ISO 9001:2008
Awareness Presentation
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
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
What is ISO 9001?
• This system has 4 components or elements and
they are applied within your business
management:
a)
b)
c)
d)
Management responsibility
Resource management
Product realization
Measurement, analysis and improvement
• Before we explore these elements, why is ISO
9001 necessary for your organization?
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
Why do we need ISO 9001?
• 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.
Global Issuance of
ISO 9001 Certificates
1,200,000
2000
1,000,000
2001
2002
800,000
2003
600,000
2004
2005
400,000
2006
2007
200,000
2008
2009
0
No of ISO 9001 certificates
ISO Survey 2010
ISO 9001 Certificates issued by region
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.
Biggest benefit
• The ISO 9001:2008 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
• A well-designed and well-implemented quality
management system can and should eliminate
What is ISO 9001?
• ISO = International
Organization for
Standardization
• isos = Greek = equal
• 9001 = unique ID
number
• 2008 = 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
ISO 9000 Family
a) ISO 9001:2008 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.
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
What is ISO 9001:2008 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 your
QMS
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 nonconformances 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)
Root cause
Effect 1
Effect 2
Root cause analysis
1.
2.
3.
4.
5.
Why did the nonconformity occur?
Why did the direct cause occur?
Why did effect 3 occur?
Why did effect 2 occur?
Why did effect 1 occur?
Effect 3
Direct cause
Nonconformity
8 Quality Management Principles
1.
2.
3.
4.
5.
Customer focus
The ISO 9001
Standard is based
Leadership
on these principles
Involvement of people
Process approach
System approach to
management
6. Continual improvement
7. Factual approach to decision
making
8. Mutually beneficial supplier
relationships
System approach
• Quality must be managed by a system to be
effective
• This system is done for you, as represented by
the ISO 9001:2008 standard
• Recall: A system is a set of interrelated or
interacting elements
• System approach is described in Clause 4.1
• The description of Clause 4.1 matches the PDCA
approach to process management - Plan, Do,
Check, Act
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.
ISO Lingo
input
process
output
• Product = Any output- physical product or
services
• Output = product
• Product = result of a process
• Process = a set of inter-relating activities focused
towards producing the output
• Input = requirements
Process approach
Can be applied to any
other process that you
manage
input
Your process
output
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)
Anatomy of a
process
Resources
Inputs
Process
Outputs
Activities
Every process
has an owner
Process management
ISO 9001:2008 ELEMENTS
input
Your QMS
output
ISO 9001:2008 Structure
•
•
•
•
•
•
•
•
Clause 1 Scope
Clause 2 Normative references
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
Quality
management
system
Resource
management
Your QMS
Product
realization
Measurement,
analysis and
improvement
General
requirements
Documentation
requirements
Clause 1 Scope
• Your organization should consider to adopt
the ISO 9001 standard if it
– needs to demonstrate its ability to consistently
provide product that meets customer and
applicable statutory and regulatory requirements,
and
– aims to enhance customer satisfaction through
the effective application of the system, including
processes for continual improvement of the
system and the assurance of conformity to
customer and applicable statutory and regulatory
requirements.
• In this International Standard, the term
“product” only applies to
a) product intended for, or required by, a customer,
b) any intended output resulting from the product
realization processes.
• All requirements of this International Standard
are generic and are intended to be applicable
to all organizations, regardless of type, size
and product provided.
Clause 1.2 Application
• Where exclusions are made,
• Where any
claims of conformity to this
requirement(s) of this
International Standard are not
acceptable unless these
International Standard
exclusions are limited to
cannot be applied due to
requirements within Clause 7.
the nature of an
organization and its
• And such exclusions do not
affect the organization's
product, this can be
ability, or responsibility, to
considered for exclusion.
provide product that meets
customer and applicable
statutory and regulatory
requirements.
Clause 2 Normative references
• This document is indispensable in the
application of the ISO 9001 standard:
– ISO 9000 – Fundamentals and vocabulary
Clause 3 Terms and definitions
• Wherever the term “product” occurs, it can
also mean “service”.
4.1 QMS General Requirements
1. Determine the QMS processes
2. Determine the sequence and interactions
3. Determine the methods of operations and
control
4. Provide resources to ensure effective operations
(Clause 6)
5. Monitor, measure and analyze processes (Clause
8.2 to 8.4)
6. Improve the effectiveness of the processes
(Clause 8.5)
QMS processes are in the circle
Clause 4.2 Documentation requirements
a) Quality Policy
b) Quality Manual – to
describe the system
c) Quality Objectives
Register – to document
your quality objectives
d) Control of Documents
Procedure
e) Control of Records
Procedure
f) Internal Audit Procedure
 Note: Templates are
available. 
g) Control of Nonconforming
Product
h) Corrective Action
Procedure
i) Preventive Action
Procedure
j) Quality Plan
k) Control plans
l) Other documents, as
necessary
m) Records (to show
evidence of work
performed in all QMS
processes)
Control of documents
Create
document
Get
approval
Register
document
Distribute
document
Review
document
Amend
document
Get reapproval
Update
register
Identify
external
documents
Register
external
documents
Check for
updates
Update
register
Dispose obsolete
document
Stamp obsolete
document if retained
Clause 4.2.4 Control of records
• Records established to provide evidence of
conformity to requirements and of the effective
operation of the quality management system
shall be controlled.
• Process owners must identify, classify and
maintain all process records in good and secure
conditions throughout retention period.
• Records shall remain legible, readily identifiable
and retrievable.
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
Types of records to maintain
• Go through the ISO 9001 standard or your Quality Manual
• Identify the following phrases where they appear: “Records ……
shall be maintained (see 4.2.4)”
• 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.
Clause 5 Management Responsibility
• Top management must
a)
b)
c)
d)
Be committed to the QMS
Be customer focused
Establish a quality policy
Plan for the QMS in terms of establishing quality
objectives and management of change
e) Assign responsibility, authority and provide
suitable communication channels
f) Review the QMS performance
What to do
•
•
•
•
•
•
•
•
•
•
•
Read the ISO 9001:2008 Standard
Establish a Quality Policy
Appoint a Management Representative (from mgt rank)
Establish a QMS Committee
Establish your Quality Manual
Establish the 6 mandatory procedures (Clause 4.2)
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 CEO/Manager 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.
Financials
Human
capital
Balanced
scorecard
Customers
Processes
• Can be used to benchmark
performance based on input
requirements (customer wants 100
units per month, so give them 100
units per month)
Quality
objectives
• 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.
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
Clause 6 Resource management
• Clause 6.1 Provision of resources
• The organization shall determine and provide
the resources needed
a) to implement and maintain the quality
management system and continually improve its
effectiveness, and
b) to enhance customer satisfaction by meeting
customer requirements.
Types of resources
• Determine , provide and manage the following:
a) Clause 6.2 Competent human resources
(competency assessment, training needs analysis)
b) Clause 6.3 Suitable and well-maintained
infrastructures (maintenance of buildings, hardware,
software, transportation, utilities)
c) Clause 6.4 Suitable and well-maintained work
environment (5S program)
d) Consider including financial management in your
QMS to ensure product conformity
PLAN
Establish Job
Description
Hire
employee
DO
Appraise
performance
CHECK
Identify
training
needs
ACT
Conduct
training
Assess
effectiveness
of training
• Clause 6.2.1
• Personnel performing work affecting
conformity to product requirements shall be
competent on the basis of appropriate
education, training, skills and experience.
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
• Create a survey form which contains these
columns:
1.
2.
3.
4.
5.
6.
7.
8.
•
•
•
•
Employee’s name
Job position
List of routine activities
List of non-routine activities
Key performance indicators
Skills required
Competency assessment per skill (use score
ratings)
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 reengineer the work processes
Output: ?
5S Program for work environment
management
SEIRI
SEITON
SEISO
SEIKETSU
SORT
SET IN ORDER
SHINE
STANDARDIZE
SHITSUKE
SUSTAIN
Product realization processes
Clause 7.1 Planning of product realization
• The organization shall plan and develop the processes
needed for product realization, in terms of
a) quality objectives and requirements for the product
b) the need to establish processes and documents,
c) providing resources specific to the product
d) required verification, validation, monitoring,
measurement, inspection and test activities specific to
the product and the criteria for product acceptance
e) records needed to provide evidence that the realization
processes and resulting product meet requirements
Clause 7.1 Create a Quality Plan
• With the following contents:
a) Assigned responsibilities (who’s doing what)
b) Quality objectives (productivity/quality targets)
c) Customer requirements/Product characteristics,
features, etc.
d) References to procedures to control production/creation,
storage, release, delivery, etc.
e) Required resources- HR, materials, equipment, etc.
f) Required verification, validation, monitoring,
measurement, inspection and test activities specific to
the product and the criteria for product acceptance
g) Types of records needed to provide evidence that the
realization processes and resulting product meet
requirements
What’s a Plan?
Duties and
responsibilities
KPI &
Quality
objectives
SOP’s and
records
Description
of activities
Flow of
activities
PLAN
Required
physical
resources
Quality
control
activities
Output
description
Clause 7.2
Determination of
customer
requirements
Customer related
process
Review of customer
requirements
Customer
communication
Planning
Clause 7.3
Create a Design Plan
Input
Output
Design & development
Review
Verify
• This clause can be
excluded from your QMS
if you don’t design the
your products
Validate
Control of changes
Design & development
•
•
Review
activity undertaken to
determine the suitability,
adequacy and
effectiveness of the
subject matter to achieve
established objectives
•
Verification confirmation,
through the provision of
objective evidence, that
specified requirements
have been fulfilled
•
•
Validation
confirmation, through the
provision of objective
evidence, that the
requirements for a specific
intended use or
application have been
fulfilled
Design & development
•
•
Review
activity undertaken to
determine the suitability,
adequacy and
effectiveness of the
subject matter to achieve
established objectives
•
Verification confirmation,
through the provision of
objective evidence, that
specified requirements
have been fulfilled
•
•
Validation
confirmation, through the
provision of objective
evidence, that the
requirements for a specific
intended use or
application have been
fulfilled
Clause 7.4
PURCHASING
Purchasing process
Purchasing information
Verification of purchased
product
PLAN
Determine
purchase
requirements
Issue RFQ
DO
Evaluate
quotes
CHECK
Issue PO
ACT
Inspect DO
Assess
supplier’s
performance
• Keep records of your purchase orders, suppliers’
quotations & delivery orders and inspection
forms for purchased products. Monitor, measure
and analyze their performance (only those who
supply materials/equipment/services used within
the product creation process
Clause 7.5 - Create a
Production/Service
Plan
Production & service
provision
Control of production and
service provision
Validation of processes for
production and service
provision
Identification and
traceability
Customer property
Preservation of product
Clause 7.6 Control of monitoring and
measuring equipment
• The organization shall determine the monitoring and
measurement to be undertaken and the monitoring
and measuring equipment needed to provide evidence
of conformity of product to determined requirements.
• Calibrate the monitoring and measuring equipment at
suitable intervals.
• Verify the monitoring and measuring equipment at
suitable intervals.
• Segregate those equipment which are not calibrated
yet or not used within the process. Tag or cage them.
• This clause can be excluded from your QMS if you don’t use such
equipment in your product creation process.
Product realization process controls
a) Quality Plan – to document how you intend
to meet your customers’ requirements
b) Customer & Legal Requirements
c) Customer complaints handling procedure
d) Design Plan
e) Purchasing Procedure
f) Production/Service Plan
g) Monitoring & Measuring Equipment Plan
(can be included in Production/Service Plan)
Clause 8 Measurement, analysis and improvement
• The organization shall plan and implement the monitoring,
measurement, analysis and improvement processes
needed
a)
b)
c)
to demonstrate conformity to product requirements,
to ensure conformity of the quality management system, and
to continually improve the effectiveness of the quality
management system.
• This shall include determination of applicable methods,
including statistical techniques, and the extent of their use.
Why monitor and measure?
• If you cannot measure it, you
cannot improve it. Lord Kelvin
• Measurements provide you
with a baseline to improve
upon.
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
Clause 8.3 Control of nonconforming products
Where applicable, the organization shall deal with
nonconforming product by one or more of the following ways:
a) by taking action to eliminate the detected nonconformity;
b) by authorizing its use, release or acceptance under
concession by a relevant authority and, where applicable,
by the customer;
c) by taking action to preclude its original intended use or
application;
d) by taking action appropriate to the effects, or potential
effects, of the nonconformity when nonconforming product
is detected after delivery or use has started.
Internal audit process
Establish
annual
audit
schedule
Distribute
Audit Plan
Perform
audit
Report
findings
Follow-up
actions
• Purpose is to verify whether your QMS
a)
b)
c)
d)
Conforms to your Quality Plan,
Conforms to ISO 9001 requirements,
Conforms to your QMS requirements, and
is effectively implemented and maintained.
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
• 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
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.
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 set
Trend chart
Use it to identify potential problems
Errors
12
10
8
6
4
2
0
What caused
this spike?
Pareto Principle
•
•
•
•
20% of the causes contributes to 80% of the effects
• Analyze your sales
Identify and classify
figures and identify
all problems
the contributors
Calculate cumulative
• Focus your efforts on
occurrences up to
customers who
80%
contribute 80% of
Focus on solving
those sales
those problems
• Focus your efforts on
Continually improve
the sales personnel
who are managing
the management of
those customers
those causes
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.
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.
Corrective action process
Detect
nonconformity
Report
nonconformity
Review
nonconformity
against criteria
Evaluate need
for corrective
action
Perform root
cause analysis
Issue CAR
Implement
corrective
action
Record the
results of
actions taken
Verify
effectiveness of
actions taken
Preventive action process
Detect
potential
nonconformity
Report
potential
nonconformity
Review against
criteria
Evaluate need
for preventive
action
Perform root
cause analysis
Issue PAR
Implement
preventive
action
Record the
results of
actions taken
Verify
effectiveness of
actions taken
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
Root cause analysis
causes
Root cause
Effect
effect
Effect
Direct cause
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.
Nonconformity
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
ISO 9001 Certification
• Performed by independent Certification Body,
such as SIRIM QAS, BVQI, LRQA, SGS
• Client gets a renewable 3-year certificate
• Phase 1 audit = Adequacy audit =
Documentation audit
• Phase 2 audit = Conformance audit = Physical
audit of personnel, records and processes
ISO 9001 Certification
• First year = Certification audit
• 2nd year = Surveillance audit
• 3rd year = Surveillance audit and/or recertification audit
• If after 3 months, nonconformities were not
corrected (via the corrective action procedure)
by the client, the ISO 9001 certificate will be
revoked by the CB.
• Decide if ISO 9001 is for you
• Purchase the standard online
• Purchase a Quality Manual
template
• Appoint a Management
Representative
• Appoint a QMS Committee
• Read the ISO 9001 Standard
and the Quality Manual
• Plan your QMS by customizing
the Quality Manual
• Plan and implement every
clause within the Quality
Manual
Plan of action
Hope you
benefited from
that presentation
