ISO 9001:2015 Clause 4.1 Understanding the organization and its context
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
Typical External issues my include, but not limited to:
•economics and financial factors
•government regulations and changes in legislation
•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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