PmU:2 @ @"Data.app)@ .12 7 @F;@O&YA* Establish procedures for review of customers' requirements.* Conduct review to determine whether customers' requirement can be met.* Ensure amendment to contracts are identified and transferred to relevant functions.* Keep records of contract review.XA* Establish document control over issue, distribution and changes to controlled documents and data.* Remove obsolete and/or invalid documents.* Maintain masterlist or equivalent to identify current status.* Identify status of all controlled documents.* Identify obsolete documents retained for legal and/or knowledge preservation purposes.A* Establish design plans, activities, responsibilities and functional interfaces.* Assign design work to qualified people.* Ensure clear and unequivocal design inputs.* Ensure design inputs address statutory and regulatory considerations (if any).* Ensure design review.* Verify design outputs and conduct design validation.* Control Design changes.* Maintain records on design work and activities.A* Establish documented work instruction.* Provide suitable equipment and environment.* Provide trained personnel for the tasks assigned.* Ensure compliance with specifications and quality plans.* Identify and control product and process variables affecting quality.* Qualify equipment and processes before release.* Provide acceptance criteria for workmanship.* Control and monitor variables affecting special processes.* Maintain records of control.* Carry out equipment maintenance.=@iTable1ColA31ColB31ColA32 dColB32 [@Table1 TextdTitle dd@ O'! 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"Arial$#A* Establish and maintain a calibration programme.* Maintain a masterlist of measuring equipment.* Ensure that equipment including test software are duly calibrated and traceable to national standards.* Establish calibration methods for all measuring and test equipment including jigs and fixtures and test software.* Identify all measuring equipment and their calibration status.DA* Provide suitable material handling methods.* Ensure appropriate methods for preservation and storage of products.* Control over issue and receipt at store.* Assess stocks periodically.* Provide suitable and adequate packaging for products.* Provide protection to products up to destination if contractually required.A* Establish methods for identifying and maintaining all quality records, including computer databases, microfilm, etc.* Ensure Legibility and easy retrieval of records.*Provide suitable environment for storing quality records.* Specify retention periods.dA* Establish audit plan and procedure to carry out audits on the quality system to check for compliance and effectiveness.* Ensure auditor independency.* Maintain records of audit results.* Ensure that deficiencies found are rectified and follow-up actions are conducted to ascertain their effectiveness.* Review results of audit at management reviews.BBRLֵ9 4.16 Control of Quality Records d4.17 Internal Quality Audits [* Identify training needs and execute training programmes.* Maintain records of training. 4.18 Training * Provide after-sales servicing if required contractually.* Provide necessary support for servicing.* verify and report that servicing is done correctly.4.19 Servicing * Identify needs for approprite statistical techniques to verify process capability and product characteristics.* Implement and control application of statistical techniques.4.20 Statistical Techniques @*Hq:8NMa:)! -* Summary of ISO 9001 system requirements. *#** ISO 9001 Cerification Schemes ** * Establish written quality policy.* Establish quality objectives.* Define quality responsibilities and authority.* Identify and provide adequate resoures.* Appoint management representative.* Conduct review of system.4.1 Management Responsibility * Document quality manual and procedures.* Define and document quality planning.* Ensure effective implementation of quality system.4.2 Quality System 4.3 Contract Review 4.4 Design Control X4.5 Document and Data Control * Establish system of assessing and controlling subcontractors.* Specify clearly requirements of products to be purchased in purchasing documents.* Review and approve all purchasing documents. 4.6 Purchaing * Inspect on receipt of the product or material.* Provide adequate storage.* Report to customer on loss, damage or unsuitability for use.(4.7 Control of Customer-Supplied Product * Establish system of product identification from receipt and during all stages.* Establish system for product traceability and ensure recording on product and batches.+4.8 Product Identification and Traceability 4.9 Process Control * Conduct incoming, in-process and outgoing inspections.* Ensure identification of materials if released for urgent production.* Maintain inspection and testing records.4.10 Inspection and Testing 84.11 Control of Inspection, Measuring and Test Equipment * Identify inspection status.* Maintain status to ensure that only products which pass required inspection are dispatched, used or installed.4.12 Inspection and Test Status * Mark or segregate non-conforming products.* Review for disposition of non-conforming products.* Re-inspect reworked items before release.&4.13 Control of Non-conforming Product * Investigate and analyse causes of non-conformance.* Initiate corrective and preventive actions.* Ensure actions taken are effective.* Record changes in procedure.* Ensure preventive actions are reviewed by management.%4.14 Corrective and Preventive Action D<4.15 Handling, Storage, packaging, Preservation and Deliveryknvg  ME~# s @Fknvg  M~# s @Dknvg  M ~# s @Aknvg  M~~# s