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Quality

Management
System

Understanding our QMS for


the achievement of
organization and business
success .
Objectives of the
Qu
al Orientation
it
y
Ma
na
ge
me To learn the benefits of implementing
nt
Sy the requirements of the quality
st management system
em
The effect of not following the

requirements.
Qu Course Outline
al
it
y
Ma
na
ge
me What is ISO and Quality
nt
Sy Management System
st Clauses and Benefits of
em
ISO 9001:2008
Qu ISO 9001 : 2008
al
it
y
Ma
na
ge
me
nt
Sy So what about it?

st
em

ISO 9001 is a
standard for
QUALITY
MANAGEMENT SYSTEM
Qu ISO 9001:2008
al
it
y
Ma
na
ge
me
Quality Management Systems
nt
Sy
st - a web of interconnected
em processes that are used to manage
a business.
International Organization for
Qu
al Standardization
it
y
Ma
na
ge
me
nt What is ISO is not an acronym
Sy
st ISO? for International
em
Organization for
Standardization
The organization ’ s
short name was taken
from the Greek word
“ isos ”, meaning
“ equal ”.
Qu 8 MANAGEMENT PRINCIPLES
al
it
y
Ma
na 1. CUSTOMER FOCUS
ge
me 2. LEADERSHIP
nt
Sy 3. INVOLVEMENT OF PEOPLE
st
em 4. PROCESS APPROACH
ISO 9001
5. SYSTEM APPROACH

6. CONTINUAL IMPROVEMENT

7. FACTUAL APPROACH
8. MUTUAL BENEFICIAL SUPPLIER RELATIONSHIPS
Qu
al
THE Process Based Approach
it
y
Ma
na
ge
me
nt • When ISO updated the 9000 series from 1994
Sy to 2000 they decided to focus on a
st process approach to the QMS versus the
em
old functional approach.
• All work is a process. This means that in
everything we do there are inputs and
outputs, suppliers and customers, and
means to get the work done.
Qu Model of Process Based QMS
al
it
y
Ma
na
ge
me
nt
Sy
st
em
Qu
The Customer-Supplier Chain
al
it
y
Ma
na Work team
ge
me
nt
Sy
st
em

Output
Input
Customer
Requirements Customer
Feedback
Qu
al
it
y
Ma
na
ge
me
nt
Sy
st
Elements of a Typical
em
Quality Management System
Manual
Qu
al
Contents
it
y
Ma
na
ge 1 Scope 1 . 1 General
me 1 . 2 Application
nt
Sy
st
em
2 Normative Reference

3 Terms and Definitions

4 Quality Management
System
4 . 1 General Requirements
4 . 2 Documentation Requirements
Qu
Contents (cont.)
al
it
y
Ma
na 5 Management
Responsibility
5 . 1 Management Commitment
ge 5 . 2 Customer focus
me 5 . 3 Quality Policy
nt
Sy 5 . 4 Planning
st 5 . 5 Responsibility , authority and
em communication
5 . 6 Management Review

6 Resource Management 6 . 1 Provision of resources


6 . 2 Human resources
6 . 3 Infrastructure
6 . 4 Work environment
Qu
al
Contents (cont.)
it
y
Ma
na
ge 7 Product
Realization
7 . 1 Planning of product realization
me 7 . 2 Customer - related processes
nt 7 . 3 Design and development
Sy 7 . 4 Purchasing
st 7 . 5 Production and service provision
em
7 . 6 Control of monitoring and measuring
devices

8 Measurement ,
Analysis and
8.1 General
Improvement 8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
Qu
al
it
y
Ma
na
ge
me
nt
Sy Quality Manual
st
em
(ISO 9001:2008)
Qu Section 1: Scope
al
it
y
Ma
na  Includes the design and construction of
ge cleanroom, ventilation and air
me
nt conditioning system, metal finishing
Sy system, environmental control system
st for automotive and other industrial or
em
commercial applications.
-
• Exclusion
- Design and development
validation …

Qu Section 2: Normative References
al
it
y
Ma
na
ge • ISO 9000:2005
me
nt • ISO 9001: 2008
Sy
st
em
• QMS ISO 9001:2000
• QMS ISO 9002:1994

Qu Section 2: Normative References
al
it
y
Ma
na ISO 9001:2000 Elements
ge 1. Scope
me
nt
Sy
2. Normative Reference
ISO 9002:1994
3. Terms and Definitions
st 4. Quality Management System
1. Scope 4.11 Control of inspection, measuring
em 5. Management
2. Normative Reference
4.2.1Responsibility
general and
test equipment
3. Definitions
6. Resource Management
4.2.2 quality system procedures
4.12 Inspection and test status
4.2.3 quality planning
7. Product
4.1 Management responsibility Realization
4.3 contract review 4.13 Control of nonconforming product
8. Measurement,
4.1.1 Quality Policy Analysis
4.4 design control and Improvement
4.14 Corrective and preventive action
4.1.2 Organization 4.5 document and data control 4.15 Handling, storage, packaging,
4.1.2.1 Responsibility and 4.6 purchasing preservation and delivery
authority 4.7 control of customer-supplied product 4.16 Control of quality records
4.1.2.2 Resources 4.8 product identification and traceability 4.17 Internal quality audits
4.1.2.3 Management 4.9 process control 4.18 Training
representative 4.10 inspection and testing 4.19 Servicing
4.1.3 Management review
4.20 Statistical techniques
4.2 Quality System
Qu Section 3: Terms and Definition
al
it
y
Ma
na
ge
 Definitions
me
nt  Terms used by an organization:
Sy
st
em
Qu Section 4: General requirements
al
it
y
Ma
na
ge Processes, interaction, improvement
me
nt The focus is on looking at:
Sy
st §What we do.
em
§Who we are doing it for.
§Improving how we provide
service.
Qu Section 4: General requirements
al
it
y
Ma
na
ge Documentation requirements
me
nt Ø Control of document
Sy
st Documents must show a control number,
em adoption and revision dates, in order to
ensure use of the most recent
information.
ØControl of records
Each record must be controlled in order
to ensure uniform quality.
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me
nt  LEVEL 1 - QUALITY MANUAL
Sy
st 1. Quality Policy
em 2. Quality Objectives
3. Requirement Standard
4. Other Statutory and Regulatory Requirements

22
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me
nt Documentation requirements
Sy
st Ø Quality manual
em
The quality manual describes our intent to
establish a quality management system with
an emphasis on continual improvement.
Section 4: General requirements

Quality Policy
The staff and management of ___ are
committed to consistent provision of quality
products and servicesthat will satisfy the
demands and expectations of customers
by continual improvement of the QMS and
conforming to local standards and prevailing
codes of practice.
Qu Section 4: General requirements
al
it
y
Ma
na
Current Objectives
n

ge
me
nt
Sy clients.
i s i o
Maintain good business relationship with the

v
st

e
em Deliver quality products and services to the

r r
satisfaction of the clients
Effect efficiency in operations by continual

F o
improvement of the Quality Management System.
Improve employee’s competence through periodic
evaluation and development of skills, knowledge
and abilities by providing appropriate training.
Qu Section 4: General requirements
al
it
y
Ma
na
ge  LEVEL 2 - QUALITY PROCEDURES
me
nt 1. Control of Documents
Sy
st 2. Control of Records
em 3. Internal Quality Audits
4. Control of Non-conforming Products
5. Corrective Action
6. Preventive Action

26
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me LEVEL 3 - QUALITY PLAN
nt
Sy 1. Incoming Inspection Plan
st
em 2. In-Process Inspection Plan
3. Final Test Report/ Inspection Plan
4. Work Instruction

27
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me LEVEL 4 - FORMS / FORMATS / RECORDS

nt
Sy 1. Testing Report forms
st
em 2. Commissioning Report Forms
3. Inspection forms
4. Check Sheets/Check List
5. Miscellaneous Documentation Forms

28
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me
nt 23 MANDATORY RECORDS

Sy 1. Management Review
st
em 2. Competence, Training and Awareness
3. Planning and Production
4. Review of Requirement Related to Product
5. Design and Development Input

29
Qu Section 4: General requirements
al
it
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Ma
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me
23 MANDATORY RECORDS ( cont ’ n )
nt 6. Design and Development Output
Sy
st 7. Design and Development Review
em
8. Design and Development Verification
9. Design and Development Validation
10.Control of Design and Development Changes

30
Qu Section 4: General requirements
al
it
y
Ma
na 23 MANDATORY RECORDS ( cont ’ n )
ge 11.Purchasing Process
me 12.Availability of Monitoring and Measuring Equipment
nt
Sy 13.Preservation of Product
st 14.Customer Property
em 15.Control of Monitoring and Measuring Equipment
16.Standards used for Calibrating Monitoring and
Measuring Equipment

31
Qu Section 4: General requirements
al
it
y
Ma
na
ge
me 23 MANDATORY RECORDS ( cont ’ n )

nt 17.Identify and Enable Calibration


Sy 18.Result of Calibration and Verification
st
em 19.Internal Audit
20.Monitoring and Measurement of Product
21.Control of Non-conforming Product
22.Corrective Action
23.Preventive Action

32
Qu Section 5: Management Responsibility
al
it
y
Ma
na
ge
me
nt
Sy Management
Responsibility
st
em
Qu Summary of Section 5
al
it
y
Ma
na
ge
Management Responsibility

me • Commitment
nt
Sy • Focus
st • Policy
em
• Objectives
• Planning

These correspond to the following


principles:
Customer focus
Leadership
Qu Section 6: Resource Management
al
it
y
Ma
na
ge
me
nt
Sy
st
em
Resource
Management
Qu
al
Summary of Section 6
it
y
Ma
na Resource
 Management
ge
me • Provide quality resources
nt
Sy
st
• Provide quality personnel
em
• Provide quality infrastructure
• Provide quality environment

This corresponds to the following


principle:
Involvement of People
Qu Section 7: Product Realization
al
it
y
Ma
na
ge
me
nt
Sy
st
em

Product /Service
Realization
Qu Section 7: Product Realization
al
it
y
Ma
na
ge 7 . 1 Plan and develop the
me processes
nt nInclude product objectives, relevant
Sy processes and resource, appropriate
st test and validation
em
7.2 Customer related processes
nCustomer requirement - stated and
implied
nStatutory and regulatory
nProduct requirements and changes
nOrganization ability
nCommunication with customers
Qu Section 7: Product Realization
al
it
y
Ma
na 7.3 Design and development
ge
nPlanning, inputs, outputs, systematic
me
nt reviews, verification and validation,
Sy control of changes
st 7.4 Purchasing
em nSupplier evaluation and selection
nRelevant purchasing information
nVerification of purchased product
Qu Section 7: Product Realization
al
it
y
Ma
na 7 . 5 Production and service
ge provision
me
nt nControlled conditions including
Sy product characteristics, work
st instructions, suitable equipment,
em measuring devices, and system
nRelease, delivery and post delivery
activities
nValidation of processes when no other
method
nIdentification and traceability of
product and it’s status
nCare of customer property
nPreservation of product
uIncludes constituent parts
Qu Section 7: Product Realization
al
it
y
Ma
na
ge 7.6 Control of monitoring and
me measuring devices
nt
Sy nCalibrated where necessary
st nAdjusted and readjusted
em nIdentifies status
nSafeguarded from invalid adjustment
nProtected from damage or
deterioration
Qu Summary of Section 7
al
it
y
Ma Control
 of the following
na
ge
process
me • realization planning These correspond to:
nt
Sy • customer communication Get the facts
st before you
em • product development decide
• purchasing function Focus
on customers
• operation Use a process
• monitoring approach
Work with your
suppliers
Section 8: Measurement, Analysis &
Qu
al Improvement
it
y
Ma
na CONTINUAL IMPROVEMENT OF THE QUALITY MANGEMENT
SYSTEM
ge
me
nt
Sy
st
em
Section 8: Measurement, Analysis &
Improvement

General
ØMeasurement and monitoring
processes
§To demonstrate product conformity,
system conformity and continually
improve the Quality Management
System.

ØCustomer satisfaction
§Perception of fulfillment.
Section 8: Measurement, Analysis &
Improvement

Monitoring and Measurement


Ø Internal planned audit, etc.
§Process Auditors, independent of their
own work will audit department process.

ØProcesses
§Demonstrate achievement of planned
results.
§
Section 8: Measurement, Analysis &
Improvement

Monitoring and Measurement


Product

§Monitor
and measure
characteristics.
§Conformity with acceptance
criteria.
§Waivers / concessions.
Nonconforming process/product
Elimination or correction of
nonconforming processes.
§
Section 8: Measurement, Analysis &
Improvement

Analysis of data
ØCustomer satisfaction
ØProduct and process requirements and
trends
ØSuppliers
Section 8: Measurement, Analysis &
Improvement

Improvement
ØContinually improve effectiveness
of the system
ØCorrective action
ØPreventive action
Qu Summary of Section 8
al
it
y
Ma  Measurement, Analysis and
na
ge Improvement
me
nt Perform remedial processes
Sy Monitor and  measure quality
st
em Control nonconforming products
Analyze quality information
Make quality improvements

This corresponds to:


Get the facts before you decide
Encourage continual improvement
Qu
al
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y
Ma
na
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me
nt
Sy

End Of Presentation
st
em 
Qu
al
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Ma
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Sy
st
em
A SHORT QUIZ
What do you do when accepting a
Qu
al task?
it (Answerable by Yes or No)
y
Ma
na 1.Before accepting an assignment, do you make
ge sure you understand completely what you
me are supposed to do?
nt
Sy 3.Are the deadlines clear?
st 5.Is it clear how much responsibility and
em
authority you have in the project?
6.Do you know which tasks you can perform on
your own. Without reporting back to your
boss?
7.Do you let your boss know if a new
assignment makes it difficult for you to
do your other jobs?
Qu What do you do when accepting a task
al (Continuation)
it
y
Ma
na 6.Do you make suggestions to make priorities on how
ge much time you will allow the project?
me 7.Do you get the information and background
nt material you need to do the job properly?
Sy 8.Do you try to imagine all the problems and
st obstacles that could arise while you are doing
em
the job – then plan accordingly?
9.Is it clear who makes decisions when your boss is
not available?
10.If a problem arises that you can’t handle, do you
talk to your boss about the situation?
11.
Qu
Are You Quality-Conscious?
al (Answerable by True or False)
it
y
Ma
na
ge 1. When it comes to quality, there’s always
me
nt room for improvement.
Sy 2. Nobody can be aware of quality needs all
st
em the time.
3. Customers pay little attention to quality.
4. A quality program must mesh with the
organization’s goals and profit plans.
5. Quality means conformance to standards.
Are You Quality-Conscious?
Qu (Continuation)
al
it
y
Ma
na
ge 6. Quality should operate in all parts of a
me business
nt
Sy 7. Personal quality standards and business
st quality standards have little in
em common.
8. Quality requires commitment.
9. Quality relates to the process as much as
to the goal.
10.People who talk about quality are mostly
idealists.
Qu Reflection
al
it
y
Ma
na
ge
me
nt Now . . .
Sy
st TELL me
em
what’s is
going on !!!
Qu
al
it
y
Ma
na
ge
Prepared by: Sid Calayag
me Presented by:
nt
Sy
st
 Sid Calayag – Lead Auditor ISO
em 9001:2008
 Reference:
• Quality Management System
• ISO 9001:2008