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?
Its 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
 What is ISO 9001?
This system has 4 components or elements and
they are applied within your business
management:
a) Management responsibility
b) Resource management
c) Product realization
d) 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
800,000 2002
2003
600,000 2004
2005
400,000 2006
2007
200,000
2008

0 2009
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:

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.
 A well-designed and well-implemented quality
management system can and should eliminate
 What is ISO 9001?
ISO = International Formation 23 February 1947
Organization for Type NGO
Standardization Purpose Intl standardization
isos = Greek = equal HQ Geneva
Membership 63 countries
9001 = unique ID Website www.iso.org
number No. of stds over 18,000
2008 = Year it was
published
 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 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?
4. Why did effect 2 occur?
5. Why did effect 1 occur?
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
 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 Inputs

Resources Process Activities

Outputs 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
 General
Quality requirements
management
system Documentation
requirements
Resource
management
Your QMS
Product
realization

Measurement,
analysis and
improvement
 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 any Where exclusions are made,
claims of conformity to this
requirement(s) of this International Standard are not
International Standard acceptable unless these
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
product, this can be affect the organization's
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 g) Control of Nonconforming
b) Quality Manual to Product
describe the system h) Corrective Action
c) Quality Objectives Procedure
Register to document i) Preventive Action
your quality objectives Procedure
d) Control of Documents j) Quality Plan
Procedure k) Control plans
e) Control of Records l) Other documents, as
Procedure necessary
f) Internal Audit Procedure m) Records (to show
evidence of work
Note: Templates are performed in all QMS
available. processes)
 Control of documents
Create Get Register Distribute
document approval document document

Review Amend Get re- Update

document document approval register

Identify Register
Check for Update
external external
updates register
documents documents

Dispose obsolete Stamp obsolete

document 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 SOPs and quality objectives

shall be created.
 Clause 5 Management Responsibility
Top management must
a) Be committed to the QMS
b) Be customer focused
c) Establish a quality policy
d) 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 KPIs and start collecting data
Implement all the procedures
 Key Performance Indicators
Ask this question when
determining KPIs: Financials

As the CEO/Manager of
this organization, what
data will instantly give me Human Balanced
Processes
capital scorecard
the ability to assess overall
performance at any given
point of time?
Customers
Then list all them down
and select your desired
KPIs.
 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, 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 DO CHECK ACT

Identify Assess
Establish Job Hire Appraise training Conduct
Description employee performance training effectiveness
needs 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 Create a survey form which contains these
columns:
activities are not
1. Employees name
defined. So theres 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: ?
 5S Program for work environment
management

SEIRI SEITON SEISO SEIKETSU SHITSUKE

SORT SET IN ORDER SHINE STANDARDIZE 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 (whos 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
 Whats a Plan?
Duties and
responsibilities
KPI &
SOPs and
Quality
records
objectives

Description Flow of
of activities PLAN activities

Required Quality
physical control
resources activities
Output
description
 Determination of
customer
Clause 7.2 requirements

Customer related Review of customer

process requirements

Customer
communication
 Planning

Clause 7.3 Input

Create a Design Plan
Output

Design & development Review

Verify

This clause can be Validate

excluded from your QMS
if you dont design the Control of changes
your products
 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 process

PURCHASING Purchasing information

Verification of purchased
product
 PLAN DO CHECK ACT

Determine Assess
Evaluate Issue PO
purchase Issue RFQ Inspect DO suppliers
quotes
requirements 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
 Control of production and
service provision
Clause 7.5 - Create a
Production/Service Validation of processes for
Plan production and service
provision
Production & service
Identification and
provision 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 dont 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) to demonstrate conformity to product requirements,

b) to ensure conformity of the quality management system, and
c) 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
Distribute Perform Report Follow-up
annual 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.
 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

Audit methodology
a) Interviewing the auditee
b) Inspection of documents
and records, etc.
c) Observation of ongoing
activities
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, thats all
5. So use the ISO 9001 Audit Checklist and
start auditing.
 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 What caused

12 this spike?

10

0
 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.
 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
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
 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
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)
 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.
 Nonconformities
Dont fear them because

We detect and report them because we

dont 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 re-
certification 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
Plan of action
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
Hope you
benefited from
that presentation