SHINE uses risk-based thinking to ensure that externally-provided processes, products, and services do not adversely affect our ability to meet requirements for custom cable assemblies, wire harnesses, and electromechanical assemblies. To identify and mitigate supply chain risk, we use a quality management system (QMS) that establishes external controls in accordance with ISO 9001:2015. For SHINE’s customers, our commitment to quality makes partnering with us a sound business decision.
ISO 9001:2015 and Risk-Based Thinking
Chapter 8.4 in ISO 9001:2015 defines requirements for the control of externally-provided processes, products, and standards. This publication from the International Standards Organization (ISO) also establishes requirements for production and service provisions, the release of products and services, control of non-conforming outputs, and performance evaluation. At a time when rapid technological changes and events can disrupt supply chains, risk assessment is critical.
External Controls and Providers
SHINE ensues that external providers such as component suppliers share our commitment to the consistent delivery of conforming products and services. To that end, externally-provided processes remain within the control of our QMS. We also apply our QMS requirements to the resulting output.
In working with external providers, SHINE communicates requirements for approvals, qualifications, control and monitoring, and verification or validation activities. Approvals include not just the products and services themselves, but the methods, processes, and equipment that are used. Documentation, identification, and traceability also support conformity to requirements.
Non-Conforming Outputs and Performance Evaluation
As part our commitment to quality, SHINE ensures that any outputs that do not conform to requirements are identified and controlled to prevent their unintended use or delivery. When nonconforming outputs are corrected, we verify conformity. As part of this effort, we retain documented information that describes the non-conformity and the corrective actions taken.
Finally, SHINE is committed to meeting quality requirements for performance evaluation. Accordingly, we monitor customer perceptions about the degree to which needs and expectations were fulfilled. That’s why when you partner with SHINE, we’ll request your feedback about delivered products and services. In turn, customer satisfaction helps drive the performance and effectiveness of our QMS.
Learn More. Contact SHINE.
Would you like to learn more about SHINE’s commitment to quality and our custom cable assembly, wire harnessing, and electromechanical assembly services? To get started, contact us.
SHINE is currently transitioning from ISO: 9001-2008 to ISO: 9001:2015. You can view our current ISO certification here.