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ISO 9001:2000
QUALITY MANAGEMENT SYSTEM
24-25 May, 2008
CONTENTS
1
Background
DAY-1
SESSION-1
1
BACKGROUND
9001
The series allocated for
Quality System standards
What
is
ISO?
International Organization for Standardization
CORE STANDARDS
ISO 9000:2000 Fundamentals and Vocabulary
ISO 9001:2000 QMS Requirements
ISO 9004:2000 Guidelines for Performance Improvement
SUPPORTING STANDARDS
ISO 10005:1995
ISO 10006:2003
ISO 10007:2003
ISO 10012
ISO 10013:2001
ISO/TR 10014:1999
ISO/TR 10015:2000
ISO/TR 10017:2003
ISO 19011:2003
ISO 10002:2004
ISO 10001
ISO 10003
2000
First revision named
as ISO 9001:1994
1994
Originally released as
ISO 9001:1987
1987
ISO 9002:1994
ISO 9003:1994
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ADVANTAGES OF
ISO-9001
WHAT IS QUALITY?
Degree of Excellence
Meeting Requirements
Delighting Customers
from
Only
Product
Quality
Organizational
Quality
Dept.-Wise
Performance
Quality Management is .
a process of identifying and solving
problems, followed by improving
performance.
OCCASIONAL QUALITY ISSUES
ADMIN,
TESTING
MARKETING
PRODUCTION
FINANCE
PROCESS
MAINT.
QA
LABS
Measurement
PRODUCT/ Cycle A
SERVICE
FIXING
Process and/or
Systems
Fixing
Cycle B
C/A
OK
Not
OK
Actions
data
Quality
Assurance
PROCESS
Performance
DESIGN
Market
Customer
Legal
Benchmarks
Process
Financial
Customers
PRODUCT
PROCESSES
Performance
Product
Fixing
Actions
Actions
Product, Process or
Systems Fixing &
Improvement
Product , Process or
Systems Fixing
& Improvement
OK
Not
OK
data
FIELD
Performance
data
Actions
data
QMS
PROCESS
Performance
DESIGN
Market
Customer
Legal
Benchmarks
Process
Financial
Customers
PRODUCT
PROCESSES
Performance
Product
Fixing
Actions
Actions
Product, Process or
Systems Fixing &
Improvement
Product , Process or
Systems Fixing
& Improvement
OK
Not
OK
data
FIELD
Performance
data
TQM+
6 Sigma
TQM
HRM
QA
GROUP
ISO9000
QC
SPC
Inspection/
Testing
Quality
Circles
Metrology
Product Insp. to Process to
Control
Knowledge
Mgt.
IT
DYNAMICS
Teams
JAR145
Efficiency
OPR MGT.
BPR
TPM
JIT/MRP
Four Levels of QM
QM Levels
IV
III
II
I
0
No Measures
Basic
Measures
QC
QA
(ISO9000)
CQI
1st Stage of QC
ADMIN
MANUFACTURING
PRODUCTION
QC
FINANCE
HRD
STORES
PURCHASING
MIS /
SEC /
PLANNING
Internal Mnt.
PRODUCT
2nd Stage of QC
ADMIN
MANUFACTURING
PRODUCTION
QC
FINANCE
HRD
STORES QC
Internal Mnt.
QC
PURCHASING QC
MIS /
SEC /
QC
PLANNING QC
PRODUCT
3rd Stage of QC
ADMIN
MANUFACTURING
QC
PRODUCTION
QC
FINANCE
QC
HRD
QC
MIS /
SEC /
QC
STORES QC
Internal Mnt.
QC
PURCHASING QC
PLANNING QC
PRODUCT
Japan
Deming Quality Award
USA
Malcolm Baldrige National Quality Award
European Union
European Quality Award
Levels of Quality:
Poor- Angry- Fighting/Good- Happy- Glad
Dimension of Product Quality
Human Resource
Financial Resources
Work Environment
Technical Resources.
Management System
Communication System
Motivation
Organizational Quality
Individual Quality
2
Eight Quality
Management Principles
8 QUALITY MANAGEMENT
PRICINIPLES
Customer-focus
Mutually beneficial
supplier relationship
Factual Approach
to Management
Leadership
8 QUALITY
MANAGEMENT
PRINCIPLES
Continual
Improvement
Involvement of
People
Process Approach
System approach to
management
1. CUSTOMER FOCUSED
Organizations depend on
their customers and
therefore should:
understand current and future
customer needs,
meet customer requirements, and
strive to exceed customer
expectations.
2. LEADERSHIP
Leaders should:
establish unity of purpose (vision and mission)
provide direction to the organization (policy and
objectives)
provide resources to achieve organizations
objectives
Corporate
Goal
3. INVOLVEMENT OF PEOPLE
4. PROCESS APPROACH
Transformation
Outputs
5. SYSTEM APPROACH TO
MANAGEMENT
6. CONTINUAL IMPROVEMENT
Plan
Results
Check
Do
Measure/Monitor Results
against Objectives
7. FACTUAL APPROACH TO
DECISION MAKING
COLLECTION
OF DATA
ANALYSIS
DECISION
8. MUTUALLY BENEFICIAL
SUPPLIER RELATIONSHIPS
+
ORGANIZATION
PRODUCT
OR
SERVICE
Five
dimensions of Service Quality
Accuracy
dependably
Physical
Infrastructure
image
Promptness
Helping
attitude
Reliability
Responsiveness
Tangibles
Access
Communication
Understanding
needs
Empathy
Assurance
Competence
Courtesy
Credibility
security
3
ISO 9001:2000
Requirements
ISO 9001:2000
New Standards
ISO 9000:2000 Fundamentals and Vocabulary
ISO 9001:2000 QMS Requirements
ISO 9004:2000 Guidelines for Performance
Improvement
NEW STRUCTURE
20 Clauses have been abandoned and merged into 5
sections with additional requirements
Clause 4:
Quality System
Clause 7:
Product Realization
Clause 6:
Resource
Management
Clause 5:
Management
Responsibility
Clause 8:
Measurement,
Analysis &
Improvement
Contents
1 Scope
2 Normative Reference
3 Terms and Definitions
1.1 General
1.2 Application
Contents (cont.)
4
5
Quality Management
System
Management
Responsibility
Resource Management
Product Realization
Contents (cont.)
Analysis
8 Measurement,
and Improvement
8.1 General
8.2 Monitoring and measurement
8.3 Control of nonconforming product
8.4 Analysis of data
8.5 Improvement
DEMINGS CYCLE
Analyze the Gaps
Take corrective and
preventive actions to
fill the gap
PLAN
ACT
Define Policy
Set Objectives & Targets
Assign Responsibilities
Provide Resources
DEMINGS
CYCLE
CHECK
Monitor and Measure
the actual
implementation against
the planned
Identify the Gaps
DO
Implement according
to planned
arrangements
Process Model
CONTINUAL IMPROVEMENT OF THE
QUALITY MANAGEMENT SYSTEM
C
U
S
T
O
M
E
R
R
e
q
u
i
r
e
m
e
n
t
s
Management
responsibility
Resource
management
Input
Product
realization
Measurement,
analysis and
improvement
Product
Output
U
S
T
O
M
E
R
S
a
t
i
s
f
a
c
t
i
o
n
Scope
Consistency of products/services
Compliance with requirements including
customer and regulatory requirements
Enhanced Customer Satisfaction
Continual Improvement
BREAK
DAY-1
SESSION-2
4 QUALITY SYSTEM
4.1: General Requirements
4.2: Documentation Requirements
Policy/
Objectives
Quality Manual
Records/Reports/Logs
SCOPE
DISTRIBUTION
LIST
MASTER
DOCUMENT
LIST
Justification of
Any EXCLUSION
MASTER
RECORDS
LIST
POLICY
OBJECTIVES &
TARGETS
SYSTEM
PROCEDURES
ORGANIZATIONAL
CHART
ROLES &
RESPONSIBILITIES
LEGAL
REQUIREMENTS
OPERATIONAL
PROCEDURES
WORK
PRACTICES
Obsolete Document
Control
Distribution
Control
DOCUMENT
CONTROL
External Document
Control
Change Control
Disposition
Indexing
RECORDS
CONTROL
Retention
Filing
Maintenance
Storage
5 MANAGEMENT
RESPONSIBLITY
New
5.1: Management Commitment
New
5.2: Customer Focus
New
New
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Identify customer
requirements.
Meet customers
requirements.
Enhance customer
satisfaction.
C
U
S
T
O
M
E
R
R
e
q
u
i
r
e
m
e
n
t
s
MONITOR &
MEASURE
Complaints
Feedback
Inputs
Organization
s
Processes
Product
C
U
S
T
O
M
E
R
S
a
t
i
s
f
a
c
t
i
o
n
5 MANAGEMENT RESPONSIBILITY
Signature
CONTINUAL
IMPROVEMENT
MEETING
REQUIREMENTS
QUALITY
POLICY
COMMITMENT
QUALITY POLICY
QUALITY POLICY
5 MANAGEMENT RESPONSIBILITY
Formulate quality
objectives.
Plan quality
management system.
5.4 PLANNING
On-time delivery = ??
Response time = ??
Complaints = ??
Rejection Rate = ??
Rework rate = ??
Failure rate = ??
TIME-BOUND
REALISTIC
ACHIEVABLE
MEASURABLE
SPECIFIC
QUALITY
OBJECTIVES
5 MANAGEMENT RESPONSIBILITY
5.1
5.2
5.3
5.4
Management Commitment
Customer Focus
Define responsibilities,
Quality Policy
authorities and
Quality Planning
communicate them.
Establish internal
communications.
5.5 Responsibility,
Authority & Communication
Defining responsibilities & authorities
in the form of:
Organizational Charts
Job Descriptions
Appointing the ISO 9001 Project
Coordinator, called Management
Representative (MR)
Establishing Internal Communication
Channels, which may include:
intranet, memos, internal
meetings, emails, phones, etc.
5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Quality Planning
5.5 Responsibility, Authority &
Communication
5.6 Perform Management
Reviews
Review quality
management system.
Examine management
review inputs.
Generate management
review outputs.
OUTPUTS
Results of Audits
Complaints/Feedback
Product Quality Status
Pending Actions
Top
Management
Review
Meeting
Resource needs
Revision of policy
Revision of objectives
Corrective Actions
6 RESOURCE MANAGEMENT
6.1: General
6.2: Human Resources
New
New
6.3: Infrastructure
6.2.1: General
New
6.2.2: Awareness & Training
Education
Experience
Skills
TRAINING &
AWARENESS
Provide training
Evaluate the
effectiveness of training
Maintain records of
training
Training
INFRASTRUCTURE
Equipment
(hardware, software)
Temperature
Humidity
Noise
Dust
Ventilation
Work
Space
Health &
Safety
Cleanliness
7 PRODUCT REALIZATION
7.5: Production
New
7.5.5 Preservation
7.1 PLANNING OF
REALIZATION PROCESSES
QUALITY PLAN
Process stages
Inspection and test stages
Parameters to be controlled/checked
Reference standards
Related records
Responsible persons
7.2 CUSTOMER-RELATED
PROCESSES
CUSTOMERS SPECIFIED
REQUIREMENTS
CUSTOMERS INTENDED
REQUIREMENTS
ORGANIZATIONS INTERNAL
REQUIREMENTS
7.2.2 REVIEW OF
REQUIREMENTS
Product requirements are defined
Records of review
are maintained
Review of
Requirements
Differences/ conflicts
are resolved
7.2.3 CUSTOMER
COMMUNICATION
Service Information
Customer
Communication
Community feedback, including
Community complaints (Community
Service)
Requirements
- Customer
- Technical
- Legal
INPUT
Design &
Development
VERIFICATION
VALIDATION
OUTPUT
7.4 PURCHASING
Procedure
Purchasing Process
(Evaluation and selection
of suppliers)
Purchasing Information
Records
Verification
of Purchased
Product
7.5.1 CONTROL OF
PRODUCTION
Product Specifications
Availability of
work Instructions
Production planning
CONTROL OF
PRODUCTION
Production
records
Maintenance of
equipment
Availability of
monitoring equipment
Use of suitable
Equipment
In-process
monitoring &
measurement
IDENTIFICATION
TRACEABILITY
Article #/Model #/
Item #/Design #
Lot #/Batch #/
Serial #/Mfg. date
INSPECTION
& TEST STATUS
Tags/Stickers/Trays for
rejected/reworked items
CUSTOMER
PROPERTY
7.5.5 PRESERVATION
Handling
Delivery
Storage
PRESERVATION
Protection
Packing
DAY-2
SESSION-1
8 MEASUREMENT, ANALYSIS
& IMPROVEMENT
8.1: General
New
Customer feedback
Product Performance
Product & Process Trends
Suppliers
8.5: Improvement
New
New
AUDIT
PLANNING
AUDIT
EXECUTION
Records
AUDIT
REPORTING
CORRECTIVE
ACTION &
FOLLOW UP
8.2.3/8.2.4 Monitoring of
Processes & Products
Quality Plan or Inspection/Test Plans
Test records
INSPECTION &
TESTING
Receiving
In-process
Final
Availability of
specifications
8.3 CONTROL OF
NONCONFORMITY
Procedure
Alternative
use
Reject/
Rework
Control
of nonconformity
Accept-as-is
Records
Re-grade
Analysis of
Suppliers Data
Analysis of
Product Data
Analysis of
Process Trends
8.5.1 CONTINUAL
IMPROVEMENT
Quality Objectives
Management
Review
Data Analysis
CONTINUAL
IMRPROVEMENT
Corrective/
Preventive Action
Quality Audits
CORRECTIVE
ACTION
Action taken to
eliminate the
problems
occurred to
avoid their
recurrence
Implement solution
PREVENTIVE
ACTION
Action taken to
eliminate the
potential
problems to
avoid their
occurrence
AUDITS:
TYPE AND PHASES
1.
Definition - ISO
A systematic and independent examination to
determine whether quality activities and related results
comply with planned arrangements and whether these
arrangements are implemented effectively and are
suitable to achieve objectives.
2.
Alternative Definition
3. TYPES
FIRST PARTY (I), SECOND PARTY (II), THIRD PARTY (III)
DEFINITION
OBJECTIVE
II
Determine suitability of
suppliers;
Appraise supplier/
subcontractors performance.
III
By a body which is
commercially and
contractually independent
of the organization, its
suppliers and customers.
Determine whether an
organizations QMS has been
documented and
implemented as per
specified standard.
4.
Planning
Preparation
Performance
AUDIT PLANNING
Basis of Planning
Points for
Planning
First Party
Frequency
previous
as agreed /
performance; required
criticality,
complexity;
change, etc.
as agreed with
client/ required
by the
Accreditation
Body (NACCB,
RAB, act)
Responsibility
qualified
auditor i.e.
Trained
Auditor.
as for internal
audits
Registered Lead
assessor who will
select teams as
necessary
Expertise
technical
knowledge
technical
knowledge of
industry essential
Basis of Planning
Points for
Planning
First Party
Criteria
organizations
own procedures/
standards/ ISO9000
as specified by ISO-9001:2000
contract or
and applicable
purchasing
regulatory
conditions
requirements
Scope
usually a
procedure,
related group of
procedure or a
department
usually
activities
directly
affecting
products or
service quality,
delivery etc.
Duration
as specified by
the client in
terms of
processes,
products,
services, sites
affected by many
variables
AUDIT PREPARATION
Obtaining
and
evaluating
the
latest
applicable
c)
d)
e)
a record;
AUDIT PERFORMANCE
1.
INTRODUCTION
The on-site audit process:
Opening meeting.
Auditors review.
Closing meeting.
Follow-up, if necessary.
2.
good communications;
cooperation;
openness.
2.1 Agenda
introduction;
attendance list;
scope of audit;
explanation of method/sampling;
explanation of
classification;
timetable/itinerary;
escorts;
closing meeting;
confidentiality;
non-compliances
and
their
3.
informal;
simple introduction;
operates correctly;
is effective.
With the amount of work and information
to be handled by an auditor it is easy to
lose sight of these aims.
people;
procedure;
documentation.
questions
or What
Close-ended question:
6.
CONTROLS BY AUDITOR:
6.1 Do not:
be side tracked;
be led or misled;
6.2 Do:
be prepared/planned;
be punctual;
avoid misunderstandings;
give compliments.
aggressive auditees;
timid auditees;
missing people;
missing documents;
pre-prepared samples (always choose your
own);
emotional blackmail;
special cases.
When faced with these situations, the auditor
must act decisively, professionally and fairly,
keeping in mind the objectives and purpose of
the on-site audit
DAY-2
SESSION-2
AUDIT REVIEW
1.
listing of non-compliances
2.
Non-compliance is:
deficiency;
finding;
Non-conformance.
3.
of
the
4.
Statement
also
define
the
applicable
procedure and its issue, area/ department/
function and the standard and clause number.
5.
6.
Immediate.
Best Points:
7.
Standard:
ISO 9001:1994
(Clause 4.6.2 Evaluation of Subcontractors)
i.
ii.
8.
9.
MAJOR
MINOR
10.
Total breakdown in
organizations QMS;
the
operation
of
the
MINOR CAR:
Deficiency or deficiencies identified in:
11.
12.
1.
2.
3.
EXIT MEETING
EXIT CRITIQUE
Constructive
System Improvement
for
4.
Very formal.
and
5.
Typical Solutions:
distribute attendance list;
have assessor log signed;
6.
avoid
giving
consultative
recommendations.
Comments should be limited to providing clarification
on acceptance criteria/requirements;
REPORTING
7.
name of organization;
assessment date(s);
assessment location;
QA Standard;
CARs issued;
attendees at meeting;
distribution list;
attachments.
8.
ambiguous statements;
10.
4
HOW TO IMPLEMENT
ISO 9001:2000
1.
2.
3.
4.
5.
STATUS SURVEY:
present activities as compared to the requirements of
ISO-9000.
CONTROL OF DOCUMENTS
ISO 9001 REQUIREMENTS
STATUS
the
of
ACTION/
COMMENTS
STATU
ACTION/
S
COMMENTS
7.
8.
9.
15. CERTIFICATION
APPOINTING A CONSULTANT, IF NECESSARY
1.
Factors Considered:
Human resource.
Training trainers.
CAUTION! DO NOT ASSIGN THE RESPONISBILITY
FOR DOCUMENTATION. COMPANY STAFF SHOULD
RETAIN OWNERSHIP OF DOCUMENTATION
EVALUATING CONSULTANTS:
Past experience.
Costs.
CAUTION!
References:
1. Some of the material presented in these lectures has been
taken from different websites
2. Slides no 22-29 has been taken from PIQC Inst of Quality
Management