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ISO 9001:2000 IN A NUTSHELL (first revision)

ISO
Sl. ISO 9001 Clause
9001 Stipulation in simple words
No. Title
Clause

1. 4.1 QMS (Quality Define your working system as a series of


Management processes and identify the criteria to measure
System) the effectiveness of each process. (E.g Timely
delivery etc)

2. 4.1 QMS (Quality Proper controls like supervision, inspection,


Management training, documentation etc. should be
System) exercised on outsourced (Subcontracted)
processes to ensure acceptable results.

3. 4.2 Documentation Say what you do – in your documents. (E.g.


Requirements methodology, Procedures, Drawings,
Specifications)

4. 4.2 Documentation Document your working system as quality


requirements manual, procedures and work instructions.

5. 4.2.3 Document Control Only approved current documents should be


made available for work. (Eg. Drawings,
Specification, Procedures etc.)This includes
external standards also.

6. 4.2.4 Control of records Prove that you are following the system by
maintaining appropriate records.

7. 5.2 Customer Focus Set targets to enhance customer satisfaction.


(E.g. better products, better delivery)
Ensure that everyone focuses on satisfying
customer needs (both internal and external).

8. 5.3 Quality Policy Express your overall intention and direction


towards Quality Improvement and customer
satisfaction.

9. 5.4.1 Quality Objectives Set measurable objectives & targets for


improvement. (E.g. reduce complaints, reduce
inventory) It should cover relevant functions

10. 5.4.1 Quality Objectives Targets for improvement should be time


bound. (That is “before 31.03.200--)

11. 5.4.2 QMS planning Prepare your system so as to meet the


requirements of 4.1 and also your quality
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ISO
Sl. ISO 9001 Clause
9001 Stipulation in simple words
No. Title
Clause

objectives.
In case you make changes in your system also
ensure the above. Do not change your actual
practise in ad hoc basis.

12. 5.5.1 Responsibility & Communicate limits of responsibility and


Authority authority what is expected from each post in
your organisation.

13. 5.5.2 Management Appoint an internal co-ordinator for


Representative implementing & following up ISO 9001 QMS

14. 5.5.3 Internal Activate top down and bottom up


communication communication. Discuss about effectiveness of
the organisation.

15. 5.6 Management How is your organisation performing as per


Review your declared system? – Check. Make decisions
for improvement

16. 6 Resource Identify and provide necessary resources.


Management (Manpower equipment & other facilities)

17. 6.2.2 Competence Identify the education skill training and


awareness & experience needed for each job. Put the right
training person on the right job. Ensure that everyone is
aware of improvement targets.

18. 6.2.2 Competence


Identify training needs based on skill gap, carry
awareness &
out training, verify effectiveness of training
training

19. 6.3 Infrastructure Give necessary building, work space, utilities


transport and communication facilities and
maintain them properly

20. 6.4 Work Sanitation, dust free conditions, lighting,


Environment ventilation, humidity control, safety etc as
needed for the work to be done properly

21. 7.1 Planning of Define your SPECIFICATION,


product realisation MANUFACTURING METHODS, And
TESTING METHODS.

22. 7.2.2 Customer Query your customer at your threshold. Do not

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ISO
Sl. ISO 9001 Clause
9001 Stipulation in simple words
No. Title
Clause

requirement
accept impossible orders.
review

23. 7.3 Design control Plan, review, verify and validate your product
design.

24. 7.4 Purchasing Select suitable suppliers and subcontractors.


Carry out rating of subcontractors /suppliers.
Ensure that they are informed about the
controls they are expected to follow while
executing your requirements.

25. 7.5.1 Control of Do what you say – follow your documents


production while doing your work

26. 7.5.2 Validation of Carry out special processes (whose results are
processes difficult to verify immediately) under
controlled conditions.

27. 7.5.3 Identification & A place for everything and everything in its
Traceability place. Allot batch number for traceability

28. 7.5.3 Identification & Templates, Jigs & fixtures should bear proper
Traceability identification. Use tags labels and boards to
show inspection status of the material

29. 7.5.4 Customer Take care of customer’s belongings. (E.g. tools,


property packing material, labels etc.) servicing items
also

30. 7.5.5 Preservation of Ensure Proper handling and storage practices


product otherwise defects will arise.

31. 7.6 Control of Are your instruments telling the truth? (Proper
monitoring & Instrument Selection & Calibration). Calibrate
measuring devices your instruments against gauges that are
traceable to national and international
standards.

32. 8.2.1 Customer What does the customer think / feel about us?
satisfaction Does the customer feel satisfied?
Listen to your customer’s voice. What are the
changes in customer needs?

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ISO
Sl. ISO 9001 Clause
9001 Stipulation in simple words
No. Title
Clause

33. 8.2.2 Internal audit Are procedures / defined processes followed


and objectives achieved? Report lapses in audit
report.

34. 8.2.3 Monitoring & Monitor and control your processes to achieve
Measurement of desired results.
process In case results are not ok, take action for
improvement

35. 8.2.4 Monitoring & Is the material / product acceptable? (As per
Measurement of our own specifications or as agreed with the
product customer) Check against the quality plan and
record it. Do not allow non-conforming
product to the next stage.

36. 8.2.4 Monitoring & Product / service delivery should be carried


Measurement of out only after ensuring that all specifications
product are met.

37. 8.2.4 Monitoring &


Only authorised persons should inspect and
Measurement of
certify product’s / service acceptance.
product

38. 8.3 Control of non Segregate & REGRADE, SCRAP, ACCEPT


conforming CONCESSIONALLY OR REWORK defects.
product Market returns are also to be treated in the
same way

39. 8.4 Analysis of data How well (or how badly) are we doing?
Measure your performance (timely delivery,
productivity, customer complaints etc), as an
aid for improvement Is the level of defects
increasing? Monitor supplier and subcontractor
performance trends.

40. 8.5 Improvement Improve your performance through systematic


analysis and action. Make improvement time-
bound

41. 8.5.2 Corrective action Find out why you have failed and ensure that it
is not repeated. Take action on the root cause of
nonconformities, which have occurred.

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ISO
Sl. ISO 9001 Clause
9001 Stipulation in simple words
No. Title
Clause

42. 8.5.3 Preventive action Find out how you may fail and ensure that
failure is avoided. Take action on the root cause
of probable nonconformities

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