Supplier issues and review
• • •
Calibration metrics
Results of internal audits
• Any other quality-related issues that impact the organization 6.0 Scope of the SKE Quality Management System
The purpose of this manual is to describe the Quality Management System (QMS) implemented by SKE. The manual serves as the primary reference document for controlling quality-related activities. Additional QMS documented procedures have been developed to support the QMS and its processes. All necessary QMS documentation is available in the QT9 software. The scope of the QMS covers the manufacture and service of vision and optical metrology products that serve the machine tool, optical, electronic, automotive, medical device, aerospace, metrology, and motion control industries. Based on an analysis of the above issues of concern, interests of stakeholders, and in consideration of its products and services, SKE has determined the scope of the certification is as follows: The scope of ISO 9001:2015 certification covers the design, development, manufacture and service of custom and standard optical and video-based metrology systems, coordinate positioning platforms, and precision motion devices that service a variety of industries including machine tools, aerospace, and medical device manufacturing. SKE uses the quality manual for planning, implementing, coordinating, and assessing our quality management system. This manual is made available to our customers when requested. This quality manual must not be reproduced in whole or part without the prior consent of the Quality Program Manager or General Manager. It is designed to be used by both internal and external audit teams during the assessment of our QMS. The quality system applies to all processes, activities, and staff within the company. The company claims no exclusions from the ISO 9001. 7.0 QMS Processes SKE has adopted a process approach for its management system. By identifying the processes within the company, and then managing each of these discretely, this reduces the potential for nonconforming products or services discovered during final processes or after delivery. Instead, nonconformities and risks are identified in real time, by actions taken within each of the processes. The following high-level functions have been identified for SKE:
Management and operations Business development and sales
• • • • • • •
Purchasing and receiving Design and development
Production
Field service/technical support
Calibration
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