03 awareness on iso 9000

“ISO 9000 is a globally recognized series of International Standards of Quality Management System (QMS)

For Manufacturing as well as Service Sector

Has been developed by a Swiss based International Organization for Standardization (ISO)”

–Interconnected and interdependent processes–Provides a systematic approach to delivering products or services meeting customer requirements–Enables continuous improvement in achieving defined objectives

What is ISO 9000?What is ISO 9000?

ISO 9000:2000

PDCA MethodologyPDCA Methodology

Plan

Do

check

Act

Standard RequirementsISO 9001:2000 OverviewISO 9001:2000 Overview

ISO 9001:2000 is contained in three ISO 9001:2000 is contained in three primary documents.primary documents.

ISO 9000 Quality management systems – ISO 9000 Quality management systems – Fundamentals and vocabularyFundamentals and vocabulary

ISO 9001 Quality management systems – ISO 9001 Quality management systems – RequirementsRequirements

ISO 9004 Quality management systems – ISO 9004 Quality management systems – Guidelines for performance improvementsGuidelines for performance improvements

A few guidance documentsA few guidance documents

Standard Requirements

1. Scope 2. Normative Reference 3. Terms and Definitions4. Quality Management System 5. Management Responsibility 6. Resource Management 7. Product Realization 8. Measurement, Analysis and Improvement

Elements of ISO 9001:2000Elements of ISO 9001:2000

4.1 General Requirements4.1 General Requirements

a) Identification of the processes for the QMSb) Determine the sequence of these processesc) Determine criteria for effective operation &

control of these processesd) Ensure the availability of resourcese) Monitor, measure and analyze these

processesf) Implement actions necessary for achieving

planned results and continual improvement

Quality Management System - 1

4.2.1 GeneralThe QMS Documentation shall include:a) Quality Policy & Quality Objectivesb) Quality Manualc) Documented procedures required by this

Standardd) Documents needed for planning, operation

and control of processese) Records required by this Standard

4.2 Documentation Requirements - 14.2 4.2 Documentation Requirements - 1Documentation Requirements - 1Quality Management System - 2

4.2.2 Quality Manuala) Scope of QMS / Justification of the

Exclusionsb) Documented procedures or reference to themc) Description of interaction between the

processes of the QMS

4.2 4.2 Documentation Requirements - 2Documentation Requirements - 2Quality Management System - 3

4.2.3 Control of documentsEstablish documented procedure to define method to:a) Approve documentsb) Review, update and re-approve documentsc) Identify the revision status / changes d) Ensure availability of relevant versions at point of

usee) Ensure documents are legible and readily identifiablef) Identification and Control the external documentsg) Identification and Control of obsolete documents


4.2.4 Control of recordsa) Establish / Maintain records to demonstrate

conformity to this International Standard b) Keep records legible, readily identifiable and

retrievable c) Establish documented procedure for

identification, storage, protection, retrieval, specify retention time and their disposition


a) Communication to the organization the importance of meeting customer, statutory and regularity requirements

b) Establish Quality Policy & Quality Objectivesc) Conducting Management Reviewsd) Ensuring the availability of resources

5.1 Management Commitment 5.1 Management Commitment Management Responsibility - 1

5.2 Customer Focus 5.2 Customer Focus

Determine and meet the customer requirements for enhancing customer satisfaction

a) Is appropriate to the purpose of the organizationb) Includes a commitment to the comply with and

continually improve the QMSc) Provides framework of establishing and

reviewing Quality Objectivesd) Is communicated and understood within

organizatione) Is reviewed for continuing suitability

5.3 Quality Policy 5.3 Quality Policy

Management Responsibility - 2

5.4.1 Quality Objectivesa) Needed to meet the requirements of the

product are established at relevant functions within the organization

b) Are measurable and consistent with the Quality Policy

5.4 5.4 Planning - 1Planning - 1


5.4.2 Quality Management System PlanningTop Management shall ensure thata) Planning is done for meeting the requirements

of this standard (4.1) and Quality Objectivesb) Integrity of the QMS is maintained when

changes to QMS are planned and implemented


5.4 5.4 Planning - 2Planning - 2

5.5.1 Responsibility and AuthorityAre defined and communicated

5.5.2 Management RepresentativeThe Management Shall appoint a Management Representative responsible to :

a) Ensure that processes for QMS are established, implemented and maintained

b) Reporting to top management on performance of QMS and any need for improvement

c) Ensure the promotion of awareness of customer requirements throughout the organization

5.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 1 - 1


5.5.3 Internal Communication Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of quality management system.

Management Responsibility - 65.5 Responsibility, Authority and Communication5.5 Responsibility, Authority and Communication - 2 - 2

5.6.1 GeneralThe management shall review the QMS at planned intervals to ensure it’s continued suitability, adequacy and effectivenessThe review shall include :

a) Assessing opportunities for improvement and need for changes to the QMS

b) Review of the Quality Policy and Quality ObjectivesRecords of the reviews must be kept

5.65.6 Management Review - 1Management Review - 1Management Responsibility - 7

5.6.2 Review InputsThe Inputs shall include information on:a) Results of audits b) Customer feedback c) Process performance and product conformity d) Status of preventive and corrective action e) Follow-up actions from previous

management review f) Changes which could affect the QMS g) Recommendations for improvement


5.65.6 Management Review - 2Management Review - 2

5.6.3 Review OutputsThe Outputs shall include any decisions and actions on:a) Improvement of the effectiveness of quality

management system and processes,b) Improvement of product related to customer

requirementsc) Resources needs


5.65.6 Management Review - 3Management Review - 3

The Organization shall determine and provideresources needed to :a) Implement and maintain the QMS and

continually improve its effectiveness b) Enhance customer satisfaction by meeting

customer requirements.

Resource Management - 1

6.16.1 Provision of ResourcesProvision of Resources

6.2.1 GeneralCompetent persons should perform work effecting quality

6.2.2 Competence, awareness and training a) Determine the necessary competence for the personnel

performing work effecting qualityb) Provide training and take action to satisfy these needsc) Evaluate the effectiveness of the action takend) Ensure that its personnel are aware of relevance and

importance of their activities and how they contribute to the achievement of the quality objectives

e) Maintain appropriate records of education, training, skills and experience

6.26.2 Human ResourcesHuman Resources


The organization shall determine, provide and maintain the infrastructure needed to achieve product conformity, it includes:

a) Building, workplace and associated utilities b) Process equipment (both hardware and

software) c) Supporting services(such as transport or

communication)

6.36.3 InfrastructureInfrastructure


The organization shall determine and manage the work environment needed to achieve conformity to product requirements

6.46.4 Work EnvironmentWork Environment


Organization shall plan and develop the processes needed for product realization, while considering the Following factors as appropriate: a) Quality objective and requirements for the product b) Need to establish processes, documents, and

provide resources specific to the product c) Required verification, validation, monitoring,

inspection and test activities specific to the product and the criteria for product acceptance

d) Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)

7.17.1 Planning of Product RealizationPlanning of Product Realization

Product Realization - 1

7.2.1 Determination of requirements related to the productThe organization shall determine: a) Requirements specified by customer including

(delivery conditions & post Delivery activities)b) Requirements not stated but necessary for the

intended use, where knownc) Statutory & regulatory requirements related to

productd) Any additional requirement determined by the

organization

7.27.2 Customer Related Processes - 1Customer Related Processes - 1


7.2.2 Review of Requirements Related to the Product

Review following before the acceptance of contract :a) Product requirements are definedb) Contract or order requirements differing from those

previously expressed are resolvedc) The organization has the ability to meet the defined

requirements.

Results of the reviews must be maintainedAny change in requirements is communicated to all



7.2.2 Customer Communication

The organization shall define and implement Effective arrangements for communicating with customers in relation to :a) Product informationb) Enquiries, contracts or order handling,

including amendments, and c) Customer feedback, including customer

complaints



7.3.1 Design and Development Planning Organization shall determine thea) Design and development stages,b) Review, verification and validation that are

appropriate to each design and development stage, and

c) Responsibilities and authorities for design and development Planning output shall be updated, as appropriate, as the design and development progresses

7.37.3 Design and Development - 1Design and Development - 1


7.3.2 Design and Development InputsInputs related to product requirements including followingshall be determined,a) Functional and performance requirements,b) Applicable statutory and regulatory requirements,c) Where applicable, information derived from previous

similar design, and d) Other requirements essential for design and

developmentThe requirements must be complete, unambiguous and not in conflict in each otherThe requirements must be reviewed for adequacy and records must be maintained

7.37.3 Design and Development - 2Design and Development - 2Product Realization - 6

7.3.3 Design and Development OutputsThe design and development outputs shall:a) Meet the input requirements for design and

developmentb) Provide appropriate information for

purchasing, production and for services provision

c) Contain or reference product acceptance criteria

d) Specify the characteristics of the product that are essential for its safe and proper use



7.3.4 Design and Development Review

Reviews by representatives of the functionsconcerned shall be performed in accordance withplanned arrangements (see 7.3.1) to :

a) Evaluate the ability of the results of design and development to meet requirements, and

b) Identify any problems and propose necessary actions.

Records of reviews and any necessary actionsshall be maintained

7.37.3 Design and Development - 4Design and Development - 4Product Realization - 8

7.3.5 Design and development verification

Verification shall be performed in accordance with planned arrangements (7.3.1) to ensure that design and development outputs have met the design and development input requirements.Records of the results and any actions shall be maintained.



7.3.6 Design and development validationValidation shall be performed in accordance with planned arrangements (7.3.1) to ensure that Resulting product is capable of meeting requirements for intended use, where known. Where practicable, validation shall be completed prior to the delivery or implementation of the productRecords of the results and any actions shall be maintained.



7.3.7 Control of design and development changes The changes will be reviewed, verified and validated as appropriate and approved before implementation.The review for change shall include evaluation of the effects of the change on constituent parts and product already delivered. Records of the changes and any actions shall be maintained.



7.4.1 Purchasing ProcessThe organization shall ensure that purchased product conforms to specified purchase requirementsThe type and extent of control applied shall be dependent upon the effect on the final product

7.47.4 Purchasing - 1Purchasing - 1


7.4.2 Purchasing InformationPurchasing information shall describe the purchased product, including where appropriate:a) Requirement for approval of product,

procedures, process and equipmentb) Requirement for qualification of personnelc) Quality management system requirements



7.4.3 Verification of the Purchased ProductEstablish and implement the inspection activities necessary for ensuring conformance of purchased product to purchase information.Where verification at the supplier’s premises is required by organization / customer, it shall be indicated so in the purchase information.



7.5.1Control of Production and Service ProvisionProduction and service provision shall be carried outunder controlled conditions, as applicable:a) Availability of information that describes the

characteristics of the product,b) Availability of work instructions, as necessary,c) Use of suitable equipment,d) Availability and use of monitoring and measuring

devices,e) Implementation of monitoring and measurement, and f) Implementation of release, delivery and post-delivery

activities.

7.57.5 Production and Service Provision - 1Production and Service Provision - 1


7.5.2Validation of processes for production and service provision

Validation of process shall be done where the resulting output cannot be verified by subsequent monitoring or measurement, the following shall be addressed: a) Defined criteria for review and approval of the

processesb) Approval of equipment and qualification of

personnelc) Use of specific methods and proceduresd) Requirements for recordse) Revalidation

7.57.5 Production and Service Provision - 2Production and Service Provision - 2Product Realization - 16

7.5.3Identification and Traceability

Identification of product by suitable means throughout product realization

Identification of the product status with respect to the monitoring and measurement requirements

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



7.5.4Customer Property

The organization shall

a) Identify, verify, protect and safeguard customer property

b) In case of loss, damage or unsuitable for use customer must be informed

c) Records must be maintained



7.5.5Preservation of Product The organization shall preserve the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packing, storage and protection. Preservation shall also apply to the constituent parts of product



The equipment Shall be:a) Calibrated or verified at specific intervals, or prior to use,

against measurement standards traceable to international or national measurement standards, where no such standards exist, the basis used for calibration or verification shall be recorded

b) Adjusted or re-adjusted as necessaryc) Identified to enable the calibration status to be determinedd) Safeguarded from adjustments that would invalidate the

measurement resulte) Protected from damage and deterioration during handling,

maintenance and storagef) Records shall be maintained

7.67.6 Control of Monitoring and Measuring DevicesControl of Monitoring and Measuring Devices


Organization must plan and implement the monitoring

measurement, analysis and improvement processes needed to :a) Demonstrate conformity of the product b) Ensure conformity of the QMS c) Continually improve the effectiveness of QMS

Determine applicable method including StatisticalTechniques and extent of their use

8.18.1 GeneralGeneral

Measurement, Analysis and Improvement - 1

8.2.1 Customer Satisfaction

Establish a method for obtaining and using the information about customer perception as to whether the organization has met customer requirements

8.28.2 Monitoring & Measurement - 1Monitoring & Measurement - 1


8.2.2 Internal AuditDocumented procedures Shall be established and internal audits shall be conducted at regular intervals to determine whether the QMS :a) Conforms to standard and other requirements

determined by organizationb) Is effectively implemented and maintainedAudit shall be:1. Planned, Criteria / Scope / Frequency and method be

defined.2. Selection / conduct of audit shall ensure impartiality3. Follow-up activities shall be performed4. Records shall be maintained



8.2.3 Monitoring and measurement of processes

Apply methods for monitoring and where applicable measurement of QMS processes.

Methods shall demonstrate the ability of the processes to achieve the planned results.

In case planned results are not obtained Corrective / Preventive actions must be taken to ensure the conformity to the product.



8.2.4 Monitoring and measurement of productMonitor the characteristics of the product at appropriate stages in accordance with planned arrangements (see 7.1)Evidence of conformity and acceptance criteria must be defined. No product or service delivery shall not proceed until the planed arrangement are satisfactorily completed and approved by authorized person. Records shall also be maintained.



The nonconforming products must be identified and controlled to prevent unintended use or delivery.Documented procedure stating responsibility and authority to deal with nonconforming products shall be defined.

8.3 Control of Nonconforming Product - 18.3 Control of Nonconforming Product - 1


The organization shall deal with nonconforming products by :a) Taking action to eliminate the detected non

conformity b) Authorizing its use, release / acceptance under

concession by relevant authority if allowed by customer.

c) Take action to prevent its original intended useRecords and actions taken shall be recorded.Incase of rework product shall be re-verifiedIncase the product has been delivered appropriate actions shall be taken

8.3 Control of Nonconforming Product - 28.3 Control of Nonconforming Product - 2


Determine, collect and analyze appropriate data to demonstrate the suitability and effectiveness of the QMS and to evaluate where continual improvement of the QMS can be made.Analysis of data shall provide information relating to:

a) Customer Satisfaction (see 8.2.1)b) Conformity of product requirements (see 7.2.1)c) Characteristics and trends of processes and and

products including opportunities of Corrective actiond) Suppliers

8.48.4 Analysis of DataAnalysis of Data


8.5.1 Continual ImprovementThe organization shall continually improve the effectiveness of QMS through the use of :

Quality Policy Quality Objectives, Audit Results Analysis of data, Corrective and Preventive Actions Management Review

8.58.5 Improvement - 1Improvement - 1


8.58.5 Improvement - 2Improvement - 28.5.2 Corrective Action

Corrective actions shall be taken to eliminate causes of nonconformities to prevent their recurrence. Documented procedure shall be established to define requirements for: a) Reviewing nonconformities (including customer

complaints)b) Determining the causes of nonconformitiesc) Evaluating the need for action to ensure that

nonconformities do not recur



d) Determining and implementing action needed e) Records of the action taken resultsf) Reviewing corrective action taken


8.5.3 Preventive Action

Preventive actions shall be taken to eliminate causes of potential nonconformities to prevent their occurrence. Documented procedure shall be established to define requirements for:a) Determining potential nonconformities and their

causesb) Evaluating the need for action to prevent

occurrence of nonconformitiesc) Determining and implementing action needed



d) Records of results action taken e) Reviewing preventive action taken



ISO 9000:2000

DocumentsDocumentsProcedure for measurement and monitoring of processes for effective

control.Methods for use of statistical techniques for process control and data

analysis for improvement.Procedure for inspection and release of final product.Procedure for dealing with non conforming product and use of material

under concession.Procedure for monitoring customer satisfaction and dealing with customer

complaints.

Clause 8Clause 8

Documentation Requirements

ISO 9000:2000

DocumentsDocumentsProcedure of internal audit of QMS, along with check list.Procedure for corrective and preventive action.Procedure for collection and analysis of data for effectiveness and

improvement of QMS.RecordsRecordsProcess monitoring data and corrective action taken for process controlRecord of product non conformities and products accepted on concession.

Clause 8 contnd..Clause 8 contnd..


ISO 9000:2000

RecordsRecordsData analysis and activities for continual improvement.Result of internal audits and follow up action.Data on customer feedback and action taken on customer complaints.

Clause 8 contnd..Clause 8 contnd..


ISO 9000:2000

No bodyNo body

Can AchieveCan Achieve

QQUUALITYALITYWithoutWithout

UU

ISO 9000:2000

Thank you !!!Thank you !!!