Iso awarenee training dr. amsavel

MALLADI DRUGS & PHARMACEUTICALS LIMITED MALLADI DRUGS & PHARMACEUTICALS LIMITED

QMS -ISO 9001:2008 QMS -ISO 9001:2008

AWARNESS PROGRAMME AWARNESS PROGRAMME

Dr. A. AmsavelDr. A. Amsavel

ISO IntroductionISO Introduction

What is QualityWhat is Quality

Quality:Quality:

Degree to which a set of inherent characteristics Degree to which a set of inherent characteristics fulfils requirementsfulfils requirements

System:System:

Set of interrelated or interactingelementsSet of interrelated or interactingelements

Quality Management:Quality Management:

Coordinated activities to direct and control an Coordinated activities to direct and control an Organization with regard to QualityOrganization with regard to Quality

Why Quality system is required?Why Quality system is required?

Quality has been widely accepted as the Quality has been widely accepted as the most powerful and sustaining factor most powerful and sustaining factor

Inspection to assure quality of products Inspection to assure quality of products and or services and or services

In earlier days there is no single standardIn earlier days there is no single standard

Globalization: impacted on the need to Globalization: impacted on the need to develop International Standards for develop International Standards for products and services. products and services.

What is ISOWhat is ISO ISO : International Organization for Standardization: ISO : International Organization for Standardization:

ISO 9001 and ISO 14001 are among ISO 9001 and ISO 14001 are among ISO's most ISO's most well known standardswell known standards ever. ever.

The The worldwide totalworldwide total of certificates toof certificates to ISO ISO 9001:20009001:2000 at the end of at the end of 20052005 was 776 608 in 170 was 776 608 in 170 countriescountries

This was This was increase of 18 %increase of 18 % over 2004 when the over 2004 when the total was 660 132 certificates. total was 660 132 certificates.

They are implemented by some They are implemented by some 887 770 887 770 organizationsorganizations in in 161 countries161 countries..

ISO An Introduction:ISO An Introduction:

o ISO was formed in 1947 ISO was formed in 1947

o Headquarters at Geneva, Switzerland, Headquarters at Geneva, Switzerland, o It is a part of UNIt is a part of UN

o ISO is a world-wide federation of standards ISO is a world-wide federation of standards bodies from more than 151 countries. bodies from more than 151 countries.

o It’s mission is to promote the developments It’s mission is to promote the developments of standardization and related activities of standardization and related activities

o ISO has so far development more than ISO has so far development more than 17000 standards.17000 standards.

ISO An Introduction:ISO An Introduction: Largest developer of StandardsLargest developer of Standards Makes a positive difference not just to engineers Makes a positive difference not just to engineers

and manufacturers but to society as a wholeand manufacturers but to society as a whole Enables supply of products more efficient, safer and Enables supply of products more efficient, safer and

cleanercleaner Trade between countries more easier and fairerTrade between countries more easier and fairer Provide government with technical base for health, Provide government with technical base for health,

safety and environment legislationssafety and environment legislations Support transfer of technology to developing nationsSupport transfer of technology to developing nations Serve to safeguard consumers and users in general Serve to safeguard consumers and users in general

of products and services – make their lives simpler.of products and services – make their lives simpler.

ISO 9000 Family standardsISO 9000 Family standards

ISO 9000 series first published in 1987 ISO 9000 series first published in 1987 Second Edition -1994

Third Edition -2000

Fourth Edition 2008 (Published in 15th Nov 2008)

Current revision is ISO 9001:2008 will be Current revision is ISO 9001:2008 will be enforced in 2010. enforced in 2010.

Other standardsOther standards

ISO 9000: 2005- QMS- Fundamentals and ISO 9000: 2005- QMS- Fundamentals and vocabularyvocabulary

ISO 9001: 2008 - QMS - RequirementsISO 9001: 2008 - QMS - Requirements ISO 9004: 2008 QMS Guidelines for performance ISO 9004: 2008 QMS Guidelines for performance

improvementsimprovements ISO 19011:2002 Guidelines for quality and/or ISO 19011:2002 Guidelines for quality and/or

environmental management systems auditingenvironmental management systems auditing ISO 10005:2005 : QMS- Guidelines for quality plansISO 10005:2005 : QMS- Guidelines for quality plans ISO 10015:1999 : QMS- Guidelines for trainingISO 10015:1999 : QMS- Guidelines for training

Evolution of 9001Evolution of 9001 QMS was focused on QMS was focused on sorting good from badsorting good from bad & &

structured documentation in the begining, structured documentation in the begining, Now it encompass the management of all Now it encompass the management of all

activities that contribute to the business.activities that contribute to the business.

StandardStandard RequirementRequirement FocusFocus

19871987 Quality controlQuality control DetectionDetection

19941994 Quality AssuranceQuality Assurance PreventionPrevention

20002000 Quality managementQuality management DirectionDirection

Quality managementQuality management..

QualityQuality refers to all those features of a product (or refers to all those features of a product (or service) which are required by the customer.service) which are required by the customer.

Quality management Quality management means what the means what the organization does to ensure that its products or organization does to ensure that its products or services satisfy the customer's services satisfy the customer's quality quality requirementsrequirements and and

comply with any comply with any regulationsregulations applicable to those applicable to those products or services. products or services.

Quality management also means what the Quality management also means what the organization does to organization does to

enhance enhance customer satisfactioncustomer satisfaction, and, and achieve achieve continual improvementcontinual improvement of its of its

performance.performance.

ISO 9000: THIRD PARTY ISO 9000: THIRD PARTY REGISTRATIONREGISTRATION

Once Quality system implemented, certification agency verify Once Quality system implemented, certification agency verify the system for effective implementation and certifies.the system for effective implementation and certifies.

Our organization has been certified by LRQA

OTHER ACCREDITED CERTIFYING AGENCIES: ( in India)

BVQI SGSBVQI SGS KPMG KPMG BSI-QA BSI-QA NQA ULNQA UL DNV Germanize Lloyd’sDNV Germanize Lloyd’s TUV KEMA (Netherlands)TUV KEMA (Netherlands) SA-QAS RINA (Italy)SA-QAS RINA (Italy) IRQS Q-CertIRQS Q-Cert

ADVANTAGES OF ISO 9000ADVANTAGES OF ISO 9000

A passport to Global market / Advantage for A passport to Global market / Advantage for exporters exporters

Sets a base line for ultimate TQMSets a base line for ultimate TQM Reduces time consuming audits by customers and Reduces time consuming audits by customers and

Regulating bodies commitment is assuredRegulating bodies commitment is assured Improves efficiency, reduces scrap and network. Improves efficiency, reduces scrap and network.

Hence, the profitability is higherHence, the profitability is higher Increased profitability is conducive to job security.Increased profitability is conducive to job security. Improves the communication across the organization Improves the communication across the organization

(IQA/MRM)(IQA/MRM) Gives International recognition of abilityGives International recognition of ability Improves the Quality costs, removes uncertainty Improves the Quality costs, removes uncertainty

about quality and improves work cultureabout quality and improves work culture

ISO 9001:2000 SurveyISO 9001:2000 Survey. (. (20052005 -776 608 -776 608))

Definition:Definition:Management system:Management system:

System to establish policy and objectives and to System to establish policy and objectives and to achieve those objectivesachieve those objectives

QMS:QMS:Management system to direct and control an Management system to direct and control an organization with regard to qualityorganization with regard to quality

Document:Document:Information and its supporting medium Information and its supporting medium Eg; specification, SOPs, drawing, report, standard. The Eg; specification, SOPs, drawing, report, standard. The medium can be paper, electronic, photograph etc.medium can be paper, electronic, photograph etc.

Record :Record :Documents stating results achieved or providing Documents stating results achieved or providing evidence of activities performed.evidence of activities performed.

Definition:Definition:

Quality:Quality:Degree to which a set of inherent characteristics Degree to which a set of inherent characteristics fulfils requirementsfulfils requirements

Requirement:Requirement:Need or expectations that is stated , generally Need or expectations that is stated , generally implied or obligatoryimplied or obligatory

Process:Process:Set of interrelated or interacting activities which Set of interrelated or interacting activities which transforms inputs into outputstransforms inputs into outputs

Product: is a result of a processProduct: is a result of a process


Measurement process:Measurement process:Set of operations to determine the value of a Set of operations to determine the value of a quantityquantity

Continual improvement:Continual improvement:Recurring activity to increase the ability to fulfill Recurring activity to increase the ability to fulfill requirements. requirements.

Non Conformity:Non Conformity: Non fulfillment of a requirementNon fulfillment of a requirement

Defect:Defect:Non fulfillment of a requirement related to an Non fulfillment of a requirement related to an intended or specified useintended or specified use


Correction:Correction:Action to eliminate a detected non conformityAction to eliminate a detected non conformity

Corrective action:Corrective action:Action to eliminate the cause of a detected Action to eliminate the cause of a detected nonconformity or other undesirable situationnonconformity or other undesirable situation

Preventive action: Preventive action: Action to eliminate the cause of a potential Action to eliminate the cause of a potential nonconformity or other undesirable potential nonconformity or other undesirable potential situationsituation

Quality managementQuality management

8 Principles of the ISO Standard8 Principles of the ISO Standard

Based on eight

quality

management

principles.

Based on eight

quality

management

principles.

LeadershipLeadership

Process

approachProcess

approach

Involvement

of peopleInvolvement

of people

System

approach to

Managemen

t

System

approach to

Managemen

tContinual

improvementContinual

improvement

Factual

approach to

decision

making

Factual

approach to

decision

making

Mutual

beneficial

supplier

relationship

Mutual

beneficial

supplier

relationship

Customer

focusCustomer

focus

# QUALITY MANAGEMENT PRINCIPLE

APPLICATION

1 Customer focus:Organizations depend on the

customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations

Understand current and future customer needs and expectations. Measure customer satisfaction and act it.

3 Involvement of people:People at all levels are essence ofan organization and their full

involvement enables and their abilities to be used for the organization’s benefit.

Create personnel ownership of the organizations target and goals by using the people’s knowledge and experience and through training achieve involvement in operational decisions and process improvement.

6 Continual improvement:Continual improvement of the

organization’s overall performance should be permanent objective of the organization.

Set realistic and challenging goals provides resources and give people the tools, opportunities and encouragements to contribute the continual improvement of the processes.

Process ApproachProcess Approach – – Continual Improvements of All ProcessesContinual Improvements of All Processes

PDCA CycleProcesses in terms

Of Added Value

DO

Continual Improvements

of Processes Based on

Objective Measurements

ACTION

Measure Results of Process

Performance and Effectiveness

- Objective Measurements

CHECK

Understanding &

Meeting the Requirements

PLAN

ISO 9001:2000 – Process ModelISO 9001:2000 – Process Model

CU

ST

OM

ER

’SC

US

TO

ME

R

ISO 9001:2000 Quality

Management System

5.ManagementResponsibility

7. ProductRealization

6. ResourceManagement

8. MeasurementAnalysis and Improvements

Requirements

Satisfaction

Continual Improvement ofthe Quality Management System

ConsumptionProduct

TrainingServices

22

Do What the Customer Wants

Managed

MeasureAnalyseImprove

GOOD COMPANY

Policy

Customer Focus

Committed

ObjectivesDetermine & CommunicateAuthority & ResponsibilitiesReview

People

Buildings, Equipment,Machinery, etcEnvironment

Planning

Provide Resources

CustomerSatisfaction

System

Processes

Product

Non-conformingProduct

Data & Info

CorrectiveAction

PreventiveAction

Control Our ProcessesControl Our Documentation

ISO

4.14.2

5.1

5.2

5.3 5.4

5.5

5.65.

6.2

6.3

6.4

6.

7.27.37.4

7.

7.1

7.57.6

8.2.1

8.2.28.

8.3

8.2.3

8.2.4

8.4

8.5.2

8.5.3

Selling

PurchasingDesigning

CalibratingDoing It

Provision of Resources

Human Resources

Infrastructure

Work Environment

6 Resource Management

General Requirements

Documentation Requirements

Planning

Customer Related Processes

Design & Development

Purchasing

Production & Service Provision

Management Commitment

Customer Focus

Quality Policy

Planning

Responsibility, Authority & Communication

Management Reviews

5 Management Responsibility

8 Measurement Analysis & Improvements

Structure of the Standard

4 Quality Management System Requirements

7 Product Realization

General

Monitoring & Measurements

Control of NCP’s

Analysis of Data

Improvements

4.04.0 Quality Management SystemQuality Management System

4.14.1 General RequirementsGeneral Requirements Establish, document, implement, maintain and continually Establish, document, implement, maintain and continually

improve the QMS,improve the QMS,

Documentation requirements to includeDocumentation requirements to include• Documented statement of policy and objectivesDocumented statement of policy and objectives

• Quality manual and recordsQuality manual and records

• Documented procedures and recordsDocumented procedures and records

• Documented procedures mandatedDocumented procedures mandated

• Documents required for effective control of processesDocuments required for effective control of processes

4.2 Quality Manual4.2 Quality Manual Establish and maintain a quality manualEstablish and maintain a quality manual

Outsourced process : QMS Organization's responsibility to

ensure all the necessary processes are in place to meet all regulatory, mandatory and customer requirements.

Determine the extent of the external documentation that requires controlling to maintain and operate the management system


4.2.34.2.3 Control of documents: Control of documents: Documents required for the QMS shall be Documents required for the QMS shall be

controlled controlled Approval, review, update and re-approvalApproval, review, update and re-approval Identify the current status/versionIdentify the current status/version Ensure current version available at the point of useEnsure current version available at the point of use Ensure legible, identifiable and retrievableEnsure legible, identifiable and retrievable Distributions are controlled Distributions are controlled Prevent unintended use of obsolete.Prevent unintended use of obsolete.

Documentation requirementsDocumentation requirements

Important pocedures Important pocedures

1.1. Control of DocumentsControl of Documents

2.2. Control of recordsControl of records

3.3. Control of Nonconforming productsControl of Nonconforming products

4.4. Internal AuditInternal Audit

5.5. Corrective ActionCorrective Action

6.6. Preventive actionPreventive action


4.2.44.2.4 Control of Records. Control of Records. Ensure that records are legible and readily identifiable Ensure that records are legible and readily identifiable

and retrievableand retrievable

Define the controls needed for identification, storage Define the controls needed for identification, storage protection, retrieval, retention time and disposition of protection, retrieval, retention time and disposition of records.records.

Where tractability is required organization shall Where tractability is required organization shall control and record the unique identification of the control and record the unique identification of the product.product.

5.05.0 Management ResponsibilityManagement Responsibility

Management Commitment:Management Commitment:Top management shall provide evidence of its Top management shall provide evidence of its commitment to the devolopement and implementation of commitment to the devolopement and implementation of QMS QMS

Customer focusCustomer focusTop Management to ensure customer requirements are Top Management to ensure customer requirements are determined and met with the aim of enhancing customer determined and met with the aim of enhancing customer satisfactionsatisfaction

Quality Policy & ObjectivesQuality Policy & Objectives MeasurableMeasurable Consistent with the quality policyConsistent with the quality policy Include for functions and levelsInclude for functions and levels Relate to requirements for the productRelate to requirements for the product

5.05.0 Management ResponsibilityManagement Responsibility5.5 5.5 Responsibility Authority and CommunicationResponsibility Authority and Communication

Responsibility and authority:Responsibility and authority:• Responsibilities and authorities are defined and Responsibilities and authorities are defined and

communicated within the organization.communicated within the organization.

Management representative: Management representative: • Person from Organization to ensure the QMS Person from Organization to ensure the QMS

followedfollowed

Internal communication:Internal communication:• Shall ensure, communication takes place within Shall ensure, communication takes place within

the organisation regarding the effectiveness of the organisation regarding the effectiveness of the QMSthe QMS

5.65.6 Management ReviewManagement Review

Top management shall review the QMS at planned Top management shall review the QMS at planned intervals.intervals.

To ensure its continuing suitability, adequacy and To ensure its continuing suitability, adequacy and effeteness.effeteness.

Asses the opportunities for improvement, change Asses the opportunities for improvement, change needed in QMS, Quality policy & objectives.needed in QMS, Quality policy & objectives.

6.0 Resource Management6.0 Resource Management6.1 Provision of resources:6.1 Provision of resources:Organization shall determine and provide resources Organization shall determine and provide resources needed needed

Implement and maintain the QMS and continually Implement and maintain the QMS and continually improve its improve its effectivenesseffectiveness

Enhance customer satisfaction by meeting customer Enhance customer satisfaction by meeting customer requirementsrequirements

6.2 Human resources:6.2 Human resources:Personnel performing work affecting product quality to be Personnel performing work affecting product quality to be competent on the basis of appropriate:competent on the basis of appropriate:

Education, Training, Skills and ExperienceEducation, Training, Skills and Experience

6.2.1 Competence, awareness and training 6.2.1 Competence, awareness and training Determine and provide the trainingDetermine and provide the training Evaluate the effectiveness of the action takenEvaluate the effectiveness of the action taken Maintain the relevant records.Maintain the relevant records.

6.0 Resource Management6.0 Resource Management

6.3 Infrastructure:6.3 Infrastructure:Determine, provide and maintain infrastructure needed Determine, provide and maintain infrastructure needed Building, workspaces and associated utilitiesBuilding, workspaces and associated utilities Processes equipment both hardware and softwareProcesses equipment both hardware and software Supporting services such as transport or communicationSupporting services such as transport or communication

6.4 Work Environment:6.4 Work Environment:

Determine and manage the work environment needed: Determine and manage the work environment needed: Creative work method and opportunities for greater Creative work method and opportunities for greater

involvementinvolvement Safety rules and guidance, PPEsSafety rules and guidance, PPEs Ergonomics, Workplace location, Social interaction, Ergonomics, Workplace location, Social interaction,

Facilities for peopleFacilities for people Heat, humidity, light, sound, airflow Heat, humidity, light, sound, airflow Hygiene, cleanliness, noise, vibration and pollution Hygiene, cleanliness, noise, vibration and pollution

7.0 Product Realization7.0 Product Realization

Planning of Product realization:Planning of Product realization:

a)a) Determine: Quality objectives and Determine: Quality objectives and requirement for the productrequirement for the product

b)b) Processes, documents and resources Processes, documents and resources neededneeded

c)c) Verification, validation, monitoring, Verification, validation, monitoring, inspection and test activities and acceptance inspection and test activities and acceptance criteriacriteria

d)d) RecordsRecords needed for process & product needed for process & product

7.2 Customer related processes. 7.2 Customer related processes.

Determination of requirements related to the productDetermination of requirements related to the product Determine the customer requirements stated and Determine the customer requirements stated and

implied needsimplied needs Statutory and regulatory requirements Statutory and regulatory requirements

Review of requirements related to the product Review of requirements related to the product Product requirements, resolve any differences Product requirements, resolve any differences

Customer communication:Customer communication: Product information, enquiry, contracts or order Product information, enquiry, contracts or order

handling, amendmentshandling, amendments Customer feedback, including complaints :Customer feedback, including complaints :

7.3 Design and development: 7.3 Design and development:

7.3.1 Design and development planning7.3.1 Design and development planning

7.3.2 Design and development inputs7.3.2 Design and development inputs

7.3.3 Design and development outputs7.3.3 Design and development outputs

7.3.4 Design and development review7.3.4 Design and development review

7.3.5 Design and development verification7.3.5 Design and development verification

7.3.6 Design and development validation7.3.6 Design and development validation

7.3.7 Control of design and development changes7.3.7 Control of design and development changes

7.4 Purchasing:7.4 Purchasing:

Purchasing processPurchasing process

Criteria for selection, evaluation and re-evaluation to Criteria for selection, evaluation and re-evaluation to be established, including service provider, sub-be established, including service provider, sub-contracting activities.contracting activities.

Purchasing informationPurchasing information

SpecificationSpecification

Verification of purchased productVerification of purchased product

TestingTesting

7.5. Production and service provision:7.5. Production and service provision:

Control of production and service provisionControl of production and service provision GMP:GMP: MI, BPR, SOPs, Specification, Equipments & MI, BPR, SOPs, Specification, Equipments &

Instruments, Cleaning, Testing etcInstruments, Cleaning, Testing etc

Validation of processes for production Validation of processes for production and service and service provisionprovision

Process, Equipments, personal, test methods, etc Process, Equipments, personal, test methods, etc

Identification and traceabilityIdentification and traceability

Customer propertyCustomer property

Preservation of product:Preservation of product: Identification, handling, packaging, storing etcIdentification, handling, packaging, storing etc..

Damage or lose of customer property shall be reported. Damage or lose of customer property shall be reported.

7.6 Control of monitoring and 7.6 Control of monitoring and measuring devicesmeasuring devices

Calibration of monitoring and measuring Calibration of monitoring and measuring devices to ensure the conformity of product.devices to ensure the conformity of product.

Standards used should traceable to national & Standards used should traceable to national & international measurement standardinternational measurement standard

Status, records.Status, records.

8.0 Measurement Analysis, and 8.0 Measurement Analysis, and ImprovementImprovement

General:General:Monitoring, measuring, analysis and improvement Monitoring, measuring, analysis and improvement processes to be planned and implemented to:processes to be planned and implemented to:

Demonstrate conformity of productDemonstrate conformity of product

Ensure conformity to the QMSEnsure conformity to the QMS

Continually improve effectiveness of the QMSContinually improve effectiveness of the QMS

Monitoring and Measurement:Monitoring and Measurement:

Customer satisfactionCustomer satisfaction Monitor information relating to the customer’s Monitor information relating to the customer’s

perception of how well requirements were fulfilled.perception of how well requirements were fulfilled. Method of obtaining and using this information to be Method of obtaining and using this information to be

determineddetermined


Internal AuditInternal Audit

Periodic audits to be performed at planned Periodic audits to be performed at planned intervals to determine whether the QMSintervals to determine whether the QMS

Conforms to ISO-9001 and planned arrangementsConforms to ISO-9001 and planned arrangements Is effectively implemented and maintainedIs effectively implemented and maintained

Audits to be objective and impartial-auditors shall not Audits to be objective and impartial-auditors shall not audit their own workaudit their own work

Internal AuditsInternal Audits

Internal AuditsInternal Audits Effectiveness & Efficiency of ProcessesEffectiveness & Efficiency of Processes Opportunities for ImprovementsOpportunities for Improvements Use of Data / InformationUse of Data / Information Effective & Efficient Use of ResourcesEffective & Efficient Use of Resources Adequacy, Accuracy and Performance of Adequacy, Accuracy and Performance of

MeasurementsMeasurements


8.2.3 Monitoring and Measurement of 8.2.3 Monitoring and Measurement of processes: processes:

Suitable methods to be used to monitor and measure Suitable methods to be used to monitor and measure the quality management system processes to ensure the quality management system processes to ensure conformity of productconformity of product

8.2.4 Monitoring and Measurement of product8.2.4 Monitoring and Measurement of product Product characteristics to be monitored and Product characteristics to be monitored and

measured to verify conformitymeasured to verify conformity Evidence and acceptance criteria to be documentedEvidence and acceptance criteria to be documented Authority for product release to be documentedAuthority for product release to be documented

Criteria for MeasurementsCriteria for Measurements

–Internal Audits•Effectiveness & Efficiency of Processes•Opportunities for Improvements•Use of Data / Information•Effective & Efficient Use of Resources•Adequacy, Accuracy and Performance of Measurements•Relationships with customers/ suppliers/ other interested parties

–Internal Audits•Effectiveness & Efficiency of Processes•Opportunities for Improvements•Use of Data / Information•Effective & Efficient Use of Resources•Adequacy, Accuracy and Performance of Measurements•Relationships with customers/ suppliers/ other interested parties

–Financial Measurements

•Prevention cost

•Non conforming / failure cost

•Lifecycle cost

–Financial Measurements

•Prevention cost

•Non conforming / failure cost

•Lifecycle cost

Self AssessmentSelf Assessment

–Satisfaction Surveys for customers and other interested parties

•Feedback on products•Customer & market requirements

–Satisfaction Surveys for customers and other interested parties

•Feedback on products•Customer & market requirements

System Performance

System Performance

Criteria for MeasurementsCriteria for Measurements

–Inspection and testing of incoming, in process and final products

–Product verification

–Product validation

–Inspection and testing of incoming, in process and final products

–Product verification

–Product validation

–Process Capability / Process validation

–Reaction time

–Cycle time / throughput (Capacity)

–Utilization of new technology

–Waste reduction

–Cost reduction

–Process Capability / Process validation

–Reaction time

–Cycle time / throughput (Capacity)

–Utilization of new technology

–Waste reduction

–Cost reduction

ProductsProducts

ProcessesProcesses

8.3 Control of non-conforming product8.3 Control of non-conforming product

A documented procedure shall define the control A documented procedure shall define the control and recording of non-conforming product including and recording of non-conforming product including

Take action to eliminate the detected non-Take action to eliminate the detected non-conformity conformity

Action to preclude original intended use and to Action to preclude original intended use and to eliminate the non-conformityeliminate the non-conformity

Authorize use by concession by relevant Authorize use by concession by relevant authorityauthority

Corrected non-conforming product to be re-Corrected non-conforming product to be re-verifiedverified

8.4 Analysis of data8.4 Analysis of data

Collect and analyze data to determine Collect and analyze data to determine suitability and effectiveness of the QMS and suitability and effectiveness of the QMS and identify improvements from sources including :identify improvements from sources including :

Customer satisfactionCustomer satisfaction

Conformance to product requirementsConformance to product requirements

Characteristics of processes, products Characteristics of processes, products and their trendsand their trends

SuppliersSuppliers

8.5 Improvement8.5 Improvement

8.5.1 Continual Improvement:8.5.1 Continual Improvement:

The organisation to continually improve the The organisation to continually improve the effectiveness of the QMS through the use of effectiveness of the QMS through the use of the Quality Policy, Quality objectives, audit the Quality Policy, Quality objectives, audit results, analysis of data, corrective and results, analysis of data, corrective and preventive action and management reviewpreventive action and management review

8.5.2 Corrective action8.5.2 Corrective action

Eliminate the cause of non-conformity and Eliminate the cause of non-conformity and prevent recurrence prevent recurrence

A documented procedure to define requirements for:A documented procedure to define requirements for:

Reviewing non-conformities and customer complaintsReviewing non-conformities and customer complaints

Determining causes of non-conformityDetermining causes of non-conformity

Evaluating need for and determining and implementing Evaluating need for and determining and implementing actionsactions

Recording results action takenRecording results action taken

Reviewing actions takenReviewing actions taken

8.5.3 Preventive action8.5.3 Preventive action

Eliminate the cause of potential non-conformity Eliminate the cause of potential non-conformity to prevent occurrence to prevent occurrence

A documented procedure to define requirements for :A documented procedure to define requirements for :

Determining potential non-conformities and their Determining potential non-conformities and their causescauses

Evaluating need for action to prevent occurrenceEvaluating need for action to prevent occurrence

Determining and implementing action neededDetermining and implementing action needed

Recording results of action takenRecording results of action taken

Reviewing actions takenReviewing actions taken

cGMP Vs ISO standardscGMP Vs ISO standards

ISO-9000ISO-9000 cGMP cGMP 11 Business Covered All Business Covered All Pharmaceutical Pharmaceutical

22 Focus Focus Quality Mgmt Quality Mgmt Safety and Safety and efficacy efficacy

3.3. Legal basisLegal basis NoNo Yes Yes 4. 4. Business processes Business processes YesYes No No5. 5. Product qualityProduct quality Not specifiedNot specified Specified Specified6. Continual Improvement Yes6. Continual Improvement Yes No No7. Customer Focus7. Customer Focus Satisfaction Protection Satisfaction Protection

More informationMore information

ISO 9000/ISO 14000 section on ISO 9000/ISO 14000 section on ISO Web ISO Web sitesite: :

iso.www.orgiso.www.org ISO Management SystemsISO Management Systems magazine magazine

www.iso.org/imswww.iso.org/ims IMS AlertsIMS Alerts free electronic newsletter free electronic newsletter

www.iso.org/imsalertswww.iso.org/imsalerts

Iso awarenee training dr. amsavel

Business

0quality management

requirements

future customer

quality management

continually

continual

management

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