Iso9001- An Introduction

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An Introduction to

ISO 9001:2000


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Prepared by Sid Calayag 2 Version 1: Date: March 22, 2007

Topics

Quality ManagementSystemISO 9001:2000StandardRequirements

Clauses and Benefitsof ISO 9001:2000


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Objectives of the Orientation

To understand ISOTo understand the requirements of ISO 9001:2000To know the benefits of conforming tothe standard


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What isISO?

ISO is not an acronymfor InternationalOrganization forStandardization

International Organization for Standardization

ISO 9000 refers to a set of quality managementstandards


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Quality Management System Model


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Version 1: Date: March 24, 2007By: Sid Calayag7

Process Based Approach

MANAGEMENTRESPONSIBILITY

RESOURCE MANAGEMENT

MEASUREMENT, ANALYSIS &IMPROVEMENT

PROCESSINPUT OUTPUT

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PRODUCT REALIZATION

Satisfaction

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Requirements


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To meet the requirements you must:DocumentImplementMaintainContinually improve effectiveness

4 Quality ManagementSystem

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This is similar to PDCA cycle principle


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THEPDCA

CYCLE PLAN

DOIMPLEMENT

CHECKSTUDY

ACTEVALUATE

VERIFY

VALIDATE


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ISO 9001:2000

So whatabout it?


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What is ISO 9001:2000?

ISO 9001:2000 is an internationalstandard for implementing a quality

management system


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ISO 9001:2000

Standard Requirement


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Section 4

4 Quality Management System

General RequirementsDocumentation Requirements


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Section 4

4.1 General Requirements

Establish, Document, Implement &Maintain a QMS and Continually Improveits Effectiveness

Identify the Processes and their applicationthroughout the organization


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Section 4

4.1 General Requirements Continued

Determine the sequence and interaction of these

processes ;

Determine criteria and methods to ensure theoperation and control of these processes areeffective;


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Section 44.1 General Requirements Continued

Ensure necessary resources and information areavailable to support the operation and monitoring of theseprocesses ;

Monitor, Measure and analyze these processes ;

Implement actions necessary to achieve planned resultsand continual improvement of these processes .


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Section 4

4.1 General Requirements Continued

Outsourced processes shall be identified and

controlledOutside processes that affect product conformitywith requirements;


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Section 4

4.2 Documentation Requirements

A QMS documentation shall include:

Statements of a Quality Policy and QualityObjectives ;

A Quality Manual ;

Procedures required by ISO (6);Records required by ISO (21);


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Procedures Required by ISO

4.2.3 Control of Documents

4.2.4 Control of Records

8.2.2 Internal Audits

8.3 Control of Nonconforming Product

8.5.2 Corrective Action

8.5.3 Preventive Action


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Records Required by ISO (21)

4.2.4 Records shall be established andmaintained to provide evidence of conformity torequirements and of the effective operation of the

QMS.5.6.1 Management Review General, Records fromManagement Reviews shall be maintained ;

6.2.2 (Human Resources) Appropriate records ofeducation, training, skills and experience;

7.1 (Planning of Product Realization) Records to provideevidence that the realization processes and resultingproduct meet requirements;


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Records Required by ISO

7.2.2 (Customer Related Processes - Review ofRequirements related to the Product) Records of the resultsof the review and actions arising from it shall be maintained;7.3.2 (Design & Development Inputs) Inputs relating toproduct requirements shall be determined and recordsmaintained;7.3.4 (Design & Development Review) Records of theresults of the reviews and any necessary actions shall bemaintained;7.3.5 (Design & Development Verification) Records of theresults of the verification and any necessary actions shall bemaintained.


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7.3.6 (Design & Development Validation) Records of theresults of validation and any necessary actions shall bemaintained;7.3.7 (Control of Design & Development Changes) Recordsof the results of the review and any necessary actions shallbe maintained;7.4.1 (Purchasing Process) Records of the results ofevaluations and any necessary actions arising from theevaluation shall be maintained;7.5.2 ( Validation of Special Processes) The organizationshall establish arrangements for these processes including requirements for records;


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7.5.3 (Identification & Traceability) Where traceability is arequirement, the organization shall control and record theunique identification of the product;7.5.4 (Customer Property) If any customer property is lost,

damaged or otherwise found to be unsuitable for use, thisshall be reported to the customer and records maintained;7.6 (Control of Monitoring & Measuring Devices)

If calibrated/verified to non-national or internationalstandards the basis shall be recorded.

Equipment found non-conforming validity of previousmeasurements shall be assessed & recorded;Records of the results of calibration and verification shallbe maintained ;


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8.2.2 (Internal Audit) The responsibilities and requirementsfor planning and conducting audits and for reporting resultsand maintaining records ;

8.2.4 (Monitoring & Measurement of Product) Evidence ofconformity with the acceptance criteria shall be maintained.Records shall indicate the person(s) authorizing release ofproduct;

8.3 (Control of Nonconforming Product) Records of thenature of nonconformities and any subsequent actionstaken, including concessions obtained, shall be maintained;


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8.5.2 (Improvement Corrective Action) Records of theresults of action taken;8.5.3 (Improvement Preventive Action) Records of

the results of action taken.


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Documentation Requirements

4.2 Documentation Requirements-Continued

Control of Documents

A documented procedure to define the followingcontrols:Approve adequacy of documents prior to issue ;

Review and update as necessary & Re-approve;

Ensure changes and current revision status ofdocuments are identified ;


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Control of Documents- ContdA documented procedure to define the following controls:- Continued

Ensure relevant versions of applicable documentsare available at points of use ;Ensure documents remain legible and readilyidentifiable;

Ensure documents of external origin are identifiedand their distribution controlled; and

Prevent the unintended use of obsoletedocuments , AND apply suitable ID if they areretained for any purpose ;


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4.2 Documentation Requirements-Continued

Control of Records

A documented procedure to define thecontrols needed for the identification , storage ,protection , retrieval , retention time anddisposition of records.


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Management Responsibility


RESOURCE MANAGEMENT


INPUT PROCESS OUTPUT

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5 Management Responsibility

Management Commitment

Customer Focus

Quality Policy

Planning

Management Review


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5.1 Management CommitmentEvidence of Commitment

Communicate to the Organization theImportance of meeting Customer , Statutory ,and Regulatory RequirementsEstablish the Quality PolicyEnsuring Quality Objectives are EstablishedConduct Management ReviewsEnsure the Availability of Resources


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Resource Management

6 Resource Management

Provision of Resources

Human Resources

Infrastructure

Work Environment


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Resource Management

6.1 Provision of Resources

Determine and Provide Resources needed to:

Implement & Maintain the QMS

Continually Improve Effectiveness ofQMS

Enhance Customer Satisfaction bymeeting customer requirements


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Resource Management

6.2 HumanResources

Personnel performingwork affecting productquality shall becompetent on thebasis of appropriate

education, training,skills and experience


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Resource Management

6.3 Competence,Awareness and Training

Determine thenecessarycompetence

Provide Training ortake other actions tosatisfy

Evaluate theEffectiveness ofactions taken


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Resource Management

6.3 InfrastructureDetermine, provide and maintain the

infrastructure needed to achieveconformity to product requirements

Buildings,Workspace & associated utilities

Process equipment(Hardware & Software)

Supporting services

(i.e. transport orcommunication


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Resource Management

6.4 Work EnvironmentDetermine & Manage the work

environment needed toachieve conformity to productrequirements[Factors that influencemotivation, satisfaction,

development and performanceof people.]Psychological FactorsPhysical Factors


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Resource Management

Work Environment - Continued

Psychological Factors

Greater Involvement &Understanding of Objectives to beAchieved

Safety Rules & Procedures

Recognition & Reward forAchievement, Improvement &Innovation

Career Planning & Development


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Resource Management

Work Environment -Continued

Physical FactorsErgonomics

Temperature

Light

Noise

Cleanliness


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Product Realization


RESOURCE MANAGEMENT



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Product Realization

7.1 Planning of Product Realization

Plan & Develop the processes needed for Product

RealizationPlanning shall determine the following asappropriate:

Quality Objectives & Requirements for the Product;

Need to establish processes, documents andprovide resources specific to the product;


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Product Realization

Planning shall determine the following:Continued

Required verification, validation,monitoring, inspection & testactivities specific to the product andthe criteria for product acceptance

Records needed to provide evidence

that the realization processes andresulting product meet requirements


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Purchasing

7.4 PurchasingPurchasing Process

Purchasing Information

Verification of Purchased Product


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Product Realization

Control of Production & Service Provision

Plan & carry out provisions under controlled conditions,including as applicable:

Availability of information that describes theproduct characteristics ;

Availability of Work Instructions, as necessary;

Use of suitable equipment;

Availability & use of Monitoring and MeasuringDevices;


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Product Realization

Plan & carry out provisions under controlledconditions, including as applicable: Contd

Implementation of Monitoring andMeasurement;

Implementation of Release, Delivery andPost-Delivery Activities.


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Product Realization

Identification & TraceabilityWhere applicable , product shall be identified by asuitable means throughout its realization process .It shall identify the product status with respect tomonitoring & measurement requirements.Where traceability is a requirement, the uniqueidentification of the product shall be controlled andrecorded .


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Product Realization

Customer PropertyCare shall be exercised with customer property whileunder the organizations control or being used by theorganization.Customer Property shall be identified , verified , protectedand safeguarded while in use or being incorporated intothe product.If lost , damaged or otherwise found to be unsuitable , it

shall be reported and records maintained .


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Product Realization

Preservation of Product

Conformity of the product shall be preserved duringinternal processing and delivery to the intendeddestination.

Preservation shall include identification , handling ,packaging and protection .

Preservation also applies to the constituent parts of a

product.


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Product Realization

7.6 Control of Monitoring and Measuring DevicesDetermine the monitoring and measurement

to be undertaken to provide evidence ofconformity to determined requirements, ANDthe monitoring and measuring devicesneeded to ensure valid results.


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Product Realization

7.6 Control of Monitoring and Measuring Devices Contd

Establish processes to ensure that

monitoring and measurement can be carriedout and in a manner consistent with themonitoring and measurement requirements.


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Product Realization

7.6 Control of Monitoring and Measuring Devices ContdWhen necessary, measuring equipment shall:

Be calibrated or verified at specified intervals, orprior to use, against measurement standardstraceable to international or national measurementstandards;

Where no such standards exist, the basis use forcalibration or verification shall be recorded.


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Product Realization

7.6 Control of Monitoring and Measuring Devices ContdWhen necessary, measuring equipment shall: -Continued

Be adjusted or re-adjusted as necessary;Be identified to enable the calibration status to bedetermined;Be safeguarded from adjustments that wouldinvalidate the measurement result;

Be protected from damage and deteriorationduring handling, maintenance and storage.


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Product Realization

7 .6 Control of Monitoring and Measuring Devices Contd

Computer software to be used in the monitoring andmeasurement of specified requirements, shall beconfirmed as to its ability to satisfy the intendedapplication.

This confirmation shall be undertaken prior to initialuse and reconfirmed as necessary.

Measurement analysis &


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Measurement, analysis &Improvement


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Measurement, Analysis & Improvement

8 Measurement, Analysis and Improvement

General

Monitoring and MeasurementControl of Nonconforming ProductAnalysis of DataImprovement


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8.1 GeneralPlan & Implement the monitoring, measurement,analysis and improvement processes needed to :

Demonstrate conformity of the product;Ensure conformity of the QMS;Continually improve the effectiveness of the

QMSDetermine the applicable methods, includingstatistical techniques, and the extent of their use


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8.2 Monitoring and MeasurementCustomer Satisfaction

Internal AuditMonitoring and Measurement of ProcessesMonitoring and Measurement of Product


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Customer SatisfactionA QMS measurement of performance

Monitor information relating to customerperception as to whether customerrequirements are being met;

Determine the methods for obtaining andusing this information


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Monitoring and Measurement of ProductMonitor and measure the product

characteristics to verify that productrequirements have been met.This is to be carried out at appropriatestages of the product realization process

IAW the planned arrangements


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Monitoring and Measurement of Product ContEvidence of conformity with the acceptance criteriashall be maintained

Records shall indicate the person(s) authorizingrelease of productProduct Release and Service Delivery shall notproceed until the planned arrangements have beensatisfactorily completed, unless otherwise approved

by a relevant authority and where applicable by thecustomer.


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8.3 Control of Nonconforming Product

Ensure that product which does not conform to productrequirements is identified and controlled to prevent itsunintended use or delivery.The controls and related responsibilities and authorities fordealing with nonconforming product shall be defined in adocumented procedure.


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8.3 Control of Nonconforming Product Contd

Nonconforming product shall be dealt with in one or moreof the following ways:

Taking action to eliminate the detected nonconformity;Authorizing its use , release or acceptance underconcession by a relevant authority and, whereapplicable, by the customer;Taking action to preclude its original intended use orapplication


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8.3 Control of Nonconforming Product ContdWhen nonconforming product is corrected it shall besubject to re-verification to demonstrate conformity to the

requirements.When detected after delivery or use has started, actionsshall be taken with the nonconforming product ,appropriate to the effects, or potential effects, of thenonconformity.


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8.3 Control of Nonconforming Product Contd

Records of the nature of nonconformitiesand any subsequent actions taken,including concessions obtained, shall bemaintained


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8.4 Analysis of DataDetermine, collect and analyzeappropriate data to demonstrate thesuitability and effectiveness of the QMSEvaluate where continual improvement ofthe effectiveness of the QMS can bemade

This shall include data generated as aresult of monitoring and measurement andfrom other relevant sources


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8.5 Improvement

Continual Improvement

Corrective Action

Preventive Action


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Continual ImprovementContinually improve the effectiveness of the QMSthrough the use of the:

Quality Policy ;Quality Objectives ;Audit Results ;Analysis of Data ;

Corrective & Preventive ActionsManagement Review


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Preventive ActionActions taken to eliminate the cause of

potential nonconformities in order toprevent their occurrenceThey shall be appropriate to the effects ofthe potential problems .

Summary and Impact of


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Summary and Impact of Changes

Use of data rather than collection of dataExpected that data is reviewed and analyzed

Analysis will need to employ suitable statisticalmethodsResults of analysis should be measured againststated goals and objectivesManagement Review - an ideal forum, will need todemonstrate active response to data


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Thank you for our attention!