QMS Context of the Organization in ISO 9001:2015 (Clause 4)

Addressing the context of the organization in the context of ISO 9001:2015 involves understanding the organization's internal and external environment and how it affects the QMS. Here are some steps that an organization can take to address the context of the organization:

Identify relevant interested parties: The organization should identify all the parties that can affect or be affected by the QMS. This may include customers, suppliers, employees, regulatory bodies, shareholders, and other stakeholders.

Determine the scope of the QMS: The organization should define the boundaries of the QMS and determine the processes, products, and services that fall within the scope of the QMS.

Analyze the internal and external context: The organization should analyze the factors that affect the QMS, both internally and externally. This can include an analysis of the organization's culture, values, mission, and vision, as well as an analysis of the industry trends, market forces, and regulatory environment.

You should develop an understanding of the key internal and external issues that influence your business, and to set up processes to capture, monitor and review these issues. The following types of documents and tools often help to provide a source of contextual information:

  1. Policy statement(s) regarding your organization's purpose and strategic direction;
  2. Individual strategy documents underpinning your organization's policies that provide a road map to achieve its goals;
  3. Records of meetings where context is routinely discussed and monitored;
  4. Structured risk assessments of external and internal issues;
  5. Use of PESTLE template (Political, Economic, Social, Technological, Legal, Environmental) analysis tools for external issues;
  6. Use of SWOT template (Strengths, Weaknesses, Opportunities, Threats) analysis tools for internal issues;
  7. Documented information describing organizational context, included as part of a quality manual.

The SWOT analysis should be developed in such a way that the weaknesses and threats become inputs to determining risk and opportunity. Internal issues might typically be influenced the following:

  1. Organizational activities;
  2. Types of product and service;
  3. Strategic direction;
  4. Capabilities (people, knowledge, processes, systems);
  5. Working practices;
  6. Employment practices;
  7. Location and conditions;
  8. Worker knowledge;
  9. Organizational structure;
  10. Policy and objectives;
  11. Values;
  12. Strategy;
  13. Competence;
  14. Culture;
  15. Knowledge;
  16. Performance;
  17. Quality, safety and environmental conditions capable of affecting or being affected by your organization.

Sources of information relating to internal issues might include:

  1. Organizational structure, including the identification of roles and responsibilities and governance arrangements;
  2. External reports showing how well your business is performing;
  3. Statements relating to your organization's mission, vision and core values;
  4. Emphasis placed upon business ethics and organizational codes of conduct;
  5. Feedback obtained from employees through opinion surveys;
  6. Information management systems and processes for capturing and deploying knowledge and lessons learned;
  7. Organizational capability studies, identification of load/capacity and resource requirements to achieve demand;
  8. Register of identified internal risks and their treatment.

PESTLE analysis provides a framework for measuring market and growth potential according to external political, economic, social, technological, legal and environmental factors. External issues might typically be influenced the following:

  1. Cultural, social, political and regulatory;
  2. Innovation, technology, industry requirements, market requirements, suppliers and partners;
  3. Financial, economic, natural and competitive issues, whether international, national, regional or local;
  4. Quality, safety and environmental conditions capable of affecting or being affected by your organization.

Sources of information relating to external issues might include:

  1. Reports relating to market environment, economic conditions, new technology, new markets, customer expectations;
  2. Reports relating to supplier intelligence, political considerations, investment opportunities, social factors, etc.;
  3. Identification of factors relating to changes in legislation and regulation, including environmental and H&S impact;
  4. Feedback relating to product/service performance and lessons learned;
  5. Register of identified external risks and their treatment.

Determine the needs and expectations of interested parties: The organization should identify the needs and expectations of interested parties and determine how these needs and expectations are relevant to the QMS.

Align the QMS with the organization's strategy: The organization should ensure that the QMS aligns with the organization's overall strategy and objectives. This can include setting quality objectives and performance indicators that align with the organization's strategic objectives.

Review and update the context analysis: The organization should periodically review and update the context analysis to ensure that the QMS remains relevant and effective in the face of changing circumstances.

By addressing the context of the organization, an organization can ensure that its QMS is aligned with its overall strategy, responsive to the needs and expectations of interested parties, and effective in meeting the organization's quality objectives. This can help the organization to improve customer satisfaction, reduce waste, increase efficiency, and enhance its reputation in the marketplace.

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