ISO 9001:2015 4.1 Context

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ISO 9001:2015 Clause 4.1 Understanding the organization and its context






ISO 9001:2015 4.1 PDCA: PLAN


Clause 4.1 Breakdown


4.1     Understanding the organization and its context


Context of the organization


Organization's leadership need to identify important internal and external issues that can influence their effectiveness to achieve predetermined objectives.  This is not just negative issues, but also positive ones...


Simplistic view... "Demonstrate an understanding of the organizational issues which can affect the strategic direction and intended outcomes".


The context of the organization will be multi-layered, for example;


external and internal issues - e.g. those that directly affect the organization and its products and services. 

relevant to its purpose - e.g. the QMS exists to supply products and / or services efficiently and effectively to its intended market

strategic direction - e.g. grow the business, increase product lines, increase market share

intended result - e.g. for example: hit targets, goals, objectives


Typical internal issues my include, but not limited to:


relevant legislation (e,g. Acts, Regulations, Statutory Instruments, etc)

industry specific requirements

standards, guidelines and models adopted by the organisation

resources (e.g. staff, capital, assets and technologies)

products and / or services

culture, social and workforce influence

competency, knowledge and relationship with workforce

optional requirements (e.g. ISO 45001, ISO 14001, CQI / IRCA Membership)


Typical External issues my include, but not limited to:


economics and financial factors

government regulations and changes in legislation

business competitors

cultural, social and economic environments

changes in technology 


Note: external factors can present sudden and unforeseen events, even with the best planning. e.g.


aggressive take-overs bids

lost of customer confidence via negative news and social media

the face (well know and respected actor, presenter, sports-person etc) of your brand suddenly becomes toxic

natural disasters (earth quakes, tsunami, hurricanes, typhoons cyclones etc)

loss of key business partnership / client           



Useful integrated management system cross references


ISO 14001-2015 4.1 - Understanding the organization and its context

ISO 45001-2018 4.1 - Understanding the organization and its context


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