What Is the ISO 9000 Standards Series?

Definition:
ISO 9000 is defined as a set of international standards on quality management and quality
assurance developed to help companies effectively document the quality system elements
needed to maintain an efficient quality system. They are not specific to any one industry and
can be applied to organizations of any size.
Explaination:
ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve
continual improvement. It should be considered to be a first step or the base level of a quality
system.
ISO 9000:2000

ISO 9000:2000 refers to the ISO 9000 update released in the year 2000.

The ISO 9000:2000 revision had five goals:

1. Meet stakeholder needs

2. Be usable by all sizes of organizations
3. Be usable by all sectors
4. Be simple and clearly understood
5. Connect quality management system to business processes

ISO 9000:2000 was again updated in 2008 and 2015. ISO 9000:2015 is the most current version.

ISO 9000:2015 principles of Quality Management

The ISO 9000:2015 and ISO 9001:2015 standards are based on seven quality management
principles that senior management can apply to promote organizational improvement.
1. Customer focus
o Understand the needs of existing and future customers
o Align organizational objectives with customer needs and expectations
o Meet customer requirements
o Measure customer satisfaction
o Manage customer relationships
o Aim to exceed customer expectations
o Learn more about the customer experience and customer satisfaction
2. Leadership
o Establish a vision and direction for the organization
o Set challenging goals
o Model organizational values
o Establish trust
o Equip and empower employees
o Recognize employee contributions
o Learn more about leadership
3. Engagement of people
o Ensure that people’s abilities are used and valued
o Make people accountable
o Enable participation in continual improvement
o Evaluate individual performance
o Enable learning and knowledge sharing
o Enable open discussion of problems and constraints
o Learn more about employee involvement
4. Process approach
o Manage activities as processes
o Measure the capability of activities
o Identify linkages between activities
o Prioritize improvement opportunities
o Deploy resources effectively
o Learn more about a process view of work and see process analysis tools
5. Improvement
o Improve organizational performance and capabilities
o Align improvement activities
o Empower people to make improvements
o Measure improvement consistently
o Celebrate improvements
o Learn more about approaches to continual improvement
6. Evidence-based decision making
o Ensure the accessibility of accurate and reliable data
o Use appropriate methods to analyze data
o Make decisions based on analysis
 o Balance data analysis with practical experience
o See tools for decision making
7. Relationship management
o Identify and select suppliers to manage costs, optimize resources, and create value
o Establish relationships considering both the short and long term
o Share expertise, resources, information, and plans with partners
o Collaborate on improvement and development activities
o Recognize supplier successes
o Learn more about supplier quality and see resources related to managing the
supply chain

ISO 9001 vs Six Sigma: How they compare and how they are different

1. Comparison

 Process Approach. 

o Both ISO 9001 and Six Sigma use a process approach in applying their
methodologies.

o ISO 9001 involves looking at an overall system as smaller, interrelated processes

to focus efforts toward more consistent and predictable results on the individual
processes of the system.

o This is done because controlling and improving the individual processes can be a
much easier and more effective way to control and improve the entire system.

o Six Sigma is used on an individual process in order to control and improve it

using a SIPOC diagram (an abbreviation for Supplier, Inputs, Process, Output,
and Customers). SIPOC is a way of representing the process in order to better
understand how it works, and how improvements are effective on the process.

 Cycle of Improvement.

o  Both systems have an underlying methodology of using a cycle for improvement.

o ISO 9001 is based on a Plan-Do-Check-Act cycle that is used to focus efforts on

improvement in the system.
 o This allows for an ongoing cycle where changes are made to improve an aspect of
the system, then checked and acted upon to either correct for problems or cement
improvements that are realized.

o The core tool used in Six Sigma for process improvement projects is the DMAIC
project methodology (an abbreviation for Define, Measure, Analyze, Improve and
Control), which is an improvement cycle based on data that is used to improve,
optimize and stabilize business processes.

o With both systems, all phases of the cycle must be followed for the cycle to work;
skipping steps can cause failure.

2. Difference

o The ISO 9001 standard is an internationally recognized set of requirements to use

as the basis to develop an entire quality management system, including all aspects
of the business such as management responsibilities, resource management and all
aspects of providing the product or service.

o Additionally, the implemented QMS can be certified against the ISO 9001
requirements Meanwhile, Six Sigma is solely a set of tools and methods used to
improve business processes, and which are not meant as a means of developing an
entire quality management system.

o Six Sigma has a subset project methodology used for design, which is referred to
as Design for Six Sigma (DFSS).

o This project replaces the DMAIC cycle used above and replaces it with a cycle
more focused on the design, which is the DMADV project methodology. These
five stages stand for Define design goals, Measure and identify critical
characteristics, Analyze to develop and design alternatives,

o Design an improved alternative, and then Verify the design. This methodology is
not equivalent to the design process defined in ISO 9001 but could be used as a
method of design improvement, which would then feed into the design change
requirements of the ISO 9001 quality management system.

o Some elements of Six Sigma will require new processes not already implemented
in a quality management system, but the addition of the processes should
complement the process improvement requirements of the system already in
place. There are no fundamental conflicts between the requirements, only
additions to what would already be present.

What Is PDCA?
Definition:
PDCA, sometimes called PDSA, the "Deming Wheel," or "Deming Cycle," was developed by
renowned management consultant Dr William Edwards Deming in the 1950s. Deming himself
called it the "Shewhart Cycle," as his model was based on an idea from his mentor, Walter
Shewhart.
Explaintion:
Deming wanted to create a way of
identifying what caused products
to fail to meet customers'
expectations. His solution helps
businesses to develop hypotheses
about what needs to change, and
then test these in a continuous
feedback loop.

PDCA / PDSA is an iterative, four-

stage approach for continually
improving processes, products or
services, and for resolving
problems. It involves systematically
testing possible solutions,
assessing the results, and
implementing the ones that are
shown to work.

The four phases are:

 Plan: identify and analyze the problem or opportunity, develop hypotheses about what
the issues may be, and decide which one to test.
 Do: test the potential solution, ideally on a small scale, and measure the results.
 Check/Study: study the result, measure effectiveness, and decide whether the hypothesis
is supported or not.
 Act: if the solution was successful, implement it.
The PDCA or PDSA Cycle

The PDCA cycle helps you to solve problems and implement solutions in a rigorous, methodical
way. Follow these four steps to ensure that you get the highest quality results.

1. Plan

First, you need to identify and understand your problem, or the opportunity that you want to take
advantage of. Using the first six steps of The Simplex Process

can help you to do this, by guiding you through a process of exploring information, defining your
problem, generating and screening ideas, and developing an implementation plan.

At the final part of this stage, state quantitatively what your expectations are, if the idea is
successful and your problem is resolved. You'll return to this in the Check stage.

2. Do

Once you've identified a potential solution, test it with a small-scale pilot project. This will allow
you to assess whether your proposed changes achieve the desired outcome, with minimal
disruption to the rest of your operation if they don't. For example, you could organize a trial
within a department, in a limited geographical area, or with a particular demographic.

As you run the pilot project, gather data to show whether the change has worked or not. You'll
use this in the next stage.

3. Check

At this stage, you analyze your pilot project's results against the expectations that you defined in
Step 1 to assess whether the idea has worked or not. If it hasn't worked, you return to Step 1. If it
has worked, you go on to Step 4.

You may decide to try out more changes, and repeat the Do and Check phases – don't settle for a
less-than-satisfactory solution. Move on to the final phase (Act) only when you're genuinely
happy with the trial's outcome.
4. Act

This is where you implement your solution. But remember that PDCA / PDSA is a loop, not a
process with a beginning and an end. This means that your improved process or product becomes
the new baseline, and you continue to look for ways to make it even better for your organization
or customers.

The Pros and Cons of PDCA / PDSA

The model is a simple, yet powerful way to resolve new and recurring issues in any industry,
department or process. Its iterative approach allows you and your team to test solutions and
assess results in a waste-reducing cycle.

It instills a commitment to continuous improvement, however small, and can improve efficiency
and productivity in a controlled way, without the risks of making large scale, untested changes to
your processes.

However, going through the PDCA / PDSA cycle can be much slower than a straightforward,
"gung ho" implementation. So, it might not be the appropriate approach for dealing with an
urgent problem or emergency.

It also requires significant "buy-in" from team members, and offers fewer opportunities for
radical innovation, if that's what your organization needs.

Source:
Question 1 link
https://asq.org/quality-resources/iso-9000
 
Question 2 link
https://advisera.com/9001academy/knowledgebase/iso-9001-vs-six-sigma-how-they-compare-
and-how-they-are-different/

Question 3 link
https://www.mindtools.com/pages/article/newPPM_89.htm