The answer – all three. They are all customer-focused quality methodologies that are underpinned by a requirement for continual improvement, however all three play separate, invaluable roles within a Hybrid Quality Management System Framework.
The ISO 9001:2015 Quality Management System standard serves as an overall framework for business operations (akin to the Baldridge Quality Framework in the USA) and includes such things as requirements for leadership, risk management, resource allocation, product and service delivery, documentation, auditing, corrective action, and continual improvement.
Six Sigma is a data-driven process improvement methodology based on reducing defects (and associated costs), whilst Lean is focused on reducing waste and improving efficiencies and speed. Six Sigma and Lean are actually key tools that can be used to support clause 8 Operation of ISO 9001, with outputs of these methods resulting in Improvements as required by clause 10 of ISO 9001 Continual Improvement.
A good Quality Management System should start with a strategic plan which includes a vision statement and clearly defined goals, as well as SMARTER (Specific, Measurable, Achievable, Relevant, Time-bound, Evaluated and Reviewed) objectives to support the delivery of the strategic plan goals (these goals have been achieved when associated objectives have been completed).
Six Sigma and Lean methods can then be utilised to provide improvements to increase speed, minimise defects and reduce waste associated with Product and Service Delivery – enabling the achievement of the established objectives and fulfillment of the goals defined in the strategic plan.
Ultimately, this means faster, better quality outputs, reduced costs, increased customer satisfaction and continual improvement for the organisation.
The Hybrid Quality Management System Framework diagram below has been developed to clearly demonstrate the inter-relationship of ISO 9001 with Six Sigma and Lean.
The following colour code system has been utilised:
- Red – Strategic Plan
- Orange – Smart Objectives to support the Strategic Plan. Also referenced at:
- ISO 9001:2015 Clause 6 Planning (establish objectives)
- ISO 9001:2015 Clause 9 Performance Evaluation (performance against established objectives is reviewed)
- Purple – Six Sigma Methodology
- Green – Lean Methodology
How Streamline can help
Streamline consultants can help you design, implement or improve Quality Management Systems to comply with ISO 9001 and utilise lean and six sigma project methodologies to achieve breakthrough change and business improvements.
Our trained and experienced ISO Consultants have a 100% track record achieving certification for our clients and we guarantee your ISO 9001:2015 quality management system will get certified by a JAS-ANZ accredited Certification Body.
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