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Unit 14: Maturity Model and Quality Standards
There are 20 crucial elements in ISO 9000 standard. It explains the measures that a company has to
follow in order to show that it is carrying out all its procedures as per the ISO 9000 rules. Each of these
elements should be clearly and completely documented.
1. Management Responsibility: The management of the organization should set the quality policy
and implement the same by providing resources, personnel and training.
2. Quality Systems: The Quality system comprises of a Quality manual which describes the Quality
processes and has supporting procedures that are created and maintained.
3. Contract Review: The needs and expectations of the customer are explicitly stated in a Contract
review.
4. Design Control: There are various design elements like Engineering drawings, the changes of
which have to be carefully documented to ensure that the changes have been fully coordinated
and approved internally.
5. Documentation and Data Control: The creation and modification of documents that support the
Quality system is controlled strictly by the ISO procedures.
6. Purchasing: Procedures for purchasing describe the requirements of raw material suppliers and
also establish the processes for ensuring compliance to the standards are developed.
7. Control of Customer Supplied Product: Procedures that detail out methods of handling the raw
material supplied by customer and its safekeeping are developed.
8. Product Identification and Traceability: Products at all stages (start to finish) have to be tracked
and methods for tracking the dates are maintained to enable traceability.
9. Process Control: Process control is established through work instructions, quality plans and
workmanship standards that verify whether each job is being done correctly.
10. Inspection and Testing: There are three stages of Inspection, namely receiving, in-process and
final inspection areas that are inspected and tested for quality. The records of inspection are
preserved as a part of quality system.
11. Inspection, Measuring and Test Equipment: The instruments that are used should be calibrated
regularly and records should be maintained.
12. Inspection and Test Status: Inspected materials may be used or processed further. An Inspected
product should be easily identified.
13. Control of Non Conforming Product: Materials or products that fail the specifications are rejected
and should be separated from the approved production. A process should be in place to handle
the rejects – whether they should be reworked or returned to the supplier.
14. Corrective and Preventive Action: Corrective action focus on identifying the root cause of the
problem and Preventive actions define the measures to ensure that defects do not happen in
future.
15. Handling, Storage, Packaging, Preservation and Delivery: The finished product should have
procedures that outline practices that protect products from damage during manufacturing and
shipping.
16. Quality Records: Quality records are required to provide an audit trail that will be used for
internal and external auditors.
17. Internal Quality Audits: It is essential that quality processes are regularly (once in a quarter, half-
yearly) audited internally to ensure that all elements of ISO are followed. The records of internal
quality should be shared with the external auditor.
18. Training: Training records are maintained that show the levels of expertise of every employee.
19. Servicing: Servicing refers to the support of the product after delivering to customer. If servicing
is specified in the contract, procedures should be established that verify that servicing meets the
indicated requirements.
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