Quality Management System awareness for all

QMS Training
An overview of the Quality
Management System
Prepared by:
Anupam Ray
Cont:-9999133689
Email id:-anupam@scs-groups.com

Suitable for all
kinds of
interested
audiences

Empty your cup and
enjoy the presentation

Facts about ISO 9001
1. ISO 9001 is being
implemented in 175
countries around the
world
2. Over 1.2 million
certificates issued
worldwide
3. ISO has 163 member
countries
Proprietary and confidential. All rights
reserved

What is ISO 9001?
• It’s a quality management
system that can be
adopted by any kind of
organization
• The system is focused
towards the meeting of
customer requirements
and enhancing of
customer satisfaction
Keywords:
1. Quality
2. Management system
3. Customer requirements
4. Customer satisfaction
reserved

“Degree to which a set of inherent characteristics
fulfils requirements”
(source – ISO 9001:2015)
What is quality….
Customers
provides
Organization
Products / services
requirements
supplies
Characteristics
How was it?
Satisfied? Not satisfied?
improve
1
2
3
4
5
Proprietary and confidential. All rights reserved

“a system to direct and control an organization with
respect to quality!!!”
(source – ISO 9001:2015)
What is Quality Management System….
Quality Management System
Processes
Objectives
Policies
reserved

“Quality Management System - Requirements”
ISO 9001:2015….
International Standard published by ISO
Prescribes set of requirements related to
a quality management system
Conformity can be assessed internally as
well as by external parties
World’s first certifiable QMS standard
reserved

QMS Model….
Results
of the
QMS
Quality Management System (4)
Organization
and its context
(4)
Customer
requirements
Needs and
expectations of
relevant
interested
parties (4)
Customer
satisfaction
Product and
services
Leadership
(5)
Improvement
(10)
Support and
Operation
(7,8)
Performance
Evaluation (9)
Planning (6)
PLAN DO
CHECKACT
reserved

Quality Policy….
Part of Quality Manual
Published on Intranet
Expresses Top Management’s
commitment towards quality
All employees MUST understand and
apply the quality policy
reserved

What is ISO 9001?
• This system has 5 components or elements and
they are applied within your business
management:
a) Leadership
b) Planning
c) Support and operation
d) Performance evaluation
e) Improvement
• Before we explore these elements, why is ISO
9001 necessary for our organization?
reserved

Why do we need ISO 9001?
• To be effective in whatever we do, we need a
system of doing things to be consistent. Just like
craftsmen, managers need a good management
tool to get the job done.
• There are too many activities in any organization.
Easy to lose track of things and focus. Easy to get
distracted. Managers need a good system to keep
things in order.
• Systemizing of activities is a natural
phenomenon. We do it all the time – privately,
publicly or commercially
reserved

Continue…..
• A business faces great risks – big
investments, customer expectations, jobs,
credibility, etc. The business owner must
do all he can to ensure success, or he/she
will fail.
• Every major economy in the world adopts
it! Governments give recognition to it.
Because it works.
reserved

Global Issuance of
ISO 9001 Certificates
0
200,000
400,000
600,000
800,000
1,000,000
1,200,000
No of ISO 9001 certificates
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
reserved

You already have a system of doing
things too!
• But is it effective? If you keep doing what you
always do, you will always get the same result.
• ISO 9001 is an option, a good one. It requires
your organization to document your business
processes (QMS), monitor, measure, analyze and
improve it.
• Business owners and top management need to
make a strategic decision on whether to
implement the ISO 9001 QMS.
reserved

Biggest benefit
• The ISO 9001:2015 Standard
provides managers with a
tool that is designed to
continually improve their
business performance.
• ISO 9001 requires you to:
– Plan what you want to do,
– Follow that plan,
– Monitor, measure and
analyze your execution of
the plan, and
– Improve the plan.
Planning
is the key
P D C A
reserved

• A well-designed and well-implemented quality
management system can and should eliminate
• Ineffectiveness
• Inefficiencies
• Problems
• Errors
• Inconsistencies
• Malicious practices
• Uncertainties
• Bad culture
reserved

What is ISO 9001?
• ISO - International
Organization for
Standardization
• isos - Greek - equal
• 9001 - unique ID
number
• 2015 = Year it was
published
Formation 23 February 1947
Type NGO
Purpose Int’l standardization
HQ Geneva
Membership 63 countries
Website www.iso.org
No. of stds over 18,000
reserved

ISO 9000 Family
a) ISO 9001:2015 Quality Management Systems –
Requirements
b) ISO 9000:2005 Fundamentals and vocabulary
c) ISO 19011:2011 Guidelines for auditing management
systems
d) ISO 9004:2009 Managing for the sustained success of
an organization — A quality management approach
• The term “ISO 9000” is frequently used to refer to the
ISO 9001 standard
• Only ISO 9001 is auditable. The rest serves as
references only.
reserved

ISO 9001 History
It all started when the US Military were getting sub-par products from their suppliers.
Then it caught on.
YEAR STANDARDS TITLE
1959 MIL-Q-9858 QUALITY PROGRAM REQUIREMENTS
1969 AQAP NATO ALLIED QUALITY ASSURANCE PUBLICATIONS
1974 BS 5179 GUIDELINES FOR QUALITY ASSURANCE
1979 BS 5750 SPECIFICATION FOR DESIGN DEVELOPMENT, PRODUCTION,
INSTALLATION AND SERVICING
1987 ISO 9001:1987 Model for quality assurance in design, development,
production, installation, and servicing
ISO 9002:1987 Model for quality assurance in production, installation, and
servicing
ISO 9003:1987 Model for quality assurance in final inspection and test
1994 ISO 9001:1994 QUALITY SYSTEMS – MODEL FOR QUALITY ASSURANCE
2000 ISO 9001:2000 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS
2008 ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS- REQUIREMENTS
reserved

What is ISO 9001:2015 Quality
Management Systems - Requirements?
• Quality - degree to which customer requirements have
been met
• Management - coordinated activities to direct and
control an organization
• System - set of interrelated or interacting elements
• Quality management system - a system to direct and
control an organization with regard to quality
• Requirements - a set of management parameters for
your QMS
reserved

More about quality
• How do you know requirements have been met?
– Review = confirm that requirements are accurate
– Verify = measure accuracy of output against requirements
– Validate = Get feedback from customer/end-user
• Nonconformance = failure to fulfill requirements
• Nonconformance = error
• All forms of nonconformance require corrections and
corrective action to prevent recurrences
• Correction = Elimination of error
• Corrective action = Elimination of the root causes of
the error (Ask WHY 5 times)
reserved

Root cause analysis
Root cause Effect 1 Effect 2 Effect 3 Direct cause Nonconformity
1. Why did the nonconformity occur?
2. Why did the direct cause occur?
3. Why did effect 3 occur?
reserved

8 Quality Management Principles
The ISO 9001
Standard is based
on these principles
1. Customer focus
2. Leadership
3. Involvement of people
4. Process approach
5. System approach to
management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier
relationships
reserved

System approach
• Quality must be managed by a system to be
effective
• This system is done for you, as represented by
the ISO 9001:2015 standard
• Recall: A system is a set of interrelated or
interacting elements
• System approach is described in Clause 4.1
• Combination of all Clause matches the PDCA
approach to process management - Plan, Do,
Check, Act
reserved

System and process approach
• Quality must be managed by a system
• The system must be managed using the
process approach because the system is made
up of processes
• These processes are linked to each other
• A process has inputs , resources, activities,
outputs and customers. Manage them all.
reserved

ISO Lingo
• Product = Any output- physical product or
services
• Output = Product/ Service
• Product = result of a process
• Process = a set of inter-relating activities focused
towards producing the output
• Input = requirements
input process output
reserved

Process approach
input Your process output
Can be applied to any
other process that you
manage
Or Service
reserved

Process approach
• Every process require specific inputs, resources,
activities, outputs and customers
• What you can do now is:
– Define and document the inputs
– Define and document the kinds of resources that your
process use
– Define and document the activities and their interactions
– Define and document the responsibilities
– Define and document the outputs
• You can name this document as Department Control
Plan
• Then execute this plan, and monitor, measure, analyze
and improve its performance (KPI)
• Thus, Plan – Do - Check – Act (Edward Demmings)
reserved

Anatomy of a
process
Process
Inputs
Activities
Outputs
Resources
Every process
has an owner
reserved

Process management
reserved

Your QMS
Quality
management
system
General
requirements
Documentation
requirements
Leadership
Support and
operation
Performance
evaluation
Improvement
reserved

Good records management
• Enables you to
a) conduct business in an orderly, efficient and
accountable manner
b) support and document decision making
c) provide continuity in the event of a disaster
d) meet legislative and regulatory requirements
e) protect the interests of customers, employees
and stakeholders
reserved

Types of records/ documented
Information to maintain
• Go through the ISO 9001 standard or your Quality Manual
• Identify the following phrases where they appear: “Documented
Information …… shall be maintained”
• Most of the records requirements are readily available, such as
product planning records, product design records, purchasing
records, production records, monitoring records, analysis records,
employee performance appraisal and training records, job
descriptions, organization chart, infra maintenance records,
contract/sales records, marketing records, customer complaints
records, etc.
• Records pertaining to the mandatory SOP’s and quality objectives
shall be created.
reserved

What to do
• Read quality policy and quality manual
• Establish a Quality Policy for your own Business.
• Appoint a Management Representative
• Establish a QMS Committee
• Establish your Quality Manual
• Establish the procedures Establish your Quality Plan
• Establish your Department/Process Control Plans
• Establish and document your quality objectives
• Establish your KPI’s and start collecting data
• Implement all the procedures

Key Performance Indicators
• Ask this question when
determining KPI’s:
• As the employee of this
organization, what data
will instantly give me the
ability to assess overall
performance at any given
point of time?
• Then list all them down
and select your desired
KPI’s.
Balanced
scorecard
Financials
Processes
Customers
Human
capital
reserved

• Can be used to benchmark
performance based on input
requirements (customer wants 100
units per month, so give them 100
units per month)
• Can be used to improve KPI
performance levels – decision must
be based on past performance data
and existing capacity to be realistic
• You can use existing performance
levels to establish your quality
objectives
• Use quality objectives to improve on
productivity levels, decrease errors,
improve speed, reduce costs, reduce
complaints, etc.
Quality
objectives
reserved

Employee responsibility
• Know the Quality Policy
• Aware of the relevance and importance
of their activities and how they
contribute to the achievement of the
quality objectives
• Comply with the requirements of the
QMS, as stated in the Quality Manual,
procedures, Quality Plan, etc.
• Provide feedbacks or ideas about the
QMS
• Report any nonconformities
reserved

Types of resources
• Determine , provide and manage the following:
a) Competent human resources (competency
assessment, training needs analysis)
b) Suitable and well-maintained infrastructures
(maintenance of buildings, hardware, software,
transportation, utilities)
c) Suitable and well-maintained work environment (5S
program)
d) Consider including financial management in your
QMS to ensure product conformity
reserved

• Create a survey form which contains these
columns:
1. Employee’s name
2. Job position
3. List of routine activities
4. List of non-routine activities
5. Key performance indicators
6. Skills required
7. Competency assessment per skill (use score
ratings)
8. Recommendation for training
• Employees fill in columns 1 to 4
• Manager fills in columns 5 to 8
• Benefits: Manager can identify work
redundancies, activity gaps, competency gaps,
need for training and maybe the need to re-
engineer the work processes
• Output: ?
Sometimes, work
activities are not
defined. So there’s
a lot of confusion
Defining staff
duties and
responsibilities
and analyzing
training needs to
ensure
competence is
essential
reserved

What’s a Plan?
PLAN
Duties and
responsibilities
KPI &
Quality
objectives
Flow of
activities
Quality
control
activities
Output
description
Required
physical
resources
Description
of activities
SOP’s and
records
reserved

Why monitor and measure?
• If you cannot measure it, you
cannot improve it. Lord Kelvin
• Measurements provide you
with a baseline to improve
upon.
reserved

What do you measure?
1. Customer satisfaction (Survey, returns rate,
complaints, lost business, etc)
2. Process conformance and effectiveness
(internal audit)
3. Process performance (Key Performance
Indicators and quality objectives)
4. Product characteristics (QC inspection before
release to customer) where nonconforming
products must be controlled
reserved

Internal audit process
• Purpose is to verify whether your QMS
a) Conforms to your Quality Plan,
b) Conforms to ISO 9001 requirements,
c) Conforms to your QMS requirements, and
d) is effectively implemented and maintained.
Establish
annual
audit
schedule
Distribute
Audit Plan
Perform
audit
Report
findings
Follow-up
actions
reserved

Audit defined
• Audit is a systematic and documented process for
gathering audit evidence and evaluating it against the
audit criteria to determine whether it has been fulfilled
• Audit criteria is a set of policies, procedures or
requirements
• Audit evidence is records, statements of fact or other
information which are relevant to the audit criteria
and verifiable
• Audit conclusion is the outcome of an audit provided
by the audit team after consideration of the audit
objectives and all audit findings
reserved

• What to ask?
• What records to inspect?
• What activities to observe?
1. Remember your purpose is to verify
conformance and effectiveness against a
specific requirement.
2. That requirement may come from the ISO
9001 Standard, your Quality Manual, SOP,
etc.
3. So the answer depends on what audit
criteria you want to verify
4. Remember, your job as an auditor is to
look for the audit evidence, that’s all 
5. So use the ISO 9001 Audit Checklist and
start auditing.
Audit methodology
a) Interviewing the auditee
b) Inspection of documents
and records, etc.
c) Observation of ongoing
activities
reserved

What do you analyze?
• Analyze what you measured:
a) Customer satisfaction levels
b) Internal audit results
c) Product QC inspection results
d) KPI results
e) Suppliers’ performance.
reserved

How do you analyze?
• Line Chart/Trend Chart/Control Chart - used to detect trends and
unusual activities within the data set,
• Pareto Chart Analysis - used to analyze the different components
that make up the data value in a descending order, complete with
the cumulative percentage line superimposed on it,
• SWOT Analysis - used to analyze process strengths, weaknesses,
opportunities and threats based on the characteristics of the data
set - whether internal or external,
• Arithmetic average or mean - used to identify the average
performance value of the process,
• Median - used to identify the actual middle value of the data set,
• Mode - used to identify the most frequent value occurring within
the data set,
• Range - used to identify the difference between the lowest and
highest values ,
• Standard deviation – used to identify the SD from the mean
• Cause and Effect Analysis - used to analyze the causes and effects
of a given data set,
• Risk Analysis - used to identify potential risks given the data setProprietary and confidential. All rights
reserved

Pareto Principle
20% of the causes contributes to 80% of the effects
• Identify and classify
all problems
• Calculate cumulative
occurrences up to
80%
• Focus on solving
those problems
• Continually improve
the management of
those causes
• Analyze your sales
figures and identify
the contributors
• Focus your efforts on
customers who
contribute 80% of
those sales
• Focus your efforts on
the sales personnel
who are managing
those customers
Joseph M. Juran suggested the principle and named it after Italian economist Vilfredo
Pareto, who observed in 1906 that 80% of the land in Italy was owned by 20% of the
population; he developed the principle by observing that 20% of the pea pods in his
garden contained 80% of the peas.Proprietary and confidential. All rights
reserved

What to improve?
• The organization shall continually improve the
effectiveness of the quality management system
through the use of the quality policy, quality
objectives, audit results, analysis of data,
corrective and preventive actions and
management review.
• All nonconformities require corrective actions
• All potential nonconformities require preventive
actions.
reserved

Corrective action process
Detect
nonconformity
Report
nonconformity
Review
nonconformity
against criteria
Issue CAR
Perform root
cause analysis
Evaluate need
for corrective
action
Implement
corrective
action
Record the
results of
actions taken
Verify
effectiveness of
actions taken
reserved

Preventive action process
Detect
potential
nonconformity
Report
potential
nonconformity
Review against
criteria
Issue PAR
Perform root
cause analysis
Evaluate need
for preventive
action
Implement
preventive
action
Record the
results of
actions taken
Verify
effectiveness of
actions taken
reserved

Risk analysis
Performing a risk analysis on your
business processes can help you
detect potential nonconformities
• Describe the risk
• Describe the potential effects
• Quantify likelihood of occurrence
(consider frequency)
• Quantify severity of consequence
(consider harm or damage)
• Assign risk rating (likelihood x
severity)
• Risk rating > 4 shall be controlled
(ALARP = as low as reasonably
practicable)
Score ratings
1 = very low
2 = low
3 – moderate
4 = high
5 = very high
reserved

Root cause analysis
Root cause Effect Effect Direct cause Nonconformity
causes effect
Sources of direct causes:
1. Human error,
2. Material defect,
3. Equipment malfunction,
4. Ineffective methods of operation or control, or
5. Flawed management policies.
reserved

Nonconformities
• Don’t fear them because
–We detect and report them because we
don’t want them to recur
–We report and record them because we
want to document the improvements made
to the QMS
reserved

Hope you
benefited from
that presentation

reserved

Quality Management System awareness for all

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