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Wynand Bester

System mindedness & ISO 9001:2015


We hear the term "systems" a lot. Edward Deming famously observed that 93% of problems are caused by "the system" and 7% by " the person" (People cannot perform better than the system allows).


But what is "the system" and systems thinking.

Generally speaking a system is a bunch of parts working together to create an output e.g. transport systems, solar systems, business systems, an automobile engine and the human body is also a system.

There are lots of systems in the workplace. We have training systems, production systems, continuous improvement systems, maintenance systems and more which form part of your business system.


System approach and ISO 9001:2015

System approach to management - Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency.


Process definition - Set of interrelated or interacting activities which transforms inputs into outputs.

A business consist of numerous linked activities called " processes" which must be defined, described and managed. All your processes should interlink to form a single integrated system aimed at the same defined outcomes, everything and everyone committed to and working together to achieve a common set of goals.


The process approach includes establishing the organizations process to operate as an integrated and complete system - business system.

  • The management system integrates processes and measures to meet objectives

  • Processes define interrelated activities and checks, to deliver intended outputs

  • Detailed planning and controls can be defined and documented as needed, depending on the organizations context

Process approach, risk based thinking and PDCA

These three concepts together form an integral part of the ISO 9001 :2015 standard. Risks that my impact on objectives and results must be addressed by the management system. Risk based thinking is used throughout the process approach to:

  • Decide how risk (positive or negative) is addressed in establishing the process outputs and prevent undesirable results

  • Define the extent of process planning and controls needed (based on risk)

  • Improve the effectiveness of the QMS

  • Maintain and manage a system that inherently address risks and meet objectives

PDCA is a tool that can be used to manage processes and systems. PDCA stands for

  • Plan - Set the objectives of the system and processes to deliver results (What to do and how to do it)

  • Do - Implement and control what was planned

  • Check - Monitor and measure processes and results against policies, objectives and requirements

  • Act - Take actions to improve the performance of processes

PDCA operates as a cycle of continuous improvement with risk based thinking at each stage.


ISO 9001 and the PDCA cycle according to clause numbers.


What are the possible benefits?

  • Systematic management of planning, implementation, checks and improvement of processes and the management system as a whole

  • Better use of resources and increased accountability

  • A focus on the more important (high risk) processes and their outputs

  • More consistent achievement of the policies and objectives, intended results and overall performance

  • Process application can facilitate the implementation of any management system

  • Enhance customer satisfaction by meeting customer requirements

  • Enhance confidence in the organization

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