The international standard ISO 9001:2015 promotes the adoption of the process approach when developing, implementing and improving the effectiveness of a QMS, to enhance customer satisfaction by meeting customer requirements;
Process approach identifies and manages numerous linked activities
Transforms inputs into outputs
Often the output from one process directly forms the input into the next process
Identifies resources needed in each process
Identification and interactions, managing of these processes can be referred to as the "process approach"
System approach definition - Identifying, understanding and managing interrelated processes as a system contributes to the organization's effectiveness and efficiency.
Process definition - Set of interrelated or interacting activities which transforms inputs into outputs
The different processes:
Management processes i.e. Company policies, management reviews, strategies
Customer orientated processes (core value chain) i.e. Manufacturing processes in direct contact with the customers product or service
Supporting processes i.e. Human resources, maintenance, IT
Typical steps in a process
Identify the process
Identify the inputs & outputs
Identify the interactions to other processes
Establish measuring criteria
Ensure continual improvement
Hierarchy of a system structure
Policy
Objectives
Processes
Documented information
Understanding and managing interrelated processes as a system (business system) contributes to the organization's effectiveness and efficiency in achieving its intended results.
This approach enables the organization to control the interrelationship and interdependence among the processes of the system, so that the overall performance of the system can be enhanced.
The process approach involves the systematic definition and management of processes and their interactions, so as to achieve the intended results in accordance with the Quality Policy and strategic direction of the organization. Management of the processes and the system as a whole can be achieved using the PDCA (Plan - Do - Check - Act) cycle with overall focus on risk based thinking, aimed at taking advantage of opportunities and preventing undesirable results.
The PDCA cycle can be applied to all processes and the QMS as a whole.
The numbers in brackets refer to the various clauses as it applies to ISO 9001:2015.
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