QUALITY MANAGEMENT
Quality begins and ends with engineering
Manage quality documentation and processes
Since the introduction of ISO9000 and quality standards, there has been a need for a more controlled way of managing documentation. No longer could the version management be entered into the file name, since quality standards only allowed for released data to be in a PDF format. Many companies implemented a document management or records management system as part of the business, but found that this easily became an island of information as ERP and PLM became bigger parts of the infrastructure.
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QMS as an integral part of the PLM environment
- A system supporting a closed loop of product quality information management.
- A system that can support finding information directly from your business processes map.
- A system that has tools for reliability, lifecycle and quality analysis.
- A system able to manage a claims process.
- A system that can support finding information directly from your business processes map.
- Support for Medical Device specific challenges like CAPA.
Enable a proactive approach to product quality, improve visibility between quality and engineering
teams, and close the loop on quality issues to both reduce the cost of quality and improve organizational efficiencies

Typical benefits of PLM integrated QMS are:
- Documents and claims are often linked to products. PLM owns all product information.
- Only one system to maintain
- Change of the document and lifecycle rules in one place, which will implement those rules companywide.
Technology PLM
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