself and its context.
This means that you need to define influences of various elements on the organization and how they reveal on the QMS, the company’s principles, objectives and goals, complexity of process, flow of processes and information, size of the organization, markets, customers, etc. It is also a means to identify risks and opportunities regarding the professional context.
Context means a set of external and internal factors that have a direct influence on the organization and its ability to continue providing products and services.
External factors encompassed the whole environment in which the organization operates: social, cultural, legal, political, regulatory, statutory, economical, etc., at all levels including local, state, country and even international.
According to ISO 9001:2015, 4.1, Note 2, external issues arise from legal, technological, competitive, market, cultural, social, and economic environments (local, regional, national, or international).
Examples of external issues:
- · Supply chain disruption
- · Loss of a key supplier
- · Oil price changes
- · Trade union regulations
- · Ventures into new markets
- · Funding for non-profits
- · Natural disasters.
- · Money exchange rates.
- · Economic situation.
- · Inflation forecast.
- · Local unemployment rates.
- · Safety perception.
- · Education levels.
- · Public holidays and working days.
- · Political stability.
- · Public investments.
- · Local infrastructure.
- · New sector technology.
- · Materials and equipment.
- · Patent expiration.
- · Professional code of ethics.
- · Competition.
- · Market share.
- · Similar products or services.
- · Market leader trends.
- · Customer growth trends.
- · Market stability.
- · Trade union regulations.
- · Regulations related to an industry.
Internal factors includes things like the organization’s culture, structure, governance, technology, strategic decisions and vision for the future.
Examples of Internal issues:
- · Overall performance of the organization.
- · Infrastructure.
- · Environment for the operation of the processes.
- · Organizational knowledge.
- · Competence of persons.
- · Organizational behavior and culture.
- · Relationships with unions.
- · Process or production.
- · Service provision capabilities.
- · Performance of the quality management system.
- · Monitoring customer satisfaction.
- · Rules and procedures for decision making or organizational structure.
At the strategic level, tools such as Strengths, Weaknesses, Opportunities and Threats analysis (SWOT) and Political, Economic, Social, Technological, Legal, Environmental analysis (PESTLE) can be used.
SWOT analysis is designed to facilitate a realistic, fact-based, data-driven look at the strengths and weaknesses of an organization, its initiatives, or an industry. The organization needs to keep the analysis accurate by avoiding pre-conceived beliefs or gray areas and instead focusing on real-life contexts. Companies should use it as a guide and not necessarily as a prescription.
PESTEL analysis is a framework or tool used by marketers to analyze and monitor the macro-environmental (external marketing environment) factors that have an impact on an organization. The result of which is used to identify threats and weaknesses which is used in a SWOT analysis.
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