World Class Manufacturing

Session 2
Quality Systems: ISO 9000-2000, ISO 14000, Frame
Work for Business
Topics of Discussion
 Definition of Quality Management System
 Quality Management System Explained
 Different types of quality management systems with examples
 ISO 9000-2000 - definition
o When and where is it applicable
o Why should companies use this
o Examples of companies successfully using it
o 1 case study of a company changing by using this system and how it benefitted (What was before case and what happened
afterwards)
 ISO 14000 - definition
o When and where is it applicable
o Why should companies use this
o Examples of companies successfully using it
o 1 case study of a company changing by using this system and how it benefitted (what was before case and what happened
afterwards)
 What is a business framework? How is it different from business model with examples
Definition of Quality Management System
• Process of ensuring that an organization or product is consistent with its focus not only on product/service quality, but also the
means to achieve it.
• It can be considered to have four main components: quality planning, quality control, quality assurance, and quality
improvement.
• ISO 9001:2015 is the most recognized and implemented quality management system standard in the world. ISO 9001:2015
specifies the requirements for a QMS that organizations can use to develop their own programs.
• Other standards related to quality management systems include:
• ISO 9000 series (including ISO 9000 and ISO 9004),
• ISO 14000 series (environmental management systems),
• ISO 13485 (quality management systems for medical devices),
• ISO 19011 (auditing management systems),
• ISO/TS 16949 (quality management systems for automotive-related products).
• Benefits of Quality Management:
• Continuous improvement and innovation
• Improved operational excellence and customer satisfaction
• Prevention of reoccurring defects
• Preventive action instead of reaction
• Reduction of process, quality, defect, and scrap/re-work costs.
 Quality Management System: Principle
• Customer Focus - The primary focus of quality management is to meet customer
requirements and to strive to exceed customer expectations.
• Leadership - Leaders at all levels establish unity of purpose and direction and
create conditions in which people are engaged in achieving the organization’s
quality objectives.
• Involvement of People - Competent, empowered and engaged people at all levels
throughout the organization are essential to enhance its capability to create and
deliver value.
• Process & System Approach - Consistent and predictable results are achieved
more effectively and efficiently when activities are understood and managed as
interrelated processes that function as a coherent system.
• Continual Improvement - Successful organizations have an ongoing focus on
improvement.
• Factual Approach to Decision Making - Decisions based on the analysis and
evaluation of data and information are more likely to produce desired results.
• Mutually Beneficial Supplier Relationships - For sustained success, an
organization manages its relationships with interested parties, such as suppliers.
Quality Management System: Approach
TQM: Breaks down every process or activity and emphasizes that each contributes or detracts from the quality and productivity of the organization
as a whole. Nine common TQM practices are as below:
1. Cross-functional product design;
2. Process management;
3. Supplier quality management;
4. Customer involvement;
5. Information and feedback;
6. Committed leadership;
7. Strategic planning;
8. Cross-functional training; and
9. Employee involvement.

Continuous Quality Improvement: Reward based improvement in process quality. Known as FOCUS-PDCA in healthcare and other services.
Find a process to improve; Organize to improve a process; Clarify what is known; Understand variation; Select a process improvement.
Plan - create a time line, including all resources, activities, dates, and personnel training; Do - implement the plan and collect data. 270 SYSTEMS
AND PROCESSES TLFeBOOK; Check - analyze the results of the plan; Act—act on what was learned and determine the next steps

Six Sigma: It was developed at Motorola in the 1980s. Its goal was to measure and eliminate waste by attempting to achieve near perfect results.
The term six sigma refers to a statistical measure with no more than 3.4 defects per million. Six sigma is a statistically oriented approach and uses a
variety of tools, including statistical process control (SPC), total quality management (TQM), and design of experiments (DOE).
Quality Management System Explained: Concept
• Recognize interested party requirements including Licenses to Trade, guidelines, customer requirements, and the chosen
management system standard(s).
• Ensure that all requirements have been met.
• Confirm that employees receive applicable training in the quality system requirements.
• Determine processes, their interaction, inputs and outputs.
• Produce records or evidence that system requirements have been met.
• Measure, monitor and report the performance of the QMS.
• Plan changes to the QMS and take actions to address risks and opportunities as a result of changes.
• Perform internal audit to analyze the QMS and correct nonconformities.
• Continually improve the QMS.
Quality Management System Explained: Characteristics
• To ensure the needs and expectations of customers and other interested parties, a process is clearly defined.
• The employees of the organization are made to understand the quality policy and the quality objectives.
• The organizations set up responsibilities of personnel and they are followed up to achieve the objectives of the firm.
• There are resources that are provided by the organizations. These resources may be in the form of a process, equipment,
an infrastructure or even people.
• For the quality management software to work efficiently the statistics are monitored for each process and the metrics are
established. If any process is not measured and monitored, it would lead to the creation of an inconsistent system.
• The organization’s management is dedicated to use the statistics for process improvements and inter organizational
communication. They also desire to hold people that are accountable for their performance.
• In case of a non conforming product or services, a process is allocated to prevent such actions.
• Quality management system is a continuous improvement approach.
• A framework is designed for the verification of the processes and products.
• The organization’s management is responsible for reviewing the whole system at appropriate intervals to confirm that the
system is working as they had thought it should have been.
Thank you