Quality Management System (QMS) is the business management system

aiming at improving overall performance of an organization by deploying

robust systems & processes, delivering high quality products & services and
enhancing customer satisfaction.

Introduction
ISO 9001 standard sets out the criteria for a quality management system
(QMS) and is released by International Organization for Standardization
(ISO). This standard encompasses best business practices and key
management principles including a customer focus, employee engagement,
the process approach and continual improvement.

The latest edition was released in 2015 and it is referred as ISO 9001:2015
This standard uses the process approach and Plan-Do-Check-Act (PDCA)
cycle with risk-based thinking for achieving enhanced performance.

Internal audits are conducted at planned intervals to ensure the conformance

of QMS to the standard requirements as well as organizational own specific
needs if any.

PDCA Cycle
PDCA (plan-do-check-act) is an iterative four-step management method used
in business for the control and continual improvement of processes and
products & services. All four stages are critical for ensuring effective and
efficient way of working resulting in improved performance. There is a famous
quote by Dr Deming (father of Quality Control) - In God We Trust, All Others
Bring Data
This is to emphasize the importance of the 'Checking' ie monitoring the
performance & data collection and to 'Act' suitably where necessary.

This cycle is also called as Deming Cycle in reference to Dr Deming, who

taught this concept to Japanese for building robust processes and continuous
improvements during their quality revolution in 1950's.
Process Approach
A "Process" can be defined as a "Set of interrelated or interacting activities,
which transforms inputs into outputs". Inputs to a process are generally
outputs of other processes.

The process approach means systematic definition and management of

processes of an organization in an effective and efficient manner, so as to
achieve the intended results with the least possible wastage in the supply
chain / value chain.
The process approach enables the organization to manage the
interrelationships and interdependences among the processes of the system
in a best possible way resulting in superior overall performance.

Risk Based thinking

The new standard also makes us to do risk based thinking there by
addressing risks and opportunities for achieving improved results and
preventing negative effects. As per ISO9001:2015, it is required to assess
the risks and opportunities at planning stage and have actions to address
them.

Risk is the effect of uncertainty that can have positive or negative effects
resulting in opportunity for better performance (not all positive effects can
give an opportunity) or threat for lower performance. The main aim of the risk
based thinking is to prevent the negative effects and enhance the
performance where an opportunity exists in a systematic way.
ISO 9001: 2015 standard requirements
1 Scope

2 Normative reference

3 Terms & definitions

4 Context of the organization PLAN

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the QMS

4.4 QMS and its processes

5 Leadership PLAN

5.1 Leadership and commitment

5.2 Policy

5.3 Organizational roles, responsibilities and authority

6 Planning PLAN

6.1 Actions to address risks & opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

7 Support PLAN

7.1 Resources

7.2 Competence
1 Scope

7.4 Awareness

7.5 Documented inforation

8 Operation DO

8.1 Operatinal planning and control

8.2 Requirements for products & services

8.3 Design & dev of P & S

8.4 Control of externally provided processes, products and services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of non-conforming outputs

9 Performance evaluation CHECK

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audits

9.3 Management review

10 Improvement ACT

10.1 General

10.2 Non-conformity and corrective actions

10.3 Continual improvement

Practicing this standard requirements shall drive quality culture across all
levels of people at all activities in an organization resulting in doing things
right all the time and improving performance from time to time.
Basic Statistical Techniques/ Quality Tools
The standard indicates the usage of statistical techniques for performance
data analysis. The 7 basic quality tools which comprises of graphical and
basic statistical techniques are most powerful in data capturing, analyzing
and problem solving for effective process management & control.

Originally used for Quality performance analysis, evaluation & improvement

in Japan and became very popular as 7 Basic Quality Tools or 7 QC tools.

The 7 basic tools are

 Cause & Effect diagram: (also called Ishikawa or fishbone chart):

Identifies many possible causes for an effect or problem and sorts ideas
into useful categories.
 Check sheet: A structured, prepared form for collecting and analyzing
data; a generic tool that can be adapted for a wide variety of purposes.
 Control charts: Graphs used to study how a process changes over
time.
 Histogram: The most commonly used graph for showing frequency
distributions, or how often each different value in a set of data occurs.
 Pareto chart: Shows on a bar graph which factors are more significant.
the 80/20 rule - states that approximately 80% of the problems are
created by approximately 20% of the causes.
 Scatter diagram: Graphs pairs of numerical data, one variable on each
axis, to look for a relationship.
 Flow chart - visual representation of the sequence of
steps/activities/actions and decisions needed to perform a process.