ISO 9001:2008

The “International”
Quality Management
Standard
An “Executive Overview”
© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 1
Rev: June 09
 WELCOME TO A NEW FOCUS
ON MANAGING OUR COMPANY
FOR:

CUSTOMER FOCUS
CONTINUOUS IMPROVEMENT
DEFECT PREVENTION

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 2

Rev: June 09
 Where are we?
● Defined processes?
● Documented Systems?
● Available Records?
● Process Action Teams?
● Quality Objectives?
● Measurable Improvement?

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 3

Rev: June 09
 Team Exercise:
● What are your expectations from your
future ISO9001 Quality Management
System?
● What are the major issues that you
want to discuss in this ISO9001
Executive Overview?

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 4

Rev: June 09
 Four Primary Standards
• ISO 9000: Quality Management Systems -
Fundamentals and Vocabulary
• ISO 9001: Quality Management Systems -
Requirements
• ISO 9004: Quality Management Systems -
Guidance for Performance Improvement.
• ISO19011: Guidelines on Quality and
Environmental Auditing
Plus: HB90.3 – Guideline for the Construction Industry

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 5

Rev: June 09
 It’s all about “…the system”
DFC 4.1 - Sequence and Interaction of Key QMS Processes Rev 3-1-03
Top Management / ISO Mgt. Rep. Sales Manager Engineering Manager Materials Manager Production Manager Quality Manager Human Resources Ofcr Info Systems Manager

All processes are

Conduct
Management
Reviews

Responsibility
Management
see SOP 5.6

interrelated. Our
Establish &
Improve QMS
see Section 4.0
and Section 5.0

task will be to take

Provide

Management
Plan & Maintain

Resource
Resources
see Section 6.0 Plan & Maintain Qualify & Train Documents/Data
Facilities Workforce see SOP 4.2.3

all of our processes,

see SOP 6.3 see SOP 6.2.2 and SOP 4.2.4

Identify and Review

Product Requirements
see Section 7.2.1 and SOP 7.2.2 Assure Plan & Control Develop Product

and create a
Supplier Quality Production Quality Plans
see SOP 7.4.1 see SOP 7.5.1 see SOP 7.1

Manage Customer No Design? Purchase and Verify Needed Materials & Services
Communications see SOP 7.4.2, Section 7.4.3 and SOP 8.2.4

documented system
Realization (Inquiries and Feedback,
Product

including Complaints)
Yes
Design/Validate Production Processes
see Section 7.2.3 see SOP 7.5.2

Establish & Maintain Product Identification and Traceability

that adds value to

see SOP 7.5.3

Plan & Control Control Customer Property Control

Design and Preserve Product Monitoring &
(Purchased Product, In-Process Material & Finished Goods) Measuring

our company, our

see SOP 7.3 Devices
see SOP 7.5.4 and SOP 7.5.5
see SOP 7.6

Monitor & Monitor

Conduct Monitor Product
Measure

employees and most

Internal Production Quality
Customer Processes
Audits (Receiving, In-Process &
Satisfaction (Operator Monitoring) Final Inspection)
see SOP 8.2.2 see SOP 8.2.1
see SOP 8.1
Measurement, Analysis

see SOP 8.2.3

and SOP 8.2.4
and Improvement

importantly, our Analyze Internal

Audit Data
Analyze Customer
Satisfaction Data
Analyze Product
Performance Data
Analyze Supplier
Performance
Data
Control Nonconforming Product

Analyze Production
see SOP 8.3

Analyze Quality
Analyze
Competency
Data
Analyze
Document &
Records
Management

customers.
Process Data (QA/QC) Data Systems Data
see Section 8.4

Initiate Corrective, Preventive and Improvement Actions

see SOP 8.5

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 6

Rev: June 09
 Process Flow
Chart
This is the road that we
will travel together. It’s
all about taking care of
our customers

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 7

Rev: June 09
 Task
Overview
● The overall
activities are
not difficult

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 8

Rev: June 09
 QUALITY MANAGEMENT SYSTEM
4 CONTINUAL IMPROVEMENT
QMS Req.
S
C R Management a C
responsibility t
u e i u
5 s s
s qu f
t i Resource Measurement, a t
r management 6
analysis 8c o
o e improvement
t
mm i
m
e
e n Input Product o e
Outputn
r s
t (and/or service) Product 7 r
Realization

Quality Management Process Model

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 9 9
Rev: June
Version 2.01
09
 4. Quality Management 4
System. QMS Req.Management
responsibility
4.1 General Requirements
4.2 Documentation Requirements 5
4.2.1 – General Resource
management Measurement,
4.2.2 – Quality Manual 6 analysis
8improvement
4.2.3 – Control of Documents
4.2.4 – Control of Records
Product
7
(and/or service)
Realization

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 10

Rev: June 09
 5 Management
Responsibility
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
Management
5.5 Responsibility, authority
responsibility and communication
5.6 Management review
5
Resource
management Measurement,
6 analysis
8improvement

Product
7
(and/or service)
Realization

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 11

Rev: June 09
 6 Resource
Management
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work environment Management
responsibility

5
Resource
management Measurement,
6 analysis
8improvement

Product
7
(and/or service)
Realization

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 12

Rev: June 09
 Management
responsibility

5
Resource
management Measurement,
6 analysis
8improvement

Product
7
(and/or service)
Realization

7 Product realization
7.1 Planning of product realization
7.2 Customer related process
7.3 Design and development
7.4 Purchasing
7.5 Production & Service provision
7.6 Control of monitoring and
measuring devices

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 13

Rev: June 09
 Management
responsibility

5
Resource
management Measurement,
6 analysis
8improvement

Product
7
(and/or service)
Realization
8 Measurement, Analysis &
Improvement
8.1 General
8.2 Monitor and measurement
8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 14

Rev: June 09
 The ISO 9001 Standards lead
an organization to . .
 Identify
 Identify all
all key
key work
work processes
processes
 Create
 Create necessary
necessary documentation
documentation to
to control
control
the
the process
process as
as well
well as
as required
required documents
documents
in
in the
the standard
standard (6
(6 procedures)
procedures)
 Perform
 Perform processes
processes as
as documented
documented
 Identify
 Identify and
and take
take needed
needed corrective
corrective actions
actions
 Continuously
 Continuously improve
improve work
work processes
processes

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 15

Rev: June 09
 Project Timing is very
important
●
● Management must monitor and provide resources to
finish the project on time.
●
● Consider the implementation of ISO9001 like any other
time-based activity.
●
● Use the project timeline to measure the process of the
project.

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 16

Rev: June 09
 ISO9001 Quality Management
System
The “FOCUS” is on process first…documentation second.
Level 1 Quality Manual
30-40 pages
•30-40 pages
Quality
Manual
Level 2 Procedures
•6 mandatory
mandatory procedures
procedures
•Many
Many other
other control
control documents
documents Procedures
•Procedure
Procedure Manual
Manual

Level 3 Work Instructions Work Instructions

• Few
Few to
to many
many Work
Work Instructions
Instructions
Forms and Records

Level 4 Forms and Records

• Many
Many forms
forms records
records in
in all
all Departments
Departments

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 17

Rev: June 09
 Eight Quality Management
Principles

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 18

Rev: June 09 Version 2.0
Eight Quality Management Principles
1. Customer-Focused Organization.
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.

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 19

Rev: June 09 Version 2.0
 The Quality System Improvement
Loop
Fix and Prevent Problems

Operate Problems/Needs
Corrective
System Corrective&&
Preventive
Preventive
Management Action
Action
Results Problems/
Review/ Review Needs
Compare

Internal
Audits Audit Results

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 20

Rev: June 09
 Organization Performance
Performance

ISO9001:2008

ISO9001:1994 ISO

Without
Quality System

Time

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 21

Rev: June 09
 The QMS must be used for
continuous improvement ...
Improve Process
through PDCA Cycle

Results
Plan Do

Act Check Measure/Monitor Results Against Objectives -

Improve Process and Change QMS as Needed
to Achieve and Sustain Desired Results
QMS
Improvement Objective

Baseline Performance
© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 22
Rev: June 09
 ISO 9000 Registration:
What is involved?
No Choose
Chooseother
other
Seek ISO 9001 Registration directions
directionsfor
foryour
your
company
company

Yes

Develop Quality System

Operate Quality System

3rd Party Audit and Registration

Maintain Registration

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 23

Rev: June 09
 ISO 9000 Registration:
What is Involved?
Step 1 - Decision
1. Benefits

••Market
Market
••Competitive
Competitiveposition
position 2. Costs
••Operating
Operating
••Initial
Initial
••Ongoing
Ongoing
3. Timing

••Priority
Priorityof
ofprojects
projects
••Resource
Resourceavailability
availability
••Readiness
Readinessof oforganization
organization

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 24

Rev: June 09
 ISO 9000 Registration:
What Is Involved?
Step 2 - Develop Quality System
Plan and Staff
•Designate
•DesignateMgmt.
Mgmt.Representative
Representative
•Choose
•Chooseandandtrain
trainkey
keyplayers
players
•Develop
•Develop implementationplan
implementation plan Document
•Select
•Selectand
andcontract
contractwith
withRegistrar
Registrar•Draft
•Communicate to employees •Draftprocedures
proceduresand
andwork
work
•Communicate to employees instructions
instructions
----Review
Review
----Verify
Verifyand
andchange
changeasasrequired
required
•Complete
•Completeprocedures,
procedures,Procedure
Procedure
Manual and Work Instructions
Manual and Work Instructions
•Complete
•CompleteQuality
QualityManual
Manual
Train
Train
TrainInternal
InternalAuditors
Auditors

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 25

Rev: June 09
 ISO 9000 Registration:
What is Involved?
Step 3 - Operate Quality System
Implement
•Communicate
•Communicateto toemployees
employees
•Work
•Work per proceduresand
per procedures andwork
work
instructions
instructions
•Keep
•Keeprequired
requiredrecords
records

Verify
•Internal audits
Review
•Management
•Managementreview
review
•Review
•Review qualityresults,
quality results, Improve
complaints,
complaints,audit
auditoutcomes
outcomes. .. .
•Take corrective action
•Make improvements

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 26

Rev: June 09
 ISO 9000 Registration:
What is Involved?
Step 4 - 3rd Party Audit/Registration
Audit
3rd
3rdparty
partyaudit
audit
Does
Does QualitySystem
Quality Systemcomply
complywith
with
standard
standard
IsIsQuality
QualitySystem
Systemputputinto
intopractice?
practice?
IsIspractice effective?
practice effective?
Outcome
Pass
Pass

(May
(Mayhave
havesome
some
non-conformances
non-conformances
to
Result
toresolve)
resolve)

Achieve
Achieveregistration
registrationwhen
whenpass
pass

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 27

Rev: June 09
 ISO 9000 Registration:
What is Involved?
Step 5 - Maintain Registration
Operate the business per Quality System

Management
Managementreview
review
•Satisfying
•Satisfyingquality
quality
•Internal audits Improve
Improvethe
thebusiness
business
policy?
policy?
•Corrective •Meeting and
and QualitySystem
Quality System
•Meetingobjectives?
objectives?
Actions •Improving
•Improvingthe
the
business?
business?
3rd
3rdparty
partysurveillance
surveillance
audits
audits

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 28

Rev: June 09
 ISO 9000 Registration
How Long Does It Take?
Seek ISO 9000 No
Registration

Yes
Develop
DevelopQuality
Quality Depends on:
System •Where you are now
System •Resources employed

Operate Depends on:

Operate •Your “Develop Quality System” phase
Quality
QualitySystem
System •Management priority

Maintain Registration
3rd
3rdParty
PartyAudit
Audit •Outcome known at end of audit
and
andRegistration
Registration •Time to correct identified deficiencies

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 29

Rev: June 09
 Short Term Action Items
Discussion Questions:

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 30

Rev: June 09
 ANY QUESTIONS?

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 31

Rev: June 09
 For Additional Information
For additional information regarding this briefing
or any other issues concerning the
implementation of this or any other standard
contact:

info@robere.com

Or Call or Fax:

Tel: 662-661-8952 (-7) or Fax: 662-661-8958

© Robere & Associates (Thailand) Ltd. 90-EXO-E-DN 32

Rev: June 09