ISO 9001:2000 Quality Productivity Society Pakistan

8/14/2019 ISO 9001:2000 Quality Productivity Society Pakistan

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Awareness toAwareness to

ISO 9001:2000ISO 9001:2000


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Tutors Introduction


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Course Structure

Lectures and value

added discussions on

each topic.Workshops to enable

delegates to increase

their understanding

regarding ISO 9001:2000

version and to

experience Quality


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ISO

International

Organization

for

Standardizatio

n

ISO9000

OHSAS18001

ISO14001

SA8000

ISO/TS

16949


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INTRODUCTIONINTRODUCTION

1


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Origin

MIL-STD-9858

(1940s)

AQAP1

(NATO)

1970s

BS5750

1979

ISO 9000:87

ISO 9000:94

ISO 9001:2000


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What is ISO? International Organization for Standardization

Develops standards do not certify companies

Around 140 countries members

Around 13000 standards produced

Technical Committees are formed to produce

standards

TC 176 for ISO 9000 International Organization for Standardization

Email: [email protected]

Web: http://www.iso.ch

http://www.bsi.org.uk/iso-tc176-sc2.


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ISO 9000:2000

Family of Standards CORE STANDARDSCORE STANDARDS

ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS Requirements ISO 9004:2000 Guidelines for Performance Improvement

SUPPORTING STANDARDSSUPPORTING STANDARDS

ISO 10005:1995 Guidelines for Quality Plans ISO 10006:1997 Guidelines for Project Management ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1, -2, -3 on Auditing ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt. ISO 10013:1995 Guidelines for Quality manuals


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ISO 9000:2000 Family of

Standards

ISO/TR 10014:1998 Guidelines for

managing economics of quality

ISO 10015 Guidelines for Training ISO/TR 10017:1999 Guidelines on

Statistical techniques


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QMS

Quality

Management System A System of coordinated activities which

is meant to direct and control an

organization with regard to quality.or

(satisfying your customer by managing your

resources, through a standardized system)


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Design ControlDesign Control

Human ResourceHuman Resource

ControlsControls Records,Records,Documents, &Documents, &

Change ControlsChange Controls

Material, EquipmentMaterial, Equipment

&&

Facility ControlsFacility Controls

Production &Production &

Process ControlsProcess Controls

Corrective &Corrective &

PreventivePreventive

ActionsActions

ManagementManagement


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QUALITY MANAGEMENT

PRINCIPLESWhat are they?

The basic principles onwhich the ISO

9000:2000 standards

are basedQuality

ManagementPrinciples


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Principles of new Standard

Basedoneightquality

management

principles

Leadership

Process

approach

Involvement

ofpeople

System

approachto

Managemen

t

Continual

improvement

Factual

approachto

decision

making

Mutual

beneficial

supplier

relationship

Customerfocus


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Organization depend on their customers andOrganization depend on their customers and

therefore should understand current andtherefore should understand current and

future customer needs, meet customerfuture customer needs, meet customer

requirements and strive to exceed customerrequirements and strive to exceed customer

expectations.expectations.

PRINCIPLE 1

CUSTOMER-FOCUSED

ORGANISATION


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People at all levels are the essence of an

organisation and their full involvement

enables their abilities to be used for theorganisations benefit.

PRINCIPLE 3

INVOLVEMENT OF PEOPLE


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PRINCIPLE 4

PROCESS APPROACH

A desired result is

achieved more efficiently

when related resourcesand activities are

managed as a process.


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Identifying, understanding

and managing a system ofinterrelated processes for

a given objective improves

the organizations

effectiveness and

efficiency.

PRINCIPLE 5

SYSTEM APPROACH TO

MANAGEMENT


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PRINCIPLE 6

CONTINUAL IMPROVEMENT

Continual improvement

should be a permanent

objective of theorganization.


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Effective decisions are based on the

analysis of data and information.

PRINCIPLE 7

FACTUAL APPROACH

TO DECISION MAKING

PRINCIPLE 8


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PRINCIPLE 8

MUTUAL BENEFICIAL

SUPPLIER RELATIONSHIPSAn organization and its

suppliers are

interdependent, and amutually beneficial

relationship enhances the

ability of both to createvalue.


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Process

Any activity that takesinputs and converts them

to outputsProcess ApproachProcess Approach

The systematic identification andThe systematic identification andmanagement of these activities andmanagement of these activities and

the interaction between activities.the interaction between activities.


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E l P h i


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Example - Purchasing

Process

Performance Measurements

Delivery status On-time, Onspec, etc

Supplier evaluation

Outputs

Receipt ofMaterial onright condition

Right QualityRight Quantity

Right Time

PurchasingProcedure

Interactions toStorageInspection andTestingManufacturingFinance

Inputs Demand for

material

Item specsand Date

Suppliersource

Supplierscapability tomeet ourrequirements


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Process Approach Model

ManagementManagement

responsibilityresponsibility

Measurement,Measurement,

analysis andanalysis and

improvementimprovement

ResourceResource

managementmanagement

ServiceService

realizationrealizationOutputInput

ProductProduct

CONTINUAL IMPROVEMENT OF THEQUALITY MANAGEMENT SYSTEM

C

US

T

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R

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a

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is

f

a

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t

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n

C

US

T

O

M

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R

e

q

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i

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e

m

e

n

t

s


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Important changes

More emphasis on customer satisfaction

Commitment to comply with legal and statutory requirements

Need to review suitability of quality policy

Need to define quantified and measurable quality objective atdifferent functions and levels

More emphasis on human resource management

Re-evaluation of suppliers on the basis of their performance

Analysis of data for continual improvement

Need to maintain suitable work environment

Term Subcontractor replaced with Supplier and Supplier

replaced with organization

Exclusions defined


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The Structure

00 IntroductionIntroduction11 ScopeScope22 Normative referenceNormative reference

33 Terms and definitionsTerms and definitions44 Quality management systemQuality management system

requirementsrequirements55 Management responsibilityManagement responsibility

66

Resource managementResource management

77 Product realizationProduct realization88 Measurement, analysis andMeasurement, analysis andimprovementimprovement


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System Requirements /

Structure of the Standard

Provision of

resources(6.1)

Human

resources(6.2)

Infrastructures(6.3

)

Work

environment(6.4)

6 Resource

Management

General

requirements (4.1)

Documentation

Requirements(4.2)

Management

Commitment(5.

1)

Customer focus

(5.2)

Quality

policy(5.3)

Planning(5.4)

Responsibility,

authority &

communication(

5.5)

ManagementReviews (5.6)

5 Management

Responsibility

8

Measurement

Analysis &

improvement

4 Quality

Management

System

7 Product

Realization

General (8.1)

Monitoring &

measurement(8.2)

Control of NCP(8.3)

Analysis of data(8.4)

Improvements(8.5)

Planning(7.1)

Customer

related

processes(7.2

)

Design &

development(7.3)

Purchasing(7.4)

Production &

service

provision(7.5)

Control of monitoring &measuring devices(7.6)


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0.4 Compatibility with other

Management Systems

Standard is intended to be

compatible with other managementsystems

It is aligned with ISO 14000 to

enhance compatibility Standard does not include

requirements for other management

system such as EMS, OHSM or


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1.2 ApplicationsRequirements may be excluded if not

appropriate due to :

nature of product

customer requirements applicable regulatory requirements

Exclusions must:

Not affect ability to provide conformingproduct

Be limited to clause 7


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4 Quality Management

System

4.1 General Requirements

Establish, document, implement,

maintain and continually improve QMS inaccordance with the standard.

4 2 G l


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4.2 General

Requirements To implement the QMS the Organization shall

Identify and manage processes necessary for QMS

Determine the sequence and interaction of processes

Determine criteria and methods to ensure effectiveoperation and control of the process

Ensure availability of information needed to support the

operation and monitoring of processes

Measure, monitor, analyze processes and act asnecessary to achieve planned results and continual

improvements

Manage the process in accordance with the standard


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4.2 Documentation

Requirements General Extent

Size and type of

organization

Complexity andinteraction of processes

Competence of personnel

Note3 (Documentation

may be in any type of

media)

To Include

Documented procedures

required by standard

Documents required byorganization to ensure

effective operation and

control process

Note 1 (Where the termdocumented procedure

appears)


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4.2.2 Quality Manual

The organization shall establish a

Quality Manual that include:

Scope of QMS

Documented procedures or reference

to them

Description of interaction between theprocess of QMS

4.2 Documentation

Requirements


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4.2.3 Control of Documents Documents required by the QMS shall be controlled

Approve, Review, Ensure current & relevant version,Identification of external origin documents, Prevent

unintended use of obsolete documents. 4.2.4 Control of Quality Records

Documented Procedure shall be established foridentification, storage, protection, retrieval, retentiontime and disposition.

Records shall be: Established and maintained to provide evidence. Legible, readily identifiable and retrievable.

4.2 Documentation

Requirements


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5 Management Responsibility

5.1 ManagementCommitment

5.2 Customer Focus

5.3 Quality policy

5.4 Planning 5.4.1Quality

objectives

5.4.2 Quality

Planning

5.5 Responsibility, authorityand communication

5.5.1 Responsibility &

authority

5.5.2 Managementrepresentative

5.5.3 Internal

communication

5.6 Management Review

5.6.1 General

5.6.2 Review input

5.6.3 Review output


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5.1 Management

Commitment Provide evidence of commitment to

the development and improvement ofQMS by:

Communicating the importance ofmeeting customer and

legal/regulatory requirements. Establishing quality policy and

objectives.

Management Reviews


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5.2 Customer Focus

Top Management shall ensure that

customer needs & expectations are

determined, converted into requirements

& fulfilled with the aim of achievingcustomer satisfaction


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5.3 Quality Policy

Appropriate to the purpose oforganization.

Commitment to meeting

requirements and continualimprovements

Frame work for establishing and

reviewing quality objectives

Communicated and understood

at appropriate levels

Is reviewed for continuing

suitabilit


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5.4 Planning

5.4.1 Quality Objectives

Establish quality objectives at relevant

functions and levels

Objectives must be measurable and

consistent with the quality policy including

the commitment to continual improvement

Include those needed to meet

requirements for product


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5.4 Planning

5.4.1 Quality Objectives (Cont)

Quality Objectives should be: Specific Measurable Achievable Realistic / Related Time Bound


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5.5 Responsibility, Authority

and Communication

5.5.1 Responsibility and

authority

Functions and theirinteraction, responsibilities

and authorities shall be

defined and communicated

to facilitate effective qualitymanagement


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5.5.2 Management

RepresentativeMember of the management who has

responsibility and authority for ensuring that processes of the QMS are

established and maintained Reporting on performance of QMS

including needs for improvement Promoting awareness of customer needs

and requirementsNote: Responsibilities may include liaison

with external parties in relation to QMS


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5.5.3 Internal Communication

Ensure communication between various

levels and functions regarding the

processes of the QMS and theireffectiveness

5 6 M t R i


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5.6 Management Review

5.6.1 General

Review of QMS by topmanagement at plannedinterval to; ensure QMS suitability,

adequacy and effectiveness Evaluate the need for

changes to QMS including

policy and objectives

Records from ManagementReviews shall be

maintained (see 4.2.4).


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5.6.2 Review Input

Review performance and improvementopportunities related to: Audit results

Customer feedback Process performance and product

conformance Status of preventive and corrective

actions Follow up actions from earlier reviewsChange that could affect the QMS

Recommendations for improvement


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5.6.3 Review Output

Output to include actions related to

improvement of the effectiveness QMS

and its processes

improvement of product related to

customer requirements

resource needs


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6 Resource Management

6.1 Provision of resourses

6.2 Human resources

6.2.1 General

6.2.2 Competence, awareness and

training

6.3 Infrastructure

6.4 Work environment


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6.1 Provision of Resources

The organization shall determine and

determine the resources needed for :

implement and maintain the QMS and

continually improve its effectiveness.

Enhance customer satisfaction by

meeting customer requirements.

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6.2 Human Resources

6.2.1 General

Those who have responsibilities defined

in the QMS must be competent on the

basis of appropriate education, training,skills and experience


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6.2.2 Competency, Awareness

and Training Identify competency needsProvide required trainingEvaluate the effectiveness of

training providedEnsure staff is aware of

relevance and importance oftheir activities and contribution

to achieving quality objectivesMaintain appropriate records of

education, training, qualification

and experience


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6.3 Infrastructure

Identify, provide and maintain theinfrastructure needed to achieve product

conformity

This shall include :

Workspace & associated utilities

Equipment, hardware and software

Supporting services (transport or

communication)


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7 Product Realization

7.1 Planning of product realization

7.2 Customer related processes

7.3 Design & development7.4 Purchasing

7.5 Production & service operation

7.6 Control of measuring &

monitoring devices

7 1 Pl i f P d t


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7.1 Planning of Product

Realization

Sequence of process to achieve product

Consistent with QMS and documented to suit

method of operations

Quality objectives and requirements for theproduct

The need for processes, documentation,

resources and facilities specific to the product Verification and validation activities and

acceptance criteria

Records


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7.2 Customer Related

Processes

7.2.1 Determination of requirements

related to the product

7.2.2 Review of product requirements

7.2.3 Customer communication

7 2 1 Determination of


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7.2.1 Determination of

requirements related to the

product

Product requirements specified by thecustomer including requirements for

delivery and post-delivery activitiesRequirements not specified but necessary

for intended or specified use

Obligations related to product, includingregulatory and legal requirements

any additional requirements determined bythe organization

7 2 2 Review of requirements


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7.2.2 Review of requirements

related to the product

Review identified requirements and ensure

before commitment to supply product that;

Product requirements are defined

For verbal orders requirements are confirmed Difference between tender and contract are

resolved

Organization has ability to meet therequirements

Records of the results arising from the review

shall be recorded.


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7.2.3 Customer Communication

Identify and implement arrangements for

communication with customers relating to:

product information

inquiry, contract or order handling,

including amendments

Customer feedback including complaints


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7.3 Design & Development

7.3.1 Design & development planning

7.3.2 Design & development inputs

7.3.3 Design & development outputs

7.3.4 Design & development review

7.3.5 Design & development verification

7.3.6 Design & development validation 7.3.7 Control of design and development

changes


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7.4 Purchasing

7.4.1 Purchasing process

7.4.2 Purchasing information

7.4.3 Verification of purchased product


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7.4.1 Purchasing Process

Purchased product meets requirements

Type & extend of control depends on effect

purchased product may have on realization

processes and their outputSelects suppliers based on their ability to

supply conforming product

Define criteria for selection and periodicevaluation and re-evaluation of suppliers

Results of evaluation and follow up actions

must be recorded


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7.4.2 Purchasing Information

Purchasing information shall describe the

product to be purchased, including where

appropriate:

Requirements for approval ofproduct,procedures, processes and

equipment.

Requirements for qualification ofpersonnel.

Quality management system

requirements.

7 4 3 Verification of


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7.4.3 Verification of

Purchased Product

Identify and implement activities needed to

verify purchased product

Where organization or its customer

purpose verification at supplier premises,organization must specify in purchasing

information:

verification arrangements method of product release.


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7.5.1 Control of production and

service provision

7.5.2 Validation of processes for

production and service provision 7.5.3 Identification and traceability

7.5.4 Customer Property

7.5.5 Preservation of Product

7 5 1 Control of production and


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7.5.1 Control of production and

service provision

Control production & services operationsthrough:

Availability of information specifying product

characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring

devices Implementation of monitoring activities Implementation of defined processes for

release, delivery and post delivery activities


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7.5.2 Validation of Processes

Validation arrangements must be definedand must include as applicable qualification of the process

qualification of equipment and personnel use of defined methodologies &

procedure

requirements for record re-valuation

7 5 3 Id tifi ti &


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7.5.3 Identification &

Traceability

Where appropriate identify product through

all stages of operations

Identify status with respect to

measurement & monitoring requirements

Where traceability is required control &

record unique identification of product

I can not rememberI can not remember


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7.5.4 Customer Property

Care for customers property being underorganizations control or being used by

organization

Identification, verification, protection &

maintenance of customer property

provided for use or incorporation

Any customer property that is lost,

damaged or found un- suitable must berecorded & reported to customer

Customer Property -

tangible / intangible


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7.5.5 Preservation of Product

Preserve conformity of product during

internal processing and final delivery to

intended destination

Include identification, handling, packaging,storage and protection

This applies to constituent parts of product

7 6 Control of monitoring &


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7.6 Control of monitoring &

measuring devices

Calibrate & adjust measuring and monitoringdevices at specified intervals as prior to use

Traceability to international or nationalstandards. Where no such standard exist record

the basis Safeguard MMD from adjustments invalidating

calibration Protect MMD from damage or deterioration

during handling, maintenance or storage Record results of calibration Assess validity of previous results when devices

found to be out of calibration

1 Measurement Analysis


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1 Measurement, Analysis

and Improvement 8.1 General

8.2 Monitoring &

Measurement

8.2.1 Customersatisfaction

8.2.2 Internal audit

8.2.3 Monitoring and

measurement ofprocesses

8.2.4 Monitoring and

8.3 Control of non-

conforming product

8.4 Analysis of data

8.5 Improvement

8.5.1 Continual

improvement

8.5.2 Corrective action 8.5.3 Preventive action

G


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8.1 General

Define, plan & implement measurement

and monitoring activities needed to assure

conformance and achieve improvement

This include determination of the need and

use of applicable methodologies andstatistical techniques

8 2 M it i d M t


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8.2 Monitoring and Measurement

8.2.1 Customer Satisfaction

Organization shall monitor information on

customer satisfaction and /or dis-

satisfaction

The methodologies for obtaining and

utilizing such information must bedetermined

8 2 2 I t l A dit


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Conduct periodic internal audit todetermine if QMS: Conforms to the requirements of the

standard

Has been effectively implemented &maintained

Plan the audit program considering: Status and importance of the activity results of previous audits

Define audit scope, frequency andmethodologies performed by personnel

not performing audited work

8.2.2 Internal Audit

8 2 2 I t l A dit


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The documented proceduremust cover:Responsibilities & authorities

for conducting audits Ensuring independenceRecording results and

reporting to management Timely corrective actions Follow up to verify & report

implementation of

verification results

8.2.2 Internal Audit

8.2.3 Measurement and


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Apply suitable methods for measurement

and monitoring of those realization

processes necessary to meet customers

requirements.


Monitoring of Product



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Measure & monitor product characteristics toverify conformance at appropriate stages of

realization processes

Evidence of conformity with the acceptance

criteria must be documented, records must

indicate the authority responsible for release

of product

Release or delivery must not proceed untilall the specified activities have been

completed unless otherwise approved by the

customer


Monitoring of Product

VERIF

IED19

/5/01 PASSED

PASSEDHOLDHOLD

8 3 Control of Non conforming


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8.3 Control of Non conforming

Product Documented procedures for control of

non conforming product to prevent

unintended use or delivery

Non conforming product shall be

corrected

Re-verify after correction

If non-conformance detected after

delivery take appropriate action It is often required that the proposed

rectification be reported for concession

to the customer, the end user,

regulatory or other body


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8.4 Analysis of Data

Collect & analyze data, determine suitabilityand effectiveness of QMS and to identifyimprovements that can be made

Data from measurement & monitoring &other related sourcesAnalyze data provide info on: Customer satisfaction and/or dissatisfaction Conformance to customer requirement Process, product characteristics and their

trends

Suppliers

8.5 Improvement


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p

8.5.1 Continual improvement

Planning for Continual Improvement The organization must plan and manage

processes necessary for continualimprovement of the QMS

Facilitate continual improvement using: quality policy objectives

audit results analysis of data corrective actions preventive actions

Mana ement Review

8 5 2 Corrective Action


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8.5.2 Corrective ActionOrganization must take corrective action to

eliminate the causes of non-conformance toprevent recurrence

Action appropriate to the impact of problem

Documented procedures shall definerequirements for: identifying non conformities determine the causes evaluating the need for corrective action determine corrective action needed and

implemented

Recording results of action

8 3 P i A i


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Organization must identify preventive actionto eliminate the causes of potential nonconformances to prevent occurrences

Actions appropriate to the impact of potential

problemDocumented procedures must define the

requirements for

Identification of potential non-conformances and their causes Determining and ensuring implementation

of preventive action needed

Recording results of action taken

8.5.3 Preventive Action

Situation Warranting


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g

Corrective Action

Identification of major non-conformance.

Large number of minor non-conformities.

The reoccurrence of a problem with aprocess or activity.

Non-conformities observed during audits.

Customer Complaints.Non-conforming deliveries from vendors.

Stages of Corrective &


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g

Preventive Action

REPORTING

INVESTIGATION

ACTION

FOLLOWUP

CLOSING

EXPECTED BENEFITS


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EXPECTED BENEFITS

Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability

Planning & scheduling improved Rework & Rejection are known and being

controlled

Customer feedback through regular

surveys

Employees Participation enhanced Continuos Improvements Program launched

Market Reputation


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Thank

You