ISO 9000 Trg.

What is ISO
 Acronym for International Organization for

Standardization
 Head Office at Geneva
 More than 110 standardization
organizations of various countries are
members
 India is represented by Bureau of Indian
Standards
 Objective is to promote development of
common standards worldwide
 Improvement in productivity, operating
efficiency and reduced cost
What is Quality
 The totality of features and characteristics
of a product or service that bears on its
ability to meet a stated or implied need
(ISO)
 Fitness for use (Juran)
 Conformance to requirements (Crosby)
 Quality Systems (getting everyone to do what they have
agreed to do and to do it right the first time) is the skeletal
structure of an organisation, finance is the nourishment and
relationships are the soul.
1-10-100 Rule
 If someone produces defective work and
rectifies it immediately, it only costs him another
equal effort.
 If it slips to is internal customer and he wants to
rectify it then, it will cost 10 times more effort.
 If it has passed on to external customer then it
costs 100 times in terms of cost, efforts and
adverse consequences that follows.
 This rule is even more significant for the service
industry.
The F-Test
Suppose that the letter F represents a defective

item, and all other letters good items.
On the next slide you will see a simple sentence
beginning with the word “FINISHED”.
You will be given 15 seconds to read through the
sentence and count the F’s, ONCE ONLY.
FINISHED FILES ARE THE RESULT OF YEARS
OF SCIENTIFIC STUDY COMBINED WITH
THE EXPERIENCE OF MANY YEARS
How Many Fs??
Three ??
Four ??
Five ??
Six ??
FINISHED FILES ARE THE RESULT OF YEARS
OF SCIENTIFIC STUDY COMBINED WITH
THE EXPERIENCE OF MANY YEARS

DO IT RIGHT THE FIRST TIME
 If you want to provide Quality products or
services to your customers, both internal
and external, you should double check your
work before you pass it on
ISO 9001:2000 lists a set of
requirements on how your
organization can establish an
effective quality management
system to meet its
“customers” needs.
The ISO 9000:2000 standards
include 3 documents...
ISO 9000:2000
Quality Management Systems -
Fundamentals and Vocabulary
ISO 9001:2000
Requirements
ISO 9004:2000
Guidelines for Performance Improvements
EIGHT QUALITY
MANAGEMENT PRINCIPLES
1. Customer focus
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 relationship
Customer Focus
 Organizations depend on their

customers and therefore should:
 understand current and future customer

needs,
 meet customer requirements, and
 strive to exceed customer expectations.

Leadership
 Leaders should:
 establish unity of purpose and direction of

the organization, and
 create and maintain the internal

environment in which people can become
fully involved in achieving the
organization’s objectives.
Involvement of People
 People at all levels are the essence

of an organization, and
 their full involvement enables their

abilities to be used for the organization’s
benefit.
Process Approach
• Organizations need to do more than
simply monitor process outputs,
(typically through inspection activities)
 they must also control all process

inputs, (people, facilities/equipment,
material and methods)
 and, they must establish appropriate

controls over the transformation
activities (if desired results are to be
achieved consistently and efficiently)
What is a Process?
Activity that transforms input into output
Input Activity Output
Resources: Results:
People Products
Facilities/Equipment Services
Material Performance
Methods
How is a Process Managed?
Monitor & Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed
Right Resources:
Desired Results:
Qualified People
Quality Products
Right Facilities/Equipment
Quality Services
Correct Materials
Customer Satisfaction
Proven Methods
How is a Process Measured?
Efficient Effective
No Waste Desired Results Achieved
Right Resources: Desired Results:

Qualified People Quality Products
Right Facilities/Equipment Quality Services
Correct Materials Customer Satisfaction
Proven Methods
System Approach
 Organizations must understand a

system is a set of interrelated
processes, and
 the output of one process is the input to

one or more subsequent processes, so ...
 It is critical to manage the “white space”

(or interface) between processes to ensure
that the overall system is effective
Continual Improvement
 Continual improvement of the
organization’s overall performance
should be a permanent objective:
 improvement must be a planned activity if

the organization desires to improve overall
performance and capabilities.
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
Factual Approach to
Decision Making
 Effective decisions are:
 based on the analysis of data and

information.
Mutually Beneficial
Supplier Relationships
 An organization and its suppliers are

truly inter-dependent, and
 a mutually beneficial relationship enhances

the ability of both to create value.
QUALITY MANAGEMENT SYSTEM
To meet the requirements you must:
Document
Document
Write
Write down
down what
what you
you do.
do.
Implement
Implement
Do
Do what
what you
you wrote
wrote down.
down.
Maintain
Maintain
Show
Show evidence
evidence that
that you
you are
are doing
doing what
what you
you said
said
you were doing.
you were doing.
Continually
Continually Improve
Improve Effectiveness
Effectiveness
Use
Use corrective
corrective action
action to
to improve
improve your
your service
service to
to your
your
customers.
customers.
Clauses of ISO 9001:2000
1. Scope
2. Normative References
3. Definitions
4. Quality Management System

5. Management Responsibility
6. Resource Management
7. Product Realization
8. Measurement, Analysis and Improvement
General requirements
 Processes, interaction, improvement
The focus is on looking at:
What we do.
Who we are doing it for.
Improving how we provide product &

services.
Documentation requirements
 General
Documents must be developed to implement,
maintain, and control the quality management
system.
 Quality manual
The quality manual describes our intent to
establish a quality management system with an
emphasis on continuous improvement.
 Control of document
Documents must show a control number,
adoption and revision dates, in order to ensure
use of the most recent information.
 Control of records
Each document must be controlled in order to
ensure uniform quality.
MANAGEMENT RESPONSIBILITY
Promote the
Support Quality
importance of quality.
Satisfy Customers
Establish a Quality Policy
Carry out Quality Planning
Control the Quality System
Perform Management Reviews

Support Quality
• Identify customer
Satisfy Customers requirements.
• Meet your customers’

requirements.
Carry out Quality Planning • Enhance customer

satisfaction.

Support Quality
• Define the
Satisfy Customers organization’s quality
policy.
• Manage the
Carry out Quality Planning organization’s quality
policy.

Support Quality
Satisfy Customers
Establish a Quality Policy • Formulate your

quality objectives.
• Plan your quality
management
Control the Quality System system.

Support Quality
Satisfy Customers • Define

responsibilities and
Establish a Quality Policy communicate them.
• Appoint a
management
representative.
• Support internal
Perform Management Reviews communications.
Support Quality
• Review quality
Satisfy Customers management
system.
• Examine
management review
Carry out Quality Planning inputs.
Control the Quality System • Generate

management review
Perform Management Reviews outputs.
RESOURCE MANAGEMENT
Provision
Human of resources
Resource to improve processes
and enhance
customer satisfaction
Work
Infrastructure
Environment
RESOURCE MANAGEMENT
Human  Determine competence.

Resource
 Provide training or
other action.
 Evaluate effectiveness
of action.
Work
Infrastructure
Environment
RESOURCE MANAGEMENT
Human
 Buildings, workspace,
Resource
utilities.
 Process equipment.
 Support services.
Work
Infrastructure
Environment
RESOURCE MANAGEMENT
Human
Resource
 Manage conditions
of environment to
Work
Infrastructure achieve product
Environment
requirement
conformance.
PRODUCT REALIZATION
• Planning for Product Realization
• Customer Related Processes
• Design and Development
• Purchasing
• Production and Service Provisions
• Control of Monitoring and Measuring Devices

MEASUREMENT, ANALYSIS,
AND IMPROVEMENT
Monitoring and Measurement
 Customer satisfaction
 Perception of fulfillment.
AND IMPROVEMENT
 Internal planned audit, etc.

 Process Auditors, independent of their
own work will audit department process.
AND IMPROVEMENT
 Processes
 Demonstrate achievement of planned
results.
AND IMPROVEMENT
 Product
 Monitor and measure characteristics.
 Conformity with acceptance criteria.
 Waivers / concessions.
AND IMPROVEMENT
Control of nonconforming product / processes
 Elimination or correction of
nonconforming product / processes.

AND IMPROVEMENT
Analysis of data
 Customer satisfaction
 Product and process requirements
and trends
 Suppliers
AND IMPROVEMENT
Improvement
 Continually improve effectiveness
of the system
 Corrective action
 Preventive action
Continuous improvement of the
Quality Management System
Management
Responsibility
Satisfaction
Measurement,
Resource
Analysis and
Management
User
User
Improvement
Requirements
Product /
Input Output Product
Service
Data Data Service
Realization
FEW QUESTIONS
Allbusiness
processes must be
documented.
FEW QUESTIONS CONTD...
 False. Only those processes which have an impact upon quality
come under the scope of ISO9000. There are a great many
activities which are vital to the overall operation of the
business, but have no direct impact upon the quality of its
products and services. While it is a good idea to document all
important processes as part of your total operational system,
those which do not relate to one of the applicable ISO9000
elements need not be included in your quality system.
 Here are two things to remember.
 Document 100% of the processes you believe are needed to
make, perform and deliver quality products products and
services, irrespective of whether or not ISO9000 specifically
requires them. If you think they are necessary, then ISO9000
thinks they are necessary.
 On the other hand, it is not the registrar’s job to tell you that
might have documented too much. Whatever documents you
include in your quality system will be fair audit subjects,
because you put them in play.
 A procedure has to be
written in step-by-step
details, so that anyone
who can read will be
able to perform the
task.
 False. You can never separate the procedure from the
person(s) performing it, from the training or qualifications
needed to perform it, or from the task at hand. Usually,
procedures will be written to the level of a trained person,
because it reflects how most of those tasks are actually
assigned. ISO9001 says it is best; the range and detail of
the procedures… depend on the complexity of the work, the
methods used and the skills and training needed by the
personnel involved in carrying out the activity.
 Driving an automobile is a highly complex process, yet it is
not suited to a detailed, step-by-step procedure. Among
other things, how would you use it? Alternately, changing a
tyre isn’t particularly complicated, yet it isn’t something
most of us do very often. A detailed procedure is perfect for
such a task.
 You (the company) decide how to write the
procedure, and just how detailed it needs to be.
The objective is to ensure that the right (qualified)
people have all the information they need to
perform the process in as consistent a fashion as
is called for to ensure that the desired result is
consistently achievable.
 You will meet

ISO9000 requirements
if you document what
you do and do what you
document.
 False. ISO9000 is not about documentation. It’s

about complying with the requirements of
ISO9001, which also require that you document
how you do them, and record your results. If you
do not comply with all the requirements, it doesn’t
matter what you document. Look at it this way. If
you have a system that is less than adequate, has
major holes in it, or can’t give you consistent
results no matter what you do, what good will it
do to document it?
 Corrective action must

be taken for all product
non-conformances.
False. Every non-conformance must be
“corrected”, I.e., scrapped, repaired, reworked,
replaced, accepted on concession, etc. However, the
need for “corrective action”, which is action taken to
eliminate the cause of the nonconformity to prevent
its recurrence, is a judgment call that you must
make. ISO9000 requires that you establish and
document a system for implementing corrective
action. Most registrars would expect you to identify
the individual(s) of function(s) responsible for
making that judgment call, and, perhaps, include
guidelines as to what corrective action is.
ISO9000 requires
Statistical Process
Control.
 False.ISO9000 requires only

analysis of data, decision
regarding techniques has to be
need-based.
All controlled
documents must be
stamped in red, have
approval signatures on
them, and be signed for
by each recipient
 False. False. False. The gist of the
ISO9000 requirement on document
control is that you must ensure the
right document is in the right place at
the right time, and that obsolete or
superceded documents are either
removed or rendered unusable. How
you accomplish that is strictly up to
you.
 A company that is
consistently profitable, and
has a high customer
satisfaction rating, probably
already meets 70% to 80%
of all ISO 9000 requirements
 True. Companies don’t get that way by
accident. Consistent performance requires
systematic operations, good communications
at all level, performance measurement, defect
avoidance, a trained, experienced and properly
tooled workforce………. all the common sense
practices that ISO9000 requires. In our
practice, when we perform a Gap analysis, it
usually includes numerical score. High
performing companies typically score in the
70% range. Those who also have good
document controls, and a mature internal
audit program score even higher.
ISO9000:2000
AUDITOR TRAINING
Clause 4 - Quality management
system
4.1 General Requirements

The management shall identify process
internal or outsourced and shall control these
processes.
E2 (PLG)
E3, E2 (D), E4, E6

CWE / GE USER
USER
E2 (D), E2 (PLG), E4, E6
E7
E8
E2 (WKS)
Clause 4 - Quality management
system (contd.)
 4.2 Documentation Requirements
 - Quality Policy and Objectives
 - Quality Manual
 - Documented Procedures
 - Other documents deemed necessary by the organisation
 - Quality Records
4 Quality Management System (Contd.)
4.2.2 Quality Manual Includes:
- Scope of the System
The Certification Scope of CE to ISO
9001:2000 is:
Design, plan, control and manage all activities in
Chief Engineer’s office from Board Stage to
Acceptance of Contracts related to construction
projects contracted by CE and monitor till the
assets are handed over to user organisations.
- Justification for “Exclusions”
Clause 7.5.4 Customer property: CE is not provided with any User (Customer) property,
therefore this clause is not addressed in quality systems requirements for the
organization.
Clause 7.6 Control of Monitoring and Measuring Devices : CE is not maintaining

monitoring and measuring devices as the nature of product does not require dimensional
accuracy high enough to need measuring instruments requiring calibration. Therefore, this
clause is not applicable.
- Documented Procedures (or a reference)

- Description of the Interaction of Processes
4.2.3 Control of Documents
 Includes:
- documents to be legible & readily identifiable
- documents of external origin to be controlled
4.2.4 Control of Quality Records
- identification, storage, retrieval, protection, retention time &
disposition
Clause 5 - Management responsibility
5.1 Management Commitment
Top management shall provide evidence of its commitment by:
- COMMUNICATING importance of customer
requirement
- ESTABLISHING Policy and Objectives
- ENSURING availability of resources
- CONDUCTING reviews
5.2 Customer Focus
a) Management shall ensure customer requirements are
determined and fulfilled for customer satisfaction.
b) Management should understand current and future
customer needs.
- at strategic level
- not project level
5 Management Responsibility (contd.)
5.3 Quality Policy
a) appropriate for the needs of the organisation and its customers
b) commitment to meeting requirements and continual improvement
c) provides a framework for establishing and reviewing quality
objectives
d) communicated, understood and implemented throughout the
organisation
e) reviewed for continuing suitability
5.4 Planning
5.4.1 Quality objectives
Quality objectives should be:
- measurable
- established at relevant function/organisation level
5.5 Responsibility, Authority & Communication
5.5.1 Responsibility and authority
- Responsibilities, authorities & interrelations to be defined
5.5.2 Management Representative

- to report on the need for improvement
- promoting awareness of customer requirements
5.5.3 Internal Communication
Top management shall ensure internal communication
which may include:
- Up/Down communication
- Lateral communication
- Methods chosen should be suitable, appropriate and
structured
5.6 Management Review
Review Input
5.6.1 Management shall conduct review at planned intervals
5.6.2 The minimum content defined
- audit results / customer feedback
- process / product analyses
- status of preventive & corrective actions
- follow-up actions from previous reviews
- changing circumstances
- improvements
5.6.3 Review outputs
Output from Review defined
- System improvements
- Product improvements
- Resources needed
6 Resource Management
6.1 Provision of Resources
The organisation shall determine and provide the resources
need to:
- Implement & improve the QMS
- To enhance Customer Satisfaction
6.2 Human Resources
6.2.1 General
- Ensure personnel assigned with responsibility are
competent
6.2.2 Competence, Awareness & Training
Establish and maintain procedures to:
a) determine training needs
b) provide training
c) evaluate effectiveness of training at defined intervals
d) maintain records
6 Resource Management (contd.)
6.3 Infrastructure
Define, provide and maintain infrastructure needed to achieve
conformity of product/service, which includes:
a) workspace and associated facilities
b) equipment, hardware and software
c) suitable maintenance
d) supporting services
6.4 Work Environment
Define and implement human and physical factors of the
work environment to achieve conformity of product or service,
including:
a) health and safety conditions
b) work methods
c) ambient working conditions
Clause 7 - Product realization
Includes the elements which may not be
applicable to all businesses
“Exclusions”.
7.1 Planning of Realization
Plan & Develop the processes needed for product
realization
Determine as appropriate….
Objectives / requirements for product
need for processes, documents, resources
verification, validation, monitoring
records needed
7 Product Realization (contd.)
7.2 Customer - related Process
7.2.1 Determination of requirements related to the
product
Determine requirements including specified and
implied; delivery and post delivery activities; related
obligations (inc. legal requirements)
7.2.2 Review of requirements related to the product
7.2.3 Customer Communication
Identify arrangements for communication of:
- Product / Service information
- Enquiry and order handling, inc. amendments
- Customer feedback & Complaints
7.3.1 Design & development plan
- stages; required review, verification &
validation activities; responsibilities; tentative date
of completion
7.3.2 Design & Development Input
- functional/ performance requirements
- statutory & regulatory requirements
- information from previous design
7.3.3 Design & Development Outputs
- meet design input requirements; acceptance
criteria
7.3.4 Design & Development Review
The purpose of the Review is now included :
- evaluate capability
- identify problems & propose solutions
Record of the results and actions required
7.3.5 Design & Development Verification
- verification to ensure output meets input
7.3.6 Design & Development Validation
- validation to ensure capability to meet requirements for a
specific intended customer use.
 7.4 Purchasing - Establish criteria for supplier
evaluation and selection, and periodic re-evaluation
 7.5 Production and service provision - Plan
& control service operations, Availability of specifications,
availability of clearly understandable work instructions,
Use & maintenance of suitable equipment and measuring
& monitoring device
 7.6 Control of measuring and monitoring
devices - Control and Calibrate/Validate
hardware/software used to verify products.
Clause 8 - Measurement, analysis
and improvement
 8.1 General - Plan and implement monitoring,
measurement, analysis and improvement processes
 8.2.1 Customer Satisfaction

- Measurement and monitoring of customer satisfaction.
 8.3 Control of nonconforming product Control
nonconforming product to prevent unintended use or
delivery, Identify, record & review nature & extent of
nonconformity, Disposition of nonconformity, Define
responsibility & authority for review & resolving
nonconformity
Clause 8 - Measurement, analysis
and improvement
8.4 Analysis of data - Analyze data to determine quality
system effectiveness and to provide information on customer
satisfaction, supplier performance, product conformance, and
process/product characteristics and trends used to identify
opportunities for preventive action
8.5 Improvement - Must improve effectiveness of the

quality management system (note: accomplish through the
use of quality policy, objectives, audit results, analysis of
data, corrective/preventive actions, and management review)
Continuous improvement of the
Management
Responsibility
Satisfaction
Measurement,
Resource
CLIENT
CLIENT
Analysis and
Management
Improvement
Requirements
Product /
Input Output Product
Service
Data Data Service
Realization
WHAT IS A QUALITY AUDIT
A systematic and independent examination

to determine whether quality activities
related results comply with planned
arrangements and whether these
arrangements are implemented effectively
and are suitable to achieve objectives
AUDIT TYPE
2nd PARTY CUSTOMER
CERTIFICATION
3rd PARTY
BODY
1st PARTY ORGANIZATION

THE AUDIT LIFE CYCLE
 FOUR PHASES
– Planning
– Conducting the Audit
– Analysis of Results
– Reports and corrective actions
(Including follow-up audits)
PART 1: PLANNING
 Prepare an overall schedule of the audit
 Decide the audit teams
 Inform the auditors and auditees
 Obtain all relevant information
 Type and scope of audit
 Examine previous audit results
 Develop check lists
 Arrange time of audit
 Prepare audit plan
CHECK LISTS
 Check lists are an extremely
powerful audit tool, if used correctly.
 Check lists can be based on:

– Recognized Quality Standards
– Departmental Operating System
– Organization standards and
procedures
– Product/User requirements
PART 2: CONDUCTING THE
AUDIT
 Audit Entry
Conducting the Audit –

The Examination
Audit Entry
 Before commencing with the audit it is a
good practice to conduct an “Opening
Meeting”.
 The purpose of this meeting should be:
– Meeting the auditees.
– Confirming the audit programme and clarifying
unclear details, agreeing to audit scope and
applicable standards
– Confirming the time frame of the audit
– Confirming the arrangements for the closing
meeting after the audit
– Agreeing the method of official communications
between the audit team and the auditees
Conducting the Audit
– The Examination
 Following are examined when
auditing:
–Documentation
–Equipment
–Materials
–People
–Processes
Documentation
(Drawings, specifications,
procedures, records etc)
– Are all required documents available
– Are documents complete and contain
necessary information
– Are documents fully identified, including
revision and status
– Are documents formally controlled
Equipment
(Measuring, testing,
inspection etc)
– Is it suitable for the task
– Is it calibrated
– Is it being used correctly
– Is it properly identified
Materials
 (Raw materials, components etc)

– Are they correct (type, grade etc)
– Are they identifiable/traceable
– Is status known
– Do they meet required standards
People
 Is the person competent to carry out

the task
 Has the person been adequately
trained
 Are the responsibilities clearly defined
 Do they understand the quality policy
and objectives of the organization /
department
Processes
 Properly planned
 Properly executed
 Properly controlled
 Adequately documented
 Appropriate environment
Part 3: Analysis of Results
Audit notes
Non- Compliances
Non-Compliance is a violation to any of the
following:
-Requirements of ISO 9001:2000 Standard
-Company’s stated policies and objectives
-Company’s documented procedures
-Work Instructions
Categorization of Non-Compliances
–Major
The complete absence of a statement or procedure to
meet a requirement of standard
The breakdown or non-observance of a specified
procedure or requirement
–Minor
A single observed lapse in the use of a defined procedure
or requirement.
–Observation
Closing Meeting
NOTE: A number (not specified) of minor NC’s against one
procedure or requirement, around the organization or in a single
department Providing a breakdown can become a MAJOR NON-
CONFORMANCE
Part 4: Reports and Corrective
Actions
 Audit Reports
 Audit notes
 Closing meeting
 Audit observations
 Non conformities
 Category of non conformities
 Supporting evidence
 Signatures
Reporting Audit Results
Key Points:
 Content of the report
 Writing nonconformities
Contents of Audit Report
 Purpose of audit
 Date
 Audit team
 Scope/areas/processes covered
 Key contacts
 Quality System documents
Contents of Audit Report
 Summary statement
 Areas for improvement
 Action items
Audit Report
 Completed checklist
 Copies of Corrective Action Requests
(nonconformities) submitted for auditee
response
 Follow-up schedule
Report Not to include
 Issues beyond the scope of the audit
 Sensitive or contentious issues
 Confidential information
 Issues not discussed
during the audit
Nonconformity
 “Nonfulfillment of a Requirement”
 (ISO 9000:2000, 3.6.2)
 Requirement:
– need or expectation that is stated, generally
implied or obligatory
WRITING OF NON-CONFORMITIES
 Non-conformities must be based

on objective evidence

Requirement Failing Evidence

Requirements
 Quality System Standard
 Quality Manual
 Procedures
 Work Instructions
 Customer Orders
 Statutory/Legislative Codes
Failure & Objective Evidence
 A failure is when the auditee is not
fulfilling specified requirements.
 Objective evidence is data supporting the
existence of something. In other words,
records, statements of fact, or other
information relevant to the agreed criteria
which can be cross-checked.
Nonconformity Form
 Note
 Noncompliance Report
 Deviation Notice
 Corrective Action Request
 Potential for Improvement Form
 Nonconformity
Writing Nonconformities
 Who?
 Where?
 What?
 How?
 Substantiated by Objective Evidence

Nonconformities Should
Indicate
 Title of person(s) involved
 Location
 Precise document reference
 Product and/or equipment ID
 Clear and concise description of the
nonconformity
 Auditor’s name and date
Check Nonconformities
 Clear
 Concise
 Correct
 Complete
4 Cs
Example of a Nonconformity
 Example 1 - Poor Version
 Preservation, specifically packaging, of
product was not adequately controlled.
– This raises the following issues:

 What was actually wrong?
 What product is involved?
 Where was the problem identified?
 Example 1 - Better Version
 Contrary to ISO 9001:2000, clause 7.5.5 and
Company Specification 2346, revision 2 ,
paragraph 2.3.7, Number 2 Dispatch Bay was
found to contain crates marked as ready for export
delivery despite being constructed to inland
standards instead of export standards. Reference
order numbers 37492 for Abu Dhabi 38345 for
Dubai.
 P.O.’s were not I.A.W. GP.01

 What are P.O.s?
 What is I.A.W.?
 Which P.O.’s?
 How were they not controlled?
 Contrary to ISO 9001:2000, clause 7.4.1, and
General Procedure GP.01, Revision 4, paragraph
3.2.5, purchase orders were released by the
Buying Department to suppliers that had not been
formally approved. Examples include purchase
orders 837/AJ and 839/PT both of which were
issued to Big Sheet Fabricators who are not
included in the records of acceptable suppliers.
 Training records were poor. They should
be maintained by a senior manager and
subject to a filing system operated by a
trained clerk.
 Which training records?
 What evidence do you have for this statement?
 Why should we do it your way?
 The current training records for production personnel held
by the training officer are not in all cases complete. The
“training history record card” was not signed and dated in
some cases and verification of previous experience was
not provided as required in Quality Manual, Issue 2,
Paragraph 5.4.6. Examples include:
– D. Travers - assembler - No History card on file.
– L. Clark - finisher - No record of previous experience.
– P. Gray - electrician - History card was incomplete for
the first three weeks of training period.
– Reference ISO 9001:2000, Clause 6.2.
When to write and NCN
 Don’t break the flow
 Take time to think
 Record all information
 Write at end of day
 Present NCN at closing meeting
Records

Maintain audit reports as records

Use results of audits as a basis for
determining future audits

Use results of audits as a basis for
continual improvement
•Corrective Actions
•Follow-Up Audits
•Ensure corrective action taken
•Evaluate effectiveness of corrective action
•To effect improvement to operations
Methods of Auditing
TRACE FORWARD
Audit of one sample from first to last activity
TRACE BACK
Audit of one sample from last to first activity
HORIZONTAL AUDITS
Audit of an activity for more than one sample
VERTICAL AUDITS
Audit in a sequence manner of all activities
or controls in a department
HORIZONTAL AND VERTICAL
AUDITS
Vertical
E-2 (Des) Horizontal
E-2 (Wks) Horizontal
E-2 (Plg) Horizontal
E-6 Horizontal
E-8 Horizontal
FORWARD AND BACKWARD
TRACE FORWARD
PROCEDURE INDEX FILE
TRACE BACKWARD
TYPES OF QUESTIONS
Open Question OPEN QUESTION:-
How Does……?
Show me how…?
Tell me about….?
Probing Question PROBING QUESTIONS

-Cross Questioning
-Further Investigation
CLOSED QUESTIONS
Closed Question To establish a fact
-When
-Who
Six Friends
What?
Why?
Where?
When?
How?
Who?
Seventh Friend
Show Me !
AUDIT INTERVIEW
Talk to the right people
Ask & Listen
Friendly & Business like
Accurate but tactful
Establish rapport
Be polite
Eliminate social barrier
Show interest
Acknowledge & reciprocate
Avoid interruptional contradiction
Remember “Please” & “Thank you”
GUIDE TO THE AUDITOR
Must have detailed knowledge of the Quality System
operating in the department
Must understand department’s operating procedures
Good knowledge of the standard
Must use checklist
Audit to be based on sample checking & objective evidence
Never volunteer opinions
Acknowledge not knowing an answer
Tactful and courteous
Cover all applicable ISO 9001:2000 clauses
Build a rapport with the Auditee
Never argue
Be brief and precise.
MANAGING AUDITS
1. Never challenge a person
2. Always present a true & fair view
3. Go fact finding not fault finding
4. Use systematic methods
5. Never loose sight of the PRODUCT
6. Find out the auditees’ interpretation not yours
7. Always be properly prepared
8. Always HELP the Auditee
9. Communicate effectively with the Auditee
10. Find & address the real cause of problems found
11. Always follow-up corrective action requests
MAX Quality Consultants
SCF – 37, 3rd Floor, Phase –V,
Mohali – 160059, Punjab
0172 – 5091436, 5098710,
09814177619

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ISO 9000 Trg.

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What is ISO

 Acronym for International Organization for

Suppose that the letter F represents a defective

OF SCIENTIFIC STUDY COMBINED WITH

THE EXPERIENCE OF MANY YEARS

 Organizations depend on their

 understand current and future customer

 meet customer requirements, and

 strive to exceed customer expectations.

 establish unity of purpose and direction of

 create and maintain the internal

 People at all levels are the essence

 their full involvement enables their

 they must also control all process

 and, they must establish appropriate

Input Activity Output

Input Activity Output

Input Activity Output

Right Resources: Desired Results:

 Organizations must understand a

 the output of one process is the input to

 It is critical to manage the “white space”

 improvement must be a planned activity if

Act Check Measure/Monitor Results Against Objectives -

 Effective decisions are:

 based on the analysis of data and

 An organization and its suppliers are

 a mutually beneficial relationship enhances

To meet the requirements you must:

4. Quality Management System

Who we are doing it for.

Improving how we provide product &

Establish a Quality Policy

Carry out Quality Planning

Control the Quality System

Perform Management Reviews

• Meet your customers’

Carry out Quality Planning • Enhance customer

Perform Management Reviews

Perform Management Reviews

Establish a Quality Policy • Formulate your

Perform Management Reviews

Satisfy Customers • Define

Control the Quality System • Generate

Human  Determine competence.

• Planning for Product Realization

• Customer Related Processes

• Design and Development

• Production and Service Provisions

• Control of Monitoring and Measuring Devices

Monitoring and Measurement

Monitoring and Measurement

 Internal planned audit, etc.

Monitoring and Measurement

Monitoring and Measurement

Control of nonconforming product / processes

nonconforming product / processes.

 You will meet

 False. ISO9000 is not about documentation. It’s

 Corrective action must

 False.ISO9000 requires only

4.1 General Requirements

E3, E2 (D), E4, E6

Clause 7.6 Control of Monitoring and Measuring Devices : CE is not maintaining