SHINE uses risk-based thinking to strengthen design assistance and development of custom cable assemblies, wire harnesses, and electro-mechanical assemblies. Through risk-based thinking, our ISO-certified company identifies risks that could cause processes to deviate from planned results. For our customers, this risk-based thinking means that we’re committed to reducing uncertainties that could affect quality.

ISO 9001:2015 and Risk-Based Thinking

Risk-based thinking is part of ISO 9001:2015, an international standard that defines the requirements for a quality management system (QMS). At SHINE, part of the value we provide is in helping you to reduce design complexity.  Our engineering support also includes component selection guidance, IPC620 workmanship, tooling review, and RoHS compliance.

Planning and Inputs

Support for design assistance and development at SHINE means considering the nature, duration, and complexity of different activities. From design assistance and development reviews to verification and validation, you’ll remain closely involved with this process. You’ll also receive documentation about how electronic contract manufacturing from SHINE meets your specific design and development requirements.

Inputs include more than just functional and performance requirements, however. That’s why SHINE considers information from previous, similar design and development activities. Sometimes, there are also industry standards and codes of practice to incorporate. These inputs need to address the potential consequences of failure and resolve any design conflicts or ambiguities.

Controls, Outputs, and Changes

Design assistance and development controls must ensure that the results you want to achieve are well-defined. Reviews, verification, and validation have distinct purposes, but can be conducted separately or in any combination. Outputs need to meet all of the input requirements and include reference monitoring or measuring along with acceptance criteria.

Ultimately, your designs for custom cable assemblies, wire harnesses, and electro-mechanical assemblies can change. That why ISO 9001:2015 also requires organizations to retain documented information about these changes, including a record of authorizations and the results of revisions. In accordance with risk-based thinking, it’s also important to document the actions taken to prevent adverse impacts.

Reduce Risk and Improve Quality

Would you like to learn more about how SHINE’s commitment to risk-based thinking and how ISO 9001:2015 can strengthen your design and development efforts? To get started, contact us

SHINE is currently transitioning from ISO: 9001-2008 to ISO: 9001:2015. Design is excluded in the SHINE ISO scope. You can view our current ISO certification here.