.png "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:
- Policy
statement(s) regarding your organization's purpose and strategic
direction;
- Individual
strategy documents underpinning your organization's policies that provide
a road map to achieve its goals;
- Records
of meetings where context is routinely discussed and monitored;
- Structured
risk assessments of external and internal issues;
- Use of
PESTLE template (Political, Economic, Social, Technological, Legal,
Environmental) analysis tools for external issues;
- Use of
SWOT template (Strengths, Weaknesses, Opportunities, Threats) analysis
tools for internal issues;
- 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:
- Organizational
activities;
- Types
of product and service;
- Strategic
direction;
- Capabilities
(people, knowledge, processes, systems);
- Working
practices;
- Employment
practices;
- Location
and conditions;
- Worker
knowledge;
- Organizational
structure;
- Policy
and objectives;
- Values;
- Strategy;
- Competence;
- Culture;
- Knowledge;
- Performance;
- Quality,
safety and environmental conditions capable of affecting or being affected
by your organization.
Sources of information relating to internal issues might
include:
- Organizational
structure, including the identification of roles and responsibilities and
governance arrangements;
- External
reports showing how well your business is performing;
- Statements
relating to your organization's mission, vision and core values;
- Emphasis
placed upon business ethics and organizational codes of conduct;
- Feedback
obtained from employees through opinion surveys;
- Information
management systems and processes for capturing and deploying knowledge and
lessons learned;
- Organizational
capability studies, identification of load/capacity and resource
requirements to achieve demand;
- 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:
- Cultural,
social, political and regulatory;
- Innovation,
technology, industry requirements, market requirements, suppliers and
partners;
- Financial,
economic, natural and competitive issues, whether international, national,
regional or local;
- Quality,
safety and environmental conditions capable of affecting or being affected
by your organization.
Sources of information relating to external issues might
include:
- Reports
relating to market environment, economic conditions, new technology, new
markets, customer expectations;
- Reports
relating to supplier intelligence, political considerations, investment
opportunities, social factors, etc.;
- Identification
of factors relating to changes in legislation and regulation, including
environmental and H&S impact;
- Feedback
relating to product/service performance and lessons learned;
- 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.