1 International Organization for Standardization

2  23 febarury 1946  165 members  Headquarters in Geneva, Switzerland GenevaSwitzerlandGenevaSwitzerland  ISO is a Voluntary Organization whose members are recognized standard authorities, each one representing one country. The bulk of the work of ISO is done by the 2700 technical committees, subcommittees and working groups. ISO's main products are the International Standards. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, and Guides ISO's main products are the International Standards. ISO also publishes Technical Reports, Technical Specifications, Publicly Available Specifications, and Guides

3 ISO 9001 REQUIREMENTS Standard has 8 clauses.  Scope  Normative referecnce  Definitions  QMS  Management responsibiltiy  Resource management  Product or service realization  Measurement,Analysis and Improvement

4 ISO IMPLEMENTATION 1. Top management commitment.  Top management should be committed.  Willing to achive certification critiera.  Roadblocks and failures if management is not committed. 2. Appoint the management representative.  Person responsible for coordinating, implementation and maintenance.  Representative may be a member of top management.

5 ISO IMPLEMENTATION  Representative should ensure that quality system is efffectivly implemented documented and maintained. 3. Awareness  Every member is required to have well know- how about the programme.  Traning sessions, short courses, notes, booklets or multimedia training can be used.

6 ISO IMPLEMENTATION 4. Appoint the implemantation team  At all levels and all areas.  Committees, supervisors, audit team, CO, etc.  Team should defined process, procedure, sequence, interaction. 5. Training  Implementation team shoud be trained.  Training sessions, seminars, classes, multimedia, on the job training,etc.  Positive results, increase efficiency, good working environment

7 ISO IMPLEMENTATION 6. Time schedule  Activity Start and end limits or time duration.  Time frame vary, depending on size and type of org.  Existing quality system.  Divide in manageable units. 7. Review the present system  Review the previous system  Copies of manuals,procedures, work instructions.  This activity is a gap analysis, and can be performed b the team or external consultant.

8 ISO IMPLEMENTATION 8. Write the document  Written quality policy, and procedure manuals.  Expose flaws and document new process.  Be prudent during documentation.  Too much or complicated documentation destroy the system. 9. Install the new system.  Integaret policies, procedures, work instruction.  Not necessary to implement all element at same time.

9 ISO IMPLEMENTATION 10. Internal audit  Conduct internal audit.  System is working effectively.  Comprehensive management review.  Minor correction are easy to imlpemet. 11. Preassessment  This step iis optional.  If a good job has been done on the previous steps, preassesment is not necessary.

10 ISO IMPLEMENTATION 12. Management review  Conduct management review.  Effectiveness of system in achieveing goals.  System is revised as needed. 13. Registration  Choosing a registar.  submitting a application.  conducting the registar’s audit system.

11 ISO DOCUMENTATION If a system is properly structured and documented, changed at one level will seldom affect the levels above it, but may effect those below.The system documentation cosist of four tiers. 1. Policy 2. Procedure 3. Records and proofs 4. Records and proofs

12 ISO DOCUMENTATION Policy  Policy manual  Defines what will be done and why.  Should be clear, precise, practical.  Statement should be short, simple, and easy to understand. Procedure  Second tier of quality system.  Method used to implement and perform the policy.  Procedures are detailed than policies.  Procedure is needed if its absence affect activity,

13 ISO DOCUMENTATION Work instructions  Detailed drawings, written work instruction, recipe, routine work sheets, job function, photographs, videos etc,.  Not every task requires instructions. Records and proofs  Records are a way of documenting that the policies, procedures, instructionshave been followed. Records may be forms that may be filled out.stamp of approval, signature and date.  Records are used to provide traceability of action.

14 QUESTIONS.. ?

15 THANKS THANKS