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ISO 9001 : 2008
Course Structure
Tutorial Sessions
Case Studies
Role Play
Games
Learning Objectives
To understand:
Purpose, benefits and typical structure of a
Quality Management System (QMS)
Plan-Do-Check Act (PDCA) methodology,
and the process approach to Quality
Management
The 8 principles of Quality Management
and how they relate to the QMS and ISO
9001
Purpose, scope and uses of the ISO 9000
series standards
Auditing Process
Roles, responsibilities and competence
requirements of auditors and lead auditors
with reference to ISO 19011
Agenda
1. Purpose and structure of
o a QMS, PDCA
o and the 8 principles of quality management
2. ISOM 9001 Explored & Understood
3. Internal Quality Audit Steps
4. Auditors Skills & Responsibility
Course assessment
Continual assessment
You will be informed of progress as we go
The exam
Ask questions
Its your tutors job to make problems go away
Session 1
What is Quality?
Q is fitness for use.
Q is conformance to requirements.
Q is conformance to customer/user
requirements.
Meet/satisfy customer/user requirements,
needs, and expectations.
What is Audit?
Systematic, independent and documented
process for obtaining audit evidence and
evaluating it objectively to determine the
extent to which the audit criteria are fulfilled
What is Auditee?
Organization being audited
What is Auditor?
Person with the competence to conduct
an audit.
What is Nonconformance?
Non-fulfillment of a
requirement
Types of Audits
First-party
Second-party
Third-party
Objectivity of Auditing
AUDIT
CRITERIA
AUDIT
EVIDENCE
AUDIT FINDINGS
Improvement
Non-Conformance
Conformance
Major
Minor
AUDIT CONCLUSION
RECOMMENDATION
FOR AUDIT
FORWARD TRACE
RECEIVE
GOODS
INSPECT
STORES
BACKWARDS TRACE
ISO 9000
ISO 9001
ISO 9004
ISO/DIS 19011
clause 4
management
info. flow
management
responsibility
responsibility
clause 5
clause 8
clause 6
meas,
resource
info. flow
meas,analysis
analysis
resource
improvement
management
improvement
management
Input
value adding
activities
clause 7
product
product
realization
realization
product
product
Output
value
adding activities
CUSTOMER SATISFACTION
CUSTOMER REQUIREMENTS
Continual
Continual Improvement
Improvement of
of the
the QMS
QMS
Clauses/Requirements
Clause 4. Quality Management System
Clause 5. Management Responsibility
Clause 6. Resource Management
Clause 7. Product Realization
Clause 8. Measurement, Analysis and
Improvement
Count the number of requirement categories.
Customer Focus
CUSTOMER SATISFACTION
CUSTOMER REQUIREMENTS
1.
2.
Leadership
management
management
responsibility
responsibility
3. Involvement of People
People are the essence of an
organization; therefore
They should be fully involved
Their abilities should be used for
organization benefits
resource
resource
management
management
4. Process Approach
Manage activities and related
resources as a PROCESS
Review Purchase Design Make
Order
Deliver
Product
Turtle Approach
?WITH WHAT
?WITH WHO
Materials /)
(Equipment
Competence / Skills)
(/ Training
PROCESS
OUTPUTS
INPUTS
?HOW
Support Processes,)
(Procedures & Methods
?OBJECTIVES/MEASURES
(Performance Indicators)
with who
Management Review
forum
Previous years results
inputs
Internal audits
Customer satisfaction
trends
Process/Product
measures
Faults/Complaints data
measures
Results vs plan
Customer surveys
Milestones
Management team
Quality manager
Team leaders
Management
responsibility
& objective
setting
support
processes
IT systems
Purchasing
HR, Training
outputs
Annual plan
Improvement
objectives
how
Implementation plan
Resource allocation
Roles & responsibilities
Communications
5.
6.
Plan
management
management
responsibility
responsibility
resource
resource
management
management
Act
meas.,
meas.,analysis
analysis
improvement
improvement
Check
Do
product
product
realization
realization
info. flow
management
management
responsibility
responsibility
meas.,
meas.,analysis
analysis
improvement
improvement
product
product
realization
realization
info. flow
CUSTOMER SATISFACTION
CUSTOMER REQUIREMENTS
7.
Interrelated
Win-Win
Supplier
product
product
realization
realization
Session 2
0.1 General
0.2 Process Approach
0.3 Relationship with ISO 9004
0.4 Compatibility with other standards
1 Scope
2Normative References
3 Terms & Definitions
4. Quality Management system
5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis & Improvement
Mandatory procedures
Manual, Policy & Objectives
General sufficiency of documentation and records
System for Document Control
System for Control of Records
5: Management Responsibility
The areas where direct Top Management
involvement is mandatory
Demonstrating commitment
Demonstrating customer focus
Input into policy development & review
Identification of objectives and input into the planning
process
Defining responsibilities, providing resources
Ensuring internal communications are effective
Involvement in management review
6: Resources
Human Resources
Ensuring adequacy particularly in respect of training
Infrastructure
Buildings, work space, equipment, vehicles,
information systems etc
7: Product Realisation
Think of this as Production or Service Delivery
Control of the core day to day operations
Operational planning (7.1)
Handling contracts, enquiries & customer
communication systems (7.2)
Design (7.3)
Management of supplies and suppliers (7.4)
Operational controls (7.5)
Calibration (7.6)
Session 3
Initiation
STEPS
1. Request Audit
2. Identify Lead Auditor
3. Define Audit Scope
RESPONSIBILITY
Program Manager
Program Manager
Program Manager
& Lead Auditor
Importance of Preparation
Exercise: Initiation
Who is responsible for scheduling the
audits?
When are internal audits scheduled?
How often are audits performed?
Who is responsible for selecting the
auditors?
What criteria are important for selecting
auditors?
SOLUTION:
Purpose:
To verify compliance with Quality Manual
and ISO 9001:2000
Audit Scope:
Training Activity
Requirements:
As specified in
ISO 9001:2008
EEICQM-01
EEICHR-P-01
Initiation
Preparation
STEPS
RESPONSIBILITY
4. Select Audit Team
Lead Auditor
5. Understand Org.
Audit Team
6. Review Documentation Audit Team
7. Plan the Audit
Lead Auditor
8. Prepare Checklist &
Working Papers
Audit Team
Audit Team
Consider team member qualifications
Consider activities being audited
Consider type and degree of experience of
the auditors
Create a balanced team
Preparation Steps
initiation
review
documents
get
approvals
plan
audit
Review Documentation
Quality manual
Procedures
Forms
Organization chart
Facility floor plan
Plan Audit
Confer with audit team members
Dont forget the approvals
Approved: ________________
Mr. Muntaser Kalahji.
Initiation
Preparation
Evaluation
STEPS
RESPONSIBILITY
9. Conduct Opening Meeting Lead Auditor
10. Meet with Management
Audit Team
11. Interview & Observe
Audit Team
12. Assess Evidence
Audit Team
An auditors memory is
.as sharp as his pencil
documented
based on interview
based on observation
quantitative
qualitative
verifiable
Checklists
Checklists plan
the flow of
questions
Checklists
Checklists
guide the course
of the audit
Checklists
Checklists
define
the sample
Checklists
Checklists
help in writing
the report
Checklist should
Be based on information available before
the audit
Be modified when necessary
Allow follow-up
Be balanced to cover priority areas
Be created by individual auditors
To Create a Checklist
What am I
?looking for
Documents
Who do I want
?to talk to
Individual
Questions on checklist
Opening Meeting
Opening Meeting
Sign-in sheet
Distribute detailed audit schedule
Address any auditee scheduling
concerns
Revise schedule, if necessary
Observing Activities
Confirm that
procedures are
being followed
?how
Observing Activities
Look for
undocumented
activities
?what
Observing Activities
Confirm answers
?who
Observing Activities
Auditee Reactions
Take over conversations
Play show & tell
Blame someone
Act defensively
Waste time
Interrupt
Provoke
Bribe!
Interviewing
Interviewing
Introduce yourself
Explain why you are there
Investigate to depth
necessary
Ask, Listen, Verify
Interview the right people
Those responsible for the
activity
Those doing the activity
Interviewing
Interview for:
elaboration
corroboration
perspective
basis for evidence
Interviewing
Two eyes
Two ears
One mouth
Ratio of use:
One of speaking
to four receiving
Interviewing
why
what
who
when
how
where
Is it really wrong?
Does he know it is wrong?
What is his explanation?
Is it an isolated event, or a
symptom of a deeper problem?
Why didnt quality system detect
it?
What lapse in the quality system
allows this to happen?
Nonconformity
Nonconformity refers to a
failure to meet a specified
requirement:
Quality Manual Policies
Procedures
ISO 9001:2000 req.
Government Regulations
W. Edwards Deming
ROLE PLAY:
Initiation
Preparation
Evaluation
Reporting
STEPS
RESPONSIBILITY
13. Write Nonconformities
Audit Team
14. Conduct Closing Meeting Audit Team
15. Write a Summary Report
Lead Auditor
Do I have a Nonconformity?
YES
if you have objective evidence that:
A requirement is not addressed
Practice differs from defined system
System is not effective
Minor
A single/isolated lapse in the system
Nonconformity Statement
State the evidence
What is it?
Informal setting
Report the results to management
Agree on follow-up
Entertain questions
STEPS
RESPONSIBILITY
16. Take Corrective Actions
Auditee
17. Verify Corrective Actions Audit Team
Follow-Up Flowchart
Identify
Identify
NC,
NC,issue
issueNCR
NCR
??Agree
Agree
Agree
Agreeon
onneed
need
for
forCA,
CA,sign
signitit
not OK
Propose
ProposeCA
CA
plan
plan
OK
Verify
VerifyCA
CA
&&
Close
CloseNCR
NCR
Implement
Implement
CA
CA
Session 4
Auditors Responsibilities
Communicating
Planning and executing
Documenting
Reporting
Verifying
Safeguarding
Cooperating
Auditors Qualifications
Education
Training
Experience
Personal Attributes
Management Skills
Auditor Skills
Communication skills
Interpersonal skills
Analytic skills
Auditor Ethics
I will inform each client or employer of any
business connections, interests, or
affiliations that might influence my
judgment or impair the equitable
character of my services.
ASQ Code of Ethics
Internal Auditor
Acts as a consultant
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