INTRODUCTION TO

ISO 9001:2008 QUALITY

MANAGEMENT SYSTEMS
-- FOR TOP MANAGEMENT
BY
ENCOUNSEL ENGINEERS,
MUMBAI

FACULTY
Mr. N. VAIDYANATHAN,

B.E.(MECH).,PG.D.O.M.,M.I.E.,F.I.V.,M.I.R.M(UK)

Chartered engineer, A grade

Insurance loss assessor (F.I.I.I.S.L.A)
Industrial valuer, lead auditor,
engineering consultant, consultant for
quality and risk management

CHIEF EXECUTIVE, ENCOUNSEL ENGINEERS,

10, HIMACHAL MITRA MANDAL BHAVAN, ROAD 5,
PESTOMSAGAR, CHEMBUR, MUMBAI 400 089.
PHONE : 25255218
EMAIL: vaida 17@gmail.com

What is ISO 9000 Quality

Management Systems ?
What is ISO 9000 Quality
Management Systems ?
How it can be adoptable to us?

QUALITY MANAGEMENT
SYSTEMS TOP MANAGEMENT
WHAT IS QUALITY ?
Quality is the degree of nearness
to the requirements.

QUALITY MANAGEMENT
SYSTEMS TOP MANAGEMENT
WHAT IS QUALITY ?
Doing the right things right the first time and around
Fitness for use
Customer satisfaction/delight
Meeting quality & delivery parameters
Defect free service, presence of value
Improvement in quality parameters
Reduced customer complaints

QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
WHAT IS MANAGEMENT ?
MANAGEMENT IS DEFINED
AS
MANAGE MEN T.
MANAGE MEN AS A TEAM.

QUALITY MANAGEMENT
SYSTEMS- TOP MANAGEMENT
WHAT IS SYSTEM ?

System is a process
done as per predetermined method.

WHAT IS QUALITY SYSTEM

MANAGEMENT ?

Quality system
management means a
team of people working
together in a predetermined
method to proceed as close
as possible to the
requirements of
customers.
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WHAT IS THEN ISO 9000 ?

ISO MEANS INTERNATIONAL
ORGANISATION FOR
STANDARDISATION.
9000 IS JUST A NUMBER AND
DENOTE NO OTHER MEANING.

QUALITY MANAGEMENT
SYSTEMS TOP MANAGEMENT

PRINCIPLES FOLLOWED:
1.Customer - focused organisation.
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.
(These are Based on Dr. DEMINGS
Principles)
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Dr. DEMINGS PRINCIPLES

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
PROCESS APPROACH.

To develop, implement, and

to improve the effectiveness
of a quality management
system, to enhance
customer satisfaction by
meeting customer
requirements.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
APPLICABLITY OF STANDARD
Requirements of standard are
generic.
Intended to be applicable to all
organisations regardless of type, size,
product or service provided.
Any requirement that cannot be
applied due to nature of organisation
and its product, the same is
considered for exclusion

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
ISO 9001:2008 REQUIREMENTS

4. General and documentation

requirements Q.M.S.
5. Management responsibility.
6. Resource management.
7. Product realisation.
8. Measurement, analysis and
improvement.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
4.2 DOCUMENT REQUIREMENTS

Quality policy & quality

objectives.
Quality manual.
Documented procedures.
Documents needed for effective
planning,
Operation & control of
processes.
Quality records.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT

LEVEL 1 QUALITY MANUAL.

LEVEL 2 QUALITY PROCEDURES.
LEVEL 3 WORK INSTRUCTIONS.
LEVEL 4
FORMATS/SPECIFICATIONS
LEVEL 5 QUALTIY RECORDS.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
4.2.2. QUALITY MANUAL.
To establish & maintain qms.
Scope of qms, including
justification of any exclusions.
Documented procedures or their
reference.
Description of interaction of
processes of the qms.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.0.MANAGEMENT
RESPONSIBILITY.

Top management.
Commitment.
Customer focus.
Policy and objectives.
Communication.
Management review.
Management representative.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.0.MANAGEMENT
RESPONSIBILITY.

Quality manual to provide sequence

& interaction of processes included
in QMS.
Management review covering current
performance and improvement
opportunities.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.0.MANAGEMENT
RESPONSIBILITY.

Evidence of commitment
Customer needs are determined.
Customer focus.
Quality policy announced.
Quality objectives are measurable
and consistent with quality policy.
Resource planning to achieve
quality objectives
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.1.MANAGEMENT
COMMITMENT.

To provide evidence of its

commitment.
Establish quality policy &
objectives.
Communicating to all concerned
Conducting management reviews
Ensuring availability of resources.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.2.CUSTOMER FOCUS

TO UNDERSTAND CURRENT & FUTURE

CUSTOMER NEEDS.

CUSTOMER
REQUIREMENTS.
DETERMINED.

FULFILLED

CUSTOMER
SATISFACTION
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.3. QUALITY POLICY

To be appropriate.
Continually improve
Framework for quality objectives.
Communicated & understood by
all within organisation.
Reviewed for continuing
suitability.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.4. QUALITY PLANNING

5.4.1. QUALITY OBJECTIVES.

TO BE ESTABLISHED AT RELEVANT
FUNCTIONS AND LEVELS.
MEASURABLE & CONSISTENT WITH
QUALITY POLICY.

QUALITY POLICY
MEASURABLE
OBJECTIVES
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.5.RESPONSIBILITY,AUTHORITY, COMMUNICATE

Responsibility & Authority

Define R & A and their
interrelation.
Communicated within the
organisation.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.5.2. MANAGEMENT REPRESENTATIVE

Appoint a member of
management
Has defined authority.
To report on the need for
improvement.
To promote awareness of
customer requirements
throughout organisation
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.6. MANAGEMENT REVIEW

TOP MANGEMENT SHALL

REVIEW:
5.6.2. REVIEW INPUT.
5.6.3. REVIEW OUTPUT.
RECORDS SHALL BE
MAINTAINED.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.6.2 MANAGEMENT REVIEW - INPUT

Results of audits.
Status of objectives achievement
Customer feedback
Product/process analysis.
Status of corrective & preventive
actions.
Follow up actions of previous
Changes in circumstances
Improvements.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
5.6.3 MANAGEMENT REVIEW - OUTPUT

System improvements.
Product improvements.
Resources needed.
To evaluate need for
change to
QMS/policy/objectives.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT

DOCUMENTED PROCEDURES NEEDED:

For control of documents.
For control of records.
For internal audits.
For control of nonconformity
For corrective action
For preventive action

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
6. RESOURCE MANAGEMENT.
OVERVIEW:

Business resources.
Human resources.
Competence.
Infrastructure.
Work environment.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
7.2.3.CUSTOMER COMMUNICATION
Implement effective
communication for.
Product/service information
Enquiry, order handling, and
amendments.
Customer feedback &
complaints.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
7.4. PURCHASING/CONTRACTING
7.4.1. Purchasing process.
To ensure that purchased product
conforms to the purchase
requirements.
To evaluate and select suppliers on
their ability. Criteria for selection,
evaluation, to be established.
Records for the same to be
maintained.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
7.4.3.VERIFICATION OF PURCHASED
PRODUCT
Implement inspection or other
activities to ensure that
purchased product meets
requirements
Verification at suppliers
premises, to be stated in
advance
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
7.5.PRODUCTION AND SERVICE
7.5.1. Control of production &
service provision.
To plan & execute under controlled
conditions, which include:
characteristics, work instructions,
suitable equipment, monitoring and
measurement with suitable devices
and implementation of release,
delivery and post delivery activities.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.2.1.CUSTOMER SATISFACTION
Very important element in the
system.
To monitor information relating to
customer perception
To fulfill customer requirements.
To define how information is
obtained and used.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.2.2.INTERNAL AUDIT
To audit at planned intervals.
To define audit criteria, scope,
frequency, and methods.
Selection of auditors & ensure
objectivity and impartiality
Not to audit their own work.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.2.2.INTERNAL AUDIT
The management responsible
shall ensure that actions are
taken without undue delay to
eliminate nonconformities and
their potential causes.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.3.NON CONFORMING PRODUCT
Identify to prevent unintended
use or delivery.
Responsibilities and authorities
for dealing with nonconforming
Documented procedure is
needed
Repair, concession, regrade,
reject.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.4.ANALYSIS OF DATA
This is an important element in
the standard.
Local review of data.
Should be on going & regular.
Analysed in a timely manner.
Not waiting for strategic
management review meetings.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.4.ANALYSIS OF DATA
Analysis should include:
Customer
satisfaction/dissatisfaction
Conformance of product
requirements.
Characteristics and trends of
processes and products.
Supplier information.
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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.5.1.CONTINUAL IMPROVEMENT
To continually improve
effectiveness of QMS through
use of Q.Policy, Objectives,
Audits results, Analysis of data,
Corrective and Preventive
actions and Management
review.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.5.2.CORRECTIVE ACTION
To establish documented
procedure to
Review nonconformities
Review customer complaints
Determine causes of NCs
Ensure NCs do not repeat
Determine & implement action.
Records of results of action
Review corrective action taken.

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
8.5.3.PREVENTIVE ACTION
To prevent occurance of NCs.
Documented procedure needed.
Evaluate results of preventive
action taken.
Review preventive action taken.

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QUALITY MANAGEMENT
SYSTEMS
1. Management processes
include
A) Customer satisfaction
B) Management review
C) Internal audits
D) Continual improvement
E) Corrective actions &
F) Preventive actions
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QUALITY MANAGEMENT
SYSTEMS
2. Core processes include:
A) Customer requirements
B) Tender/order
C) Product design
D) Production processes
E) Process verification
F) Product verification
G) Packing & delivery
H) Warranties and after sales service
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QUALITY MANAGEMENT
SYSTEMS
3. Support processes include:
A) Document control
B) Record control
C) Training
D) Purchase
E) Non conforming product
F) Calibration

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
LIST OF QUALITY RECORDS
SR. NO

ELEMENT DESCRIPTION

5.6.1.

MANAGEMENT REVIEW

6.2.2.

TRAINING RECORDS

7.1.

PRODUCT REALISATION

4.

7.2.2.

CONTRACT REVIEW

5.

7.3.2.

DESIGN INPUT

6.

7.3.4.

DESIGN REVIEW

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
LIST OF QUALITY RECORDS.. CONTD
7.

7.3.5.

DESIGN VERIFICATION

8.

7.3.6.

DESIGN VALIDATION

9.

7.3.7.

DESIGN CHANGES

10

7.4.1.

SUPPLIER EVALUATION

11

7.4.2.

PURCHASE ORDERS

12

7.5.2.

SPECIAL PROCESSES

13

7.5.3.

IDENTIFICATION & TRACE

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QUALITY MANAGEMENT
SYSTEMS-TOP MANAGEMENT
LIST OF QUALITY RECORDS.. CONTD
14 7.5.4.

CUSTOMER PROPERTY

15 7.6.

CALIBRATION

16 8.2.2

INTERNAL QUALITY AUDITS

17 8.2.4.

INSPECTION & TEST

18 8.3.

NON CONFORMING PRODUCT

19 8.5.2.

CORRECTIVE ACTION

20 8.5.3.

PREVENTIVE ACTION

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OUR OTHER MANAGEMENT

WORKSHOPS

Time Management
Leadership Enhancement
Selling and Negotiation Skills
Decision Making and Problem Solving Skills
Motivation & Positive Attitude culture
Insurance and Risk Management
Personal Excellence
Stress Management
Interpersonal Skills
Body Language
Customer Service
Communication Skills
Team Building Skills

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Any Questions?

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