8.0 Documentation Requirements
General
SKE has documented procedures as required to implement an ISO 9001:2015 and ISO/IEC 17025: 2017 quality management system. We maintain the documented procedures necessary to ensure the effective operation and control of our processes. SKE ensures that all employees have access to QMS documentation and are aware of relevant procedures. Customer representatives also have access to QMS documentation upon request. Quality Manual SKE will operate a QMS that is based upon policies and procedures that are documented and controlled. Two diagrams describing the interaction between SKEs QMS processes are included in this manual (see Appendix A). The interrelationships of our processes are also described in other process maps, operating procedures, and work instructions. The SKE management team is responsible for establishing an effective QMS. It is the responsibility of all SKE employees to familiarize themselves with QMS requirements and to ensure that they are observed while performing their jobs and during audits. Control of Documents and Information Documentation and records used to control the quality of SKEs products and services, from the quote process and the receipt of customer orders through fulfillment of those orders to the customer’s destination, are controlled. The operating procedures forming the QMS are also controlled. SKE uses four primary mechanisms to control information:
SAP Sales Cloud software This software provides the sales team with the quoting platform for products and services.
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• Number Cruncher/Quick Books software This software primarily controls inventory management, quoting (for service only), and financial records. • Solid Works Product Data Management (PDM) software This software primarily controls engineering specifications, drawings, models, internal standards, work instructions, manuals, and technical bulletins.
QT9 Quality Management Software This software controls all ISO-related documents, procedures, work instructions, calibration records, and training records. Zendesk software Customer service software that enables the SKE Technical Services team to track, monitor, and respond to customer support requests.
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SKEs Quality Program Manager is responsible for maintaining the documentation control system. A list of controlled documents is maintained in the QT9 quality management software. It is the responsibility of all company personnel originating, acquiring, or amending any process or material within the scope of controlled documentation to ensure that such activities are recorded in accordance with the appropriate procedures.
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