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GOOD MORNING TO

ALL

ISO 9001 : 2008

WHAT IS ISO AFTER ALL?

WHAT IS ISO ?
ISO

= (INTERNATIONAL ORGANIZATION FOR


STANDARDIZATION)
ISO HAS REPRESENTATION FROM 162 COUNTRIES AND

HAS ISSUED MANY STANDARDS.


ISO 9001 : 2008 IS A MODEL FOR A QUALITY

MANAGEMENT SYSTEM.

ISO ORIGINATION?
THE INTERNATIONAL ORGANIZATION FOR STANDARDIZATION,
WIDELY KNOWN AS ISO, IS AN INTERNATIONAL STANDARDSETTING BODY COMPOSED OF REPRESENTATIVES FROM
VARIOUS NATIONAL STANDARDS ORGANIZATIONS. FOUNDED
ON FEBRUARY 23, 1947, THE ORGANIZATION PROMULGATES
WORLDWIDE PROPRIETARY INDUSTRIAL AND COMMERCIAL
STANDARDS. IT HAS ITS HEADQUARTERS IN GENEVA,
SWITZERLAND.

WHAT IS ISO 9001:2008 QUALITY


MANAGEMENT SYSTEMS - REQUIREMENTS?
QUALITY = DEGREE TO WHICH CUSTOMER REQUIREMENTS HAVE BEEN MET
MANAGEMENT = COORDINATED ACTIVITIES TO DIRECT AND CONTROL AN
ORGANIZATION

SYSTEM = SET OF INTERRELATED OR INTERACTING ELEMENTS


QUALITY MANAGEMENT SYSTEM = A SYSTEM TO DIRECT AND CONTROL AN
ORGANIZATION WITH REGARD TO QUALITY

REQUIREMENTS = A SET OF MANAGEMENT PARAMETERS YOUR QMS

HOW DO YOU KNOW REQUIREMENTS HAVE BEEN MET IN YOUR ORGANIZATION?


REVIEW = CONFIRM THAT REQUIREMENTS ARE ACCURATE
VERIFY = MEASURE ACCURACY OF OUTPUT AGAINST REQUIREMENTS
VALIDATE = GET FEEDBACK FROM CUSTOMER/END-USER

The ISO 9001 Standard is based on these 8 principles

ISO 9001:2008 ELEMENTS

ISO 9001:2008 REQUIREMENTS


1. Scope
2. Normative references
3. Terms & definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product realization
8. Measurement, analysis & improvement

5 MAIN CLAUSES OF ISO 9001:2008


4 Quality
Management
System

General
requirements
Documentation
Requirements

5 Management
Responsibility

Management
Commitment
Customer
focus

6 Resource
Management

7 Product
Realization

Provision of
resources

Planning

General

Customer
related
processes

Monitoring &
measurement

Human
resources

Quality policy
Infrastructures
QMS Planning

Responsibility,
authority &
communicatio
n
Management
Reviews

Work
environment

Design &
development

8
Measurement
Analysis &
improvement

Control of NCP
Analysis of data

Purchasing
Improvements
Production &
service
provision

4.1 QMS GENERAL REQUIREMENTS

Determine the Process &


Sequence of the Product

Ensure the availability of


resource to support production

Determine the criteria and method of process

Monitoring and analysis the process and


take necessary to achieve planned result

4.2 DOCUMENT REQUIREMENTS


4.2.1. GENERAL
4.2.2.QUALITY MANUAL
4.2.3 CONTROL OF DOCUMENTS
4.2.4 CONTROL OF RECORDS.

4.2.1 GENERAL

QUALITY POLICY
QUALITY MANUAL
QUALITY OBJECTIVES
PROCEDURES
RECORD

DOCUMENTS CAN BE IN ANY FORM (OR) TYPE OF MEDIUM

4.2.2

This documents is the backbone of the


management system, and is where you
announce your intentions

4.2.3CONTROL OF DOCUMENTS

PLEASE ENSURE THAT DOCUMENTS REMAIN LEGIBLE AND READILY


IDENTIFIABLE

4.2.3 MANDATORY DOCUMENT.


a)
b)
c)
d)
e)
f)
g)
h)
i)
j)
k)
l)

QUALITY POLICY.
QUALITY MANUAL TO DESCRIBE THE SYSTEM.
QUALITY OBJECTIVES REGISTER TO DOCUMENT YOUR QUALITY OBJECTIVES.
CONTROL OF DOCUMENTS PROCEDURE.
CONTROL OF RECORDS PROCEDURE.
INTERNAL AUDIT PROCEDURE.
CONTROL OF NONCONFORMING PRODUCT.
CORRECTIVE ACTION PROCEDURE.
PREVENTIVE ACTION PROCEDURE.
QUALITY PLAN.
CONTROL PLANS.
OTHER DOCUMENTS, AS NECESSARY.

4.2.4 CONTROL OF RECORDS

Proper Identification

Proper Storage and Easy


retrieval of record

Retention & Dispose of the record


RECORDS (TO SHOW EVIDENCE OF WORK PERFORMED IN ALL QMS
PROCESSES).

5 - MANAGEMENT RESPONSIBILITY
5.1 MANAGEMENT COMMITMENT.
5.2 CUSTOMER FOCUS.
5.3 QUALITY POLICY.
5.4 PLANNING.
5.5 RESPONSIBILITY , AUTHORITY AND COMMUNICATION.
5.6 MANAGEMENT REVIEW.

5.1 MANAGEMENT COMMITMENT

Management should Provide the


evidence for establishing QUALITY
POLICY AND QUALITY
OBJECTIVE

Conducting the management review and


ensure the availability of resource.

5.2 CUSTOMER FOCUS

TOP Management shall ensure the customer requirement are determined


and are met with the aim of CUSTOMER SATISFACTION

5.3

It gives the general direction of the organization and its commitment to


quality and customer satisfaction.
CONVEY THE GOAL OF THE ORGANISATION

5.4

5.4.1 Quality objectives Shall be measurable and consistent with the


quality policy.
5.4.2 Quality management system planning The Planning of the
QMS is carried out in order to meet the customer requirement as well as
quality objective

5.5 RESPONSIBILITY, AUTHORITY AND


COMMUNICATION

5.5.1 Responsibility and authority must be Precisely defined and


communicated to all hierarchical level of the organization

5.5.2 MANAGEMENT REPRESENTATIVE


Ensure the Promotion of awareness of customer
requirement throughout the organization.
Reporting to top management on the performance of the
QMS

5.5.3 Internal communication


Communication downwards: (from manager to employee),used for
giving order, coordination, evaluation.
Communication upwards : (from employee to manager)
communications like reports, suggestion, ideas etc.,

5.6 MANAGEMENT REVIEW

REVIEW INPUT
Result of audit.
Customer feedback
Top management should review
Process Performance
the performance of QMS at
Product conformity
planned interval.
Status of Preventive and
REVIEW OUTPUT
corrective action
Resource Needed
Follow up actions from
Improvement of product
Effectiveness of QMS and previous management review
Process

6.1 PROVISION OF RESOURCES.


6.2 HUMAN RESOURCE.
6.3 INFRASTRUCTURE.
6.4 WORK ENVIRONMENT.

6.RESOURCE MANAGEMENT

Provide the Resource Needed.

Provide the Proper Training and awareness to


employee to achieve the customer requirement

Provide the infrastructure needed to


achieve the conformity of customer
requirement
Provide the proper work environment such
as noise, temperature, lighting, etc

7.1 PLANNING OF PRODUCT REALIZATION


THE ORGANIZATION SHALL PLAN AND DEVELOP THE
PROCESSES NEEDED FOR PRODUCT REALIZATION, IN TERMS OF

a)
b)
c)
d)

QUALITY OBJECTIVES AND REQUIREMENTS FOR THE


PRODUCT
THE NEED TO ESTABLISH PROCESSES AND DOCUMENTS,
PROVIDING RESOURCES SPECIFIC TO THE PRODUCT
REQUIRED VERIFICATION, VALIDATION, MONITORING,
MEASUREMENT, INSPECTION AND TEST ACTIVITIES
SPECIFIC TO THE PRODUCT AND THE CRITERIA FOR
PRODUCT ACCEPTANCE

7.2 CUSTOMER- RELATED PROCESS

Determine the requirement of


product

Review of the requirement related to


product
Good communication with customer can
provide valuable information about the product
and customer satisfaction.

7.3 DESIGN AND DEVELOPMENT

Design and development


Planning

Design and development input and output

Review, verify and


validate the output

7.4 PURCHASING

7.4.2 Purchasing information


7.4.1 Purchasing Process

7.4.3 verification of purchased product

7.5 PRODUCTION AND SERVICE


PROVISION

Control of Production and Service


Provision

Validation of process Identification and traceability


of product

Preservation of product
with proper traceability
Customer Property

7.6 CONTROL OF MONITORING AND MEASURING


EQUIPMENT

Management ensure the


measuring instrument are
calibrated and monitored

Segregate the measuring instruments are not


calibrated and working with error

Organization must maintain the records about


calibration and verification of instrument

8.1 GENERAL

THE ORGANIZATION SHALL PLAN AND IMPLEMENT THE MONITORING,


MEASUREMENT, ANALYSIS AND IMPROVEMENT PROCESSES NEEDED

a)
b)
c)

TO DEMONSTRATE CONFORMITY TO PRODUCT REQUIREMENTS,


TO ENSURE CONFORMITY OF THE QUALITY MANAGEMENT SYSTEM, AND
TO CONTINUALLY IMPROVE THE EFFECTIVENESS OF THE QUALITY MANAGEMENT
SYSTEM.

8.2 MONITOR AND MEASUREMENT


IF YOU CANNOT MEASURE IT, YOU CANNOT
IMPROVE IT.

- LORD KELVIN

MEASUREMENTS PROVIDE YOU WITH A BASELINE


TO IMPROVE UPON.

WHY DO YOU MEASURE?


1.
2.
3.
4.

CUSTOMER SATISFACTION.
PROCESS CONFORMANCE AND EFFECTIVENESS (INTERNAL AUDIT)
PROCESS PERFORMANCE (KEY PERFORMANCE INDICATORS AND QUALITY
OBJECTIVES)
PRODUCT CHARACTERISTICS (QC INSPECTION BEFORE RELEASE TO
CUSTOMER) WHERE NONCONFORMING PRODUCTS MUST BE CONTROLLED

8.2.1

It is required to measure your own performance as a supplier in order to


get information about users observation.

8.2.2 INTERNAL AUDIT PROCESS

PURPOSE IS TO VERIFY WHETHER YOUR QMS

a) CONFORMS TO YOUR QUALITY PLAN,


b) CONFORMS TO ISO 9001 REQUIREMENTS,
c) CONFORMS TO YOUR QMS REQUIREMENTS, AND
d) IS EFFECTIVELY IMPLEMENTED AND MAINTAINED.

8.3 CONTROL OF NCR PRODUCT


IDENTIFICATION OF NONCONFORMING PRODUCT
DETERMINATION OF DISPOSITION
EVALUATION OF THE NON CONFORMANCE
DOCUMENTATION OF THE NON CONFORMING PRODUCT
SUMMARY

8.4 ANALYZE

ANALYZE WHAT YOU MEASURED:


a) CUSTOMER SATISFACTION LEVELS
b) INTERNAL AUDIT RESULTS
c) PRODUCT QC INSPECTION RESULTS
d) KPI RESULTS
e) SUPPLIERS PERFORMANCE.

8.5 IMPROVEMENT
THE ORGANIZATION SHALL CONTINUALLY IMPROVE THE EFFECTIVENESS OF THE
QUALITY MANAGEMENT SYSTEM THROUGH THE USE OF THE QUALITY POLICY,
QUALITY OBJECTIVES, AUDIT RESULTS, ANALYSIS OF DATA, CORRECTIVE AND
PREVENTIVE ACTIONS AND MANAGEMENT REVIEW.

ALL NONCONFORMITIES REQUIRE CORRECTIVE ACTIONS


ALL POTENTIAL NONCONFORMITIES REQUIRE PREVENTIVE ACTIONS.

8.5.2CORRECTIVE ACTION
PROCESS

8.5.3 PREVENTIVE ACTION


PROCESS

Hope you
benefited from
that presentation