Iso Awareness - 90012008PPT Format

ATOZ QUALITY MANAGEMENT
PVT.LTD
ISO 9001:2008Awareness
WELCOME TO ALL
CM-21 Rev No:01, Date: 01.10.2001 1

ISO 9001:2000 Awareness
Today’s Agenda
• Introduction to Quality Management System

• Evolution of Quality Management System Standards
• Process Approach towards QMS.
• Requirements of ISO 9001:2000.
• Benefits of implementing ISO 9000
CM-21 Rev No:01, Date: 01.10.2001 2

Evolution of Quality Management System Standards.

• These standards are
BS 5750 Base Standard developed by ISO
• ISO means “Equal”

ISO 9000 Developed in 1987 by ISO body
• These standards are
generic.
ISO 9000 Revised in 1994
• Applicable all types of
organizations
Revised in 2000
ISO 9000
CM-21 Rev No:01, Date: 01.10.2001 3

4.0 Quality Management System
4.1 General Requirements
Determine Method
Identify Process Determine Sequence
to Control
Ensure Resources Measure, Monitor CA/PA & CI

Available & Analysis
CM-21 Rev No:01, Date: 01.10.2001 4

4.0 Quality Management System – Contd. …
4.2 Documentation Requirements
• Documented statements of Quality Policy & Objectives
• Document process as required
• Document in any form.
CM-21 Rev No:01, Date: 01.10.2001 5

4.2.2 Quality Manual
• Define Quality Policy
• Define Process within the organization
• Define interfaces between the processes identified
• Define Scope & Justification for Exclusions of requirements
CM-21 Rev No:01, Date: 01.10.2001 6

4.2.3 Control of Documents
• Approve documents for adequacy prior to issue
• Review and update as necessary
• Maintain Record of Change
• Update all documents
• Prevent unintended use of obsolete documents
CM-21 Rev No:01, Date: 01.10.2001 7

4.2.3 Control of Records
• Identify
• Legible
• Storage & Preservation
• Retain records to meet Customer & Legal requirements
CM-21 Rev No:01, Date: 01.10.2001 8

5.0 Management Responsibility – Contd. …
Mutual beneficial
supplier Customer
relationships Focus
Factual
approach to
decision 8 Leadership
making Management
Principals
Continual Involvement
Improvemen of people
t
System Process
approach to Approach
management
CM-21 Rev No:01, Date: 01.10.2001 9
5.0 Management Responsibility
• Define Quality Policy
• Appropriate to the purpose of organization
• provide framework for establishing and reviewing
objectives
POLICY
CM-21 Rev No:01, Date: 01.10.2001 10

• Define Quality Objectives
S - Specific
M - Measurable
A - Attainable
R - Realistic
T - Time Bound
CM-21 Rev No:01, Date: 01.10.2001 11

• Define Responsibility & Authority
• Assign Responsibility for Quality
• Provide Authority to Stop Production in case of NC.
CM-21 Rev No:01, Date: 01.10.2001 12

ATOZ QUALITY MANAGEMENT ISO
9001:2000 Awareness
• Management Review to address
Achievement of
Quality Policy
All Elements of and Objective
Quality System
Field Failure & Its

impact on Safety
& Environment Cost of Quality
Performance of
Quality System Customer
Satisfaction
CM-21 Rev No:01, Date: 01.10.2001 13

6.0 Resource Management

• Assign Competent Personnel for work affecting Quality
• Define Competency Level for each Job.
Define Job
• Provide training and evaluate effectiveness Specifications
• Designers to be skilled in applicable tools
DOE, QFD,
DFMEA, etc.
CM-21 Rev No:01, Date: 01.10.2001 14

6.0 Resource Management – Contd. …
• Cleanliness of Premises – Ensure Premises maintained in the
state of orderliness.
Maintain 5S
CM-21 Rev No:01, Date: 01.10.2001 15

7.0 Product Realization – Contd. …
• Plan & identify the processes required for product realization
Understand customer
Design & Development Purchase & Store
requirements
Dispatch Inspection Production
CM-21 Rev No:01, Date: 01.10.2001 16

• Maintain confidentiality to customer contracted product.
• Process to manage the changes in the Product & Process
• Determine quality objectives and requirement of the product
• Establish processes, documents and provide resources specific
to the product.
CM-21 Rev No:01, Date: 01.10.2001 17

9001:2000 Awareness
Customer Related Process:-
• Customer designated Special Characteristics – Compliance in
terms of designation, control and monitoring
Critical product
characteristics
Implement SPC/
Poke Yoke
CM-21 Rev No:01, Date: 01.10.2001 18

Purchasing:-
• Purchase material used in product – to comply with all Govt.
Safety / Environmental Regulation
• Customer approved sources – Purchase from customer approved

source, if part of contract.
CM-21 Rev No:01, Date: 01.10.2001 19

• Incoming Product Quality – Acceptance of incoming material
can be based on following
• Receiving inspection
• Receipt and evaluation of Statistical data
• Part evaluation by external lab
• Any other method agreed with the customer.
CM-21 Rev No:01, Date: 01.10.2001 20

• Monitor supplier performance:-
Delivered part
quality performance
Customer including line
complaints due rejection
to Suppliers
part
Delivery
performance
CM-21 Rev No:01, Date: 01.10.2001 21

• Identification & Traceability
• Mandatory to identify the products at various stages of
Product realization.
• Customer owned tooling – Identify visually
CM-21 Rev No:01, Date: 01.10.2001 22

• Storage & Inventory
• Periodically assess the condition of the stock
• Use Inventory Management system to optimize inventory
levels.
• Use FIFO, where applicable.
CM-21 Rev No:01, Date: 01.10.2001 23

• Control of Monitoring and Measuring Devices.
• Calibrate all Measuring devices..
As received
Out of
condition
Calibration
Calibration
Records
Gage revision
Statement of status
conformance
CM-21 Rev No:01, Date: 01.10.2001 24

8.0 Measurement, Analysis and Improvement
• Identify & Implement Statistical Techniques
• Impart basic Knowledge on Statistical tools to all employees
• Knowledge of Variation, Control, Stability & Capability.
7 QC
Tools
SPC
Charts
CM-21 Rev No:01, Date: 01.10.2001 25

• Customer Satisfaction Measurement
Delivered Field Returns

part Quality
Performance
Customers
Customer
complaints / Delivery
feedback Performance
CM-21 Rev No:01, Date: 01.10.2001 26

• Internal Audits
System Audit
Internal Audits
• Internal Auditor Should be Qualified
CM-21 Rev No:01, Date: 01.10.2001 27

9001:2000 Awareness
• Control of Nonconformance Product
Suspect
Customer product - NC
deviation-
maintain record
Nonconformance
Rework
Inform
Instruction
customer if
for R/w
NC is
shipped
CM-21 Rev No:01, Date: 01.10.2001 28
• Analysis of Data
• Identify Key Quality & Organizational performance data
• Monitor the performance
• Timely reporting of the performance
• Monitor trends in performance .
CM-21 Rev No:01, Date: 01.10.2001 29

• Improvement
• Define Process for Continual Improvement
• Focus on reduction of variation in product / process
parameters.
CM-21 Rev No:01, Date: 01.10.2001 30

• Corrective Actions
To avoid recurrence of the non-conformance.
• Preventive Actions
To avoid potential failures / non-conformance.
CM-21 Rev No:01, Date: 01.10.2001 31

THANK YOU
FOR FURTHER DETAILS PLEASE CONTACT
MR.JIVAN KATHE(Lead Auditor for QMS/HOD)
(9930141710)
E.MAIL-atozjivan@gmail.com
CM-21 Rev No:01, Date: 01.10.2001 32

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ATOZ QUALITY MANAGEMENT

CM-21 Rev No:01, Date: 01.10.2001 1

• Introduction to Quality Management System

CM-21 Rev No:01, Date: 01.10.2001 2

Evolution of Quality Management System Standards.

• ISO means “Equal”

CM-21 Rev No:01, Date: 01.10.2001 3

Ensure Resources Measure, Monitor CA/PA & CI

CM-21 Rev No:01, Date: 01.10.2001 4

• Document process as required

• Document in any form.

CM-21 Rev No:01, Date: 01.10.2001 5

CM-21 Rev No:01, Date: 01.10.2001 6

CM-21 Rev No:01, Date: 01.10.2001 7

CM-21 Rev No:01, Date: 01.10.2001 8

CM-21 Rev No:01, Date: 01.10.2001 10

CM-21 Rev No:01, Date: 01.10.2001 11

• Define Responsibility & Authority

• Assign Responsibility for Quality

• Provide Authority to Stop Production in case of NC.

CM-21 Rev No:01, Date: 01.10.2001 12

Field Failure & Its

CM-21 Rev No:01, Date: 01.10.2001 13

6.0 Resource Management

CM-21 Rev No:01, Date: 01.10.2001 14

CM-21 Rev No:01, Date: 01.10.2001 15

Dispatch Inspection Production

CM-21 Rev No:01, Date: 01.10.2001 16

CM-21 Rev No:01, Date: 01.10.2001 17

CM-21 Rev No:01, Date: 01.10.2001 18

• Customer approved sources – Purchase from customer approved

CM-21 Rev No:01, Date: 01.10.2001 19

CM-21 Rev No:01, Date: 01.10.2001 20

CM-21 Rev No:01, Date: 01.10.2001 21

• Customer owned tooling – Identify visually

CM-21 Rev No:01, Date: 01.10.2001 22

CM-21 Rev No:01, Date: 01.10.2001 23

CM-21 Rev No:01, Date: 01.10.2001 24

CM-21 Rev No:01, Date: 01.10.2001 25

Delivered Field Returns

CM-21 Rev No:01, Date: 01.10.2001 26

• Internal Auditor Should be Qualified

CM-21 Rev No:01, Date: 01.10.2001 27

CM-21 Rev No:01, Date: 01.10.2001 29

CM-21 Rev No:01, Date: 01.10.2001 30

CM-21 Rev No:01, Date: 01.10.2001 31

CM-21 Rev No:01, Date: 01.10.2001 32

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