Six Sigma and ISO 9001
When it comes to taking a decision on methodology to improve quality and processes in a company, managers often struggle with a dilemma to choose between Six Sigma or ISO 9001. It is believed that these 2 are a different set of methodologies which will achieve the end objective of improving the processes in an organization and either of these two can be used to achieve this. While there is nothing wrong with this belief, many people fail to understand that these can be used together and can complement each other very well. Let’s understand these 2 models first and their concepts before we delve into details on how these can be used together to bring in process improvements in an organization.
What is ISO 9001?
ISO 9001 is an internationally renowned standard for defining Quality management System ISO 9001 is published by ISO (International Institution of Standardization) with the most recent publication ISO 9001:2015 released in Sept 2015. The key principles on which ISO 9001 is based are:
- Customer Focus
- Engagement of People
- Process Approach
- Evidenced-based decision making
- Relationship Management
These 7 Principals gives a framework for establishing quality management systems within an organization. ISO 9001 can help an organization in exceeding customer satisfaction, meeting regulatory requirements, and achieving continual improvement.
ISO 9001 takes a process approach and uses PDCA (Plan-Do-Check-Act). Each individual process can be improved by using the PDCA cycle, and an overall system like a Quality Management System may also be based on this philosophy.
What is Six Sigma?
Six Sigma is a set of management techniques intended to improve business processes by greatly reducing the probability that an error or defect will occur. Six Sigma is a methodology for process improvement introduced by Motorola in the mid-1980s which was further developed at General Electronics (GE). Six Sigma uses an elaborate set of statistical tools and follows a defined set of steps with specific value targets to achieve its objective of attaining process improvements saving cost and time.
There are two project methodologies defined in Six Sigma which are also based on Plan-Do-Check-Act methodology. These methodologies are:
- DMAIC (Define-Measure-Analyse-Improve-Control) is used for projects where existing processes need to be improved.
- DMADV(Define-Measure-Analyse-Design-Verify) is used for projects where a new process or product need to be designed.
How can ISO 9001 and Six Sigma work together?
If you look at the overview of ISO 9001 and Six Sigma, both seem to be aiming at
- Reducing Defects and enhancing the quality of deliverable
- Process Improvement
- and they both are based on PDCA
One major difference between both the systems is that ISO 9000 is a set of generic requirements which are defined to build a complete quality management system, whereas Six Sigma is an amalgam of tools and data-driven methods to improve business processes, and is not meant for developing the complete quality management system.
ISO 9001 provides guidelines for a complete framework with the aim of exceeding customer expectation and continuous process improvement. The ISO 9001 principles on customer focus, leadership, engagement of people, relationship management, etc. focuses on all aspects of business and all stakeholders and ensures a complete framework is developed that leads to improved customer satisfaction and continual improvement. Six Sigma with its strong set of statistical tools and methods can plug-in to achieve requirements of ISO 9001 in a more sophisticated and defined manner. Let’s explore the requirements of some of the Quality Management Principles and how Six Sigma tools may help in meeting these requirements.
Customer focus: ISO 9001 requires that an organization understands the needs and expectations of all its customers. Six Sigma has a defined method called ‘Voice of Customer (VOC)’ which can be used to understand the needs and expectation of its customers. This methodology stresses on capturing customer needs which are both stated and unstated. This method may be used along with other methods to capture the needs and expectation of the customer.
Leadership: The ISO 9001 Principal on leadership requires that leaders develop quality objectives based on their quality policy and monitor the achievement of these objectives. To meet the objective, organizations need to define measures or key performance indicators. Six Sigma vast toolset may come in handy to define key performance Indicators, defining operational definitions for these measures (what, how, when, who, where, why) and creating dashboards to monitor these.
Process Approach: ISO 9001 requires that process approach should be followed which means a set of interrelated activities with inputs and outputs. The SIPOC (Supplier, Input, Process, Output, and Customers) approach defined in Six Sigma may be used to understand how the processes in an organization work and their interrelation.
Evidence-based Decision making: ISO 9001 requires that key decisions in the organization are based on data and its analysis. Using Six Sigma methods, operational definitions of measurements can be easily defined. Six Sigma methods can also help in providing tools to address situations where capability and predictability of the processes need to be measured. The data analysis may help to derive key business decisions that are required to fulfil the requirements of ISO 9001.
Improvement: The DMAIC (Define-Measure-Analyse-Improve-Control) methodology may be used to achieve process improvement at a project level which can further be enhanced to define process improvements at the organization level.
To conclude, Six Sigma should be viewed as a methodology which is a key part of a continually improving quality management system. One of the key business objectives of having a Quality management system and ISO 9001 is an improvement in cost and time savings and having a set of six sigma tools to help you in your ISO 9001 initiative can make a lot of difference in achieving your organization’s business objective.