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International Organization for International Organization for StandardizationStandardization

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23 febarury 194623 febarury 1946 165 members 165 members Headquarters in Headquarters in Geneva , , Switzerland ISO is a ISO is a Voluntary OrganizationVoluntary Organization whose whose

members are recognized standard authorities, members are recognized standard authorities, each one representing one country. The bulk of each one representing one country. The bulk of the work of ISO is done by the the work of ISO is done by the 2700 technical 2700 technical committeescommittees, subcommittees and working , subcommittees and working groups. groups.

ISO's ISO's main productsmain products are the are the International International StandardsStandards. ISO also . ISO also publishes Technical publishes Technical Reports, Technical Specifications, Publicly Reports, Technical Specifications, Publicly Available Specifications, and GuidesAvailable Specifications, and Guides

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ISO 9001 REQUIREMENTSISO 9001 REQUIREMENTSStandard has 8 clauses.Standard has 8 clauses. ScopeScope Normative referecnceNormative referecnce DefinitionsDefinitions QMSQMS Management responsibiltiyManagement responsibiltiy Resource managementResource management Product or service realizationProduct or service realization Measurement ,Analysis and ImprovementMeasurement ,Analysis and Improvement

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ISO IMPLEMENTATIONISO IMPLEMENTATION1. 1. Top management commitment.Top management commitment. Top management should be committed.Top management should be committed. Willing to achive certification critiera.Willing to achive certification critiera. Roadblocks and failures if management is not Roadblocks and failures if management is not

committed.committed.

2. 2. Appoint the management representative.Appoint the management representative. Person responsible for coordinating , Person responsible for coordinating ,

implementation and maintenance.implementation and maintenance. Representative may be a member of top Representative may be a member of top

management.management.

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ISO IMPLEMENTATIONISO IMPLEMENTATION Representative should ensure that quality Representative should ensure that quality

system is efffectivly implemented documented system is efffectivly implemented documented and maintained.and maintained.

3. Awareness3. Awareness Every member is required to have well know-Every member is required to have well know-

how about the programme.how about the programme. Traning sessions, short courses, notes, Traning sessions, short courses, notes,

booklets or multimedia training can be usedbooklets or multimedia training can be used ..

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ISO IMPLEMENTATIONISO IMPLEMENTATION4. Appoint the implemantation team4. Appoint the implemantation team At all levels and all areas.At all levels and all areas. Committees, supervisors, audit team, CO, etc.Committees, supervisors, audit team, CO, etc. Team should defined process, procedure, Team should defined process, procedure,

sequence, interaction.sequence, interaction.5. Training5. Training Implementation team shoud be trained.Implementation team shoud be trained. Training sessions, seminars, classes, Training sessions, seminars, classes,

multimedia, on the job training,etc.multimedia, on the job training,etc. Positive results, increase efficiency, good Positive results, increase efficiency, good

working environmentworking environment

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ISO IMPLEMENTATIONISO IMPLEMENTATION6. Time schedule6. Time schedule Activity Start and end limits or time duration.Activity Start and end limits or time duration. Time frame vary, depending on size and type of Time frame vary, depending on size and type of

org.org. Existing quality system.Existing quality system. Divide in manageable units.Divide in manageable units.

7. Review the present system7. Review the present system Review the previous systemReview the previous system Copies of manuals,procedures, work instructions.Copies of manuals,procedures, work instructions. This activity is a gap analysis, and can be This activity is a gap analysis, and can be

performed b the team or external consultantperformed b the team or external consultant..

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ISO IMPLEMENTATIONISO IMPLEMENTATION88. Write the document. Write the document Written quality policy, and procedure manuals.Written quality policy, and procedure manuals. Expose flaws and document new process.Expose flaws and document new process. Be prudent during documentation.Be prudent during documentation. Too much or complicated documentation destroy Too much or complicated documentation destroy

the system.the system.

9. Install the new system.9. Install the new system. Integaret policies, procedures, work instruction.Integaret policies, procedures, work instruction. Not necessary to implement all element at same Not necessary to implement all element at same

time.time.

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ISO IMPLEMENTATIONISO IMPLEMENTATION10. Internal audit10. Internal audit Conduct internal audit.Conduct internal audit. System is working effectively.System is working effectively. Comprehensive management review.Comprehensive management review. Minor correction are easy to imlpemet.Minor correction are easy to imlpemet.

11. Preassessment11. Preassessment This step iis optional.This step iis optional. If a good job has been done on the If a good job has been done on the

previous steps, preassesment is not previous steps, preassesment is not necessary.necessary.

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ISO IMPLEMENTATIONISO IMPLEMENTATION

12. Management review12. Management review Conduct management review.Conduct management review. Effectiveness of system in achieveing goals.Effectiveness of system in achieveing goals. System is revised as needed.System is revised as needed.

13. Registration13. Registration Choosing a registar.Choosing a registar. submitting a application.submitting a application. conducting the registar’s audit system.conducting the registar’s audit system.

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ISO DOCUMENTATIONISO DOCUMENTATIONIf a system is properly structured and If a system is properly structured and

documented, changed at one level will documented, changed at one level will seldom affect the levels above it, but seldom affect the levels above it, but may effect those below.The system may effect those below.The system documentation cosist of four tiers.documentation cosist of four tiers.

1.1. PolicyPolicy

2.2. ProcedureProcedure

3.3. Records and proofsRecords and proofs

4.4. Records and proofsRecords and proofs

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ISO DOCUMENTATIONISO DOCUMENTATIONPolicyPolicy Policy manualPolicy manual Defines what will be done and why.Defines what will be done and why. Should be clear, precise, practical.Should be clear, precise, practical. Statement should be short , simple, and easy to Statement should be short , simple, and easy to

understand.understand.

ProcedureProcedure Second tier of quality system.Second tier of quality system. Method used to implement and perform the policy.Method used to implement and perform the policy. Procedures are detailed than policies.Procedures are detailed than policies. Procedure is needed if its absence affect activity,Procedure is needed if its absence affect activity,

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ISO DOCUMENTATIONISO DOCUMENTATIONWork instructionsWork instructions Detailed drawings, written work instruction, Detailed drawings, written work instruction,

recipe, routine work sheets, job function, recipe, routine work sheets, job function, photographs, videos etc,.photographs, videos etc,.

Not every task requires instructions.Not every task requires instructions.

Records and proofsRecords and proofs Records are a way of documenting that the Records are a way of documenting that the

policies, procedures, instructionshave been policies, procedures, instructionshave been followed. Records may be forms that may be followed. Records may be forms that may be filled out.stamp of approval, signature and date.filled out.stamp of approval, signature and date.

Records are used to provide traceability of action.Records are used to provide traceability of action.

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QUESTIONS. . ?QUESTIONS. . ?

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