What is context of organization as per ISO 9001 2015

ISO 9001 2015 focuses upon context of organization.

context of organization can be termed as present conditions in which organization operates.

Present condition of any organization is influenced by many internal and external factors.

Internal factors that influences present condition are

  • Competence of employees
  • Performance of employees
  • organizational work culture
  • Infrastructure that includes  plant and machinery, instruments, utilities, IT infrastructure, communication facilities, Building and work space, transportation arrangements etc.
  • Work environment
  • Raw material specifications
  • Raw material storage condition
  • Structure – interaction and sequence of processes employed
  • Performance of processes employed
  • Focus on new product development
  • Focus on modification of existing product
  • Strategy to remain in market competition etc

There are many other internal factors which influences present condition / context of an organization.

ISO 9001 2015 standard focuses upon determining internal issues with respect to internal context. Issues may be termed as factors that influences Quality management system intended outcome – Enhancement of customer satisfaction, legal compliance and improvement. All above factors are influencing intended outcome of Quality management system. Organization may priortize them considering its purpose and strategy towards quality management system.

 

External factors that influences present condition are

 

  • suppliers
  • focus on new suppliers development
  • Performance of suppliers
  • focus on new customer development
  • customer requirements
  • customer satisfaction
  • statutory requirements that organization abide with
  • compliance with statutory requirements and customer requirements

There are many other external factors which influences present condition / context of an organization.

ISO 9001 2015 standard focuses upon determining external issues with respect to external context. Issues may be termed as factors that influences Quality management system intended outcome – Enhancement of customer satisfaction, legal compliance and improvement. All above factors are influencing intended outcome of Quality management system. Organization may priortize them considering its purpose and strategy towards quality management system.

Internal and external issues determined above may be considered in the risk management. E.g. if customer satisfaction is a present issue that organization is facing then it shall be considered in risk management and necessary actions ( corrective actions ) shall be addressed in risk management to overcome this issue. These actions ( corrective actions ) / solution of issue may invite some change in the context  ( present condition ).

Hence from above it is understood that at begining of implementation of Quality management system as per ISO 9001 2015,

  • organization has to study present condition  / context
  • determine and priortize present issues
  • consider these issues in the risk management
  • address actions ( corrective actions )
  • change present condition / context as per corrective action taken

So context is linked with issue is linked with risk is linked with corrective action is linked with revised context.