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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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