** ISO 9001 Cerification Schemes ** * Summary of ISO 9001 system requirements. * 4.1 Management Responsibility * Establish written quality policy. * Establish quality objectives. * Define quality responsibilities and authority. * Identify and provide adequate resoures. * Appoint management representative. * Conduct review of system. 4.2 Quality System * Document quality manual and procedures. * Define and document quality planning. * Ensure effective implementation of quality system. 4.3 Contract Review * 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. 4.4 Design Control * 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. 4.5 Document and Data Control * 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. 4.6 Purchaing * Establish system of assessing and controlling subcontractors. * Specify clearly requirements of products to be purchased in purchasing documents. * Review and approve all purchasing documents. 4.7 Control of Customer-Supplied Product * Inspect on receipt of the product or material. * Provide adequate storage. * Report to customer on loss, damage or unsuitability for use. 4.8 Product Identification and Traceability * Establish system of product identification from receipt and during all stages. * Establish system for product traceability and ensure recording on product and batches. 4.9 Process Control * 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. 4.10 Inspection and Testing * Conduct incoming, in-process and outgoing inspections. * Ensure identification of materials if released for urgent production. * Maintain inspection and testing records. 4.11 Control of Inspection, Measuring and Test Equipment * 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. 4.12 Inspection and Test Status * Identify inspection status. * Maintain status to ensure that only products which pass required inspection are dispatched, used or installed. 4.13 Control of Non-conforming Product * Mark or segregate non-conforming products. * Review for disposition of non-conforming products. * Re-inspect reworked items before release. 4.14 Corrective and Preventive Action * 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. 4.15 Handling, Storage, packaging, Preservation and Delivery * 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. 4.16 Control of Quality Records * 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. 4.17 Internal Quality Audits * 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. 4.18 Training * Identify training needs and execute training programmes. * Maintain records of training. 4.19 Servicing * Provide after-sales servicing if required contractually. * Provide necessary support for servicing. * verify and report that servicing is done correctly. 4.20 Statistical Techniques * Identify needs for approprite statistical techniques to verify process capability and product characteristics. * Implement and control application of statistical techniques.