QMS Training

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 Keywords:
customer requirements 1. Quality
2. Management system
and enhancing of 3. Customer requirements
customer satisfaction 4. Customer satisfaction
reserved
What is quality….
Satisfied? Not satisfied?
3
How was it?
provides 4
1
requirements
2
Products / services
Customers Organization
supplies
improve 5
Characteristics
“Degree to which a set of inherent characteristics

fulfils requirements”
(source – ISO 9001:2015)
Proprietary and confidential. All rights reserved
What is Quality Management System….
Policies
Objectives
Processes
Quality Management System
“a system to direct and control an organization with

respect to quality!!!”
Proprietary and confidential. All rights (source – ISO 9001:2015)
reserved
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
“Quality Management System - Requirements”

reserved
QMS Model….
Quality Management System (4)
Support and
Organization Operation
(7,8)
and its context
(4)
Customer
PLAN DO satisfaction
Results
Customer Leadership Performance
Planning (6)
(5) Evaluation (9) of the
requirements
QMS
Product and
ACT CHECK
services
Needs and
Improvement
expectations of (10)
relevant
interested
parties (4) Proprietary and confidential. All rights
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
1,200,000
2000
1,000,000
2001
800,000 2002
2003
600,000 2004
2005
400,000 2006
2007
200,000
2008
0 2009
No of ISO 9001 certificates

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:

Planning
– Plan what you want to do,
– Follow that plan,
is the key
– Monitor, measure and
analyze your execution of P D C A
the plan, and
– Improve the plan. Proprietary and confidential. All rights
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 Formation 23 February 1947
Organization for Type NGO
Standardization Purpose Int’l standardization
• isos - Greek - equal HQ Geneva
Membership 63 countries
• 9001 - unique ID Website www.iso.org
number No. of stds over 18,000
• 2015 = Year it was
published

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 Effect 1 Effect 2 Effect 3 Direct cause Nonconformity
Root cause analysis

1. Why did the nonconformity occur?
2. Why did the direct cause occur?
3. Why did effect 3 occur?

reserved
8 Quality Management Principles
1. Customer focus The ISO 9001
2. Leadership Standard is based
on these principles
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
input process output
• 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
reserved
Process approach
Or Service
Can be applied to any

other process that you
manage
input Your process output

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 Inputs
Resources Process Activities
Outputs Every process

has an owner
reserved
Process management

reserved
Quality General
management requirements
system
Documentation
requirements
Leadership
Your QMS
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: Financials
• As the employee of this

organization, what data
will instantly give me the Human Balanced
Processes
capital scorecard
ability to assess overall
performance at any given
point of time?
Customers
• Then list all them down
and select your desired
KPI’s.
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
Quality be based on past performance data
and existing capacity to be realistic
objectives • 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,
Proprietary and confidential. All rights etc.
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
Sometimes, work • Create a survey form which contains these
columns:
activities are not
1. Employee’s name
defined. So there’s 2. Job position
a lot of confusion 3. List of routine activities
4. List of non-routine activities
5. Key performance indicators
6. Skills required
Defining staff 7. Competency assessment per skill (use score
ratings)
duties and
8. Recommendation for training
responsibilities
and analyzing • Employees fill in columns 1 to 4
training needs to • Manager fills in columns 5 to 8
ensure • Benefits: Manager can identify work
competence is redundancies, activity gaps, competency gaps,
need for training and maybe the need to re-
essential engineer the work processes
• Output: ?
reserved
What’s a Plan?
Duties and
responsibilities
KPI &
SOP’s and
Quality
records
objectives
Description Flow of
of activities PLAN activities
Required Quality
physical control
resources activities
Output
description

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
Establish
annual Distribute Perform Report Follow-up
audit Audit Plan audit findings actions
schedule
• 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.
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.
Audit methodology
a) Interviewing the auditee 2. That requirement may come from the ISO
9001 Standard, your Quality Manual, SOP,
b) Inspection of documents etc.
and records, etc.
c) Observation of ongoing
activities
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
Proprietary and auditing.
confidential. All rights
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 toProprietary
identify potential risks given the data set
and confidential. All rights
reserved
Pareto Principle
20% of the causes contributes to 80% of the effects
• Identify and classify • Analyze your sales
all problems figures and identify
• Calculate cumulative the contributors
occurrences up to • Focus your efforts on
80% customers who
contribute 80% of
• Focus on solving those sales
those problems • Focus your efforts on
• Continually improve the sales personnel
the management of who are managing
those causes 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.
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
Review
Detect Report
nonconformity
nonconformity nonconformity
against criteria
Evaluate need
Perform root
for corrective Issue CAR
cause analysis
action
Implement Record the Verify

corrective results of effectiveness of
action actions taken actions taken

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

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

QMS Training

Hochgeladen von

Dokumentinformationen

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

QMS Training

Hochgeladen von

Copyright:

Verfügbare Formate

QMS Training

An overview of the Quality

1. ISO 9001 is being

2. Over 1.2 million

3. ISO has 163 member

Proprietary and confidential. All rights

• The system is focused

“Degree to which a set of inherent characteristics

Quality Management System

“a system to direct and control an organization with

International Standard published by ISO

Prescribes set of requirements related to

Conformity can be assessed internally as

World’s first certifiable QMS standard

“Quality Management System - Requirements”

Proprietary and confidential. All rights

Part of Quality Manual

Expresses Top Management’s

All employees MUST understand and

Proprietary and confidential. All rights

• Before we explore these elements, why is ISO

Proprietary and confidential. All rights

Proprietary and confidential. All rights

• ISO 9001 requires you to:

Proprietary and confidential. All rights

Proprietary and confidential. All rights

• The term “ISO 9000” is frequently used to refer to the

Root cause analysis

Proprietary and confidential. All rights

Proprietary and confidential. All rights

Proprietary and confidential. All rights

• Product = Any output- physical product or

Can be applied to any

input Your process output

Proprietary and confidential. All rights

Resources Process Activities

Outputs Every process

Proprietary and confidential. All rights

Proprietary and confidential. All rights

Proprietary and confidential. All rights

• Identify the following phrases where they appear: “Documented

• Most of the records requirements are readily available, such as

• Records pertaining to the mandatory SOP’s and quality objectives

• As the employee of this

• Can be used to improve KPI

objectives • You can use existing performance

• Use quality objectives to improve on

Proprietary and confidential. All rights

Proprietary and confidential. All rights

Proprietary and confidential. All rights

• If you cannot measure it, you

• Measurements provide you

Proprietary and confidential. All rights

• Purpose is to verify whether your QMS

a) Conforms to your Quality Plan,

Proprietary and confidential. All rights

1. Remember your purpose is to verify

4. Remember, your job as an auditor is to

5. So use the ISO 9001 Audit Checklist and

Proprietary and confidential. All rights

• All nonconformities require corrective actions

Implement Record the Verify

Proprietary and confidential. All rights

Implement Record the Verify