Better understanding for clause 4.

0 Organizational Context
Determining the context of your organization
Determining organizational context is a new requirement to ISO 9001:2015, ISO 14001:2015
and ISO 45001:2018, and such requirements could assist and help the consultant to underpin
your clients’ organization’s policies and to provide a road map to achieve future goals.
Also known as contextual intelligence, this approach is not a new to those familiar with
business planning and strategic development, but it is new in terms of its specific inclusion
into ISO management system standards.
The organization is now required to identify and assess all internal issues and external issues
that could impact upon management system’s ability to deliver its intended results. So, it is
important to develop an understanding of the key internal and external issues that influence
the 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.
A review of organizational context could include interviews with senior management,
questionnaires, surveys, and research. Cross-functional input is essential for the specific
expertise required to identify the full breadth of issues, such as finance, training, human
resources, commercial, engineering and design, etc.
Not only will this ensure a broader appreciation of organizational context but also wider
engagement, particularly with those functions not previously involved with the management
system.
As well, we need to determine and understand the various quality, safety and environmental
conditions that could become inputs to internal and external issues, which are typically
experienced in your type of organization that can have positive or negative impacts. It is
important to remember that Clause 4.1 'Understanding the Organization and its Context'
interacts with the following clauses:
 1. Clause 4.3 - 'When determining the scope, the organization shall consider the external
and internal issues referred to in 4.1';
2. Clause 5.1.1 - 'Top management shall ensure that the quality, environmental or health
& safety policies and objectives are established for the management system and are
compatible with the organization’s strategic direction and its context';
3. Clause 5.2.1a - 'Top management shall establish, review and maintain its quality,
environmental or health and safety policies appropriate to the purpose and context of
the organization';
4. Clause 6.1.1 - 'When planning the management system, the organization shall consider
issues referred to in 4.1 and determine risks and opportunities that need to be
addressed';
5. Clause 9.3.1 - 'The management review shall be planned and carried out taking into
consideration changes in external and internal issues relevant to its management
system that includes its strategic direction'.
Under this understanding, I found that it is no need to have separate a contextual description
for each environmental, health and safety or quality management system. In theory; a single,
integrated, contextual statement that suits the requirements of each management system
since there would be a degree of overlap between the context of a OHSMS, a QMS or an EMS.
In practice however, the needs and expectations; and the types of interested party will likely
have some degree of overlap too, as well as, subtle but important differences which would
require clear definition. You should consider the focus of your QMS as being different to the
focus of your EMS, or your OHS management system; your organizational context must
reflect that.
Identifying and analyzing internal issues
To help understand the business's internal issues, at the micro-level, you need to understand
its strengths and weaknesses and be able to identify relevant opportunities and threats.
Undertake a SWOT analysis to review and evaluate current business strategies, the position
and direction of your organization, business propositions and other commercial leads.
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:
6. Organizational activities;
7. Types of product and service;
8. Strategic direction;
9. Capabilities (people, knowledge, processes, systems);
10. Working practices;
11. Employment practices;
 12. Location and conditions;
13. Worker knowledge;
14. Organizational structure;
15. Policy and objectives;
16. Values;
17. Strategy;
18. Competence;
19. Culture;
20. Knowledge;
21. Performance;
22. 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.
The ISO standards do not specify that internal issues, or their monitoring and review be
documented, so there might not be ‘lists of internal issues’ or records of reviews. However,
information can be obtained via interviews with relevant Top management in relation to your
organization’s context and its strategic direction, the identified issues and conditions, and
how these may affect the intended outcomes of your management system.
Identifying and analyzing external issues
External issues might include political, financial or economic trends, customer demographics
or emerging product developments. You should undertake a PESTLE analysis in order to
establish a suitable understanding of these circumstances, and the market in which your
business operates at the macro level.
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.
A workshop approach often allows ideas to be shared and provides an effective and efficient
way of achieving a valuable outcome. The workshop could simply be a discussion identifying
the issues that can be mapped out using Political, Economic, Social, Technological, Legal and
Environmental (PESTLE) analysis. This method helps to structure the conversation and will
also help to achieve buy-in to what is often seen as a peripheral or niche area.
To be compliant, evidence should be reviewed that proves that your business has identified
all pertinent internal and external issues at periodic intervals. Although there is no
requirement for any documented information to defining organizational context, it is helpful
to retain the following types of documented information to help justify compliance:
1. Business plans and strategy reviews;
2. Quality manual
3. Competitor analysis;
4. Economic reports from business sectors or consultant’s reports;
5. SWOT template analysis output;
6. PESTLE template analysis output;
7. Risk and opportunity assessments;
8. Statement contained within a Management System Manual;
 9. Minutes of management review meetings (that show decisions and actions relating
organizational context);
10. Process maps, tables, spreadsheets, mind mapping diagrams.
To assess whether your organization has a high-level, conceptual understanding of its
internal and external issues that affect it, either positively or negatively, its ability to achieve
the intended outcomes, you should describe the processes used by your organization to
identify internal and external issues and make reference to all objective evidence, including
examples of these issues.