There are two main aspects to quality management within a successful engineering development environment.
Firstly our engineering team follows the processes and guidelines set out within the business Quality Management System (QMS). The QMS contains the processes and procedures by which repeatable quality is ensured across all aspects of engineering development. For ISO9001:2015 engineering management is responsible for ensuring that processes are continuously reviewed and updated, training and awareness of the QMS is measured within the organisation, customer satisfaction is measured and supply chain issues are considered. At Hot Solder we continue to evolve our pragmatic and practical QMS which ensures that our customers receive a value service.
The second aspect of quality management involves ensuring that the regulatory requirements for the product development are captured within the product requirements for the project. At Hot Solder we have experience in medical device development (to ISO13485), development of aerospace products and meeting the needs for ATEX environments such as is needed in offshore and hazardous industrial applications. Common to many products designed for highly regulated markets is the need to create a Design Failure Modes and Effects Analysis (DFMEA) where end use risks are considered in conjunction with failure modes. This process needs to begin early in design and should run concurrently throughout the entire design phase.
Some knowledge of regulatory needs are retained in-house but we also use third party consultants to help our customers navigate through the regulatory requirements for each of the industry sectors.
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